disease state plasma newsflash - august 2014 - bbi solutions
DESCRIPTION
In this month’s newsflash view our latest inventory of autoimmune, infectious disease and ethically approved disease state plasma units. You can also find out about our ethics approval scheme and our speciality blood products.TRANSCRIPT
Inventory Newsflash August 2014
New Products
Disease State PlasmaCapabilities
New Inventory
Clinical SamplesCapabilities
New Inventory
Specialty blood productsCapabilities
Inventory correct at time of publication
Save time and optimise your success rate by selecting from our highly characterised disease state plasma units.
Have confidence in supply sustainability and traceability by choosing a trusted partner with global collections directly from hospitals and blood banks.
Representative set of samples – we have rare materials from early disease diagnosis available, stored at a HTA licenced facility.
Many of our disease state plasma, samples and remnant materials are collected with ethics approval and donor consent when relevant.
Why choose BBI ?
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Latest News
Ethics approval / IRB recently granted for our following infectious disease plasma units:
HIV HBV HCV Syphilis
Increased inventory levels, and an improved turnaround time on our screening programs taking place at both our UK and South African facilities.
Ethics approval – key facts
Specimen donors participate voluntarily and give prior informed consent in accordance with local regulations and practices.
Ethics approval / IRB is a mandatory FDA requirement for 510k submission for a new diagnostic device.
Remnant samples are often exempt from consenting process when delinked from patient / donor identifiable data.
Many of our patient samples have ethics approval / IRB.
Infectious Disease Autoimmune Cardiac
Chlamydia IgG / IgM Anti-GBM Cholesterol
CMV IgG / IgM / Negative Anti-RNP / Anti-SSA HDL
EBV IgG / IgM ANCA (Anti-MPO / Anti-PR3) Hypertension
H. Pylori Celiac Disease LDL
HAV IgG / IgM Crohn’s Disease Triglyceride
HCV IgG Gliadin Antibodies IgA / IgG
HBsAg HAMA Organ Failure / Impairment
HBc IgM / Total Ab Rheumatoid Factor Renal Failure
HBeAg / HBeAb SLE / dsDNA Ab Kidney Transplant
HIV 1 Tissue Transglutaminase Abs Liver Transplant
HIV 2 Anti-CCP Negative - NEW
HIV O Intrinsic Factor Ab – NEW Diabetes
HSV 2 IgG / IgM VGKC Ab - NEW Glucose
HTLV-1 HbA1c
HTLV-2 Autoimmune Thyroid Disease Diagnosis (Type I / II)
HEV Anti-Tg
Lyme IgG / IgM Anti-TPO Pregnancy
Malaria Graves Disease Amniotic Fluid
Parvovirus B19 Hashimoto’s Disease Pregnancy Serum
Rubella IgG / Negative Chronological Bulk Urine
Rubella IgM – NEW Inflammation / Allergy
Syphilis IgG / IgM CRP Other Biomaterials
Toxoplasma IgG / IgM / Negative SAA CSF
Specific IgE (Allergy) Urine
Biochemistry Saliva
Vitamin D Drugs of Abuse Cord Serum
CDT
Our Capabilities: Disease State Plasma
New Inventory: Disease State Plasma
Autoimmune Disease
Biomarker Product CodeQuantitative
resultsVolume available
in stock (ml)Collection
Method
FDA Tested Negative for other virals
Serum Amyloid A SH127-3 Yes >5,000 ml Apheresis Yes
Voltage Gated Potassium Channel Ab
SH128-3 Yes >2,500 ml Apheresis Yes
p-ANCA (MPO) Ab SH152-3 Yes >9,000 ml Apheresis Yes
dsDNA Ab SH237-3 Yes >2,500 ml Apheresis Yes
Intrinsic Factor Ab SH448-3 Yes >3,000 ml Apheresis Yes
Anti-CCP Negative SH159-3 Yes >11,000 ml Apheresis Yes
New Inventory: Disease State Plasma
Disease Type
Product CodeQuantitative
results & other markers Tested
Volume available in stock (ml)
Collection Method
FDA Tested Negative for other virals
Rubella IgM SH252-9 Rubella IgM >6,000 ml Synthetic Matrix Yes
Hepatitis E SH264-4 Viral Load / Serology / Genotype
~200 ml Recovered Yes
HAV SH265-4 S/CO Ratio >5 ~1,500 ml Apheresis Yes
Infectious Disease
Ethically Approved
Disease Type
Product CodeQuantitative
results & other markers Tested
Volume available in stock (ml)
Collection Method
FDA Tested Negative for other virals
Syphilis SH266-4 RPR / TPHA > 6,000 ml Recovered Yes
HCV SH259-4 Viral Load / Serology / Genotype
> 1,500 ml Recovered Yes
“Our synthetic rubella IgM serum is an
economical alternative to native serum”
New Product: Synthetic Rubella IgM Serum
What is synthetic rubella IgM serum?
A human monoclonal rubella IgM antibody formulated in a delipidated, defibrinated plasma.
Why do we need it?
