lab medical international vol.28.8-9

Vol. 28 No.5 • 8-9/2011ISSN 1068-1760

Tuberculosis Test to Serve Developing World

AAmolecular diagnostic test fortuberculosis (TB) has proven to

be both effective and rapid in coun-tries in the developing world thatare endemic for the disease.

The assay is a real time poly-merase chain reaction (rt-PCR)amplification test that simultaneously

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Prenatal Test IdentifiesTrisomy 21 and Trisomy 18

AAprenatal test accurately identi-fied multiple fetal chromosomal

abnormalities from maternal blood. In a study carried out in 13 US

clinics a classification algorithm wasdeveloped using the prenatal testthat correctly classified all trisomy21 and trisomy 18 test samples.

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AAnew test for prostate cancerthat measures levels of

prostate specific antigen (PSA) aswell as six specific antibodiesfound in the blood of men withthe disease is more sensitive andmore specific than the conven-tional PSA test used today, accord-ing to a new study.

Researchers at the Universityof California Los Angeles (UCLA;USA; www.ucla.edu) developedthe new test, called the A+PSAassay, which checks simultane-ously for PSA and antibodies tosix prostate-cancer associatedantigens in a single reaction testdone in a laboratory.

New Prostate Cancer DiagnosticImproves Over Conventional PSA Test

DAILY CLINICAL LAB NEWS

V I S I T

Gene Expression Test Targets Breast Cancer Recurrence


Image: Scanning electron micrograph (SEM) of a breast cancer cellSee article on page 8

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Acompact and cost-effectivepoint of care (POC) immu-

noassay analyzer offers rapidturnaround times for the determi-nation of critical biomarkers,such as D-dimers, and provides

Biochemical Test forAlzheimer’s Diagnosis

AAn innovative biochemical testhas been designed that can

identify a brain hormone in theblood of patients with Alzheimer’sdisease (AD).

A clinical study has shown thata noninvasive blood test, based ona biochemical process, may besuccessfully used to diagnose

Molecular Test for SexuallyTransmitted Parasite

AAmolecular based assay thatdetects the protozoan para-

site, Trichomonas vaginalis, hasreceived official approval for usein clinical laboratories.

The assay is an in vitro qualita-tive nucleic acid amplification test(NAAT) that utilizes target cap-ture, chemiluminescent probe

Salivary ImmunoassayDiagnoses Dengue Fever

AAn antigen capture techniquehas been used to test the sali-

va of febrile patients for the pres-ence of dengue virus (DENV) anti-bodies. This assay, which detectsthe specific immunoglobulin A(IgA) of DENV in salivary samples,has been evaluated in the earlyphases of a dengue infection.

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POC Immunoassay Analyzer Detects Venous Thromboembolism

Amultigene expressionassay of tumor tissue

is set to help doctorsdecide the prognosis andtreatment of breast cancer.The new test could spareunnecessary chemothera-py for women whose breastcancer spread to as muchas three lymph nodes.

cont’d from cover

hybridization that detect ribosomal ribonucleicacid (rRNA) from T. vaginalis.

The assay is designed to test the following spec-imens from symptomatic or asymptomatic individ-uals: clinician-collected endocervical swabs andvaginal swabs, female urine specimens, and speci-mens collected in specific transport solution. Theassay utilizes Target Capture, Transcription-Mediated Amplification (TMA), and HybridizationProtection Assay (HPA) technologies

When the APTIMA Trichomonas vaginalisAssay (Gen-Probe Incorporated, San Diego, CA,USA; www.gen-probe.com) is performed, the tar-get rRNA is isolated from the specimen by use ofcapture oligomers via target capture that utilizesmagnetic microparticles. The capture oligomerscontain sequences complementary to specific

regions of the T. vaginalis rRNA target moleculesas well as a string of deoxyadenosine residues.During the hybridization step, the sequence-spe-cific regions of the capture oligomers bind to spe-cific regions of the T. vaginalis rRNA target mole-cule. The capture oligomer target complex isthen captured out of solution by decreasing thetemperature of the reaction to room temperature.The assay is used on the fully automated TIGRISsystem, which is also manufactured by Gen-Probe.

Carl W. Hull, MBA, Gen-Probe’s president andCEO, said, “Our assay will provide a convenienttool for physicians and laboratories because itemploys the same technology as our market-leadingtests for Chlamydia and gonorrhea, can be usedwith the same female samples, and runs on ourunique, fully automated TIGRIS system.” The APTI-MA Trichomonas assay has been cleared for mar-keting by the US Food and Drug Administration,(FDA, Silver Springs, MD, USA; www.fda.gov).

T. vaginalis is a sexually transmitted parasite thatcauses vaginitis, urethritis and cervicitis in women.If left untreated, complications can include prema-ture labor, low-birth-weight offspring, and prema-ture membrane rupture in pregnancy. The USCenters for Disease Control and Prevention (CDC;Atlanta, GA, USA; www.cdc.gov) estimate that 7.4million American men and women are infectedwith this parasite annually.

Molecular Test for Sexually Transmitted Parasite

Image: Scanning electron micrograph (SEM) ofTrichomonas vaginalis, the human parasitic flagellatethat causes the sexually transmitted disease trichomo-niasis (Photo courtesy of David M. Phillips / SPL).

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August-September/2011

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POC Immunoassay Analyzer Detects Venous

Thromboembolismcont’d from cover

a valuable diagnostic tool for ruling out venousthromboembolism (VTE). The easy-to-use AQT90FLEX can simultaneously measure cardiac markers,coagulation markers, infection markers, and pregnan-cy markers from a single sample. No sample prepara-tion is required, and, as a closed tube system, the riskof users coming into contact with blood or wasteproducts is eliminated.

A product of Radiometer (Crawley, UnitedKingdom; www.radiometer.co.uk), the compact, cost-effective AQT90 FLEX enables clinicians to performrapid, accurate, POC D-dimer measurements in lessthan 20 minutes. AQT90 FLEX delivers completedata capture with continuous synchronization of ana-lyzers and laboratory information systems/hospitalinformation systems (LIS/HIS).

The Radiance software solution provides completeremote control that emulates the data control andflow of a central laboratory, with the potential toencompass multiple hospitals within a region.

Reports have estimated that 25,000 people dieannually as a result of VTE, and that more than 10,000lives could be saved if all patients were screened onadmission to hospital. Patients with negative D-dimertest results are at very low risk of VTE. Rapid point-of-care testing with the AQT90 FLEX saves time andreduces costs by improving patient flow and decreasingthe number of unnecessary procedures requested.

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4LabMedica InternationalAugust-September/2011

LabMedicaLabMedica

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Scientists at the Environmental Health Institute,Singapore National Environment Agency (Singapore,Singapore; www.nea.gov.sg) have developed an anti-gen capture anti-DENV IgA (ACA) enzyme-linkedimmunosorbent assay (ELISA) technique for the diag-nosis of dengue fever. They collected 69 saliva sam-ples from dengue-confirmed patients at three timepoints, using Oracol saliva collection swabs (MalvernMedical Development Ltd., Barbourne UK; www.malvernmedical.uk.com). Blood samples were col-lected at the same time.

The ACA-ELISA on saliva had an overall sensitivi-ty of 70% in the first three days after fever onset andsubsequently rose to over 90% between the third dayand eighth day following fever onset. The same tech-nique on sera gave similar results. The sensitivity ofACA-ELISA in saliva was higher than that of thePanBio immunoglobulin M (IgM) Capture ELISA(Alere Inc., Waltham, MA, USA; www.alere.com),on sera. The IgM assay detected only 10% of thedengue-confirmed patients after one to three days offever, and only rose to around 90% after six days offever. The specificity of the ACA-ELISA test was alsofound to be high at 97%. Among the 75 DENV-nega-tive control patients, only one patient tested positive,at day seven and day 27, respectively.

The investigators noted that the saliva assay elimi-nates the need to collect blood from dengue-suspect-ed patients and is painless, nonintrusive, and reducesthe risk of needle stick injury. Moreover, the ELISA-based technique is simple and cost effective. Patients,

especially the very young and the old, will be morewilling to undergo a dengue test. Together, these ben-efits can potentially improve surveillance and earlydetection of cases, which in turn can translate toprompt dengue control effort. Due to its high sensitiv-ity among secondary dengue infections, this tech-nique could be very useful in highly endemic areaswhere the majority of the dengue cases are secondary.Dengue fever is the most common identifiable causeof acute febrile illness among travelers returning fromSouth America, South Central Asia, Southeast Asia,and the Caribbean. The study was published onlineon May 10, 2011, in the Public Library of Science(PLoS) journal Neglected Tropical Diseases.

Image: Colored transmission electron micrograph(TEM) of dengue fever virus particles (blue) in a cell(Photo courtesy of Science Photo Library).

Salivary Immunoassay Diagnoses Dengue Fever

cont’d from cover

Verinata Health, Inc. (St Carlos, CA, USA; www.verinata.com), a privately-held company dedicated tomaternal and fetal health, developed the prenatal test,which uses massively parallel DNA sequencing of cell

free fetal DNA from maternal blood.For the study, blood samples were collected from

1,014 pregnant women at 13 US clinic locations priorto an invasive prenatal procedure (chorionic villus sam-pling (CVS), or amniocentesis). Samples were selectedfor use as training or test samples. From the 119 sam-ples selected for the study, cell-free DNA (cfDNA) wasextracted from the maternal plasma and the cfDNA wassequenced using massively parallel sequencing. Sixty-five of the samples were used as a training set to definea classification algorithm that was able to identify cor-rectly 100% of trisomy 21 and trisomy 18 samples in anindependent test set.

The algorithm also detected trisomy 9 in one testsample as well as the presence of trisomy 21 in two setsof twin pregnancies having at least one affected fetus.All 47 test samples were correctly classified for theautosomes and sex chromosomes.

Lawrence W. Platt, MD, professor of obstetrics andgynecology at the David Geffen School of Medicine atthe University of California Los Angeles (UCLA; USA;http://healthsciences.ucla.edu) and director of the cen-ter for fetal medicine and Women’s Ultrasound in LosAngeles, remarked, “As the standard of practice is nowto offer prenatal diagnosis to all of our patients, inde-pendent of age, the need for noninvasive diagnostic test-ing for chromosomal abnormalities without risk of mis-carriage continues to be one of the highest priorities indiagnostic testing.” Results of the study appeared onlinein the April 2011 issue of Clinical Chemistry.

Prenatal Test Identifies Trisomy 21 and Trisomy 18

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Tuberculosis Test to Serve Developing World

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detects rifampicin resistance and is used in conjunc-tion with an automated platform, which integratessample processing and greatly simplifies testing.

A multicenter study is being conducted underthe auspices of the Foundation for Innovative NewDiagnostics (FIND; Geneva, Switzerland; www.finddiagnostics.org).

South African participants at the University ofCape Town (Cape Town, South Africa; www.uct.ac.za), and others from Peru, India, Azerbaijan,the Philippines, and Uganda, enrolled 6,648 eligibleadults. The study groups were all aged 18 years orolder, with at least two weeks of cough who pre-sented consecutively to urban or periurban primary-care health centers from August 11, 2009, untilJune 26, 2010. The primary impact outcomesassessed were the time between the first presenta-tion to clinic of a patient with symptoms and thestart of appropriate treatment for TB and, secondly,the proportion of patients in each site with undiag-nosed TB, two months after the first TB test.

The rt-PCR assay is an automated cartridge baseddiagnostic system, known as the Xpert MTB/RIF, andwas developed for the GeneXpert platform (Cepheid,Sunnyvale, CA, USA; www.cepheid.com). The testcorrectly detected tuberculosis in more than 90% ofpatients with positive cultures, with a 99% specificityfor nontuberculosis samples. Performance was muchthe same during validation and implementation phas-es. A onetime MTB/RIF test identified significantlymore cases of tuberculosis than did 2-3 smearmicroscopy examinations per patient, which detected699 of 1,041 culture-positive patients and 3,700 of3,718 patients without tuberculosis. The sensitivityof the MTB/RIF assay was not significantly affectedby human immunodeficiency virus (HIV) coinfectionstatus, which significantly decreased the sensitivity ofsmear microscopy.

The authors concluded that overall, their findingssuggest that decentralized MTB/RIF test implemen-tation is feasible and could lead to an improvement intuberculosis care and control. Any improvement willrequire increased detection of tuberculosis and mul-tidrug-resistant-tuberculosis to coincide with scale-upof first-line, and more importantly, second-line treat-ment. Whether early and appropriate treatment afterMTB/RIF testing can reduce tuberculosis-associatedmorbidity and mortality, and its effect on transmis-sion, still needs to be established. The study was pub-lished on April 30, 2011, the Lancet.

Image: Colored scanning electron micrograph (SEM)of a macrophage white blood cell (purple) engulfing atuberculosis (Mycobacterium tuberculosis) bacterium(pink) (Photo courtesy of Science Photo Library).



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The six specific prostate-cancer associated anti-gens include NY-ESO-1, SSX-2,4, XAGE-lb, AMACR,p90, and LEDGF, which are found predominantly inpatients with prostate cancer and not in benignprostate conditions. The new test takes about twohours, similar to the PSA test. The test results in anindex used to diagnose prostate cancer, with a score

of 0-0.5 indicating a benign result and 0.5-1 indicat-ing the presence of cancer. In the new test, sensitivi-ty – the percentage of men with prostate cancer whowere correctly identified as having a malignancy –was 79%, compared to the 52% found in PSA test-ing. Specificity – the percentage of healthy men whowere correctly identified as not having prostate can-cer – was 84%, compared to the 79% found when

testing for PSA alone. Additionally, while the rate offalse-positives using conventional PSA testing is 21%,the new A+PSA assay delivers a false-positive rate of16%. The study was published in the May 2011issue of Translational Medicine.

“Science has improved so much since the PSAtest was developed and I think it’s time for a morespecific and sensitive test to be developed,” saidsenior author Gang Zeng, MD, PhD, an associateprofessor of urology. “I think we have a test that hasgreat potential to improve the diagnosis of prostatecancer. I knew it would be better than the classicPSA test, but I was amazed at how much better itreally was in this study.”

“While measuring PSA is useful in identifyingmen with prostate cancer, some men with prostatecancer have a normal PSA level and small eleva-tions in PSA above normal may be produced bothby prostate cancer as well as an enlarged but benignprostate,” added coauthor associate professor ofurology Allan Pantuck, MD, MS. “Combining PSAwith a panel of tests that measure an individualman’s anticancer immune response may betteridentify who has prostate cancer and who can bespared an unnecessary invasive biopsy.”

The conventional PSA test for prostate cancer hasbeen used for nearly 30 years and is not specificenough in delineating between malignancies and non-malignant diseases of the prostate, such as benign pro-static hyperplasia (BPH), an enlarging of the prostatecommon in aging men that increases PSA levels.

New Prostate Cancer Diagnostic Improves Over Conventional PSA Test


cont’d from cover

Alzheimer’s at an early stage and differentiate it fromother types of dementia. Scientists at McGillUniversity Health Center (MUHC; Montreal, QC,Canada; www.muhc.ca) based the Alzheimer’s bloodtest on the production of a brain hormone calleddehydroepiandrosterone (DHEA). This hormone ispresent at high levels in the brain where it has a widerange of biological effects. A total of 86 subjects wereincluded in this study: 19 male and 20 female ADpatients; 18 male and 22 female age-matched con-trols; and 4 men and 3 women with mild cognitiveimpairment. The scientists were able to promote the

production of DHEA, using a chemical process calledoxidation, in blood taken from non-Alzheimer’spatients. However, serum oxidation, by way of fer-rous iron (Fe2+), on the blood from Alzheimer’spatients did not result in an increase of DHEA.

Currently the diagnosis of Alzheimer’s follows thesequence of family history, information, mentalassessment and the physical exam, focusing on neu-rological signs. Vassilios Papadopoulos, D.Pharm.,PhD, a lead author of the study, said, “There is a clearcorrelation between the lack of ability to produceDHEA through oxidation in the blood and the degreeof cognitive impairment found in Alzheimer’s disease.

We demonstrated we could accurately and repetitive-ly detect Alzheimer’s disease, with small samples ofblood. This test also allowed for differential diagnosisof early stages of Alzheimer’s disease, suggesting thiscan be used as a test to diagnose the disease in itsinfancy.” Professor Papadopoulos believes that anaccurate, easy, and specific noninvasive biochemicaltest that correlates with clinical findings is vital. Theresults of the study demonstrate that the DHEA-oxi-dation blood test can be used to diagnose AD at a veryearly stage and monitor the effect of therapies and theevolution of the disease. The study was published inApril 2011, in the Journal of Alzheimer’s Disease.

Biochemical Test for Alzheimer’s Diagnosis

AAmultigene expression assay of tumor tissuewill help doctors decide the prognosis and

treatment of breast cancer.The test measures the expression or activity

level of 21 specific genes within a tumor sampleand based on that pattern assigns a recurrencescore of anywhere from 0 to 100. Earlier trialshave shown that the higher the recurrence score,the more likely the patient’s cancer will recur.

Scientists, specializing in cancer, havelaunched a clinical trial that could keep thousandsof breast cancer patients from getting chemother-apy that is unlikely to do them any good. The trialwill reveal whether chemotherapy benefitspatients with node positive breast cancer whohave low to intermediate Oncotype DX recur-rence scores. The trial also seeks to determinewhether there is an optimal recurrence score cut-

point for these patients, above which chemother-apy should be recommended.

The scientists plan to enroll 4,000 womenwith recurrence scores of 25 or less who haveearly stage, hormone receptor-positive, HER2-neg-ative breast cancer that has been found to involveone to three lymph nodes. They expect to screenabout 9,000 breast cancer patients in order to reg-ister these 4,000, who will be randomized toreceive either chemotherapy with endocrine ther-apy or endocrine therapy alone.

The Oncotype DX assay is a product ofGenomic Health Inc. (Redwood City, CA, USA;www.genomichealth.com), and is only one of sev-eral gene expression profile tests oncologists nowuse to help them judge how likely it is a patient’scancer will return or to inform treatment deci-sions. The investigators plan to evaluate other

tests as well, including the PAM50 test, whichmeasures the expression level of a set of 50 genesto determine a patient’s “risk of recurrence”score. The PAM50 (ARUP Laboratories, Salt LakeCity, UT, USA; www.aruplab.com) uses a reversetranscription/quantitative polymerase chain reac-tion on formalin fixed paraffin embedded tissue.

Ana M. Gonzalez-Angulo, MD, the study coor-dinator from the MD Anderson Cancer Center(Houston, TX, USA; www.mdanderson.org), said,“If the treatment (Rx) for Positive Node, EndocrineResponsive Breast Cancer (RxPONDER) trial con-firms findings from earlier studies, it will mean thatwe know more precisely how to use a genomic-based test to spare thousands of women whosebreast cancer has spread to as many as three lymphnodes, the grueling side effects and staggering costsof chemotherapy they do not need.”


8LabMedica InternationalAugust-September/2011106LMI-09-11LINKXPRESS COM




TThe DNA from a bacterium that is the mostcommon cause of persistent and fatal lung

infections in cystic fibrosis patients has beensequenced.

Molecular technology has been utilized to char-acterize the organism, called Pseudomonas aerugi-nosa, and identify a particularly virulent strainfound in chronic infections.

Scientists at the University of Liverpool,(Liverpool, UK; www.liv.ac.uk), took samples frompatient’s sputum and cough swabs to understandwhy the infection is so aggressive in people withcystic fibrosis. They used new DNA sequencingtechnology to read the genetic code of the infec-tion. The technology used can read 30 billion let-ters of DNA sequence per day, compared to four bil-lion using current machines. The technologyallowed the scientists to investigate the mutations

of the infection in precise detail, giving them valu-able information about the progress of this seriousmedical condition.

The scientists identified a strain, called theLiverpool Epidemic Strain (LES), that can causeaggressive infection and results in progressive lungdecline. This strain is referred to as a cystic fibrosis“superbug.” They demonstrated that the greatestcontribution to the extremely high levels of diversi-ty is within individual patient sputum samplesrather than between patients, and they showed cor-relation between greater prevalence of a virulence-related phenotype and acute pulmonary symptoms.They found that during chronic infections P. aerug-inosa has the ability to mutate rapidly, resulting inextensive diversity in the bacterial population. Testsalso showed that when the bacteria have an over-production of pyocyanin, a quorum-sensing-con-

trolled virulence factor, this could be the trigger forepisodes of acute infection in patients.

Craig Winstanley, PhD, a member of theBiomedical Research Center at Liverpool University,explained that patients with LES need to be separat-ed from others in hospitals, so that infection does notspread between cystic fibrosis patients on wards.Once established, these chronic infections can neverbe cleared. P. aeruginosa has the ability to diversifyinto hundreds of distinct subtypes, making it very dif-ficult to decide which antibiotic to use for a success-ful outcome. Each cystic fibrosis patient can beinfected with a diverse population of bacteria and itis therefore essential to test samples of the diseasefrom a number of patients in order to understandhow it evolves. The article was published onFebruary 4, 2011, in the American Journal ofRespiratory and Critical Care Medicine.

Bacterial DNA Sequenced from Cystic Fibrosis Patients

AAbacteriophage amplification platform enablesearly identification of Staphylococcus aureus

and determination of antibiotic resistance or sus-ceptibility.

The blood culture test enables clinicians tooptimize therapy by identifying S. aureus directlyfrom Gram-positive blood cultures and determineantibiotic susceptibility on the same day.

The KeyPath MRSA/MSSA Blood Culture Testcan determine methicillin resistance (MRSA) orsusceptibility (MSSA) of the bacteria far fasterthan standard antibiotic susceptibility testing. Thetest, which takes a little over five hours to get aresult, is 98.9% accurate (178/180) for MRSAidentification and 99.4% accurate (153/154) indetermining MSSA within the organisms identi-fied as S. aureus.

