disease state plasma newsflash - january 2014 - bbi solutions

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Inventory Newsflash January 2014 Disease State Plasma Capabilities Current Inventory Clinical Samples Capabilities Current Inventory Specialty blood products Capabilities Inventory correct at time of publication Quality Innovation Results Partnership

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The BBI Solutions Disease State Plasma Newsflash gives details about our current inventory of disease state plasma, clinical samples and speciality blood products. This months features include our new autoimmune products and our rare infectious disease products.

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Page 1: Disease State Plasma Newsflash - January 2014 - BBI Solutions

Inventory Newsflash January 2014

Disease State PlasmaCapabilities

Current Inventory

Clinical SamplesCapabilities

Current Inventory

Specialty blood productsCapabilities

Inventory correct at time of publication

Quality InnovationResultsPartnership

Page 2: Disease State Plasma Newsflash - January 2014 - BBI Solutions

Save time and optimise your success rate by selecting from our highly characterised disease state plasma units

Have confidence in supply sustainability by choosing a partner with global collections directly from hospitals and blood banks

No longer struggle to collect a representative set of samples – we have rare materials from early disease diagnosis available

Never question quality or traceability by choosing products collected with ethics approval and donor consent when relevant, stored at a HTA licenced facility

Why choose BBI ?

Quick Links

What’s New?

Disease State PlasmaOur Capabilities >Current Inventory >

Clinical SamplesOur Capabilities >Current Inventory >

Speciality BloodOur Capabilities >

How to order >

Page 3: Disease State Plasma Newsflash - January 2014 - BBI Solutions

What’s New?

New Biosafety Level 3 labs set

up at our site in South Africa

New Defibrination Process

offered on request for many of our

DSP

New Heat Inactivation Process

available for many of our infectious

DSP

Autoimmune Disease State Plasma

A-GBM

A-RNP / A-SS-A

SAA

Infectious Disease State Plasma*:

HTLV-1 / HTLV-2

Parvovirus B19

Hepatitis E Virus

Toxoplasma IgM / IgG /

Negative

CMV IgM / IgG / Negative

Rubella IgM */ IgG / Negative

Newly Sourced Products

New Capabilities

* Arriving in February

Page 4: Disease State Plasma Newsflash - January 2014 - BBI Solutions

Our Capabilities | Disease State PlasmaInfectious Disease Autoimmune CardiacChlamydia IgG / IgM Anti-GBM CholesterolCMV IgG / IgM / Negative - NEW ANCA (Anti-MPO / Anti-PR3) HDLEBV IgG / IgM Celiac Disease HypertensionH. Pylori Crohn’s Disease LDLHAV IgG / IgM Gliadin Antibodies IgA / IgG TriglycerideHCV IgG HAMAHBsAg Rheumatoid Factor Organ Failure / ImpairmentHBc IgM / Total Ab SLE Renal FailureHBeAg / HBeAb Tissue Transglutaminase Abs Kidney TransplantHIV 1 Anti-RNP / Anti-SSA - NEW Liver TransplantHIV 2 - NEWHIV O Autoimmune Thyroid Disease Drugs of AbuseHSV 2 IgG / IgM Anti-Tg CDTHTLV-1 - NEW Anti-TPO HTLV-2 - NEW Graves Disease PregnancyHEV - NEW Hashimoto’s Disease Amniotic FluidLyme IgG / IgM Pregnancy SerumMalaria - NEW Inflammation / Allergy Chronological Bulk UrineParvovirus B19 CRPRubella IgG / Negative – NEW SAA Other BiomaterialsSyphilis IgG / IgM Specific IgE (Allergy) CSFToxoplasma IgG / IgM / Negative - NEW Urine

Diabetes SalivaBiochemistry Glucose Cord Serum

Vitamin D HbA1c

Diagnosis (Type I / II)

Page 5: Disease State Plasma Newsflash - January 2014 - BBI Solutions

Current Inventory | Disease State PlasmaInfectious Diseases

Disease Type

Product CodeQuantitative

results & other markers Tested

Volume available in stock (ml)