Native disease state plasma is used in the manufacture of controls and calibrators. However, since most people are vaccinated for rubella at a young age it is very difficult to source a native plasma. Our synthetic rubella IgM serum is a great alternative to native disease state plasma for the consistent manufacture of controls and calibrators.
Our results demonstrate that synthetic rubella IgM serum is comparable with a native sample, and has excellent batch to batch consistency across a dynamic range.
Proven performance on the top commercial testing platforms
0 1 2 3 4 5 6 7 8 9 100
4
8
12
16
20Abbott Architect
Batch 1
Batch 2
Batch 3
Positive Control
Negative controlDilution Factor
s/co
In
dex
Val
ue
0 1 2 3 4 5 6 7 8 9 10048
121620
Siemens Immulite
Batch 1
Batch 2
Batch 3
Positive Control
Negative controlDilution Factor
s/co
In
dex
Val
ue
0 1 2 3 4 5 6 7 8 9 10048
121620
Roche COBAS
Batch 1
Batch 2
Batch 3
Positive Control
Negative controlDilution Factor
s/co
In
dex
Val
ue
0 1 2 3 4 5 6 7 8 9 10048
121620
BioMerieux VIDAS
Batch 1
Batch 2
Batch 3
Positive Control
Negative controlDilution Factors/
co I
nd
ex V
alu
e
Why use this product in your next control?
Eliminate the supply issues often faced when sourcing rare native rubella IgM serum
Have confidence in a product with proven performance across various commercial platforms
Ensure correct results every time with no batch to batch variations
Use a product with a high efficacy to the disease, eliminating the need for infected donors.
Eliminate false positives with a product with that has been proven to not detect IgG
Order your evaluation sample today
[email protected] or +44 (0) 2920 767 499
Our Capabilities: Clinical Samples
Infectious Disease Autoimmune Thyroid DiabetesChlamydia pneumoniae IgA/IgG ASO Free T3 (Triiodothyronine) HbA1cChlamydia trachomatis IgA/IgG Anti-Cardiolipin Free T4 (Thyroxine) Diagnosis (Type I / II)CMV IgG / IgM / Negative Anti-CCP Parathyroid Hormone (PTH)EBV Anti-dsDNA TSH Organ Failure/ImpairmentHCV IgG Anti-GBM Renal FailureHBsAg / Anti-HBs Anti-Nuclear Antibodies (Includes: Pregnancy Hepatic ImpairmentHBc IgM / Total Ab SS-A/Ro, SS-B/La, Sm, RNP hCGHBeAg / HBeAb Jo-1, PM-SCL, KU, Centromere, Pre-eclampsia OncologyHEV AMA-M2, RIB-P, RO52) Pregnancy serum AFPHIV 1 / 2 / O Anti-Tg CA 125HTLV-1 / HTLV-2 Anti-TPO Cardiac CA 15-3Malaria ANCA (Anti-MPO / Anti-PR3) Cholesterol CA 19-9Measles IgG Celiac Disease CK-MB CEAMycoplasma pneumoniae Crohn’s Disease D Dimer CYFRAParvovirus B19 Gliadin Antibodies IgA / IgG HDL PSA
Rubella IgM / IgG / Negative HAMA HypertensionSepsis Histone Antibodies LDL EndocrineSyphilis IgG / IgM Rheumatoid Factor Myoglobin CortisolToxo IgG / IgM / Negative SLE NT proBNP FSHYersinia IgG / IgM Tissue Transglutaminase Abs Triglyceride LH
Troponin I Oestradiol
Biochemistry Neurological ProgesteroneVitamin D Alzheimer’s Disease Drugs of Abuse ProlactinBilirubin (Total) NSE Urine SHBG
Calcium CDT Testosterone
Potassium Allergy
CRP Raised Specific IgE
New Inventory: Clinical Samples
Code No. Marker Category Panel Type Matrix
SG338-2 Toxoplasma IgG ToRCH Positive Serum
SG340-2 Toxoplasma IgM ToRCH Positive Serum
SG342-2 CMV IgG ToRCH Positive Serum
SG350-2 Rubella IgG ToRCH Positive Serum
SG352-2 Rubella IgM ToRCH Positive Serum
Infectious Disease Panels
Supplied with . . .
Age Gender Draw date Testing method
Our Capabilities: Specialty Blood Products
Normal serum and plasma and
speciality products in a variety of
anticoagulants.
Range of volume from 1ml to full single
serum / plasma units.
Large scale collections possible
>1,000 L.
Custom control of the pre-analytical
phase available.
Custom Plasma collection in FDA licensed facilities
Custom anticoagulant, capabilities of >500L per month.
“Packed” red cells
Available in bulk in K3-EDTA.
How to Order
USA: 1-800-423-8199
Intl: +44 (0) 2920 747 232
Quote NFAUG on ordering
Please get in touch to arrange a quote for any of our products.
If you can’t find what you are looking for, take a look at some of our customised services:
Custom collections
Pooling service
Custom testing / screening
Custom specifications for products
requiring regular supply for production