As many as half of all patients with S. aureusinfections are initially prescribed inappropriate orsuboptimal antibiotics before traditional test meth-

ods return information about thebacteria’s antibiotic susceptibility.The KeyPath test provides crucialdiagnostic information that enablesdoctors to prescribe the most appro-priate antibiotics for a patient’s infec-tion up to two days sooner than ispossible with current test methods.

The KeyPath MRSA/MSSABlood Culture Test is a product ofMicroPhage, Inc. (Longmont, CO,USA; www.microphage.com). The test, devel-oped using MicroPhage’s proprietary Bacterio-phage Amplification Technology (BAT) platform,meets the Clinical and Laboratory StandardsInstitute (CLSI; Wayne, PA, USA; www.clsi.org)and US Food and Drug Administration (FDA;Silver Springs, MD, USA; www.fda.gov) criteria.

Drew Smith, PhD, chief science officer atMicroPhage, said, “The MicroPhage BAT platform

provides a phenotypic result that directly assessesthe organism’s response to an antibiotic. The plat-form can be extended to a broad range of bacteri-al pathogens and sample types thus enablingdevelopment of a long pipeline of clinically usefulsusceptibility tests and test panels.”

Image: The KeyPath MRSA/MSSA blood culture test(Photo courtesy of MicroPhage).

Blood Culture Test OptimizesAntimicrobial Therapy




AA system enables safe transportation of bloodculture vials. The Bactec SafePod was

designed for the safe transportation of blood cul-ture vials in pneumatic tube systems, and for safetransportation of positive blood cultures fromsatellite sites to a central laboratory.

Becton, Dickinson and Company (BD; Oxford,United Kingdom; www.bd.com) developed theSafePod, an enclosed system that was designed toaccommodate up to two BD Bactec bottles, whichwill fit all pneumatic tube transport systems, toconvey safely blood culture vials from point of col-lection to point of analysis.

The SafePod contains an absorbent insert thatseparates the Bactec blood culture vials to cushionthem during high-speed transportation, and iscapable of absorbing 100 mL of liquid–more thansufficient for the contents of two bottles. SafePodis manufactured from clear plastic for easy inspec-tion prior to opening, and is sterilizeable for reuse.

The BD Bactec SafePod is fullycompliant with all UN 3373transportation requirements fordiagnostic blood specimens, bothinside and outside the hospital.BD Bactec blood culture bottlesare fully compliant as the primaryreceptacles, and the BD BactecSafePod is fully compliant as thesecondary receptacles. The BDBactec bottles and the BD BactecSafePod count as the first two lay-ers, enabling further packaging into either a pneu-matic tube for transportation within the hospital,or a rigid box for transportation within sites.

Chris Head-Jenner, Marketing Manager, UKand Ireland, BD, who led the product design,says, “Historically, there has been a reluctance totransport biological compounds in glass bottlesthrough hospital pneumatic tube systems, for

fear of breakage. The BD Bactec SafePodaddresses these customer concerns by providinga system that safely transports biological com-pounds, meets HPA requirements, whilst alsosaving space and time.”

Image: The Bactec SafePod for transportation ofblood culture vials (Photo courtesy of BD).

Blood Culture Vials Can Be Transported Safely

AAn assay has been developed that measures cir-culating cell-free DNA in the serum of patients

with cancer using a fluorochrome, and withoutextraction and amplification.

The assay is simply performed by adding dilutedfluorochrome to the samples and measuring the flu-orescence obtained. The assay is accurate, sensi-tive, and reproducible.

The assay was developed at the SorokaUniversity Medical Center, (Be’er Sheva, Israel;www.soroka.org) and compared with a commercialkit for carcinoembryonic antigen (CEA). The inno-vative fluorescent assay was first evaluated on amouse model and then tested on colorectal cancer(CRC) patients’ serum. There were 38 unselectedpatients with confirmed primary CRC recruitedamong whom 55% were women and 45% weremen. The age range was 43-86 years, and the mean

age was 68 years. The primary colon carcinomasites were as follows: right colon, sigmoid colon,left colon, rectum, and simultaneous carcinoma inthe right and left colon. Serum from healthy volun-teers was also tested. The concentration of CEAwas determined by using the ARCHITECT CEAassay (Abbott Laboratories, Abbott Park, IL, USA;www.abbott.com).

The cell-free DNA (CFD) assay used dilutedSYBR Gold Nucleic Acid Gel Stain (Invitrogen;Carlsbad, CA, USA; www.invitrogen.com), whichwas added to the serum samples and the resultingfluorescence measured with a 96-well fluorometer.Concentrations of unknown samples were calculat-ed from a DNA standards curve by extrapolation ina linear regression model. The 38 patients withCRC had higher preoperative CFD levels of 798 ±409 ng/mL, when compared with healthy subjects

with CFD levels of 308 ± 256 ng/mL. CFD levelswere elevated in patients who remained with thedisease or died as compared with patients free ofdisease at one year.

Colorectal cancer (CRC) is the third most com-mon type of cancer worldwide, with an estimatedone million new cases and a half million deathseach year. Early diagnosis is fundamental in reduc-ing morbidity and mortality, with patients diag-nosed at early stages demonstrating increasedlong-term survival. The authors concluded that byusing a simple fluorometric assay, they were ableto find elevated CFD levels in cancer patients,confirming the findings of previous studies thatwere performed with a complex and time-con-suming method. The study was published inFebruary 2011, in the American Journal ofClinical Pathology.

Fluorescent Assay Determines Free DNA in Cancer Patient’s Serum

TThree different tests have been compared forthe detection of human papillomavirus

(HPV) on cervical specimens and correlated withthe presence of cancer.

The tests are molecular diagnostic kits thateither identify messenger ribonucleic acid(mRNA), or use hybrid capture DNA technology.A real-time multiplex nucleic acid sequence-based amplification assay (NASBA) for isothermalamplification and detection of mRNA was alsocompared.

Scientists from the Memorial University (St.John’s, NL, Canada; www.mun.ca) collaboratingwith others, tested cervical specimens from arandom sample of 1,418 women referred for col-poscopy and assessment of cervical cancer riskand 1,373 women undergoing routine screen-ing. The three tests were the Aptima HPV assaywhich detects E6/E7 mRNA of 14 oncogenictypes, a Hybrid Capture 2 DNA test (HC2), andan HPV Proofer assay which amplifies anddetects E6/E7 mRNA from five high-risk onco-genic types. The oncogenes E6 and E7 are asso-ciated with HPV and these proteins are involvedin initiation and mediation of oncogenic processthat leads to cervical cancer, and to other HPV-associated cancers.

The investigators report that among 1,418women studied, the Aptima HPV test (Gen-Probe Inc.; San Diego, CA, USA; www.gen-probe.com) detected 96.3% of women withhigh-grade cervical intraepithelial neoplasia(CIN) or worse (CIN 2+) compared to 94.3% forthe HC2, (Qiagen; Mississauga, ON, Canada;www.qiagen.com). The Aptima test has far fewerfalse positives than HC2. Across histologicalgrades, the Aptima assay showed significantlyhigher sensitivity and significantly lower speci-ficity than the PreTect HPV-Proofer NASBA assay(Norchip; Klokkarstua, Norway; www.norchip.com), however, the Proofer test detected all eight

cases of invasive cervical cancer, and this includ-ed the case which tested negative by HC2.

The authors concluded that their data indicat-ed that the Aptima test is as sensitive as HC2, butmore specific for detecting CIN 2+ and has thepotential to serve as a reliable test for both pri-mary cervical cancer screening and the triage ofborderline cytological abnormalities. SamuelRatnam, PhD, the senior author of the study,said, “Reducing false-positive result avoidsunnecessary additional tests and follow-up, theassociated health care costs, and distress towomen. HPV infection is highly prevalent, butonly a small fraction of the infected is at risk ofdeveloping HPV-associated cancers.” The studywas published in February 2011, in the Journalof Clinical Microbiology.

Image: Colored transmission electron micrograph(TEM) of hundreds of particles (red) of the humanpapillomavirus (HPV) infecting a host cell (Photocourtesy of Steve Gschmeissner / Science PhotoLibrary).

Molecular Test Increases Specificity for Human Papillomavirus



LabMedicaLabMedica

AAnew qualitative polymerase chain reaction(PCR)-based Human immunodeficiency virus

1 (HIV-1) test produces highly accurate results fromdried blood spot and plasma specimens. The diag-nostic tool can be used by health officials in Africannations and other resource-limited areas to detectHIV-1 infected infants at early stages and begintreatment when success is more likely.

Abbott (Abbot Park, IL, USA; www.abbott.com)has received the CE marking for the new assay,which reports qualitative results of HIV-1 totalnucleic acids from human plasma and dried bloodspots. The assay is highly sensitive for detectingHIV in pediatric and adult specimens. The test isdesigned to aid in diagnosing HIV infection in chil-dren and adults and is not intended for screeningblood donors.

The assay is performed on Abbott’s automated,high-throughput m2000 system. It detects both

DNA and RNA of HIV-1. Dried blood spot samplesare more convenient for testing infants becauseonly a small volume of sample is needed and thesample remains stable under various environmentalconditions.

Kristina Rodnikova, divisional vice presidentand general manager of Abbott's molecular diag-nostics business in Europe said, "Early detection ofinfants with HIV is now more practical and possiblein remote areas because a drop of blood can beapplied to a paper card for HIV testing, whichallows for easy collection, transport, and storage.The sample can be stored at room temperature andwill remain stable for three months."

The new RealTime HIV-1 qualitative assay willbe available for diagnostic laboratories and suppliedto nongovernmental organizations (NGOs) andhealth agencies collaborating with the Ministries ofHealth in countries most affected by the epidemic.

HIV-1 Qualitative Assay Improves Testing Access in Remote Areas

TThe range of minimum inhibitory concentra-tion evaluator (MICE) strips has been

expanded to include the antibiotic tigecycline.MICE strips provide a gradient of stabilized

antimicrobial in a convenient polymer strip for-mat. When applied to an inoculated agar plate,the antimicrobial is released from the strip, form-ing a defined concentration gradient in the sur-rounding agar. Following appropriate incubation,the MIC value is easily read at the point whereorganism growth is no longer inhibited along thelength of the strip.

Each strip is individually foil-wrapped with desiccant to maintain itsintegrity until use. For convenience,and to meet the needs of every labora-tory, MICE strips are available in stack-able boxes of 10 or 50.

The newly added tigecycline strips togetherwith other recently added antimicrobials, includ-ing ceftazidime and amikacin, ensure that thecomprehensive MICE range for the accuratedetermination of minimum inhibitory concentra-tion (MIC) values meets the current needs ofclinical microbiologists for antimicrobial suscep-tibility testing.

The new MICE strips were released by Oxoid(Basingstoke, UK; www.oxoid.com), a specialtymicrobiology company of Thermo Fisher ScientificInc. (Fremont, CA, USA; www.thermofisher.com).

Image: The range of M I C Evaluator ( M I C E) Stripshas been expanded to include the antibiotic tigecy-cline (Photo courtesy of Oxoid).

MICE Strips Expanded to Include the Antibiotic Tigecycline

LabMedicaLabMedicafor daily laboratory medicine news click to www.labmedica.comfor daily laboratory medicine news click to www.labmedica.com

15 LabMedica InternationalAugust-September/2011


miRNA TargetIdentification Technology

Being Developed

NNew technology is being developed andcommercialized for the identification

and validation of microRNA (miRNA) tar-gets in clinical diagnostics and research.

miRNAs are critical regulators of geneexpression in eukaryotic cells, with over1,000 different miRNAs in the humangenome already known to play multipleroles in gene regulation. Although the spe-cific targets of most miRNAs are largelyunknown, aberrant expression of miRNAshas been implicated in numerous diseasestates, making them important targets forclinical investigation in oncology, woundhealing, and infectious disease.

Sigma Life Science (St. Louis, MO, USA;www.sigma-aldrich.com), the biologicalproducts and services research business ofSigma-Aldrich and King’s College London(United Kingdom; www.kcl.ac.uk) an-nounced an exclusive license agreement toidentify miRNA targets.

Currently, identification of miRNA tar-gets is laborious and inefficient, relying oncomputer algorithms and subsequent vali-dation by in vitro assays. Scientists in thedivision of cancer studies at King’s havedeveloped a technology allowing simple,accurate identification and validation ofmiRNA targets. Dr. Joop Gaken, lead inves-tigator of this project, explained: “The roleof miRNAs in cancer is well established,and several miRNAs clearly function aseither oncogenes or tumor suppressorgenes, although the target genes areunknown in the majority of cases. This newtest is expected to enable the straightfor-ward identification of target genes that arestrongly regulated by a given miRNA, help-ing to elucidate important gene regulationevents in vivo.”




AAmagnetic biosensor test detects the fungalpathogen Candida directly in whole blood

from patients with the fungal infection.The new technology enables detection of mul-

tiple pathogens and species in a single-process testwith rapid diagnostic results within minutes toless than two hours.

Developed by T2 Biosystems (Lexington, MA,USA; www.t2biosystems.com), magnetic biosen-sor technology combines nanotechnology withthe power of magnetic resonance detection. A“dirty sample” of a patient’s blood, saliva, urine,or other biofluid is loaded directly into a desktopinstrument via a disposable cartridge. The sampleis then mixed with magnetic nanoparticles andanalyzed for the presence of specific fungal, bacte-rial, or viral pathogens, or biomarkers using atechnique similar to magnetic resonance imaging

(MRI). The system is able to detect low concentra-tions of target agents or specific pathogens.

In comparison, today’s conventional diagnostictechnologies use optical signals, require pre-processed biologic samples, and can take days toyield useful results.

Candidemia, a systemic fungal infection thatoccurs when Candida organisms are present inthe blood, is a potentially life-threatening blood-stream infection. Each year, an estimated 60,000patients contract Candidemia in the United Statesalone and this incidence continues to rise. It is themost deadly of the common hospital-acquiredbloodstream infections, and currently results insignificant increased hospital stays, healthcarecosts, and patient mortality.

T2 Biosystems, Inc., a company developingnext generation diagnostic products, presented

data on the rapid and sensitive detection of fiveCandida species (C. albicans, C. krusei, C. glabra-ta, C. tropicalis, and C. parapsilosis) at theAnnual Meeting of the Mycoses Study Group inPhiladelphia (PA, USA) on April 7, 2011.

Image: Colored scanning electron micrograph (SEM)of budding threads (hyphae) of a Candida fungus(Photo courtesy of Steve Gschmeissner / SPL).

Candida Rapidly Detected by Magnetic Biosensor Test

AAn oncology testing service utilizes a newmicroarray technology to aid in the faster, ear-

lier, and more accurate diagnoses of hematologicalmalignancies.

The OncoChip offering is among the very firstmicroarrays that can detect balanced transloca-tions, their partners, and their breakpoints associat-ed with the hematological malignancies.

PerkinElmer, Inc. (Waltham, MA, USA; www.perkinelmer.com) Signature Genomics Laboratoriesintroduced the new service, which quickly identi-fies chromosome abnormalities to aid in cancerpatient diagnosis and prognosis. The results of theOncoChip microarray technology may allow formore targeted, rapid, and accurate treatments ofpatients with hematological cancers, such as chron-ic lymphocytic leukemia, chronic myelogenous

leukemia, acute myeloid leukemia, T-cell and B-cellacute lymphoblastic leukemia.

Clinicians can select from a broad menu of can-cer-specific panels that will be run by Perkin-Elmer’s Signature Genomics Laboratories, usingsoftware applications that have been designed toallow for customization suiting the needs of eachindividual patient.

Two distinct OncoChip microarray options areoffered by PerkinElmer – Copy Number Evalua-tion (CNE) and Translocation Assessment (TA).CNE detects all clinically relevant copy-numbergains and losses commonly seen by karyotype. Italso measures gains and losses below the resolu-tion of karyotyping and fluorescent in situhybridization (FISH), providing more detailedinformation. The TA microarray option detects

the clinically relevant balanced translocationsidentified by FISH and karyotype and preciselyrecognizes balanced translocation breakpoints, aswell as balanced translocation partners not distin-guishable by these methods.

“Findings using OncoChip have the potentialto help clarify or alter a patient’s diagnosis andprognosis as well as reclassify the disease. Resultsare provided faster, accurately, and with moreclinical relevance than current standard methods,which furthers our goal to enable a more person-alized approach to treatments,” said Lisa G.Shaffer, PhD, president, PerkinElmer’s SignatureGenomics Laboratories. “The OncoChip alsoallows for the detection of even more chromo-some abnormalities than has been possible previ-ously.”

Oncology Testing Service Utilizes New Microarray Technology

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AAreal-time polymerase chain reaction (PCR) assayof Pneumocystis jiroveci was validated in a mul-

ticenter trial. MycAssay Pneumocystis is a commer-cial assay that targets the MycAssay Pneumo-cystis that targets the P. jirovecii mitochondrial largesubunit.

Myconostica (Manchester, United Kingdom;www.myconostica.co.uk), a company specializing inrapid molecular diagnostic tests for life-threateningfungal infections, announced the results of theprospective trial of its CE marked kit, MycAssayPneumocystis. The trial results compared well withclinical diagnosis using nonmolecular methods anddemonstrated the high sensitivity and specificity ofthe PCR diagnostic assay.

The multicenter trial recruited 110 subjects froma variety of underlying diseases and conditionsincluding solid organ transplants, leukemia, solidtumors, and HIV. Respiratory bronchoalveolar sam-

ples were analyzed and 13/14 patients with clinical-ly proven Pneumocystis pneumonia (PCP) wereidentified and 9/96 patients without PCP at the timeof the test also gave positive results. Subsequentlyone of these patients developed PCP while the oth-ers were considered to be colonized with P. jirovecii.

PCP is a very dangerous infection in both AIDSand non-AIDS patients with mortality rates in excessof 20%. Currently, establishing the diagnosis of PCP isperformed by microscopy of lung tissue, bronchiallavage, or other deep respiratory samples. PCP prima-rily affects the alveoli; consequently, deep pulmonarysamples are necessary for adequate microscopy.However, microscopic diagnosis, including theMerifluor-Pneumocystis direct fluorescent antigen(MP-DFA) test, has limitations. For example, a muchlower number of organisms are usually present innon-AIDS patients with PCP, which makes the micro-scopic tests more difficult to perform and lees reliable.

Commenting on these results, Dr. JohnThornback, Chief Business Officer of Myconosticacommented, “This is, to our knowledge, the firstmulticenter prospective trial of a commercial PCRtest for Pneumocystis. Pneumocystis PCR is clearly avery sensitive means of detecting this fungalpathogen in at risk patients. The introduction of newtechnologies such as Pneumocystis PCR often resultsin reappraisal of disease, and this may be the casehere. The early identification of infected patients mayopen opportunities for early interventions. Myco-nostica is committed to working with the clinicalcommunity to better understand the role that PCRcan play in the diagnosis of life threatening fungalinfections, such as Pneumocystis, as early as possiblein at risk patient populations.”

The results of the trial were published, ahead ofprint, in the March 2, 2011, Journal of ClinicalMicrobiology.

Pneumocystis Jiroveci Assay Evaluated in Multicenter Trial

AAmultiplexed nucleic acid (NA)test simultaneously detects 15

respiratory viruses in one hour.The FilmArray detects viral

nucleic acids in nasopharyngealswabs obtained from individualssuspected of respiratory tractinfections. The system representsa significant advancement in userfriendliness and multiplex infec-tious disease testing capability forhospital clinical labs. It requiresonly two minutes of hands-ontime and has a one-hour turn-around time.

The following virus types andsubtypes can be tested for using theFilmArray: Adenovirus, Corona-

virus HKU1, Coronavirus NL63,Human Metapneumovirus, In-fluenza A, Influenza A subtype H1,Influenza A subtype H3, InfluenzaA subtype H1 2009, Influenza B,Parainfluenza virus 1, Parainfluenzavirus 2, Parainfluenza virus 3,Parainfluenza virus 4, Rhinovirus/Enterovirus, and Respiratory Syn-cytial Virus.

Idaho Technology, Inc. (ITI; SaltLake City, UT, USA; www.idahotech.com) announced that the USFood and Drug Administration(Silver Spring, MD, USA; www.fda.gov) has issued a 510(k) clear-ance for its FilmArray instrumentand the FilmArray Respiratory Panel.

Idaho Technology, Inc. is a pri-vately held biotechnology companythat licensed rapid PCR technologyfrom the University of Utah. Thecompany has additional FilmArrayinfectious disease applications in its

R&D pipeline, including a blood cul-ture ID panel, gastrointestinal panel,and an STI panel.

Image: The FilmArray fully automat-ed biodetection system (Photo cour-tesy of Idaho Technology).

Multiplexed NA Test Simultaneously Detects 15 Respiratory Viruses

MICROARRAY TESTAstra Biotech

The latest microarray test isdesigned for rapid simultaneousdetection of 25 of the most commonmutations causing cystic fibrosis.The test ensures reliable detectionwith enhanced specificity and sensi-tivity, and applications include new-borns through adults.

ELECTROLYTE ANALYZERCaretium Medical Instruments

The XI-921 features the option to runeither Cl or Li on the F model (Na, K,Cl/Li). Other key features includeenhanced accuracy and improvedsoftware version 7.01, along with a12-month life span for the elec-trodes.

TUMOR MARKER CONTROLFujirebio Diagnostics

The latest tumor marker control isintended for use as a quantitative,assayed serum control. The multi-constituent control also contains theovarian biomarker HE4, which alongwith CA 125 is used to determinerisk for cancer and monitor reoccur-rence.