Collection Method

FDA Tested Negative for other virals

HAV SH265 HAV IgM >6,000 ml Apheresis Yes

HBV SH256

Hep B Core IgM Ab Hep B Core Total Ab

Hep B e AgHep B e Ab

>25,000 ml Recovered Yes

HCV SH259Viral loadGenotype

~1,000 ml Recovered Yes

HIV SH315RNA+, Ab+Viral LoadGenotype

>20,000 ml Recovered Yes

Syphilis SH266 TPHA, RPR, IgM >9,000 ml Recovered Yes

Toxoplasma SH275 Toxo IgM >1,000 ml Recovered Yes

Page 6: Disease State Plasma Newsflash - January 2014 - BBI Solutions

Current Inventory | Disease State PlasmaAutoimmune / Non-infectious Diseases

Disease Type Product CodeQuantitative

resultsVolume available in

stock (ml)Collection

Method

FDA Tested Negative for other virals

A-GBM SH336 Yes >11,000 ml Apheresis Yes

dsDNA SH237 Yes >10,000 ml Apheresis Yes

p-ANCA (MPO) SH152 Yes >12,000 ml Apheresis Yes

SAA SH127 Yes >12,000 ml Apheresis Yes

Anti-RNP /Anti-SS-A (Ro)

SH293 Yes >6,000ml Apheresis Yes

Celiac Disease SH235 Yes >1,000 ml Apheresis Yes

Thyroid Disease SH245 / SH244 Yes >100,000 ml Apheresis CE marked

Allergy / Raised IgE SH166 / SH234 Yes >5,000 ml Apheresis Yes

Pregnancy(1st / 2nd / 3rd trimester)

SH285 / SH283 / SH284

Yes >10,000 ml Apheresis Yes

Renal Failure SH507 Yes >3,000 ml Apheresis Yes

Contraceptive Pill Positive

SH312 No >4,000 ml Apheresis Yes

Page 7: Disease State Plasma Newsflash - January 2014 - BBI Solutions

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

Page 8: Disease State Plasma Newsflash - January 2014 - BBI Solutions

Current Inventory

Code no. Description Type Characteristics

SHK510-4GHIV Plasma

PanelGenotyped

Genotypes B, C, F and K Testing results for multiple markers Quantitative viral load result

SHK510-4HCHIV Plasma

PanelHighly Characterised

Testing results for multiple markers Quantitative viral load result

SHK256-4RSHBsAg Plasma

PanelRare specimen

Rare combination of HBV markers, including early stages Testing results for multiple markers

SHK259-4HCHCV Plasma

PanelHighly Characterised

Quantitative viral load result Genotyping results Semi-quantitative methods for serology / NAT

SHK266-4HCSyphilis Plasma

PanelHighly characterised

Testing results for multiple markers Syphilis IgM status

SHK505-0 SH505-1

SHK505-2

Toxoplasma Plasma Panel

Characterised Quantitative IgG & semi-quantitative IgM results IgM avidity testing data

SG202-4Parvovirus Plasma

PanelCharacterised

Consecutive samples over 7 - 14 days IgG & IgM levels measured by PCR & ELISA

Panel specifications

Citrated plasma Extensive donor demographics Tested for HIV1 & 2 Abs, HBsAg, HCV Ab,

HIV-1/HBV/HCV PCR and Syphilis Individual donors (no duplicates) Donor consent

Infectious Disease Panels

Page 9: Disease State Plasma Newsflash - January 2014 - BBI Solutions

Current Inventory | Clinical Samples

Code No. Marker Category Panel Type Matrix IRB

SG186-1 HbA1c Diabetes High Titre W/Blood Y

SG336 Type I Diabetes Diabetes Diagnosis Serum Y

SG187-1/2 Diabetes Type II Diabetes  DiagnosisK2 EDTA Plasma /

SerumY

SG316-2 FSH Endocrine Mixed Titre * Serum  Y

SG608-2 Procalcitonin Endocrine Mixed Titre Serum Y

SG369-2 Progesterone Endocrine  High Titre Serum  Y

SG490-2 SHBG Endocrine Mixed Titre * Serum Y

SG360-2 AFP Oncology Mixed Titre * Serum Y

SG355-2 CA125 Oncology High Titre Serum Y

SG362-2 CA15-3 Oncology High Titre Serum Y

SG321-2 CEA Oncology High Titre Serum Y

SG358-2 CA19-9 Oncology High Titre Serum Y

NEW CYFRA 21-1 Oncology Mixed Titre * Serum Y

SG317-2 PSA Oncology Mixed Titre Serum Y

Non-Infectious Disease Panels (1)