CLINICALCHEMISTRY ANALYZER

Gen-ProbeThe Panther features maximum pro-ductivity with minimal hands-on timerequired. Additional benefits includeenhanced flexibility, a range of CE-marked assays, ease of use, andreliability of performance.

TThe number of lymphocytes in the blood is a possible prognosticindicator for renal cell carcinoma (RCC). The lymphocytes are

one of the types of white blood cells that are routinely enumeratedin clinical laboratories and the low counts may be indicative of a sup-pressed immune system.

Medical oncologists at the Fox Chase Cancer Center, (Phi-ladelphia, PA, USA; www.fccc.edu), evaluated data from morethan 500 patients with the most common form of RCC, calledclear cell RCC, who had their kidneys surgically removed at FoxChase between 1994 and 2009. They found a clear relationshipbetween low lymphocyte counts within three months prior to sur-gery and a poor prognosis.

The scientists found that lower lymphocyte levels were associ-ated with a higher tumor grade, ahigher pathologic tumor stage, thepresence of distant metastases, and ahigher classification of malignanttumors (TNM) stage, which is a com-bined indicator of tumor stage, spreadto regional lymph nodes, and distantmetastasis. They also found that lowcounts were associated with a loweroverall survival rate, even when theyaccounted for patient age, tumorstage, and metastasis.

Sunil Saroha, MD medical oncolo-gy fellow at Fox Chase and leadauthor on the study, said, “There hasbeen this need for looking at prognos-tic markers that are available prior tosurgical procedures. It would be niceto know before the surgery if thetumor is going to be aggressive andhow aggressive we need to be, withthe goal of individualizing therapies.”This simple test can really help identi-fy patients at the outset who are atrisk of very aggressive disease andwho may not do well with currenttherapies.

Each year, kidney cancer is diag-nosed in nearly 60,000 people in theUS Many of these patients undergosurgery to remove the affected kidney,but this procedure can be risky for theelderly and those who have otherhealth problems. Unfortunately, theprognosis of kidney cancer patientsoften cannot be determined untiltumor samples are surgically removedand evaluated. For example, if ayoung RCC patient does not have alow lymphocyte count, and is other-wise healthy, a doctor may decide notto pursue the more aggressive thera-pies, such as surgery and chemothera-py. The study will be presented at theAnnual Meeting of the AmericanSociety of Clinical Oncology on June5, 2011, in Chicago (IL, USA).

Image: Colored scanning electron micro-graph (SEM) of red blood cells (erythro-cytes) and a white blood cell (lympho-cyte, blue) (Photo courtesy of SteveGschmeissner / SPL).

White Cell Count Predicts Kidney Disease Prognosis


19 LabMedica InternationalAugust-September/2011 117LMI-09-11LINKXPRESS COM




AAmolecular test has been developed that ascer-tains which bladder cancer patients may have

malignant involvement in their lymph nodes at thetime of surgery.

A gene expression model (GEM) has been devel-oped that predict the pathological node status in pri-mary tumor tissues. Archival formalin-fixed paraffinembedded (FFPE) tissues can be analyzed bymicroarray technology to support the model.

A multicenter collaborative study was performedat the University of Colorado Cancer Center,(Aurora, CO, USA; www.uch.edu), whereby 20genes were analyzed on specimens from three inde-pendent cohorts of patients who underwent cystec-tomy and lymphadenectomy for bladder cancer. Allpatients were clinically node negative before cystec-tomy and had complete pathological staging infor-

mation. Archival tissues could only be retrieved for200 of 327 patients reported, of which 185 pro-duced nucleic acid extracts of sufficient quality formicroarray analysis.

Tissue core were extracted from the FFPE blockand these samples were used for nucleic acid extrac-tion, verification, amplification, and hybridization toHG-U133 plus 2.0 arrays (Affymetrix; Santa Clara,CA, USA; www.affymetrix.com), with analysis byrobust multichip average (RMA). The investigatorsbroadened the study by identifying ribonucleic acid(RNA) transcripts detected with high fidelity inde-pendently of sample preservation, either fresh freez-ing or FFPE, before development of the GEM. Tothat end, they used 32 paired fresh frozen and FFPEtissues profiled by microarrays to identify probeswhich were further refined to ensure they are

expressed in transurethral resection (TUR)-acquiredtumors as well as cystectomies.

Bladder cancer is the fourth most common can-cer diagnosed in males in the USA, who are threetimes more likely to be diagnosed with the diseasethan women are. Dan Theodorescu, MD, PhD, uro-logical surgeon, and lead author of the study, said,“Randomized clinical trials have shown that givingneoadjuvant chemotherapy extends patient lives,but only 5% to 15% of patients benefit. Patients whohave cancer in the lymph nodes at time of diagnosisare likely to benefit the most. We validated the test’sability to predict lymph node spread of the cancer ina large sample of patients from a randomized trial.”A clinical trial of using the test as a treatment guideis being planned. The study was published February2011, in Lancet Oncology.

Gene Expression Model Predicts Pathological Node Status

AApossible role of the squamous cell-carcinomaantigen (SCCA) has been discovered in the

progression of breast cancer.Molecular and pathology analyses revealed

SCCA expression in breast cancer-tissue samplesincreased when patients had high grade andadvanced cancer and the presence of SCCA pre-dicted poor prognosis.

Scientists at Stony Brook University School ofMedicine, (Stony Brook, NY, USA; www.stonybrookmedicalcenter.org), analyzed theSCCA expression on 1,360 breast tumor tissuesamples and 124 samples of normal breast tissueas controls. They used various techniques includ-ing immunoblot analysis, tissue microarrays, andimmunohistochemistry. Expression of SCCA wasobserved in only 0.3% of grade 1 tumors, butincreased to 2.5% and 9.4% in grades 2 and 3tumors, respectively. For the various stages ofbreast cancer in nonmetastatic disease, the pro-gression was similar. Positivity for SCCA was doc-

umented in 2.4% of Stage I cancers, 3.1% of StageII cancers, and 8.6% of Stage III cancers.

Squamous cell carcinoma antigen belongs tothe serine protease inhibitor (Serpin) family of pro-teins and is an inhibitor of cellular proteases thatdigests other proteins. Elevated expression ofSCCA has been used in medicine as a biomarkerfor aggressive squamous-cell carcinoma in cancersof the cervix, lung, and head and neck. Its expres-sion has also been detected in cancers that are notoriginated from squamous cells such as liver can-cer. The scientists also found that SCCA-express-ing cells are specifically sensitive to drugs thatinduce misfolded proteins.

Wei-Xing Zong, PhD, associate professor and asenior author of the study, said, “While there hasbeen significant progress in treating breast cancer,aggressive disease remains difficult to treat andcure. Our findings open the door for SCCA to beexplored as a useful marker for predicting out-comes of those suffering from aggressive breast

cancers and for SCCA to become a potential ther-apeutic target to treat cancers unresponsive tocurrent therapies.” The study was publishedonline on April 19, 2011, in Public Library ofScience ONE (PLoS ONE).

Image: Colored transmission electron micrograph(TEM) of a section through carcinoma cancer cells ina female breast (Photo courtesy of SteveGschmeissner / SPL).

Potential Biomarker for Aggressive Breast Carcinoma

PIPETTORGlobe Scientific

The Diamond Advance Pipettor isfully autoclavable and features anadjustable volume. The lightweightpipettor is easy to use and offers anergonomic design for comfortablehandling, a recalibration tool, shelf-mounting stand, and a sample packof pipette tips.

USER INTERFACEHelmer

The i.C3 offers constant temperaturemonitoring and control on all i.Seriesrefrigerators and freezers. The full-color touch screen offers easy-to-use icon navigation, and allows mul-tiple information logs with historicaldata to be downloaded and saved.

ANTIBODY KITHemagen Diagnostics

The Virgo Cardiolipin IgG antibodykit is an ELISA designed for thequantitative measurement of circu-lating IgG autoantibodies to cardi-olipin. Two options offer either a 480determinations kit, or a 96 determi-nations kit with lyophylied reagents.

CHEMISTRY ANALYZEROrtho Clinical Diagnostics

The VITROS 4600 is designed toprovide high-quality, reliable testresults for mid- to high-volume labo-ratories. The state-of-the-art analyz-er completes the VITROS x600 fam-ily of systems, which includes the5600 integrated and 3600 immun-odiagnostic systems.

AAberrant DNA can be tracked on anindividual basis in the blood of patients

suffering from primary aggressive braintumors.

Following surgery to remove a tumor,the tissue can be sequenced and the bloodtaken at the same time can analyzed for thepresence of the specific glioblastoma DNA.

Scientists at University of Cincinnati,(Cincinnati, OH, USA; www.uc.edu),working with a multidisciplinary team,have begun sequencing individual glioblas-toma genomes and tracking abnormali-ties through the bloodstream. Theyhope that by mapping the various DNArearrangements of glioblastoma tumorsthey will be able to establish biomarkersthat will help them track the cancer’sprogress and guide their efforts to treatpatients more effectively. They also hopethe biomarkers will help them identifytargets for new, improved therapies forthe future.

The sequencing of glioblastoma mul-tiforme (GBM) tumors will be done onthe GenomeAnalyzer (Illumina Inc.; SanDiego, CA, USA; www.illumina.com),and performed by the department ofgenetics at Albert Einstein College of Medicine (New York, NY, USA;www.einstein.yu.edu). Equally impor-tant, the discovery of biomarkers mayprovide scientists with new therapeu-tic targets. By identifying a specificgenetic abnormality or mutation, forexample, they can work to develop afuture therapy that attacks that muta-tion.

Olivier Rixe, MD, PhD, the study’sprincipal investigator, said, “There willbe some circulating DNA in the bloodcoming from the tumor, and we will fol-low those very specific abnormalities. Itis very much a personalized study,because we are not talking about thegenetic abnormalities of other patients.We are talking about the sequencing ofa biopsy of a specific individual’s tumor.And we are talking about tracking indi-vidualized, personalized abnormalities.”

Glioblastoma multiforme (GBM) is

the most common and most aggressive typeof primary brain tumor in humans, involv-ing glial cells and accounting for 52% of allparenchymal brain tumor cases and 20% ofall intracranial tumors. Despite being themost prevalent form of primary braintumor, GBMs occur in only 2-3 cases per100,000 people in Europe and NorthAmerica.

Image: The GenomeAnalyzer, designed forthe sequencing of GBM tumors (Photo cour-tesy of Illumina).

Blood Biomarker Associated with Risk of Alzheimer’s





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V I S I T




TThe development of a new genetic-based riskassessment test for colorectal cancer with clin-

ical validation is being supported by collaborationbetween two companies.

Bar Harbor BioTechnology (BHB; Trenton,Maine, USA; www.bhbio.com), Inc. and ClinicalReference Laboratory, Inc. (CRL; Lenexa,Kansas, USA; www.crlcorp.com) have an-nounced the collaboration, which involves thecontinued development of BHB’s new genetic-based test for colorectal cancer risk with clinicalvalidation support provided by CRL’s CLIA-certi-fied laboratory services.

CRL will provide laboratory-testing services in

molecular diagnostics and clinical trials of the newtest. The new arrangement will give CRL and BHBthe opportunity to combine BHB’s bioinformaticsand quantitative polymerase chain reaction (qPCR)assay development team with CRL’s extensivemolecular lab testing experience to create newmolecular diagnostic tests.

Further details of the tests remain undisclosedbut both companies indicate that the agreementenvisions future projects and the development ofadditional tests. “CRL is an ideal partner for ourcompany as we continue to develop our risk assess-ment tests. Their CLIA-certified testing servicesaccelerate our development plans by leveraging on

their expertise and state of the art laboratory; wewill get the results we need immediately,” saidRobert Phelps, CEO of BHB.

Bar Harbor BioTechnology manufactures soft-ware and consumables for purposes of geneticresearch in areas of cancer, stem cell research,immunology, metabolism, and specific neurologicaldisorders. The company created a new diagnosticdivision in 2010.

CRL is a privately held reference laboratoryoffering testing services in the areas of clinical tri-als, corporate wellness programs, genomics,insurance, molecular diagnostics, bioanalytics,and toxicology.

Genetic-Based Risk Test for Colorectal Cancer Being Developed

AAnew Clostridium difficile diagnostic testenables processing of up to 94 patient speci-

mens in about an hour.The Simplexa C. difficile universal direct test is

performed on liquid or unformed human stoolsamples, and detects toxin-producing strains of C.difficile, including NAP1/B1/027. The new CEmarked in vitro diagnostic (IVD) test enables fast,high volume lab testing, eliminating the tradition-al extraction step.

The C. difficile diagnostic is the first test fromthe Focus Diagnostics (Cypress CA, USA;www.focusdx.com) Simplexa product line for thehospital-acquired infection (HAI) market. It wasunveiled by Focus together with the CE markedSimplexa Epstein Barr (EBV) and BK Virus testsduring the European Congress of ClinicalMicrobiology and Infectious Disease (ECCMID)Tradeshow, which took place May 7-10, 2011, inMilan (Italy). The three Simplexa tests are CEmarked and available in Europe.

Simplexa tests are run on the 3M IntegratedCycler and employ real-time polymerase chainreaction (RT-PCR) to detect viruses, bacteria, andother agents qualitatively and quantitatively.

C. difficile infection (CDI) is abacterial infection that generallyaffects patients over 65 in age, onprolonged use of broad-spectrumantibiotics, and those who haverecently undergone gastrointesti-nal surgery or are immunocom-promised. In major EuropeanUnion (EU) countries, such asBelgium, Denmark, France,Germany, Italy, Netherlands,Spain and the United Kingdom,CDI is estimated to be responsiblefor 1.1 in 1,000 hospital admis-sions and is expected to doubleover the next four decades.

“Clostridium difficile is a com-mon cause of antibiotic-associated diarrhea and anextremely important and serious hospital-acquiredinfection,” said Jay M. Lieberman, MD, medicaldirector for Quest Diagnostics (Madison, NJ, USA;www.questdiagnostics.com) and Focus Diagnostics.“C. difficile infections (CDI) range in severity frommild diarrhea to life-threatening pseudomembra-nous colitis, and result in significant suffering and

deaths. Timely diagnosis is essential for clinicianswhen treating patients presenting with possible C.difficile disease.” Focus Diagnostics is a whollyowned subsidiary of Quest Diagnostics.

Image: Colored scanning electron micrograph (SEM)of dividing C. difficile bacterial cells (yellow) (Photocourtesy of Paul Gunning / SPL).

Rapid Diagnostic for C. difficileEliminates Extraction Step

DUCTLESS FUME HOODAir Science

The Purair 20 features a face veloc-ity at 100 fpm that ensures contain-ment of fumes, and an alarm to alertthe operator when the airflow falls toan unacceptable level. Additionalbenefits include a removablespillage tray, and optional integrallighting.

CARDIAC MARKER TESTSAlfa Scientific Designs

The Instant-View tests are designedto aid in the diagnosis of an acutemyocardial infarction using wholeblood or serum. The one-step testsare over 94.2% specific, can bestored at room temperature, andoffer results in 15 minutes.

CLINICAL ANALYZERAudit Diagnostics

The Liqui-Stat offers quality POCTanalysis at any medical location orremote area. Key features includeprefilled barcoded cuvettes R1 andR2, LCD touch screen, enhancedversatility, compatibility with LIS,integrated printer, and results avail-able in two to five minutes.

MICROPLATE WASHERAutobio Labtec Instruments

The iWO is designed to meet therequirements of microplate-basedimmunoassays. Product highlightsinclude 8- and 12-way manifold for96-well microplates, flexible washprocedure, priming and rinsing,choice of wash liquids, and a mag-netic particle washing option.


23 LabMedica InternationalAugust-September/2011 119LMI-09-11LINKXPRESS COM

AAcommercially available assay for detection ofBlastomyces dermatitidis antigen has been

modified to permit quantitation in subjects withnewly diagnosed blastomycosis. An sandwichenzyme immunoassay (EIA) is available that willdetect the antigen of the pathogenic mycoses B.dermatitidis in patients’ serum, urine, cerebralspinal fluid, and other sterile body fluids.

In a study carried out at the University ofArkansas for Medical Sciences (Little Rock, AR,USA; www.uams.edu), samples were assayedfrom patients with newly diagnosed blastomyco-sis. Specimens from 27 subjects were analyzedand urine specimens from 25 healthy subjects and25 subjects with conditions other than histoplas-

mosis or blastomycosis were analyzed to providenegative controls. If no antigen was detectable,the urine specimen was concentrated 10-fold andreanalyzed. Serum specimens were tested beforeand after treatment with ethylenediaminete-traacetic acid (EDTA) to dissociate immune com-plexes. Treatment of specimens with EDTA hasnot been shown to cause false-positive results inanother fungal assay.

The assay used was the Mvista Blastomycesdermatitidis Antigen EIA, (MiraVista Diagnostics,Indianapolis, IN, USA; www.miravistalabs.com).Of 27 patients, 23 (85.1%) had detectable B. der-matitidis antigen detected in their urine sampleswith a median of a 1.49 ng/mL, with a range of0.21 ng/mL - 16.90 ng/mL. In two of these 23,positive results were obtained only after concentra-tion of the urine specimen. Nine of 11 (81.8%)subjects had detectable B. dermatitidis antigen intheir serum, including three subjects with negative

results before treatment of serum with EDTA andpositive results after EDTA treatment. B. dermati-tidis antigen was not detected in specimens from50 control subjects, but was detected in 15patients with histoplasmosis. The authors conclud-ed that the B. dermatitidis antigen was detected inmost of the patients with blastomycosis and that itcan be a useful tool for timely diagnosis. The studywas published in February 2011, in the journalDiagnostic Microbiology and Infectious Disease.

Blastomycosis is an infection caused by inhal-ing microscopic spores produced by the fungus B.dermatitidis. Blastomycosis may be limited to thelungs or also involve the skin and bones. In itsmost severe form, the infection can spreadthroughout the body and become systemic. Thefungus that causes the disease is found in moistsoil and wood in the southeastern US, theMississippi River valley, southern Canada, andCentral America.

Antigen Test Evaluated for Blastomycosis

Blood Transfer DevicesAssessed for Malaria Test

AAcomparison has been made of different devicesfor transferring blood to the rapid diagnostic test

(RDT) for malaria in three developing countries. The five blood transfer devices evaluated were the

loop and inverted cup, made of hard plastic; a straw-pipette and calibrated pipette, made of soft plastic,and a glass capillary tube.

A study was conducted between August andNovember 2009 among 227 health workers inNigeria, the Philippines, and Uganda, under the aus-pices of the Foundation for Innovative NewDiagnostics, (FIND; Geneva, Switzerland; www.finddiagnostics.org). The participants were recruitedfrom the staff of frontline health centers and commu-nity-based malaria programs. The devices were evalu-ated for accuracy, safety, and ease of use. The partici-pating health workers used each device to transferblood from a simulated finger prick site to filter paper.Blood volume transferred was calculated from thearea of blood spots deposited on filter paper.

The overall mean volumes transferred by devicesdiffered significantly from the target volume of 5 µLwhich is the minimum amount recommended for themost RDTs. The new inverted cup device transferreda mean of 4.6 µL, which most closely approximatedthe target volume. The glass capillary was excludedfrom volume analysis, as the estimation method usedis not compatible with this device. The calibratedpipette accounted for the largest proportion of bloodexposures to 10% of the health worker. Blood expo-sures for the other four devices ranged from 2% to6%. According to 91% of the health workers, theinverted cup was considered easiest to use in bloodcollection, while the straw-pipette and calibratedpipette were rated the most difficult to use.

Rapid diagnostic tests are becoming the standardmethod of detection of malaria in poor resource set-tings. The blood transfer device is an essential part ofthe kit because the sensitivity of the tests is compro-mised when an inadequate volume is transferred tothe RDT cassette, especially when parasite densityfalls below 200 parasite/µL. The findings of thisstudy have relevance for any point-of-care diagnosticsthat require blood sampling. The variability in deviceperformance demonstrated the need to devote atten-tion to this issue when implementing RDT-based diag-nostic programs. The study was published online onFebruary 8, 2011, in the Malaria Journal.




AAnewly discovered association has been foundbetween three genes and the most common

form of breast cancer. The genes were found directly next to the estro-

gen receptor gene, the main driver of hormonalbreast cancer. The estrogen receptor has beenintensively studied by scientists for decades and islocated in one of the intensively studied areas ofthe genome.

Scientists at The Institute of Cancer Research,(ICR; London, UK; www.icr.ac.uk), studied 104patients with hormonal, also known as estrogenreceptor (ER) positive, breast cancer. They wantedto find the genes that were most closely linked tothe estrogen receptor. The three genes identifiedwere: chromosome 6 open reading frame 96(C6ORF96), C6ORF97, and C6ORF211. All threewere found to be linked to the estrogen receptor,but working separately from it. As a result, theiractivity is unlikely to be affected by current treat-ments, such as tamoxifen, which target the estro-

gen receptor. This could mean that they are poten-tial targets for new drug treatments.

The human gene C6ORF211 was shown to drivethe growth of tumors and the team sees this as themost likely target for new treatments. The geneC6ORF97 was shown to be an indicator of a tumornot relapsing, and also a good predictor of responseto tamoxifen. Less is known about the geneC6ORF96, but it is being investigated by the team.

Mitchell Dowsett, PhD, professor of biochemi-cal endocrinology at the ICR, said, “This investiga-tion is exciting because it shows that while theestrogen receptor is the main driver of hormonalbreast cancer, there are others next door to it thatalso appear to influence breast cancer behavior.We now need to better understand how they worktogether and how we can utilize them to save livesof women with breast cancer.” In Britain, nearly48,000 women and around 300 men are diag-nosed every year with breast cancer; the mostdiagnosed commonly cancer in the UK.

Three Supplementary Genes Linked to Breast Cancer


BENCHTOP CENTRIFUGEBeckman Coulter

The Allegra X-30 is a compact instru-ment designed to provide high-levelperformance in a wide range ofapplications. The X-30 is availableindividually, or packaged with theappropriate rotors and labware, andis intended for general research useand clinical sample preparation.

STRIP PLATESBRAND

The BRANDplates 96-well stripplates 12x8 feature ideal opticalcharacteristics, and offer high flexi-bility in allowing the user to decideon the number of cavities to be filled.The strip plates are available with orwithout grid in versions with high-binding or medium-binding capacity.

HISTOLOGYCASSETTE LABEL

ComputypeThe TS968 is a high-performance,resilient label that is resistant toharsh chemicals and extreme tem-peratures. It requires no additionallabel attachment equipment, con-serves lab space, and is intended tosave time and trouble in the lab.

PCR DETECTION KITSDaan Diagnostics

The latest real-time PCR pathogendetection kits are easy to use, andoffer sensitive primers and accuratedetection. The efficient kits are alsocompatible with most PCR instru-ments, and allow for timesaving setups and cycling conditions.

AAbarcode driven, conveyor-connected speci-men-processing system utilizes robotic plate

management to automate workflow inMicrobiology. The system, which can managemany different aspects of specimen processingand workup, is called WASPLab. It can handleplanting and streaking, Gram slide preparation,enrichment broth inoculation, robotic incubationand storage, plate image analysis, identificationand antimicrobial susceptibility testing (AST/ID)inoculum preparation, Kirby-Bauer disk applica-tion, and even Maldi-Tof target plate seeding.

Copan Diagnostics (Murrieta, CA, USA; www.copanusa.com) unveiled the system in Milan(Italy) during the 21st European Congress ofClinical Microbiology and Infectious Diseases(ECCMID) General Meeting from May 7 to May10, 2011, and plans to display the system in New

Orleans (LA, USA) during theAmerican Society for Microbiology(ASM) 111th General Meeting fromMay 21 to May 24, 2011.

“We have developed WASPLab withthe future of Microbiology in mind andan ongoing commitment to provide asolution for an automated single-pieceflow system for specimen processing,”said Norman Sharples, CopanDiagnostics’ executive VP.

Copan is a manufacturer of collec-tion and transport systems and is wellknown in the field of preanalytics. Thecompany offers a complete line of automation anda range of microbial sampling products used fortraditional culture analysis and molecular diagnos-tic assays. It supplies bacteriology swabs (flocked

swabs and eSwabs), viral transport media (VTM),and molecular systems.

Image: The WASP walkaway specimen processor(Photo courtesy of Copan Diagnostics).

Specimen Processing System Utilizes Robotic Plate Management

AArapid diagnostic test (RDT) for malaria hasbeen evaluated in a standard reference labora-

tory using stored and fresh blood samples.In nonendemic settings, where microscopic

expertise is lacking due to low incidence, malariaRDTs are of value for the diagnosis of malaria andthey provide information about the possibly fatalPlasmodium falciparum infections.

Scientists at Maastricht University, (Maastricht,The Netherlands; www.maastrichtuniversity.nl),performed both a retrospective study on 341 storedblood samples and prospective study. In theprospective study, the SD Bioline Malaria Ag05FK40, (SDFK40), RDT was used on 181 freshsamples and run side by side with two other RDTs,OptiMAL and SDFK60. The SDFK40 is a lateralflow antigen-detection test in a cassette format, tar-geting P. falciparum-specific parasite lactate dehy-drogenase (Pf-pLDH) and pan-Plasmodium LDH,(pan-pLDH). The prospective part was performedbetween March 2009 and October 2010, andincluded first samples of each patient for whichmicroscopy or one of the both routinely used RDTs(OptiMAL and SDFK60) were positive for malaria.

Overall sensitivities for P. falciparum tested ret-rospectively and prospectively were 67.9% and78.8%, reaching 100% and 94.6% at parasite den-sities greater than 1,000/µL. Sensitivity at parasitedensities less than 100/µL was 9.1%. Overall sen-sitivities for P. vivax and P. ovale were 86.7% and

80.0% (retrospectively) and 92.9% and 76.9%(prospectively), reaching 94.7% for both species(retrospective panel) at parasite densities greaterthan 500/µL. Sensitivity for P. malariae was21.4%. None of the Plasmodium negative samplesin the retrospective panel reacted positive.

The authors concluded that SDFK40 RDT(Standard Diagnostics Inc.; Suwon, Korea;www.standardia.com), performed exceptionally forP. falciparum samples at high parasite densities aswell as for detection of P. vivax and P. ovale at par-asite densities greater than 500/µL. The SDFK40was evaluated as easy to use, with an excellentclearance of the background and clearly visible testlines. Compared to OptiMAL Rapid Malaria test,(Diamed AG; Cressier, Switzerland; www.diamed.com), and Standard Diagnostics other RDT,called SD Bioline Ag Pf/Pan 05FK60 (SDFK60),SDFK40 showed lower sensitivities for P. falci-

parum, but better detection of P. ovale. The studywas published online on January 12, 2011, in theMalaria Journal.

Image: Colored scanning electron micrograph(SEM) of a freeze-fractured red blood cell (erythro-cyte, green) infected with a Plasmodium falciparumprotozoan (orange and blue) (Photo courtesy of theNIBSC).

Malaria Test Assessed in Nonendemic Setting

Circulating MicrovesicleBased Assay Is Potential

Prostate Cancer Diagnostic

AAcirculating microvesicle (“cMV”)-based test is apotentially powerful diagnostic tool for detect-

ing prostate cancer.cMVs are sub-cellular membrane-bound vesicles,

ranging from 30 nm to 1,500 nm in size, that arefound circulating in the blood and other body fluids.They are released from various cell types under bothnormal and pathologic conditions, including cancer.Each population of cMV expresses an array of pro-teins which reflects its cell-of-origin.

Carisome Technology is a versatile blood-based,highly reproducible testing technology. The technol-ogy platform identifies and characterizes cMVs, cre-ating disease-specific, cMV-based biosignatures,which can be made up of a combination of biomark-ers. The unique cMV biosignature can then be usedfor the diagnosis, prognosis, and measurement oftherapeutic response.

The assay that enables the isolation, capture, andcharacterization of cMVs specific to prostate cancerwas developed by Caris Life Sciences (Dallas, TX,USA; www.carislifesciences.com). It has potential todeliver more accurate diagnoses for men withprostate cancer than current methods.

A poster highlighting the potential of the circulat-ing microvesicle (cMV)-based prostate cancer testwas presented at the American UrologicalAssociation (AUA) 2011 Annual Meeting (www.aua2011.org), which was held in Washington DC(USA) from May 14-19, 2011.



AA n optical biosensor diagnostics devicedetects tuberculosis in urine samples in 15-

20 min. The waveguide-based system is capableof providing a qualitative tuberculosis diagnosisin a very short time using only a few drops ofhuman urine. This is a significant breakthroughcompared to sputum, blood, and skin tests thatoften take several days or weeks for results.Recently developed polymerase chain reaction(PCR)-based diagnostics, which take approxi-mately two hours to produce results, are signifi-cantly more expensive.

Biomagnetics Diagnostics Corporation (Orange-vale, CA, USA; www.biomagneticsbmgp.com) is currently developing the waveguide-basedadvanced integrated optical biosensor through itscooperative research and development agreement

with Los Alamos National Security, LLC (Santa Fe,NM, USA; www.lansllc.com). The biosensor willinitially be used for cholera, tuberculosis, andmalaria diagnosis.

The optical biosensor was introduced in avideo that can be viewed at www.youtube.com/watch?v=pIkGKlm-KZg.

Clayton Hardman, CEO of BiomagneticsDiagnostics commented, “While the current costprofile is already significantly lower than othertests, we are already working on a new wave-guide design that will likely allow us to reduce thecost per test even further. The unit shown in thisvideo is a desktop unit; however, the products forultimate delivery to the market will also include ahandheld device that can be operated by relative-ly untrained medical personnel at the point of

patient care. We see nothing on the market today,or on the immediate horizon, that can compare tothe capabilities of this technology.

Image: The KeyPath MRSA/MSSA blood culture test(Photo courtesy of MicroPhage).

Urine-Based Diagnostics Tool Detects Tuberculosis

GA Assay Better forMonitoring Diabetic

Kidney Patients

TThe glycated albumin (GA) assay appears to befar more effective than the hemoglobin A1c

(HbA1c) for managing patients with diabetes andadvanced kidney failure.

A study evaluated 444 patients with diabetesundergoing dialysis. Patients continued their normaltreatment and HbA1c monitoring, but also agreedto have a GA test every three months for an averageof more than 2.3 years.

Barry I. Freedman, MD, John H. Felts IIIProfessor at the Wake Forest Baptist Medical Center(Winston-Salem, NC, USA; www.wakehealth.edu)and colleagues compared the patients’ HbA1c andGA test results, assessing their ability to predict hos-pitalizations and survival. They found that theHbA1c failed to predict medical outcomes. In con-trast, the GA was a strong predictor of patient sur-vival and hospitalizations.

The GA test, developed by Asahi Kasei PharmaCorp. (Tokyo, Japan; www.asahi-kasei.co.jp), meas-ures blood sugars over the past 17 days, as opposedto the longer time frame for HbA1c. In situationswhere rapid changes occur in blood sugar, the GAgives a more accurate picture of diabetes control.The GA test used in this study is available in Japan,China, and South Korea, but is not yet approved bythe US Food and Drug Administration (FDA; SilverSpring, MD, USA; www.fda.gov).

The gold standard long-term glucose-monitoringtest for patients with diabetes is the HbA1c test. Itmeasures an individual’s average blood sugar levelover the prior three months. It is the most common-ly used long-term blood sugar test, and is widelytrusted in the medical community.

However, HbA1c results are only accurate whenred cells have a normal lifespan. Dialysis patientshave shorter red cell survival – reducing the timethat sugar in the bloodstream has to interact withhemoglobin, and causing lower HbA1c values.

The study appeared online in the May 19, 2011edition of Clinical Journal of the American Societyof Nephrology.




AApatient’s ST2 level helps physicians make aprognosis for cardiac patients. The ST2 level

indicates change in cardiac status and developmentof cardiovascular complications such as heart fail-ure, at critical clinical decision points, such as ini-tial presentation with chest pain, after recoveryfrom myocardial infarction, and in the cardiacintensive care unit.

The Presage ST2 assay was developed by CriticalDiagnostics (www.criticaldiagnostics.com). It iden-tifies patients at increased risk of morbidity andmortality from heart disease and helps physiciansoptimize patient care.

The protein cardiac biomarker was highlightedin three presentations at the American College ofCardiology (ACC) meeting held in New Orleansfrom April 2-5, 2011.

In a poster presentation, J. Zilinski et al. demon-strated in a study of 30 patients that measurementof ST2 can assist in care decisions in advanced stageheart failure patients. A second poster presented byS. Aldous et al. showed that levels of ST2 predictedheart failure and all cause mortality in patients pre-senting to the emergency department with chestpain. In the third poster presented by M. C. Kontoset al., the scientists showed that increased ST2 and

brain naturietic peptide (BNP) levels identified postmyocardial infarction (MI) patients who had clini-cal and echocardiograph variables associated withworse prognoses.

Referring to the posters displayed at the ACCmeeting James Snider, president of CriticalDiagnostics said, “The studies presented hereshow that ST2 can be a valuable tool for cliniciansacross the spectrum of heart failure: from predict-ing onset to predicting outcomes in late-stagepatients. These clinical data continue to build evi-dence that ST2 may help aid physicians in clinicaldecision-making.”



ST2 Levels in Blood Predict Outcomes for Cardiac Patients

AAnew sensor would enable people to draw tearfluid from their eyes to get a glucose-level test

sample. Glucose in tear fluid may give an indicationof glucose levels in the blood as accurately as a testusing a blood sample. The technology was designedby bioengineer Jeffrey T. LaBelle, a professor in theSchool of Biological and Health SystemsEngineering, one of the Arizona State University(Tempe, AZ, USA; http://asunews.asu.edu) Ira A.Fulton Schools of Engineering.

Prof. LaBelle is leading the ASU-Mayo team

along with Mayo Clinic (Scottsdale, AZ, USA;www.mayoclinic.org/arizona) physicians Curtiss B.Cook, MD, an endocrinologist, and Dharmendra(Dave) Patel, MD, chair of Mayo’s Department ofSurgical Ophthalmology.

Many people with diabetes suffer due to the diffi-culty of managing their blood glucose levels. It is rec-ommended that they monitor their own glucose lev-els, but current monitoring devices typically requirepatients to perform the painful task of pricking theirfinger to draw blood for a test sample – and many

patients must do it several times each day.The major challenges are performing the test

quickly, efficiently, with reproducible results, with-out letting the test sample evaporate and withoutstimulating a stress response that causes people torub their eyes intensely, Prof. LaBelle said.

Because of its potential impact on health care,the technology has drawn interest from BioAccel(Phoenix, AZ, USA; www.bioaccel.org), an Arizonanonprofit that works to accelerate efforts to bringbiomedical technologies to the marketplace.

Blood Glucose Measurements Can Be Made From Tears

CCurrent early-onset sepsis rates among newborns,the pathogens involved, and associated morbid-

ity and mortality were determined in the UnitedStates. The multisite national study demonstratedthat the most frequent pathogens associated withsepsis were group B streptococci (GBS) in full-terminfants and Escherichia coli in preterm infants.

Nearly 400,000 newborns were included in thestudy, which also found that infection rates increasedwith decreasing gestational age and birth weight.The overall rate of infection was 0.98 per 1,000 livebirths; 0.41 per 1,000 live births involving GBS and0.28 per 1,000 live births involving E. coli.

Bloodstream infections in newborns can lead toserious complications with substantial morbidity

and mortality. The pathogens responsible for neona-tal infections have changed over time. In recentyears, however, antibiotic prophylaxis given to at-risk mothers has reduced the incidence of early-onset group B streptococcal infections among theirbabies.

“Infections occur in almost one case per thou-sand live births,” said Barbara Stoll, MD, lead inves-tigator for the study. Prof. Stoll is the George W.Brumley, Jr., professor and chair, Department ofPediatrics in Emory University School of Medicine(Atlanta, GA, USA; www.med.emory.edu). “Withapproximately 4 million births a year in the UnitedStates, this equates to a substantial burden of dis-ease. We estimate that approximately 3,000 infants

a year develop early-onset sepsis. With current mor-tality rates, approximately 300 to 350 deaths peryear are associated with neonatal sepsis. So, it’s notinconsequential.”

The study also shows that opportunities for pre-vention of neonatal GBS infections continue to bemissed. “Missed opportunities for prevention ofGBS include failure to screen all women who deliv-er at term, failure to provide antibiotics to all colo-nized women or to those who delivered pretermwith unknown colonization status, and false nega-tive GBS screens among women who deliver withGBS infection,” added Prof. Stoll.

The study appeared online on April 25, 2011and in the May 2011 issue of Pediatrics.

Early-Onset Sepsis Rates in Newborns Determined

AAn innovative blood test has been developedas an additional test to distinguish rapidly

individuals with active tuberculosis (TB), andfrom these, those with latent TB infection.

By simply performing an extra blood test usinga protein of the bacillus, Mycobacterium tubercu-losis, named heparin-binding hemagglutininadhesin (HBHA), it was possible to distinguishbetween those infected from those who have pro-gressed to the pathological phase of the disease.

Scientists at the Catholic University of theSacred Heart (Rome, Italy; www.unicatt.it) devel-oped the test in collaboration with others at the L.Spallanzani National Institute for InfectiousDiseases (INMI; Rome, Italy; www.inmi.it). Theteam assayed the blood of 87 individuals at differ-ent stages of TB who scored positive with theQuantiFERON TB Gold In-Tube test (QFT-IT;

Cellestis GmbH; Darmstadt, Germany; www.cellestis.com). The QFT-IT blood test is an inter-feron-γ release assays (IGRA), based on the releaseof interferon-γ in response to M. tuberculosis-spe-cific antigens, and is able to identify selectivelythose who have contracted TB infection.

In the study, the scientists developed an inno-vative diagnostic algorithm, which consists of aresponse to the protein HBHA in combinationwith the IGRA and the results have shown thatthe response to HBHA is associated with latent TBinfection. This procedure allows the rapid identifi-cation those who really need the treatment foractive TB. They showed that the lymphocyte T-cell response to a recombinant and methylatedHBHA of M. tuberculosis produced in M. smeg-matis – a nonpathogenic microorganism – is use-ful to discriminate between active and nonactive

TB disease among those responsive to QFT-IT in awhole blood system. The study was publishedonline on March 29, 2011, in the Public Libraryof Science journal PLoS ONE.

Image: Colored scanning electron micrograph (SEM)of a macrophage white blood cell (red) engulfing aMycobacterium tuberculosis bacterium (green)(Photo courtesy of Science Photo Library).

Diagnostic Test Distinguishes BetweenActive and Latent Tuberculosis




EE levated levels of the prostate-specific antigen(PSA) blood test is indicative of prostate cancer,

but can also be caused by prostate inflammation orenlargement or other conditions.

The PSA test is used to screen patients at risk forprostate cancer, but even after a negative biopsy, ifthe PSA levels increase with time, a manifestationof the disease is the mostly likely consequence.

Urologists at Northwestern Memorial Hospital,(Chicago, IL, USA; www.nmh.org), looked in theirdatabase at the history of 1,358 patients whounderwent prostate biopsy after previous screeningwith three PSA tests between 2003 and 2010.There were 106 who had a PSA velocity score of0.35 ng/mL/year and a negative biopsy. Fromthese, of the 97 patients with a rising PSA trend or

velocity, who had a subsequent negative biopsy,they found that 66% of patients were eventuallydiagnosed with prostate cancer, 20% had a benignprostate, 8% had prostatitis and 6% had premalig-nant lesions. False-negative tests can often beexplained by low volume or high Gleason grade dis-ease, prior resolved prostatitis, or possible PSAassay standardization bias.

William Catalona, MD, director of the clinicalprostate cancer program at the Robert H. LurieComprehensive Cancer Center of NorthwesternUniversity said, “Our findings show an elevatedand rising PSA level or velocity should lead a clini-cian to follow a patient more closely, even if he hasa negative biopsy. One negative biopsy isn’t the endof the road.” Prof. Catalona, known as the father of

the PSA screening, was the first to show in 1991that a simple blood test measuring PSA levels couldbe used to detect prostate cancer.

The PSA test has come under fire as a screen-ing test because it sometimes prompts biopsiesthat turn out to be normal. Gregory Auffenberg,MD, a resident in urology at the Feinberg School,commented, “This underscores the importance ofusing a patient’s individual PSA trend whendeciding whether to pursue a prostate biopsy. It isnot enough to only look at an individual PSAvalue when historical data is also available.” Theresults of the study were presented on May 18,2011, at the American Urological AssociationAnnual Meeting (www.aua2011.org) held inAtlanta (GA, USA.

Velocity of PSA Test Indicates Prognosis

AA long, noncoding (lnc) RNA is elevated inmelanoma cells, where it promotes cellular

survival and invasion.Scientists have discovered that levels of a rela-

tively understudied group of RNAs–long, noncod-ing RNAs (lncRNAs)–are altered in humanmelanoma. Dr. Ranjan Perera, associate professorat Sanford-Burnham Medical Research Institute(Sanford-Burnham; Orlando, FL, USA; www.sanfordburnham.org), and collaborators at theUniversity of Queensland (Brisbane, Australia;www.uq.edu.au) compared lncRNAs in severallaboratory cell-lines of melanoma and normal skincells, as well as in 30 different human patientsamples. They found that levels of the lncRNA,SPRY4-IT1, were particularly high in melanomacells, but not in normal skin cells.

The study, published online May 10, 2011, inthe journal Cancer Research showed that the ele-vated levels of SPRY4-IT1 in melanoma cells, pro-moted cellular survival and invasion.

To further probe the function of this lncRNA,they looked at what happens in a melanoma cell-line where SPRY4-IT1 levels are significantly

reduced. Cellular growth wasimpaired and cell death wasincreased in the SPRY4-IT1-defi-cient melanoma cells, as com-pared to melanoma cells withfully functioning lncRNAs. Inaddition, the ability of melanomacells to invade the extracellularmatrix (an early step in cancercell metastasis) was reduced incells lacking SPRY4-IT1.

“The elevated expression ofSPRY4-IT1 in melanoma cells,its accumulation in the cell cyto-plasm, and effects on celldynamics all suggest thatincreased SPRY4-IT1 may play an important rolein the molecular underpinnings of humanmelanoma,” said Prof. Perera. “Based on thisinformation, we believe SPRY4-IT1 could be anearly biomarker for the detection of melanoma.”

In a separate study published in the journalPLoS ONE, in November 2010, Dr. Perera’s groupreported that melanoma cells have lower levels of

a different noncoding RNA, called miR-211.Together, these two studies give scientists a betterunderstanding of melanoma development, whichin turn will help them design new diagnostics andtherapeutics for this often-fatal disease.

Image: Colored scanning electron micrograph (SEM)of a melanoma cancer cell (Photo courtesy of SteveGschmeissner / SPL).

RNAs Altered in Melanoma

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The E-Sphere stool DNA extractionkit allows manual DNA extractionfrom 12 stool samples in less than30 minutes. The streamlinedprocess includes just nine steps, andminimizes sample contaminationrisk with only two sample transfers.