* Many of the Mixed Titre samples fall within the clinically significant range

Page 10: Disease State Plasma Newsflash - January 2014 - BBI Solutions

Current Inventory | Clinical Samples

Code No. Marker Category Panel Type Matrix IRB

SG320-2 CRP Biochemistry Mixed Titre * Serum Y

SG323-2 cTnI Cardiac Mixed Titre * Serum Y

SG324-4 D Dimer Cardiac Low Titre Citrate Pl. Y

SG587-2 Triglyceride Cardiac  Mixed Titre * Serum Y

SG312-2 Free T3 Thyroid Mixed Titre *  Serum Y

SG313-2 Free T4 Thyroid Mixed Titre *  Serum Y

SG314-2 TSH Thyroid High Titre  Serum  Y

SG505-2 Hepatic Impairment Organ Failure / Impairment High Titre  Serum  Y

SG507-2 Renal Failure Organ Failure / Impairment

 High Titre Serum Y

SG522 Alzheimer's Disease Neurological DiagnosisLith Hep / EDTA

PlasmaY

SG383-2 Pregnancy Pregnancy 1st Trimester Serum Y

SG384-2 Pregnancy Pregnancy 3rd Trimester Serum Y

SG335-2 Coeliac Disease Autoimmune Diagnosis Serum Y

SG521-2 Crohn’s Autoimmune Diagnosis Serum  Y

Non-Infectious Disease Panels (2)

* Many of the Mixed Titre samples fall within the clinically significant range

Page 11: Disease State Plasma Newsflash - January 2014 - BBI Solutions

Current Inventory | Clinical Samples

Code No. Marker Category Panel Type Matrix IRB

SG508-2 Allergy (Specific IgE+) Allergy Mixed Titre Serum Y

d1 House Dust Mite, European (Dermatophagoides pteronyssinus)

d2 House Dust Mite, American (Dermatophagoides farinae)

e1 Cat dander (Felis domesticus)

e3 Horse dander (Equus caballus)

e5 Dog dander (Canis familiaris)

e82 Rabbit epithelium (Oryctolagus cuniculus)

f1 Egg White (Gallus spp.)

f13 Peanut (Arachis hypogaea)

f2 Cow's Milk (Bos spp.)

f84 Kiwi (Actinidia deliciosa)

g6 Timothy grass pollen (Phleum pratense)

i3 Common wasp, Yellow jacket wasp venom (Vespula spp.)

t2 Grey alder pollen (Alnus incana)

t3 Common silver birch pollen (Betula verrucosa)

t4 Hazel pollen (Corylus avellana)

Non-Infectious Disease Panels (3)

Page 12: Disease State Plasma Newsflash - January 2014 - BBI Solutions

Current Inventory | Clinical Samples

Code No. Marker Category Panel Type Matrix IRB

SG375-2 Normal Healthy Donors Serum

25 donors, 2 x 1ml drawn from each donor

Male & female donors Not viral tested

N

SG609-2 Normal, Female Healthy Donors Serum Minimum volume of 2ml Collected and frozen

within 24 hours Age, Gender, Race,

Collection Date Non viral tested

N

SG610-2Normal,

MaleHealthy Donors Serum N

SG609-6 Normal, Female Healthy Donors Lith Hep Plasma Drawn from hospitalised non-cardiac patients

Minimum volume of 2ml Collected and frozen

within 24 hours Age, Gender, Race,

Collection Date, Confirmation of non-cardiac status,

Non viral tested

N

SG610-6Normal,

MaleHealthy Donors Lith Hep Plasma N

Normal, Health Donor Panels (1)

Stephane Argivier
There is no mix titers for normals as there is no biomarker tested
Page 13: Disease State Plasma Newsflash - January 2014 - BBI Solutions

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

Page 14: Disease State Plasma Newsflash - January 2014 - BBI Solutions

How to Order

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

Defibrination service

Heat inactivation

Pooling service

Custom testing / screening

Custom specifications for products

requiring regular supply for production

[email protected]

USA: 1-800-423-8199

Intl: +44 (0) 2920 747 232

Quote on ordering – NF JAN