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BIOCHEMISTRY ASSAYRandox Laboratories

The latest quantitative, automatedassay is a highly sensitive and spe-cific biomarker for myocardialischemia. The assay is designed forH-FABP, to be used in the diagnosisand management of patients withsuspected acute coronary syn-drome.

MMolecular tests aid in detecting infectious dis-ease viruses for organ transplant and other

immunocompromised patients.Two new Simplexa-branded molecular test kits

enable hospital labs to perform advanced molecu-lar testing for Epstein-Barr (EBV) and BK viruses.They are the first products from the Simplexa lineto aid in the clinical management of patients withcompromised immunity.

Simplexa tests, running on the 3M IntegratedCycler, employ real-time polymerase chain reac-tion (RT-PCR) diagnostic technologies to detectviruses, bacteria, and other agents qual-itatively and quantitatively. The EBVtest is performed on whole blood spec-imens and the BK virus test is per-formed on either urine or plasma spec-imens to quantitatively detect theviruses.

Most healthy people are infectedwith EBV, the cause of mononucleosis,and BK polyomavirus at some pointduring their lives. After the primaryinfection, the viruses typically becomelatent in the body. However, the virus-es can reactivate when the immunesystem is significantly weakened, forexample after organ transplantation,and cause fever, organ rejection, andeven death.

Quest Diagnostics Inc., (Madison,NJ, USA; www.QuestDiagnostics.com)a provider of diagnostic testing, infor-mation, and services, announced thatthe two new Simplexa-branded molec-ular test kits developed by its FocusDiagnostics (Cypress, CA, USA; www.focusdiagnostics.com) business havebeen CE marked for distribution toapproximately 35 countries inEurope.

“The success of solid organ trans-plantation can hinge on how well aphysician detects and prevents compli-cations from infectious diseases likeEBV and BK,” said John G Hurrell,PhD, vice president and general man-ager, Focus Diagnostics. “CE markingof our new Simplexa EBV and BK virus

tests will enable hospital and other labs in Europeto generate reliable results quickly in their ownlabs, an important advantage for managing thesepatients.”

In April 2011, the Simplexa/3M technologywon a 2011 Edison Award for new science andmedical diagnostic product, based on criteria thatincluded technological innovation and market-place success.

Image: Colored transmission electron micrograph(TEM) of BK virus particles (Photo courtesy of Dr.Linda Stannard, UCT).

Molecular Tests Detect Epstein-Barr and BK Viruses





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BB lood bank refrigerators, plasma and ultra-lowtemperature freezers, or CO2 incubators to

preserve or cultivate cells, tissues, and blood com-ponents for human use will be certified as medicaldevices.

Products include the MCO-19AIC CO2, anincubator with rapid hydrogen peroxide vapordecontamination option, the MBR-305GRblood bank refrigerator, and the MDF-U74Vultra-low temperature freezer. Two new ultra-low freezer models will also gain certification:MDF-U55V, the latest V.I.P. freezer, and MDF-U700VX, which offers an innovative dual-cool-ing system for the highest level of sample secu-rity.

Designed and manufactured by Sanyo Electric

Co Ltd. (Osaka, Japan; http://biomedical.sanyo.com), these instruments preserve or culti-vate cells, tissues, and blood components forhuman use. The company was awarded certifica-tion to manufacture blood bank refrigerators,freezers, and incubators as Class IIa MedicalDevices by TÜV-Süd (www.tuev-sued.de), aninternational certification agency, in 2010.

Sanyo is one of the first major internationalcompanies to gain Medical Device certification toEuropean Council directives 93/42/EEC and2007/47/EC across a wide range of refrigerationand incubation products.

Image: The MCO-19AIC CO2 incubator (Photo cour-tesy of Sanyo Electric).

Blood Bank Refrigerators, Incubators and Freezers to BeCertified as Medical Devices

TT he BRAF V600E mutation was present in allpatients with hairy-cell leukemia (HCL) who

were evaluated. This finding has implications forthe diagnosis, pathogenesis, and targeted therapyof HCL.

Scientists looked for HCL-associated mutationsby performing massively parallel sequencing of thewhole exome of leukemic and matched normalcells purified from the peripheral blood of anindex patient with HCL. Findings were validatedby Sanger sequencing in 47 additional patientswith HCL.

Hairy-cell leukemia (HCL) is a well-defined clin-icopathological entity whose underlying geneticlesion is still obscure. The single mutation occurredin every patient in a cohort with hairy cellleukemia, suggesting that targeting the mutationcould have major implications for treating the dis-ease, Italian investigators reported.

Gene-expression profiling and genome-widesingle-nucleotide polymorphism genotyping

failed to pinpoint any recurrent genetic alter-ations in HCL.

Brunangelo Falini, MD, Enrico Tiacci, MD,and colleagues of the University of Perugia (Italy;www.unipg.it) using the more powerful approachto examining the genetic basis of cancer: genome-wide massively parallel sequencing of tumor andnormal cells from the same patient. They soughtto identify recurrent somatic mutations in pro-tein-coding genes, with the goal of gaining moreinsight into the origin of the disease and identify-ing new options for diagnosis and treatment.

A consequence of this discovery may be thatspecific drugs/molecules can be developed thatinhibit the activated, mutated BRAF gene, there-by preventing continuous stimulation of leukemiccells to divide. The first laboratory results employ-ing these specific inhibitors show promisingresults.

Hairy cell leukemia is characterized by the pilingup of leukemic cells in the bone marrow with a lack

of production of normal blood cells, which mightbe life-threatening, as well as a large spleen, whichmay lead to significant complaints to the patientsinvolved.

“The BRAF V600E mutant is a potential thera-peutic target in patients with hairy cell leukemiawho do not have a response (or have a suboptimalresponse) to initial therapy with purine analogs, aswell as in patients with repeated relapses or unac-ceptable toxic effects,” Dr. Falini and coauthorswrote in conclusion.

“Notably, BRAF V600E inhibitors have shownremarkable activity in patients with BRAF-mutatedmetastatic melanoma. These results, along with ourin vitro finding that a specific active BRAF inhibitorcauses MEK and ERK dephosphorylation in primaryhairy cell leukemia cells, warrant the clinical testingof active BRAF inhibitors.”

The findings were published online in theNew England Journal of Medicine (NEJM) onJune 11, 2011.

BRAF Mutation Discovered in Hairy-Cell Leukemia

HEMOSTASIS ANALYZERTem Systems

The ROTEM delta analyzer providesin-depth information on all stages ofhemostasis. The information aboutthe coagulation process is intendedto assist surgical teams with deci-sions about transfusion, and whichproducts to transfuse to the patient.

TISSUE PROCESSORThermo Fisher Scientific

The STP 420ES dual-chamberdesign allows for processing ofSTAT samples, as well as special ordifficult tissues, without interruptingroutine workflow or requiring the useof a second instrument. The unit isdesigned for same-day diagnosisand streamlined workflows.

IMMUNOASSAY ANALYZERTosoh Bioscience

The AIA-360 automated analyzerfeatures a compact size, and a fulltest menu of ST assays. The analyz-er fits in multiple lab environments,and offers STAT assay results in lessthan 20 minutes, as well as athroughput of 36 results per hour.

IHC/ISH SYSTEMVentana Medical Systems

The BenchMark ULTRA withUltimate Reagent Access allowslabs to process IHC and ISH sam-ples as soon as they arrive in thelab. The flexible system also allowslab technicians the ability to add andremove slides and reagents at anytime throughout the day.


172LMI-09-11LINKXPRESS.COM 173LMI-09-11LINKXPRESS.COM




AAnew laboratory will supportexpansion of clinical testing

services for hard-to-detect bacteriasuch as Bartonella.

The most effective means ofdetecting active infection ofBartonella spp. involves the com-bination of enrichment culture inBartonella alpha-Proteobacteriagrowth medium (BAPGM) fol-lowed by polymerase chain reac-tion (PCR) amplification and DNAsequence identification and detec-tion of organism-specific DNAsequences.

Galaxy Diagnostics’ (ResearchTriangle Park, NC, USA; www.galaxydx.com) EnrichmentPCR im-proves accuracy of Bartonella detec-tion by more than a factor of 4 overother available techniques. Bartonella

is extremely difficult to detect; con-ventional tests suffer a high degree offalse negatives, leading to misseddiagnosis and treatment.

The new laboratory facility wasopened by Galaxy Diagnostics,which is seeking approval under theClinical Laboratory ImprovementAct (CLIA), a necessary step in per-forming tests on human blood sam-ples. “Our new facilities will enableus to meet the growing demand forour EnrichmentPCR test forBartonella. People are becomingincreasingly aware of the dangersposed by [these] bacteria throughnews reports, emerging papers, andarticles,” said Galaxy presidentAmanda Elam, PhD.

The key agent in cat scratch dis-ease (CSD), Bartonella henselae is

increasingly implicated in a widerange of chronic patient conditionsaffecting the central nervous sys-tem, joints, and vascular system.Transmission of the bacteria fromhost animals to humans is thoughtto occur most often by flea/tick

bites and by animal bites andscratches.

Image: Bartonella henselae bacilli incardiac valve of a patient with blood cul-ture-negative endocarditis. The bacilliappear as black granulations (Photocourtesy of Warthin Starry / CDC).

New Facilities Support Clinical Testing Services for Bartonella

AAblood test has been recommended for screen-ing newborns or infants for all forms of an

inherited blood disorders as this may reduce mor-bidity. The hemoglobinopathy is known asHemoglobin H disease or Alpha Thalassemia and isdiagnosed by a variety of tests including high per-formance liquid chromatography (HPLC). Samplescontaining more than 25% hemoglobin Bart’sshould be selected for confirmatory testing.

Over a 15-year period, scientists at the Chil-dren’s Hospital Oakland, (CA, USA; www.childrenshospitaloakland.org), observed and tested86 patients, of whom 23 had hemoglobin HConstant Spring mutation (HCS). Diagnosis wasconfirmed by thin-layer isoelectric focusing, andspecific α-globin gene deletions or mutations wereidentified by multiplexed gap-polymerase-chain-reaction assay. Patients with hemoglobin H have

moderately severe anemia because of gene defectsleading to insufficient production of hemoglobin.The disorder does not usually cause significanthealth problems, except in cases of HCS, a severeform of the disease, which often results in life-threatening anemia.

The study provided a previously undocument-ed natural history of the disease in young children.The patients with HbH exhibited relatively normalgrowth and development without needing bloodtransfusions, but patients with HCS were at high-risk for life-threatening anemia even during infan-cy. There were significant differences in hemoglo-bin levels between the HbH group and the HCSgroup and the absolute reticulocyte count andbilirubin level were consistently higher in patientswith HCS.

A diagnosis of HCS avoids expending precious

time, which could save a young life and money try-ing to diagnose the problem. The study also demon-strated that hemoglobin H is not restricted to thetraditional Asian ethnic populations. Although 81%patients studied had an Asian background, 5% wereHispanic, 3% were African-American, and 10% hadmixed ancestry.

The study shows that the advanced DNA testingat Children’s Hospital Oakland can predict thecourse of the disease during childhood, which helpsto ensure proper treatment for all patients.Hemoglobin H disease arises from the deletion ofthree of four α-globin genes and HCS is caused bythe deletion of two α-globin genes and the ConstantSpring mutation. In California, one in 10,000 new-borns is diagnosed with hemoglobin H disease. Thestudy was published on February 24, 2011, in theNew England Journal of Medicine (NEJM).

Screening Test Recommended for Heritable Blood Disorder

ELISA ANALYZERInstitut Virion\Serion

The Immunomat is a four-platebenchtop automat with an integratedpipetting system, plate transporter,ELISA washer and reader. The fea-tures of the fully automated analyzerensure an efficient workflow, andallow the processing of up to sevenmicrotitre plates.

ELECTROLYTE ANALYZERWiener Lab Group

The IC features direct potentiometrythrough ISE, and options for bothsample liquids and calibration.Additional benefits include anautosampler dish with 39 positions,maintenance-free electrodes, twooptions for operation, and a through-put of 60 tests/hour.

DRUG PANEL CUPWondfo

The T-Cup eliminates the possibilityof donor tampering, and is user-friendly for females. The T-Cup isaccurate and reliable and shows adark line present in as soon as aminute, and offers tests for up to 15drug panels plus adulteration.

URINALYSIS REAGENT STRIPS

Stanbio LaboratoryThe Uri-Chek 10SG strips feature ahigh quality color chart, long shelflife, high sensitivity, and room tem-perature storage. When read on theUri-Trak 120 urine analyzer, the cost-effective strips are part of an eco-nomical system for urine analysis.


AAhypertonic glucose agar hasbeen used for phenotypic char-

acterization of two Candida speciesfollowing molecular classification.

Isolates of Candida dubliniensisand C. albicans were distinguishedas species by growing them onhypertonic Sabouraud glucose agar(SGA) with 6.5% sodium chloride.

Scientists at the University ofDelhi (Delhi, India; www.du.ac.in)tested the SGA method on 84 iso-lates of C. albicans, 18 of C. dublin-iensis, and 2 reference strains. Ofthe test C. albicans isolates, 41 orig-inated from the oropharynx of 27human immunodeficiency virus(HIV) positive patients and the restfrom 41 patients with lung diseases.

Identity of the test fungi was basedon their typical phenotypic charac-teristics and confirmed by a diagnos-tic polymerase chain reaction (PCR),that targets the novel C. dublinien-sis group I intron in the large riboso-mal subunit.

All of the 84 test and 2 referenceC. albicans isolates grew on hyper-tonic SGA, while, in strong contrast,none of the test and reference C.dubliniensis isolates exhibited anygrowth up to seven days of incuba-tion. Of the 84 C. albicans isolates,77 (91.6%) inoculated on hyperton-ic SGA showed growth at 72 hoursof incubation and the remainingseven at 96 hours. On Staib agar, 19of the 20 test C. dubliniensis iso-

lates showed chlamydospore forma-tion at 48 hours of incubation andthe solitary remaining isolate at 96hours. In comparison, most C. albi-cans isolates did not grow well onthis medium. Growth inhibition at45 °C was observed by all of the testand reference C. dubliniensis iso-lates. However, growth inhibitionalso occurred in a large majority ofthe C. albicans isolates at this tem-perature indicating poor specificity.

The authors concluded that their

observations are highly significant inthat hypertonic SGA with 6.5%sodium chloride was entirely freefrom any false positive or false-nega-tive results. The hypertonic SGAwas strongly recommended forwider application as a reliable andinexpensive medium for routine dif-ferentiation of C. dubliniensis fromC. albicans. The study was pub-lished online on March 9, 2011, inthe journal Diagnostic Microbiologyand Infectious Disease.

Hypertonic Culture Medium Differentiates Fungal Species

MMolecular techniques haverevealed that high levels of a

particular protein in tumor cells are areliable indicator that the cancer willmetastasize.

By measuring a protein biomark-er in a tumor and comparing the lev-els in surrounding tissue, it is possi-ble to predict whether the cancerwill spread to other organs withintwo years.

Scientists collaborating with theUniversity of Hong Kong, (HongKong SAR, China; www.hku.hk)studied the protein carboxypeptidaseE (CPE) in a form known as CPE-delta N. CPE-delta N, a variant ofCPE, and is present in high amountsin tumors that have spread, and onlyin small amounts in the surroundingtissues. Ordinarily, CPE is involved inprocessing insulin and other hor-mones. They tested for CPE-delta Nindirectly, by measuring levels ofribonucleic acid (RNA). RNA workswith the information in a gene tomake a particular protein as in thiscase, CPE-delta N. In an analysis oftissue from 99 patients with liver can-cer, they compared the amount ofCPE-delta N RNA from the patients’tumors with the RNA levels in sur-rounding tissue. The status of thepatients’ morbidity was tracked forup to eight years.

The scientists found that whenthe level of CPE delta-N RNA intumors was more than twice that inthe surrounding tissue, the cancerwas highly likely to return or tometastasize within two years. At orbelow this threshold level, the can-

cer was much less likely to recur.Using this threshold measure, theinvestigators accurately predictedmetastasis or recurrence in morethan 90% of the cases. Conversely,their predictions that tumors wouldnot return in the two-year periodwere accurate 76% of the time. Theyalso measured CPE-delta N RNA lev-els from stored tumor tissue original-ly removed from 14 patients withpheochromocytoma, a rare tumor ofthe adrenal glands, and paragan-glioma, a rare tumor primarily occur-ring in the adrenals but sometimes inother parts of the body. The numberof copies ranged from 150,000 to 15million per 200 micrograms of tis-sue. In all of the cases where cancerwas found to have recurred or metas-tasized, CPE-delta N RNA levelswere greater than one million. Theresearchers found no metastasis orrecurrence in cases in which tumorshad less than 250,000 copies.

In addition, the scientists exam-ined cells from liver, breast, colon,and head and neck, tumors and foundthat those known to spread mostaggressively had the highest levels ofCPE-delta N RNA. Y. Peng Loh, PhD,a senior author of the study, explainedthat the method used in the studymight someday be used to treat can-cers in human beings. Currently,there are no means to deliver the anti-sense RNA to tumor cells. A potentialapproach might involve modifying avirus to carry the antisense RNA intocells. The study was published onFebruary 1, 2011, in the Journal ofClinical Investigation.

Concentration of Tumor Protein Predicts Metastatic Cancer

Image: Scanning electron micrograph (SEM) of candida (Photo courtesy of D.Phillips / Science Photo Library).






FF low cytometry analysis of leuko-cyte surface antigens has been

used to characterize infectious andseptic processes in patients.

Factors that affect leukocyteimmunophenotyping include sam-pling and processing temperature,the anticoagulant used, and the stor-age temperature of the blood sample.

Scientists at the University ofOulu (Oulu, Finland; www.oulu.fi)investigated the possible effects ofanticoagulant, sample collection,storage and processing temperature,and sample storage time, on theexpression of several leukocyte sur-face antigens. They collected bloodfrom five male patients, aged 44-68,with severe sepsis requiring intensivecare and five healthy staff members(two males and three females, aged22-62). In this study, the patients and

the healthy volunteers were com-bined into one study population.

Blood was collected into siliconizedvacuum tubes containing acid citratedextrose (ACD) or sodium heparin asan anticoagulant and stored either at 4 °C or at room temperature (RT).Aliquots of the blood samples wereincubated with various antibodies atdifferent temperatures and times andanalyzed on a FACSCalibur flowcytometer (BD Bioscience; San Jose,CA, USA; www.bdbiosciences.com).The surface antigens of interest wereneutrophilic cluster of differentiation(CD)11b and CD64, monocyticCD11b, CD14, CD40, CD64, CD80and human leukocyte antigen, HLA-DR, and lymphocytic CD69 (separate-ly in CD4+ and CD8+ T cells, B cells,and natural killer cells).

The fluorescence intensities were

higher at RT than at 4 °C. During stor-age the intensities increased at RT, butat 4 °C there were only minor changes.The effects were similar with both anti-coagulants studied. The authors con-cluded that the study shows in a quan-titative way that storing the bloodsamples at RT may have pronouncedeffects on the intensities of severalleukocyte surface antigens, something

which is of interest in leukocyte acti-vation studies, such as patients withsepsis. They recommended that flowcytometric analysis of leukocyte sur-face antigen expressions should beperformed using 4 °C temperaturethroughout the process and within sixhours. The study was published onlineMarch 15, 2011, in the Journal ofClinical Laboratory Analysis.

Temperature Affects Leukocyte Surface Antigen Expression

GGene variants of different clottingfactors were studied for a possi-

ble connection with colorectal cancerrisk. The occurrence of six variantswas analyzed in approximately 1,800colorectal cancer patients and in thesame number of healthy control per-sons. Scientists at the GermanCancer Research Center (DeutschesKrebsforschungszentrum, DKFZ;Heidelberg, Germany; www.dkfz.de)headed by Prof. Dr. HermannBrenner studied the six gene vari-ants of different clotting factors for apossible connection with colorectalcancer risk.

The team found a variant that sub-stantially increases the risk of throm-bosis, which is known as factor VLeiden (FVL). Study participants whocarry this genetic variant on bothcopies of their chromosome 1 werefound to have a six-fold increase incolorectal cancer risk compared toparticipants who carry two copies ofthe “standard variant” of factor V. Ifonly one copy of chromosome 1 hadthe FVL variant, bowel cancer riskwas not elevated.

Another connection with bowelcancer prevalence was found by the

team for a particular gene variant ofclotting factor XIII: people with thismutation are more slightly less affect-ed by venous thrombosis than thosewho carry the factor XIII standardversion. The DKFZ team showed thattheir colorectal cancer risk is also15% lower. For the other four genevariants studied, the team found noconnection with bowel cancer risk.

The knowledge of these connec-tions is the first prerequisite for find-ing out whether and for whom drugsthat affect blood clotting may preventbowel cancer.

It is known that coagulation andcarcinogenesis are associated. Thus,the interplay of all coagulation factorsleads to the formation of activethrombin, which, in turn, activateshemostatic fibrin. However, throm-bin also contributes to the formationof new blood vessels and is able todissolve the extracellular matrix,which is the adhesive that keeps cellstogether. Thrombin may thus make iteasier for cancer cells to invade sur-rounding tissue.

The study appeared ahead of printin the March 2011 edition of theJournal of Clinical Oncology.

Blood Clotting Factors Affect Bowel Cancer Risk

AAmonoclonal antibody microarraywas developed to assess the

level of multiple proteins simultane-ously in human plasma.

Using the QuantiPlasma array itis possible to assess directly the plas-ma proteome of normal and diseasestate plasma samples for the identifi-cation of novel biomarkers. Each kitcontains 300 unique monoclonalantibodies that can be assessedsimultaneously using Biochip ArrayTechnology.

Currently biomarker discovery bymass spectrometry is an expensiveand laborious method, with limita-tions in reproducibility and sensitivitydue to the wide range of protein con-

centrations in plasma and extensiveprocessing requirements. Biomarkervalidation and follow-on studies canalso be impeded by a lack of availableimmunoaffinity reagents.

Randox Pharma Services (Crum-lin, United Kingdom; www.randoxpharmaservices.com) designed anddeveloped the QuantiPlasma array.The company invested in developingsolutions for biomarker discoverybecause of their broad range of appli-cations for the diagnosis, prognosis,and monitoring of disease progressionand the monitoring of clinicalresponses. The solutions should leadto therapeutic intervention and per-sonalized medicine.

Monoclonal Antibody Microarray Assesses Multiple Protein Levels in Plasma

BLOOD CLOTTING MONITORMicrovisk

The Smartstrip device is a handheldsystem that monitors the blood clot-ting status of patients taking the drugWarfarin. The system uses a dispos-able strip with embedded sensors tomeasure the clotting speed of bloodfrom a fingerprick sample, withresults displayed on the unit.

IMMUNOBLOT TESTOrgentec Diagnostika

The Liver-9-Line is designed for therapid diagnosis of autoimmune hep-atitis and primary biliary cirrhosis in asingle step. The cost-effective testalso is suitable for initial and differ-ential diagnosis, while optional soft-ware allows for the automated eval-uation of the immunoblots.

ANTIGEN DETECTION TESTOtsuka Pharmaceutical

The RAPIRUN S. pneumoniae kitoffers rapid and easy detection ofStreptococcus pneumoniae antigenin as little as 5-minute sampleextraction and 20 minutes to results.Easy sample collection optionsinclude sputum, rhinopharyngealswab, middle ear fluid, and otorrhea.

BENCHTOP CENTRIFUGERemi Elektrotechnik

The CM-8 Plus offers quiet operationand a compact footprint, and pro-vides the flexibility to alternate frommicrovolume to medium-volumecentrifugation. Additional featuresinclude a backlit LCD panel, shortspin button, various timer settings,and a range of safety mechanisms.

SScientists have discovered that DNA methylationpatterns, a key process in cell development,

could accurately detect early bowel cancer.Investigators from Cancer Research UK’s

Cambridge Research Institute (Cambridge, UnitedKingdom; www.cambridgecancer.org.uk) analyzed261 tumor samples taken from patients who hadeither benign bowel polyps or had developed bowelcancer.

They found that DNA methylation patterns oftwo genes called SFRP2 and IGF2 identified anddistinguished between tumors and benign polyps,

with an accuracy of more than 90%.Levels of an enzyme called DNMT3B, which

helps add methyl groups to DNA, were also meas-ured. Enzyme levels in tumor samples increasedfrom lower amounts present at the polyp stage tohigher levels in bowel cancer. The increase inenzyme levels corresponded with the increasedamount of DNA methylation – and provided anexplanation for the changes.

Dr. Ashraf Ibrahim, lead author of the study,which was published online in Gut on November10, 2010, said, “The molecular signals, which tell

genes whether to make proteins or not, canbecome jumbled in cancer cells. We’ve identifiedseveral places where this signal becomes damagedand shown this is linked to bowel cancer develop-ment.”

“The majority of bowel cancers develop frombenign polyps that turn cancerous - and this crucialresearch deepens our understanding of the molecu-lar changes behind this development. This first stepin detecting molecular ‘flags’ for bowel cancer,could, one day, lead to a simple test to search DNAfor the early signs of the disease.”

DNA Methylation Patterns Accurately Detect Early Bowel Cancer

NNew HLA Primer Sets achieve high- and medi-um-resolution genotyping of class I and class

II loci of the Human Leukocyte Antigen (HLA)genes. Introduced by 454 Life Sciences (Branford,CT, USA; www.454.com), a Roche Company, thenew GS GType New HLA Primer Sets aredesigned for use with the company’s benchtop GSJunior and GS FLX next-generation sequencingsystems – enabling high-resolution typing andunambiguous allele assignment in a single run.

The kits are the first in a series of assays in theareas of immunogenetics, infectious disease, andcancer to be launched for use with 454Sequencing Systems, allowing scientists to inte-grate easily the platforms into application-specificlaboratory workflows.

The HLA genes encode for the immune systemproteins that recognize foreign cells and otherantigens. Accurate characterization of an individ-ual’s HLA type is important for tissue transplanta-tion matching, while variations in these geneshave known association with a wide variety of

autoimmune diseases, infectious diseases,and some cancers.

The long, clonal reads provided by 454Sequencing Systems enable straightforwardhigh-resolution of multiple samples at a time.In many cases HLA typing achieves unam-biguous allele identification within a singlesequencing run. Sequence output is compati-ble with third party HLA genotyping softwaretools – offering scientists a complete solution fromDNA to genotype assignment.

Genotyping of HLA genes can be challengingbecause of the highly polymorphic nature of thisregion of the human genome. Traditional sequence-based typing using Sanger capillary electrophoresistechnology is unable to resolve ambiguities and setphase without requiring multiple iterations, inter-spersed with significant manual analysis of the data,and often the use of multiple technologies.

The GS GType HLA Primer Sets are the result ofan extensive multisite study, which was publishedMarch 2011 in the journal Tissue Antigens.

“454Sequencing Systems offer a majoradvance for high-resolution, high-throughput HLAtyping,” explained Henry Erlich, PhD, seniorstudy author and Director of the Department ofHuman Genetics at Roche Molecular Systems.“The ability to quickly achieve such high accura-cy and resolution will have a significant impact onresearch and, ultimately, on clinical application ofHLA typing.”

Image: The GS GType HLA MR Primer Set (bluelabel) and GS GType HLA HR Primer Set (yellowlabel) each contain four 96-well plates (Photo cour-tesy of 454 Life Sciences).

HLA Primer Sets Achieve High- andMedium-Resolution Genotyping

AAneonatal total bilirubin assay requires only 100µL of blood and offers test results in about 60

seconds. The neonatal total bilirubin (nBili) test isperformed on the RAPIDPoint 405 blood gas ana-lyzer with software version 3.7. With one smallblood sample, a full range of analytes can be meas-ured including bilirubin, blood gases, electrolytes,glucose, total hemoglobin, and other critical careparameters required to assess critically ill infants.

The RAPIDPoint 405 offers a no-maintenance,cartridge-based solution for critical care testing ofwhole blood – unlike the reagent-based chemistryanalyzers that require the separation of plasma fromthe red blood cells prior to analysis. Ease of use,minimal sample size, and fast turnaround of testresults enhance patient care. Siemens (Erlangen,Germany; www.medical.siemens.com) nBili test onthe RAPIDPoint 405 Blood Gas Analyzer is intend-ed to measure the concentration of bilirubin in aninfant’s blood as an aid for assessing the risk for ker-nicterus in a point-of-care setting.

Kernicterus is due to marked jaundice in thenewborn period. The high blood level of the pig-ment bilirubin results in its deposition in thebrain, which damages the brain. Today, no babyshould develop brain damage from untreated jaun-

dice. If a baby gets too jaundiced, the baby can betreated with phototherapy. The baby can be putunder blue lights most of the day. If the baby gets

very jaundiced, an exchange transfusion can bedone. Kernicterus is also called bilirubinencephalopathy.

Bilirubin Assay for Neonates Takes Only 60 Seconds







CCongenital syphilis is easily prevented by test-ing mothers while they are pregnant.

Testing should occur at the first prenatal visitand in communities where the risk is high; itshould be repeated during the third trimester andonce more at delivery. Mothers who are diag-nosed with syphilis during pregnancy can be treat-ed to prevent syphilis infection of the baby.

Syphilis is caused by the sexually transmitted bac-teria known as Treponema pallidum. Sexually trans-mitted diseases (STDs) including syphilis, chlamydia,gonorrhea, herpes, human papillomavirus (HPV),and human immunodeficiency virus (HIV) can betransmitted to infants during pregnancy.

A study of 41,000 women, published in theearly online edition of the Lancet InfectiousDiseases on June 16, 2011 showed that testingand antibiotics could more than halve the number

of deaths of babies whose mothers were sufferingfrom syphilis. The UK experts said screening wascheap and cost-effective.

The study was lead by Dr. S. Hawkes PhD,reader in global health, UCL Institute for GlobalHealth and Center for International Health andDevelopment, University College London (UnitedKingdom; www.ucl.ac.uk).

Congenital syphilis in infants can result in still-birth, premature delivery, low birth weight, andsignificant birth defects (bone, blood, brain,heart). Syphilis causes 500,000 stillbirths andnewborn deaths globally, mostly in Sub-SaharanAfrica.

Image: Colored Transmission Electron Micrograph(TEM) showing a Treponema pallidum bacterium(Photo courtesy of Alfred Pasieka / Science PhotoLibrary).

Testing Pregnant Mothers Prevents Congenital Syphilis

AA test has been developed that can detect aspecific protein in the urine of men that is

linked to prostate cancer.A small sample is used to find whether the pro-

tein is secreted into the urine where it can be eas-ily detected using the new test that is simple,quick and has the potential to be used in familyphysicians’ surgeries.

Scientists at the University of Surrey,(Guildford, UK; www.surrey.ac.uk), tested 194urine samples for the presence of a protein calledEngrailed-2 (EN-2), between June 2007 to June2010. Included in the study participants weremen with lower urinary tract symptoms, individ-uals concerned they may have an asymptomaticprostate cancer, for instance having a positivefamily history, and men with an abnormalprostate specific antigen (PSA) test. Two groups ofcontrols were also tested. Samples were assayedusing an in house enzyme-linked immunoassay(ELISA) that used two mouse monoclonal anti-

bodies. Other studies were conducted to detectthe presence of EN-2 included Western blot, andsemiquantative polymerase chain reactions (RT-PCR).

The stability of En-2 protein in urine wasshown to be at least four days at room tempera-ture, allowing postal collection of some samples.EN2 protein was detected in 54 of the 82 (66%)men with prostate cancer confirmed by biopsy,using a cutoff point of 42.5 µg/L, and in ninemen in this EN2 positive group, their PSA wasless than 2.5 ng/mL. The authors reported thatusing the 42.5 ng/mL cut off point, the EN2 testhas a sensitivity of 66% and a specificity of almost90%. The potential utility of EN2 as a prostatecancer biomarker was demonstrated by its pres-ence in the urine of men with low PSA of lessthan 2.5 µg/L, but histologically confirmedprostate cancer on biopsy.

The ELISA based assay for EN-2 will potential-ly allow a number of different detection platforms

including a lateral flow application with a “dipstick” test, which could be performed quickly andcheaply in primary care or as a component of alarge-scale screening program. EN2 is an impor-tant protein in the development of the humanembryo and, like many similar fetal proteins, itsproduction is switched off at birth. However, thisstudy showed that EN2 is switched back on againin prostate cancer.

Hardev Pandha, MD, PhD, professor of oncol-ogy at the university, said, “In this study weshowed that the new test was twice as good atfinding prostate cancer as the standard PSA test.Only rarely did we find EN2 in the urine of menwho were cancer free, so if we find EN2 we canbe reasonably sure that a man has prostate cancer.EN2 was not detected in men with noncancerdisorders of the prostate such as prostatitis orbenign enlargement.” The study was publishedon March 1, 2011, in the journal Clinical CancerResearch.

Simple Urine Test Diagnoses Prostate Cancer

FOBT ANALYZERKyowa Medex

The HM-JACKarc fecal occult bloodtest analyzer features a rack systemintended to achieve enhanced oper-ability and increase throughputspeed. Other key benefits include afull-color indicator that allows usersto visually monitor operating condi-tions by patterns of emission.

TISSUE-STAININGINSTRUMENT

Leica MicrosystemsThe BOND-III fully automated sam-ple staining system is designed forthe detection and diagnosis of can-cer and infectious diseases. The sys-tem provides results 50% faster thanprevious generations stainers, whilealso reducing hazardous waste.

URINE ANALYZERMacherey-Nagel

The Uryxxon 500 high performanceanalyzer offers a capacity of 400strips per hour, with memory storagefor up to 500 patient tests. The sys-tem provides reliable results todetect early stages of such diseasesas UTIs, kidney disease, and dia-betes, among others.

BOTTLE TOP DISPENSERMicrolit

The Classic and Research modelsare fully autoclavable, and providehigh precision and accuracy alongwith effortless plunger movement forbubble-free dispensing. The dis-pensers have six adjustable volumesizes, and come with five adaptorsto fit most lab reagent bottles.



Monoclonal AntibodiesProduced for Alzheimer’s

Blood Test

MMonoclonal antibodies (mAbs) were successful-ly produced for a diagnostic blood test for

Alzheimer’s disease (AD).A simple, easy to use diagnostic blood test for AD

is ready for clinical testing. Human sample testinghas begun and will run over the next few months.

biOasis Technologies Inc. (Vancouver, BC,Canada; www.bioasis.ca) announced the comple-tion of a project intended to produce proprietarymonoclonal antibodies (mAbs) for its Cognitestblood test for Alzheimer’s disease. Working in col-laboration with Fleet Bioprocessing (Hartley Witney,United Kingdom; www.fleetbioprocessing.co.uk),and OxFabs (Oxford, United Kingdom; www.oxfabs.com), the company generated numerousantibodies and assessed their performance in proto-type assays. The best performing mAbs were select-ed for use within production prototypes.

Current initiatives within the Cognitest programinclude product and method development, valida-tion using human samples, and regulatory approvalin Europe. To enable faster adoption and greater useof Cognitest the company intends to out-license it toleading in vitro diagnostic companies.

Lipid Particles TestAccurately Predicts

Cardiovascular Disease

AAblood test for low-density lipoprotein (LDL)particles is a more accurate predictor of cardio-

vascular disease (CVD) events than LDL cholesterol(LDL-C). A high value proprietary blood test usingnuclear magnetic resonance (NMR) technology hasdemonstrated that the amount of cholesterol perlow-density lipoprotein particle (LDL-P) is variableand related in part to particle size, with smaller par-ticles carrying less cholesterol.

Scientists at Wake Forest University School ofMedicine (Winston-Salem, NC, USA; www.wfu.edu) analyzed blood samples obtained at studyonset from 5,598 middle-aged men and women freeof cardiovascular disease, who participated in aprospective observational study. Participants werefollowed for a mean of 5.5 years for incident CVDevents, including heart attack, coronary heart dis-ease death, angina, stroke, stroke death, or otheratherosclerotic or CVD death.

Of 319 total CVD events recorded, 159 occurredin persons with LDL-C and LDL-P numbers that dis-agreed. The CVD risk of these individuals trackedwith LDL-P number regardless of levels of LDL-C andonly LDL-P numbers were associated with incidenceof CVD. LDL particle levels were measured using theNMR LipoProfile test (LipoScience Inc., Raleigh, NC,USA; www.liposcience.com). LDL-P information canhelp clinicians personalize and refine LDL treatmentdecisions, particularly to minimize residual risk inpatients with low LDL-C levels. Clinicians historical-ly have used the LDL-C level, the amount of choles-terol carried within LDL particles, to determine howmuch treatment, if any, a patient needs. The studywas published online on February 14, 2011, in theJournal of Clinical Lipidology.

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AAdiagnostic test for early detection of acute kidneyinjury helped predict delayed graft function

(DGF) in kidney transplant patients.A study examined how serial urine neutrophil

gelatinase-associated lipocalin (NGAL) concentrationschange over time following kidney transplants andwhether urine concentrations of NGAL could predictthe onset of delayed graft function or prolongeddelayed graft function.

One-hundred and seventy-six renal transplantpatients were evaluated in the study. Urine sampleswere collected before transplantation and for several

days afterward. Seventy patients had DGF and 26 ofthem were prolonged. The NGAL assay was per-formed by a two-step chemiluminescent microparti-cle immunoassay on the Architect standardized clini-cal platform of Abbott Diagnostics (Abbott Park, IL,USA; www.abbott.com).

The patients who developed DGF had a signifi-cantly slower decrease in urinary NGAL compared tothose without DGF. Urine NGAL levels measured aday following transplant predicted prolonged DGF(14 days or longer), which had significantly worseone-year graft survival (73 %) compared with shorter

DGF (100 percent). The scientists concluded thaturine NGAL measurements could predict prolongedDGF and identify patients with severe kidney injuryand inferior long-term organ survival. They addedthat the test also provides a simple method to quanti-fy recovery from kidney injury.

The Finnish study was published in the September2010 edition of Kidney International, the journal ofthe International Society of Nephrology. Abbott(Abbott Park, IL, USA; www.abbott.com) introducedthe automated urine NGAL assay in Europe onArchitect, the company’s flagship instrument system.

Urine Biomarker Helps Predict Delayed Graft Function

AAset of plasma biomarkers reason-ably predicted the risk of metasta-

sis among patients with melanoma.Scientists tested the plasma of 216individuals, including 108 patientswith metastatic melanoma and 108patients with stage 1 or 2 disease.They identified seven plasma biomark-ers: CEACAM, ICAM-1, osteopontin,MIA, GDF-15, TIMP-1, and S100B.

All of the biomarkers were higherin patients with metastatic melanomathan in patients with early-stage dis-ease. Seventy-six percent of patientswith early-stage disease had no eleva-tions at all whereas 83% of metastat-ic patients had elevations of at leastone marker.

The investigators from YaleUniversity School of Medicine (NewHaven, CT, USA; http://medicine.yale.edu) concluded that these bio-markers could be used for monitoringmelanoma patients for metastatic dis-ease. However, the findings need to beconfirmed prospectively before the bio-marker set can be used in the clinic.

Melanoma is the fifth most com-

mon cancer in men and the seventhmost common cancer in women. It isestimated that 68,130 people in theUnited States were diagnosed in2010, and 8,700 died. If melanomais caught early enough it can beremoved with surgery; mortality typ-ically comes when the cancer metas-tasizes.

Patients with melanoma are typi-cally subjected to a combination ofimaging tests, blood tests, and physi-cal examinations, but there is noclear consensus on how often thesetests should occur or how reliablethey are.

“The rate at which melanoma isincreasing is dramatic, and there is ahuge number of patients under sur-veillance,” said Harriet Kluger, MD,associate professor of medicine atYale University School of Medicine.“Our current method of surveillanceincludes periodic imaging, which cre-ates huge societal costs.”

The study was published in theApril 15, 2011, edition of the journalClinical Cancer Research.

Plasma Biomarkers Identified in Patients with Metastatic Melanoma

AA comprehensive portfolio of invitro and in vivo products for

obstetrics and gynecology (OB/GYN) patient management featuresboth clinical laboratory diagnosticsolutions and ultrasound imaging.The products were designed to helpphysicians deal with the clinicalreproductive health needs ofpatients.

Siemens Healthcare (Erlangen,Germany; www.medical.siemens.com) displayed its integrated solu-tions for OB/GYN patient manage-ment at the 59th Annual ClinicalMeeting of the American College ofObstetricians and Gynecologists(ACOG), held in Washington DC(USA) from April 30-May 4, 2011.

Highlights of Siemens OB/GYNdiagnostic solutions that wereunveiled at the meeting included theImmulite 1000 Immunoassay Systemand the latest Loci fertility assaysavailable on Dimension Vista In-telligent lab systems. The Immulitebenchtop analyzer is engineered foreasy operation and reliability. It offers

an extensive menu for routine andspecialty immunoassay testing,including Siemens’ broad range ofreproductive endocrinology assays,such as estradiol, progesterone, andtestosterone. Information aboutSiemens’ full line of reproductiveendocrinology platforms includingthe ADVIA Centaur ImmunoassaySystems, Dimension integrated sys-tems, and Immulite 2000 immunoas-say system, was also available at themeeting.

Loci technology requires fewerreaction steps resulting in fast turn-around times. The Loci assaysinclude luteinizing hormone (LH),follicle-stimulating hormone (FSH),and prolactin. LH and FSH are usefulin the clinical evaluation of gonadaland pituitary disorders, while pro-lactin is used in the diagnosis andtreatment of disorders of the anteriorpituitary gland and hypothalamusportion of the brain.

Several of Siemens’ ultrasoundimaging solutions for OB/GYN carewere also introduced at the meeting.

New OB/GYN Products Designed forClinical Reproductive Health Needs

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Multigene Tests Compared for Breast

Cancer Prognosis

TTwo multigene assays were examined to calcu-late their agreement in predicting the prognosis

in different types of breast cancer. Several commercial assays are being introduced

to assign clinical subtype or predict risk of recur-rence for breast cancer of which there are at leastfour different subtypes with clinical relevance.

Scientists at Mater Misericordiae UniversityHospital (Dublin, Ireland; www.mater.ie) extractedribonucleic acid (RNA) from 119 formalin-fixed,paraffin-embedded tissue blocks from breast cancerpatients who have been classified as being at clini-cally intermediate risk for recurrence based on sev-eral criteria: median tumor size 1.5 cm, all estrogenreceptor (ER)-positive, Human Epidermal growthfactor Receptor 2 (HER2) -negative, lymph-nodenegative and most of them were classified as gradeII. Working with colleagues in the USA, the scien-tists performed the PAM50 Breast Cancer IntrinsicClassifier Reverse Transcription/QuantitativePolymerase Chain Reaction and compared it to theOncotypeDX recurrence score (RS) assay.

The results showed that all patients with high RSaccording to the OncotypeDX were classified as“luminal B” or “basal-like” by the PAM50 classifier,whereas 83%, the majority of low RS cases were“luminal A” type. Half of the Intermediate RS can-cers were recategorized as low risk “luminal A”cancers by the PAM50. All “luminal A” cancers areeither low (70%) or intermediate (30%) risk by RS,whereas “luminal B” cancers are comprised of amixed risk group by RS including 33% that are highrisk by OncotypeDX.

These results indicate that there is a reasonablygood agreement between the two methods for highand low prognostic risk assignment. According tothe authors of the study, intermediate risk groupsby one assay often include cases with discordantrisk prediction by the other method. When discor-dant risk results are obtained it is currentlyunknown which assay will predict outcome moreaccurately.

The OncotypeDX test (Genomic Health;Redwood City, CA, USA; www.genomichealth.com) is intended for use in patients with hormonereceptor-positive, lymph node-negative breast can-cer to identify women at low risk of breast cancerrecurrence who can safely avoid chemotherapy. Itmeasures the activity of 21 genes and generates arecurrence score (RS) which categorizes patientsinto low, intermediate or high risk groups depend-ing on the risk of distant recurrence.

The PAM50 breast cancer intrinsic classifier,(ARUP Laboratories; Salt Lake City, UT, USA;www.aruplab.com) measures the expression of 50genes and stratifies breast cancers into five sub-types; luminal A, luminal B, basal-like, Her2-enriched and normal-like, so the target populationis not just patients with ER-positive breast cancers.This test is currently undergoing clinical validation.The study was presented at the Improving Care andKnowledge Through Translational Research(IMPAKT) Breast Cancer Conference, 5-7 May,2011, held in Brussels (Belgium).



AA sensitive assay has been used todetect myocardial infarction

(MI) within two hours of a patientbeing admitted to hospital.

An increase in the concentrationof troponin in the blood is used todetect whether patients with acutecoronary syndrome (ACS) havemyocardial infarction and this canbe used as a diagnostic marker.

A study performed at theCatharina Hospital (Eindhoven, TheNetherlands; www.cze.nl) exam-ined the concentration of troponinin 157 patients with suspected non-ST elevated ACS. Blood was drawnon arrival (T0) and 2 (T2), 6 (T6)

and 12 (T12) hours later. Levels ofcardiac troponin I, creatinekinase–myocardial band fraction(CK-MB) and myoglobin were meas-ured on an immunochemistry ana-lyzer. The assay for troponin was thesecond-generation TnI-Ultra tro-ponin kit and all tests were analyzedon the manufacturer’s Advia Cen-taur analyzer (Siemens HealthcareDiagnostics; Erlangen, Germany;www.medical.siemens.com).

The TnI-Ultra troponin kit is asecond generation, high-sensitivitytest with a 10% coefficient of varia-tion (CV) at 0.05 µg/L and a tro-ponin concentration of 0.06 µg/L

at the 99th percentile of a referencepopulation. The 99th percentilewas established on 221 samplesfrom outpatients with no history ofmyocardial disease. At T2, a tro-ponin concentration above the MIcutoff is 87% sensitive and 100%specific for MI detection. A differ-ence of more than 30% betweenthe troponin measurements at T0and T2 in the absence of anabsolute troponin increase abovethe 99th percentile of a referencepopulation was also considered

indicative of MI, the sensitivityincreases to 100% and specificitydecreases to 87%.

The authors concluded that byusing a sensitive troponin assay andsimple algorithms, the diagnosis ofMI can be determined within twohours after arrival at the emergencydepartment, and the measurementof myoglobin and creatine kinase –MB has no added value. The studywas published in March 2011 inthe American Journal of ClinicalPathology.

Rapid Blood Test Detects Myocardial Infarction

AAnew liquid stable haptoglobin kitprovides a highly sensitive and

specific method for the quantitativedetermination of haptoglobin inhuman serum.

The method is fully automatedand suitable for use on the RX seriesof bench top clinical analyzers includ-ing the RX daytona and RX imola.Liquid, ready-to-use quality controlsand calibrators are also available.Liquid specific protein controls arestable for 30 days at 2 °C to 8 °C andare 100% human in origin. Threeclinically significant levels are avail-able with assayed target values andranges for 27 different analytesincluding haptoglobin.

A product of Randox (Crumlin,UK, www.randox.com) the haptoglo-bin assay is based on an immunotur-bidimetric method where haptoglobinin the sample is diluted and reactedwith specific antiserum, yieldinginsoluble aggregates that can be meas-

ured turbidimetrically at 340 nm.A wide measuring range of 0.13

g/L to 3.68 g/L ensures that theassay is capable of accurately measur-ing above and below the patient nor-mal range while an extendedonboard stability of 28 days mini-mizes reagent waste.

The assay is precise, traceable tocertified reference material, and haslimited interference from bilirubin,hemoglobin, and triglycerides.Prozone effects are not demonstratedup to at least 7.64 g/L and the assayshows excellent correlation to stan-dard methods.

In addition to quality controls,Randox also offers a specific proteinEQA program providing customerswith a complete quality managementsolution. The bi-weekly RIQAS pro-gram comprises 26 proteins and allowsassessment of analytical performancein comparison to other laboratoriesusing the same method/instrument.

Kit Provides Quantitative Determination of Haptoglobin in Human Serum


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The Council is the overall governing body of IFCC. It meets once every threeyears, usually in association with the IFCC WorldLab congress. Accordingly,

the 2011 IFCC Council meeting was held on Sunday May 15, in Berlin.Approximately 100 people, including 57 representatives from IFCC Full MemberNational Societies who were empowered to vote, attended the Council meeting.

PresentationsThe first part of the Council meeting was chaired by Paivi Laitinen (HonorarySecretary) and comprised reports from:

Graham Beastall, President; Chris Lam, Vice President; Ghassan Shannan,Treasurer; Joseph Pasarelli, Corporate Member representative; Ian Young, Chairof Scientific Division; Janet Smith, Chair of Education & Management Division;Ellis Jacobs, Chair of Communications and Publications Division

Copies of all these reports are available from the Executive Board section ofthe IFCC website www.ifcc.org

Election of Executive Board for 2012-2014:Professor Jocelyn Hicks (Past President)conducted the election of the nextExecutive Board. The following individu-als were elected to serve from January 1,2012, until December 31, 2014:

President: Graham Beastall (UK)Vice President: Howard Morris (AU)Secretary: Sergio Bernardini (IT)Treasurer: Bernard Gouget (FR)Member: Ulisses Tuma (BR)Member: Vanessa Steenkamp (ZA)Member: Larry Kricka (US)In addition, Jocelyn Hicks (US) will

continue as Past President for the dura-tion of the next Executive Board. A pho-tomontage of the new Executive Board isshown. The new Executive Boardincludes four new faces. Short biogra-phies of each of these newly appointedindividuals are included.

Prof. Howard Morris, Australia:Newly Elected Vice President of IFCCProf. Howard Morris is Professor ofMedical Science at the University ofSouth Australia and a Chief MedicalScientist in Chemical Pathology at SAPathology, Adelaide Australia. He leads aresearch group investigating the patho-physiology of metabolic bone diseaseand the effects of hormones, includingvitamin D, funded by the National Healthand Medical Research Council andAustralian Research Council, the majorcompetitive funding bodies in Australia.His latest work has identified the basis forvitamin D requirement to reduce the riskof fractures among the elderly. He wasinvited to present the Louis AvioliMemorial Lecture at the 2009 AnnualScientific Meeting of the AmericanSociety for Bone and Mineral Researchon this topic. He is also Deputy Chair of aSouth Australian Department of HealthWorking Party on Osteoporosis andFracture Prevention. He has 18 yearsexperience working in diagnostic clinicalbiochemistry in the field of immunoassayand endocrinology and continues anactive professional life in laboratory med-icine. Between 2002 and 2008, he wasthe secretary of the Scientific Division ofthe International Federation of ClinicalChemistry and Laboratory Medicine(IFCC) and a member of the IFCC TaskForce on the Global Campaign on

President’s Report from the 2011 IFCC Council Meeting

by Dr. Graham Beastall, President, IFCC

Edited by Edgard Delvin, Ph.D., FCACBIFCC members may send news to: Edgard Delvin, Ph.D., FCACB, Head, Dept of Clin Biochemistry, CHU Ste-Justine, 3175 Cote Ste-Catherine, Montreal, Quebec H3T1C5Tel: (1) 514-345-4831 (ext. 5635); E-mail: [email protected] NEWS


IFCC Executive Board (2012-2014)

Cont’d on page 44

Diabetes Mellitus. He currently is a member of theIFCC Task Force on International Clinical Liaison.Between 2003 and 2009, he was the director of theHanson Institute in Adelaide, South Australia.

Prof. Sergio Bernardini, Italy:Newly Elected Secretary of IFCCProf. Sergio Bernardini MD, PhD, currently is a fullprofessor of Clinical Biochemistry and ClinicalMolecular Biology at the Department of InternalMedicine of the University of Rome Tor Vergata, andthe head physician of the Clinical Molecular BiologyUnit at the Tor Vergata University Hospital.

He received his degree in Medicine in 1986 andthe PhD in Pediatric Sciences in 1995. He has spe-cialized in Pediatrics (1990) and in ClinicalChemistry and Biochemistry (1998).

He act as the president of the undergraduatecourse in "Diagnostic laboratory techniques in themedical field," and, as a clinical laboratory researchconsultant with Bambino Gesu’ Children’s Hospital inRome.

He is a member of the Italian Society of ClinicalBiochemistry (SiBioC), where he forms part of thecommittee of Clinical Molecular Biology, as well asthe Italian Society of Biochemistry (SIB) and theItalian Society of Allergology and Immunology(SIAIC). His international activities include member-ship of the Editorial Advisory Board of TheEncyclopedia of Life Sciences.

As a professor, he has several teaching responsi-bilities including a Bachelor’s course in diagnosticlaboratory techniques in the medical field, degreecourses in medicine, medical biotechnologies,movement sciences and postgraduate courses inClinical Biochemistry, Gastroenterology, Neurology,Medical Genetics, Allergology, and Immunology, andPediatrics.

His research interests are diverse in nature andhave included work in pediatric endocrinology withparticular interest in growth hormone and insulin likegrowth factors and their binding proteins. He hasalso worked on apoptotic pathways in oncology, inparticular neuroblastoma, as well as on glutathionetransferases, a family of enzymes involved in celldetoxification and in the control of the programmedcell death. He has collaborated in the application ofmolecular biology and proteomic methods and tech-niques in research applied to neurodegenerative dis-eases, oncology, and pharmacogenetics. Since2009, he has collaborated in the application ofmolecular biology and biochemical methods to mon-itoring of sport training and performance.

Sergio is married to Elisabetta since 1998 andhas a son, Andrew 21 years old, and a daughterMarta aged 19. His personal interests include foot-ball, the theatre, and travelling.

Prof. Vanessa Steenkamp, South Africa:Newly Elected Member of IFCC EBVanessa obtained her MSc cum laude inBiochemistry at the University of Pretoria whileemployed as a junior lecturer. She took up a positionat the South African Institute for Medical Research,now the National Health Laboratory Services in theDepartment of Endocrinology. She was appointedLecturer in the Department of Chemical Pathology,University of the Witwatersrand and obtained herPhD in Clinical Toxicology. She returned to theUniversity of Pretoria as senior lecturer in theDepartment of Urology and transferred to theDepartment of Pharmacology as head of thePhytopharmacology Unit. Vanessa’s research inter-est focuses on traditional herbal remedies and theireffect on patients, as well as the development ofmethods for the detection of these active com-pounds in biological fluids. She is also involved in

preclinical testing of traditional herbal remedies,which includes the isolation of active compoundsand development of new drugs. Vanessa is theauthor and coauthor of over 60 scientific papers. Shehas received a number of awards for her researchboth nationally and internationally, among which isthe prestigious Friedel Sellschop award, formerlyknown as the University of the Witwatersrand YoungResearcher in 2001 and Exceptional YoungResearcher of the University of Pretoria in 2006, twoof the leading academic institutions in the country. In2007, she received two international awards in herrecognition to research as a young scientist: from theInternational Association of Therapeutic DrugMonitoring and Clinical Toxicology and the AmericanAssociation of Clinical Chemistry. Currently she issupervising 15 postgraduate students.

She is the president of the African Federation ofClinical Chemistry, vice-president of the ToxicologySociety of South Africa, secretary-general of theSouth African Association of Basic and ClinicalPharmacology, treasurer of the Federation of theSouth African Society of Pathologists and past pres-ident of the South African Association of ClinicalBiochemistry. She serves as reviewer for 18 interna-tional peer-reviewed journals and is on the editorialboard of 4 journals. She has 149 conference contri-butions and has been the invited speaker on 16occasions.

Vanessa is the mother of four boys; tripletsBrendon, Dylan, Lance (10) and Jacques, 14. Bothherself and husband, Johan are very involved withcoaching of children in school sports. She is themanager of a provincial chess team (under 16). Shethoroughly enjoys gardening and nature and spendsher free time reading.

Prof. Larry J. Kricka, USA:Newly Elected Member of IFCC EBLarry J. Kricka D. Phil., FACB, CSci, CChem, FRSC,FRCPath., is professor of Pathology and LaboratoryMedicine at the University of Pennsylvania anddirector of the General Chemistry Laboratory andDirector of the Critical Care Laboratory at theUniversity of Pennsylvania Medical Center.

Awards and honors include the Society ofAnalytical Chemistry Silver Medal (Royal Society ofChemistry) (1981), British Technology GroupAcademic Enterprise Competition Award (1985),Prince of Wales Award for Innovation and Production(1989), Queens Award for TechnologicalAchievement (1990), Rank Prize for Optoelectronics(1991), the AACC Award for OutstandingContributions to Clinical Chemistry in a SelectedArea of Research (1998), and the Ullman Award(2006). In 2002 Dr. Kricka was the DistinguishedVisiting Scholar at Christ's College, Cambridge,England.

Research interests include analytical applicationsof bioluminescence and chemiluminescence, DNAprobe assays, analytical microchips for genetic andother types of testing, analytical applications of nan-otechnology, analytical interferences caused by het-erophile antibodies and direct to consumer testing.Dr. Kricka holds over 30 US patents, and is theauthor/coauthor of over 500 articles, abstracts, bookchapters, and papers, and 22 books.

He is editor-in-chief of Luminescence, a mem-ber of the editorial board of Clinical Chemistry, Lab-on-a-Chip, and Analytical Biochemistry, and pasteditor of the Journal of Immunoassay. He was pres-ident of the American Association for ClinicalChemistry in 2001, and is currently president of theInternational Society for Bioluminescence andChemiluminescence and will be a member of theInternational Federation of Clinical Chemistry andLaboratory Medicine (IFCC) Executive Boardbeginning in 2012.

Changes to the Governance:Under the chairmanship of the President, theCouncil considered and voted on a number of pro-posals for changing the governance and operation ofIFCC. Council approved:

President Elect: At the next Council elections in2014, the post of Vice President will be discontinued.The President Elect will replace it.

Terms of Office for President Elect and PastPresident: With effect from January 2015, the termof office of the Past President will be reduced fromthree years to two years. The President Elect will beelected at a time that enables him/her to take overfrom the Past President and serve for the final yearof an Executive Board, before submitting himself/herself for election as the next President

Electronic Voting: The next Council elections forthe Executive Board that will commence in 2015 willbe conducted by an electronic ballot of Full Membersrather than by personal vote at the Council meeting.

The IFCC Rules and Statutes will require amend-ment to permit these changes in governance. Thatwill be a task for the next Executive Board.

Membership Subscription: The Council noted thatthe membership subscription had remainedunchanged for 12 years. It then agreed to anincrease in the baseline membership subscriptionfrom 6.0 to 6.5 Swiss Francs per member of theNational Society. This revised membership subscrip-tion will apply from 2012 and last for at least threeyears. In order to soften the financial burden a littlethe Council also agreed to a modest differentialaccording to the wealth of the country as defined bythe World Bank. Therefore, the membership sub-scription that will apply will be:

6.5 Swiss Francs per member in High Incomecountries; 6.0 Swiss Francs per member in UpperMiddle Income countries; 5.5 Swiss Francs permember in Lower Middle Income countries; 4.0Swiss Francs per member in Low Income countries

IFCC WorldLab 2017: The President announcedthat the Executive Board, on the advice of theCommittee for Congresses and Conferences, hadselected Durban in South Africa as the host city forIFCC WorldLab 2017.

Nomination of the Editor-in-Chief of the IFCC eJournal

Gabor L. Kovacs MD,PhD, DSc, professor oflaboratory medicine atthe University of Pecs(Hungary) has beenappointed as the new edi-tor of the eJIFCC.Professor Kovacs is theDirector of the Institute ofLaboratory Medicine andVice-Rector of research

and innovation of the University of Pecs, the oldestHungarian university founded in 1367. Between2000 and 2007, he was member-at-large of theExecutive Committee of the Forum of EuropeanSocieties of Clinical Chemistry (FESCC). Hisresearch interests are related to early diagnosticmarkers in endocrinology and neuroendocrinology.He has published 431 original papers and inresponse, obtained more than 5,000 citations.Since 2004, Dr. Kovács is a member of theHungarian Academy of Sciences. The professorsucceeds Prof. Grazyna Sypniewska who has ledthe eJournal for the past 6 years. His tenure willstart on January 1, 2012.

News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine

Visit www.ifcc.org for more informationNEWSPresident’s Report from the 2011 IFCC Council Meeting


Cont’d from page 43

The Society of Medical Biochemists of Serbiaorganizes every year educational seminars super-

vised by the Chamber of Biochemists and carries sixCME credits. The 14th educational seminar entitled“Education of Medical Biochemists and Improvementof Work Quality” was held last April. The lectures were“Postgraduate Qualification in Pharmacy: TempusPQPharm Project Goals and Harmonization with theEU,” by Prof. Dr. Jelena Parojicic (Faculty ofPharmacy, University of Belgrade, Serbia), “Thedevelopment of Standardization Business andIntegrated Management System”, by Prof. Dr. VidosavMajstorovic (Faculty of Mechanical Engineering,University of Belgrade, Serbia), “The Needs, Rules,and Process of Continuing Medical Education,” byProf. Dr. Svetlana Ignjatovic (Faculty of Pharmacy,University of Belgrade, and Institute of MedicalBiochemistry, Clinical Center of Serbia, Serbia) andDr. Velibor Canic (Chamber of Biochemists ofSerbia, Serbia). Prof. Dr. Nada Majkic-Singh(Faculty of Pharmacy, University of Belgrade, andInstitute of Medical Biochemistry, Clinical Center ofSerbia, Serbia) talked about “Education andRecognition of Professional Qualifications in theField of Medical Biochemistry of Serbia.” In additionto these distinguished speakers from Serbia, wewere honored and very pleased to have two lectur-ers from the EC4 Register Commission – Dr.Simone Zerah and Ms. Janet McMurray.

The President of the EFCC ProfessionalCommittee and Chair of the EC4 RegisterCommission, Dr. Simone Zerah, spoke on theEC4 Register for Specialists in LaboratoryMedicine. She highlighted the structure and theperspective of the EC4 Register, described theaims of the Commission, and stressed the impor-tance of choosing the right name for the profes-sion and of the relations with the EuropeanCommission and Parliament. She also introducedthe foundations of the Register – EC4 Syllabus(which is in accordance with ISO/EN/15189Standard and the European Directive on therecognition of professional qualifications) and theCode of conduct (representing the ethical valuesrequired for professional behavior), and of theSelf-Regulation Database of the EuropeanEconomic and Social Committee’s Single MarketObservatory (EESC/SMO). Dr. Zerah finallyemphasized that the Register enables promotionof the profession of specialist in laboratory medi-cine in the EU and strengthens our influence at theEuropean Commission and the Parliament.

EC4 Register Commission Secretary, JanetMcMurray, elaborated about the implementation ofthe EU Directive on recognition of professionalqualifications as applied to specialists in clinicalchemistry and laboratory medicine. In her lecture,Ms. McMurray talked about systems for recogni-tion of qualifications and Directive 2005/36/EC ofthe European Parliament on the recognition ofprofessional qualifications, its effects on special-ists in laboratory medicine, common platforms,education, and training levels, as well as trainingcontents in European countries, with the review ofcurrent status of common platforms and theirfuture.

Prof. Dr. Nada Majkic-Singh followed these

excellent lectures by presenting the situa-tion of the recognition of professional quali-fications in the field of medical biochemistryin Serbia. In her talk, Prof. Majkic-Singh pre-sented the syllabus of pharmacy-medicalbiochemistry of the University of BelgradeFaculty of Pharmacy, as well as the profes-sional program of specialization and aca-demic doctoral studies in medical biochem-istry, the conditions and regulations for prac-tice and for recognition of foreign highereducation, together with equivalence ofstandard of education, training and competence incomparison with EC4 standards.

Overall, this seminar painted a clear picture of theposition of specialists in clinical chemistry and labo-ratory medicine in Europe today, of the current plat-

form on training requirements. It also gave theopportunity to realize that Serbian laboratory profes-sionals were not far removed from their Europeancolleagues in terms of their professional programsand regulations for practice.

News from the World of the International Federation of Clinical Chemistry and Laboratory MedicineVisit www.ifcc.org for more information NEWS

14th Serbian Seminar Focuses on Biochemistry Education and Training

by Snezana Jovicic, Institute of Medical Biochemistry, Clinical Center of Serbia, Belgrade, Serbia


Photo: Lecturers on Seminar from left to right: S. Ignjatoviç, V.Caniç, J. McMurray, N. Majkiç-Singh, J. Parojãiç, S. Zerah


IFCC OFFICE

Via Carlo Farini 81, 20159 Milan, ITALYTel: (39) 02-6680-9912 • Fax: (39) 02-6078-1846E-mail: [email protected] • Web: www.ifcc.orgOffice Hours: 9.00-13.00 and 14.00-18.00Staff Members: Paola Bramati, Silvia Cattaneo,Silvia Colli-Lanzi

The European directive relating tothe recognition of professional

qualifications needs to be revised bythe end of the year to facilitate themobility of European workers a littlemore, especially health professionals.The objective is to live and work inany country of the European Union,with the same rights as nationals.This is possible in part thanks to thedirective relating to professional qual-ifications (directive 2005/36/EC),which provides a system for recogniz-ing diplomas from one Europeancountry to another. More than 4600types of professionals are concerned,including doctors, biologists, andnurses, etc.

Currently, the European Commis-sion wishes to modernize this text tofix the delays in transposition intonational law and the numerous com-plaints due to time-consuming andpoorly transparent bureaucratic pro-cedures in the member countries.

The Commission published aGreen Paper last June in order to pro-vide “new tools for mobility.” It revivedthe idea of European professionalcards for the various health profes-sions that should allow access todatabases like those of the profes-sional associations of the country oforigin. Furthermore, it plans to triggeran alert mechanism throughout theEU as soon as a practitioner has losthis/her right to practice his/her spe-cialty in another member country, or

even to adjust the minimum trainingrequirements in some specialties.Professionals are also invited toexpress themselves regarding thesereforms with the idea of arriving at alegislative proposal by December2011.

Meanwhile, the 2005 directive wasnot in vain. In fact, more than 10% ofthe doctors in Austria, Belgium,Spain, Ireland, Norway, Portugal, theUnited Kingdom (up to 37%),Slovenia, Sweden, and Switzerlandare foreigners, according to a studyon European health professionalmobility conducted by the EuropeanObservatory on Health Systems andPolicies in 17 member countries, andpublished last April. There are manyreasons for expatriation, includingfinding the best working conditions ora better salary and staying togetherwith one's spouse. Efficiency alsoposes problems in some countries,which see their professionals emi-grate, leaving them with skill short-ages.

Accordingly, the European Feder-ation of Public Service Unions(EPSU) and the European Hospitaland Healthcare Employers' Associa-tion (HOSPEEM) adopted a "code ofconduct and follow up on EthicalCross-Border Recruitment andRetention in the Hospital Sector," sothat cross-border recruitment is suc-cessful and beneficial for the employ-ers and workers concerned.

Finally, mobility is also ap-proached as an opportunity by some,such as the European Hospital andHealthcare Federation (HOPE) whoare trying to promote the exchange ofbest practices by offering Europeanhealth professionals a one-monthobservation internship in another hos-pital of the EU.

Healthcare services are an essen-tial part of the European Socialmodel. This implies a multifacetedstrategy that has to take into accountthe various challenges different coun-tries are experiencing in terms ofhealthcare shortages and the reasons

why healthcare workers decide tomigrate.

Strategies, which promote ade-quate workforce supply in all coun-tries, should be supported. As EFCCmembers we can therefore encour-age, and as far as possible contributeto, the development and implementa-tion of policies at local, national andEuropean level with the purpose toenhance work force retention andpromote accessible and high-qualityhealth care in developed and devel-oping countries. On the other hand,EFCC partners in the laboratory med-icine sector acknowledge the possiblemutual benefits of migration for work-ers and employers in sending andreceiving countries, deriving from theexchange of practices, knowledge,and experience.

Anecdotally, the mobility of healthprofessions is increasing; the eco-nomic crisis experienced by someEuropean countries serves to accel-erate the phenomenon.

by Dr. Bernard GougetSFBC-EFCC Representative; Secretary General International Francophone Federation of Clinical Biology and Laboratory Medicine (FIFBCML); IFCC Executive Board Member

New Opportunities for HealthProfessional Mobility in the EU

European Federation of Clinical Chemistry and Laboratory Medicine

EFCC CORNER



Dr. Corneliu Chiriloiu, an eminentbiochemist in the “N Gh. Lupu”

Institute of Internal Medicine, died onJune 21, 2011. He was born in ArgesCounty in Romania, in 1933, and waseducated at the faculty of medicine inBucharest. He carried on a fruitfulactivity being successively appointed,researcher, senior researcher head oflaboratory, devoted his long activity toproblems of biochemistry. The mostimportant part of his activity, as aresearcher was the introduction of thenew tendencies in the methodology ofbiochemical investigation with wideimplications in the studies of generalbiology and multiple applications inclinical medicine. The laboratory ofbiochemistry headed until he retiredwas one of the standard units of theInstitute. With his team of workers, hebrought important contributions to thevalue of the study of enzymes in thediagnosis of hepatic, cardiovascular,renal, and hematopoietic diseases.His constant preoccupation was forthe standardization of methods usedin clinical laboratories. One of hismain concerns was organization ofpostgraduate courses for specialistsall over the country.

He was co-founder of the Ro-manian Society of Clinical Laborato-ry. For four years, he was formerlyactive president of the RomanianSociety of Clinical Laboratory. Dr.Chiriloiu also served for many yearsas editor in chief of RomanianJournal of Clinical Laboratory andMedical Technique. He helped todevelop research programs; he wasalso an enthusiastic member of manyother scientific medical societies.

Dr. Chiriloiu devoted a large part ofhis activity to the training of techni-cians in which he proved remarkable,

always guided by his concept that thevocation of a teacher should not beconditioned by the accumulation of anavalanche of data, in a more or lessrestricted field of clinical laboratory,but by a powerful personality able totrace the significant directions in labo-ratory. The administrative staff of clin-ical laboratory has appreciated hiscompetence as well as great kindnessand understanding. By his studies onthe pathology, he has widely con-tributed to the diagnosis, the methodsof prevention, as well as to clinical tri-als of new drugs. The results of hismanifold activities were introduced inmore than 200 publications issued inRomanian and foreign periodicals. Dr.Chiriloiu was an invaluable collabora-tor and a good fellow. Dr. Chiriloiu wasa highly committed, highly enthusias-tic. He was a model of competenceand devotion, kindness and honesty.For his valuable research activity, hewas awarded in 2011 the “Diploma ofExcelence” from Romanian Society ofLaboratory Medicine.

Aside from his lifelong devotionfor his professional activity, Dr.Corneliu Chiriloiu was also a keenlover of art and culture.

For his untiring research activityand for the permanent help and guid-ance of many series of biochemiststhe memory of Dr. Corneliu Chiriloiuwill always remain vivid in the mindof his colleagues and collaborators.He was a very kind man, genuinelydevoted to the cause of laboratorymedicine. His competence and hardwork truly set an example for theyounger generation.

Contributed by Assoc. Prof. Dr. Manole Cojocaru,

President of RSLM

Corneliu Chiriloiu, MD, PhD (1933-2011)IN MEMORIAM

On 25 February in Rome, Italy, the final conferenceof the EUROPLAN (www.europlanproject.eu/

Home.aspx) project was held. Europlan, a three-yearDG Sanco-funded project coordinated by the ItalianNational Center for Rare Diseases (Instituto Superioredi Sanita) launched in April 2008, as an instrument tohelp the European Union Member States (MS) definea strategic plan for rare diseases following the adop-tion of a Council Recommendation on an Action in theField of Rare Diseases that calls on the MS to elabo-rate and adopt a rare disease plan or strategy by theend of 2013. Europlan is an inclusive project, with 57associated and collaborating partners - including clini-cians, scientists, health authorities, and patient groupsfrom 34 countries. The Europlan project created a“toolbox” designed to aid countries determine their pri-ority areas and actions to include in a national plan.Some 15 individual EU countries hosted national con-ferences via the project. These conferences,designed to move forward the process of developinga national strategy for rare diseases, followed a for-mat based on Europlan guidance documents. Thefinal reports of these national conferences are avail-able on the Eurordis website (www.eurordis.org).

The European dimensionAt the final Europlan meeting, it was observed thatone of the strongest elements of the Europlan proj-ect was its role in adding the European dimensionto individual national strategies. This point is criticalto the field of rare diseases, which relies on coordi-nation and collaboration at the European and inter-national levels. The recent Eurobarometer surveyresults demonstrate that there is support forEuropean cooperation (www.orpha.net/actor/EuropaNews/2011/110316.html#Edito). CatherineBerens (DG Research) adduced the E-Rare project(www.e-rare.eu/) as an effective strategy for thefunding of collaborative research.

A Round Table meeting reviewed some of theoverall results of the Europlan project such as itsrole in harmonizing concepts and terminologybetween the MS and in helping to raise awarenessat the MS level for key EU documents in the field ofrare diseases and orphan drugs. During this ses-sion, the need for integrating the elements of thenational rare disease plans into the national healthcare systems was discussed. The importance ofmapping existing resources - which Orphanet, thepan-European information portal for rare diseasesand orphan drugs, is doing – was also evoked.Other elements identified include the need for inclu-sivity – i.e., involving all the various stakeholders inthe development of a national plan; the need for thenational protocols for diagnostics and care of a dis-ease to include the provisions for patient coveragefor testing and care; and the healthcare pathways –the multidisciplinary algorithms of care structured tosupport the implementation of clinical guidelinesand protocols.

At the national levelDiscussion of the status of particular countrieswas also raised. While Bulgaria has a concreteplan, accessing funding remains problematic,especially in the area of diagnostics. Croatiahopes to put forward a plan in 2012. Denmark isin a period of regression, illustrated by the coun-try’s information center exclusively for rare dis-eases that has been extended to encompass alldiseases. Greece has a plan on paper, but it is notyet legally recognized, and the country has nonational committee to implement it. There are alsosignificant problems with access to orphan drugsin Greece. Starting a process to develop a plan in

a country with 21 autonomous regions is a priorityItaly – but the country’s organization presents adaunting challenge. Italy also reports a long timefor orphan drug approvals to be processed. TheNetherlands is a country with a solid general healthplan, which could explain why the Minister ofHealth is not in favor of developing a plan specifi-cally for rare diseases. Furthermore, the country’sSteering Committee for Orphan Drugs is to beshelved at the end of 2011. In Poland, the processof elaborating a plan has not yet began, but aware-ness is increasing. Poland needs to focus on allelements of rare disease strategizing – not just theorphan drugs. Spain does have a plan, but it hasneither a budget nor a timetable. The UK seems tobe moving forward, thanks in large part to thesteam of the Rare Disease UK and similar patient-driven efforts.

A challenging dynamicWith several plans existing only on paper, othercountries such as Denmark and the Netherlandsreporting a regression, and other MS lackingresources, the dream that each MS will have a spe-cific strategy to care for its rare disease patients,and which includes cooperation between the EUcountries to share resources, is a fragile one. Thisis a critical time for each stakeholder to continueacting as a catalyst to push change forward. Therecent adoption of the Cross Border Health CareDirective increases the need for concerted effort,with each EU country identifying its pockets ofexpertise and making them known, within the con-text of acknowledging and respecting the individualdynamic of each country, particularly its size andresources. Analysis of the results of this first

Final Europlan Conference Takes Stock of Progress in National Strategies for Rare Diseases



EFCC CORNER


Cont’d on page 48

In Serbia, accreditation is granted by the Accredita-tion Body of Serbia (ATS) funded by the govern-

ment of the Republic of Serbia. Other organs of theATS are the Management Board director and theSupervisory Board. ATS became an associate mem-ber of the international Laboratory accreditationcooperation-ILAC, and it is in the process of theEuropean Cooperation for Accreditation (EA) peer-evaluation that will grant official recognition of thecertificates and reports issued by our laboratories atregional and international level by signing multilater-al agreement-MLA with EA members. It makesaccreditation a passport, which facilitates access tothe EU and international markets. Except for thosepermanent employers, assessors and technical

experts could be appointed to the ATS to be includ-ed in the process of accreditation, doing assessmentvisits, evaluating the quality of work and writingreports with clearly documented evidence.

A few years ago, another institution was respon-sible for the accreditation services in Serbia, whenthe Agency for Accreditation of health careInstitutions of Serbia was funded. Establishment ofthe program for accreditation of health care institu-tions in Serbia began as a part of Serbia Health proj-ect of the Minister of Health of the Republic of Serbiaand World Bank. This project has been tested in fourpilot hospitals and sixteen primary health care cen-ters, including medical laboratories based in theseinstitutions.

Accreditation is voluntary in the Republic ofSerbia. At this moment, only 3 medical laboratoriesare accredited according ISO 15189, and 17 accord-ing ISO 17025. The first is the Institute for MedicalBiochemistry in Clinical Center of Serbia that in 2000started working on the introduction of quality man-agement systems according to ISO 9001 standard,in 2006, on accreditation based on ISO 17025, andin 2008, on ISO 15189. Prof. S. Stankovic explainedall those different stages in medical laboratoryaccreditation in her country from her own experienceand the formalizing of initial contacts with ATS, lateron, through the application for obtaining accredita-tion, and self-assessment, preassessment visit,external assessment (evaluation by team of asses-sors), and accreditation decision which grantedaccreditation. Accreditations have to be renewedevery 4 years.

Finally, Prof. S. Stankovic concluded that thosebasic characteristics of accreditation were first, theprevailing sense of volunteerism, second, the strongtradition of self-regulation, and third, the reliance onevaluation techniques, and their primary concern forquality. But, what are the main benefits of accredita-tion? Accreditation provides prestige, excellence,accredited status, with the possibility of recognizingthe strength and the weakness of the medical labo-ratory. It is clear now that "Accreditation is a journey,and not a destination. Bon voyage!"

EFCC CORNER


Strategic Framework for Quality Management and Accreditation at Medical Laboratories in Serbia

by Sanja Stankovic, Institute for Medical Biochemistry, University School of Pharmacy & Clinical Center of Serbia


Europlan project can help refine the second leg ofthe plan, which is being funded via the upcoming DGSanco three-year joint action support to the imple-mentation of national plans/strategies on rare dis-eases and related measures to implement CouncilRecommendation and Commission Communicationon rare diseases. The second Europlan will continueto offer support and guidance to countries that have

delineated a strategy and will aid countries that havenot developed a plan to move forward, taking intoaccount the specifics of each country in terms ofsize, prioritization of measures and health care sys-tems. There will also be an emphasis on theexchange of expertise between countries, as well asidentifying outcome indicators that can be monitored.Twenty national conferences are being planned forthe second Europlan.

Final Europlan Conference Takes Stock of Progress in National Strategies for Rare Diseases

Cont’d from page 47

AA lere (Waltham, MA, USA; www.alere.com) has received the

licence for worldwide marketingrights to VitaPath’s (Foster City CA,USA; www.vpgenetics.com) spinabifida risk assessment assay, which is expected to be commerciallylaunched in 2012. In addition, Alerehas licensed the right to develop withVitaPath additional product lineextensions primarily focused in thearea of fetal health. The terms of thetransaction were not disclosed.

The assay is a genetic test thatidentifies elevated risk in women ofchildbearing age for the commonbirth defect spina bifida, which canbe prevented with high-dose folicacid under the care of a physician.

Spina bifida is the most common

permanently disabling birth defect inthe United States. Spina bifida occurswhen the backbone and spinal canaldo not close completely in the firstmonth of pregnancy.

VitaPath Genetics develops molec-ular assays to predict disorders thatcan be prevented or safely treatedwith vitamin-based therapeutics.VitaPath’s discovery and clinical vali-dation platform focuses on commonand rare functional genetic variantsthat are associated with serious dis-ease and can be remediated withminimal risk.

Alere’s global products and servic-es, as well as its new product develop-ment efforts, focus on infectious dis-ease, cardiology, oncology, drugs ofabuse, and women’s health.

Alere Inks Worldwide Marketing Rightsfor Spina Bifida Risk Assessment Test

OO raSure Technologies, Inc. (Beth-lehem, PA, USA; www.orasure.

com) will acquire privately held DNA Genotek Inc. (Ottawa, Canada;www.dnagenotek.com), a leadingprovider of oral fluid sample collec-tion, stabilization, and preparationproducts for molecular diagnosticapplications. The transaction valuedat approximately US$53 million isanticipated to close in the third quar-ter of 2011. The acquisition of DNAGenotek will strengthen OraSure’sleadership in oral fluid diagnostics, byproviding a complementary portfolio ofproducts that enable easy and reliablecollection, stabilization, transportation,and storage of high quality nucleic acid(DNA and RNA) samples. These sam-ples can then be used for a wide rangeof diagnostic and research applications.

The Oragene DNA sample collec-tion kit is DNA Genotek's lead prod-uct, providing an all-in-one system forthe collection, stabilization, trans-portation and purification of DNAfrom saliva. Genetic samples are col-lected using a simple, noninvasivemethod; collected samples may betransported and stored for extendedperiods at ambient temperatures.

DNA Genotek products are used inclinical genetic testing, pharmacoge-nomics, personalized medicine, aca-demic research, animal genetics, andlivestock genetics markets. DNAGenotek is a leading provider of oralfluid collection devices to the direct-to-consumer personal genetics testingmarket. The company supplies prod-ucts that provide substantial advan-tages over traditional methods of sam-pling such as blood or buccal swabs.

OraSure Technologies is a leaderin the development, manufacture,and distribution of oral fluid diagnos-tic devices and other technologiesdesigned to diagnose critical medicalconditions and diseases. Its innova-tive products include rapid tests forthe detection of antibodies to HumanImmunodeficiency virus (HIV) andHepatitis C virus (HCV) at the pointof care (POC) and testing solutionsfor detecting various drugs of abuse.

OraSure’s products are sold globallyto various clinical laboratories, hospi-tals, clinics, community-based organi-zations, and other public health organ-izations, distributors, governmentagencies, physicians' offices, and com-mercial and industrial entities.

OraSure Acquisition Expands Oral Fluid Diagnostics Range


INDUSTRY NEWSINDUSTRY NEWS

AA s Taiwan's elderly populationincreases the in vitro diagnostics

(IVD) market is expected to grow at astable compound annual growth rateof 6.1 per cent from 2010 to 2017.

In a new analysis, the growth part-nership company Frost & Sullivan(New York, NY, USA; www.frost.com) found that the market earnedrevenues of US$252 million in 2010and expects this to reach $381 mil-lion in 2017.

End users' growing willingness touse advanced tests and products willdrive manufacturers to introduceconstantly novel tests. Biotech partic-ipants will also be sustained by thecontinuous Government support to

standardize medical device and initia-tives to develop the country into ahealthcare hub. For example, theGovernment implemented the “TheTaiwan Diamond Plan for Biotech-nology Development” to encourageR&D, accumulate biotechnology ven-ture capital (BVC), and aid start-upenterprises.

However, the lack of clarity onreimbursement coverage for molecu-lar tests could impede the market'sgrowth. In addition, intellectual prop-erty (IP) issues and legal issues deterforeign companies from setting uptheir R&D centers in Taiwan. Thesuccess of local companies alsodepends on insurance coverage.

Increase in Elderly Population Drives IVD Market Growth

SEPTEMBER 2011RNAi and miRNA Europe. September 8-9;Munich, Germany; Web: www.selectbiosciences.com

qPCR Europe. Sep 8-9; Munich, Germany;Web: www.selectbiosciences.com

Epigenetics Europe September 8-9; Munich,Germany; Web: www.selectbiosciences.com

CAP 2011 – The Pathologists’ Meeting.September 11-14; Grapevine, TX, USA; Web:www.cap.org

7th European Course on Clinical Cytometryand 11th Euroconference on Clinical CellAnalysis. September 13-17; Dublin, Ireland;Web: www.cytometry2011.eu

19th ECDO Euroconference on Apoptosis –European Cell Death Organization. Sep 14-17; Stockholm, Sweden; Web: www.ecdo.eu

11th Analytica Latin America. September 20-22;Sao Paulo, Brazil; Web: www.analiticanet.com.br

14th Annual Meeting of the European Societyfor Clinical Virology. Sep 21-24; Funchal,Portugal; Web: www.escv.org

BCLF 2011 - 19th Annual Meeting of theBalkan Clinical Laboratory Federation.September 21-23; Bucharest, Romania; Web:www.bclf.info

36th European Congress of Cytology.September 22-25; Istanbul, Turkey; Web:www.cytologyistanbul2011.com

10th Czech National Congress of ClinicalBiochemistry. September 25-27; Pilsen, CzechRepublic; Web: www.sjezdcskb2011.cz

50th Annual ESPE Meeting – EuropeanSociety of Paediatric Endocrinology. Sept 25-28; Glasgow, UK; Web: www.espe2011.org

OCTOBER 201112th International Congress of TherapeuticDrug Monitoring & Clinical Toxicology.October 2-6; Stuttgart, Germany; Web: www.iatdmct2011.de

Biotechnica 2011. October 11-13; Hannover,Germany; Web: www.biotechnica.de

12th International Congress of HumanGenetics. October 11-15; Montreal, Quebec,Canada; Web: www.ichg2011.org

Analytica Anacon India. October 12-14;Mumbai, India; Web: www.analyticaindia.com

ASHG 2011 - Annual Meeting of theAmerican Society of Human Genetics.October 13-15; Montreal, QC, Canada; e-mail:[email protected]; Web: www.ashg.org

67th Annual Meeting of the American Societyfor Reproductive Medicine. October 15-19;Orlando, FL, USA; www.asrm.org

37th Annual Meeting of the American Societyfor Histocompatibility and Immunogenetics(ASHI). October 17-21; New Orleans, LA, USA;e-mail: [email protected]; Web: www.ashi-hla.org

26th WASPaLM – World Association ofPathology and Laboratory Medicine. October19-23; Las Vegas, NV, USA; Web: www.waspalm.org

NOVEMBER 2011Annual Assembly of the Swiss Society ofClinical Chemistry & Tri-National Congressof Laboratory Medicine. November 2-4;Zurich, Switzerland Web: www.congress-info.ch/sscc2011/p1.html

58th Annual Scientific Meeting of the

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LabMedica International Vol. 28 No. 5 • 8-9/2011


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