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Disease State Plasma

Disease State Plasma

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Page 1: Disease State Plasma

Disease State Plasma

Page 2: Disease State Plasma

“We identify rare materials for early disease or esoteric

markers through our extensive screening

programme”

Save time & optimise your success rate - highly characterised disease state plasma units. Large inventory stored at our facilities

Confidence in supply - collecting directly from hospitals and blood banks

Quality/traceability - materials collected

with ethics approval and/or donor consent when relevant, storage at a HTA licenced facility

Global operations - Facilities in the UK and Containment Level 3 laboratories in South Africa to process infectious disease state plasma

Disease state plasma and clinical specimens

Page 3: Disease State Plasma

Local sourcing in three continents

Partnerships with local

blood banks and

hospitals

Shipping hubs in three

continents

Ethical & regulatory

compliance

CL2 laboratory Non-infectious DSP

collection at source Screening Processing Testing

CL3 laboratory Infectious DSP

collection at source Can be collected

liquid 2-8C Screening / viral

load testing / genotyping

Processing Testing

Kent, UK

Cape Town, South Africa

Page 4: Disease State Plasma

Suggested disease phase *Number of Units

characterised in 20131) HBV, Early Acute Phase 62) HBV, Acute Phase (Infectious & Carrier), HBcAb 33) HBV, Early Acute Phase (infectious), HBeAg 24)N HBV, Acute Phase (Infectious & Carrier), HBeAg & HBcAb 25) HBV, Acute Phase (Carrier), HBc IgM 36) HBV, Late Acute Phase 101

Hepatitis B screening program

* Suggestions based on biomarker results interpretation, not actual diagnosis

Page 5: Disease State Plasma

Hepatitis B screening

programme

HCV / HIV Recovered

Plasma

Syphilis Recovered

Plasma

Specialty infectious disease state plasma

• Units of 250ml• Semi-quantitative

immunological data• Viral load &

genotyping data• Donor consent

• Units of 250ml +• Large range of titres• Donor consent• Measured MHA-TP

ratio from 1:4 through to 1:256

• Rare early acute phase• Screened for numerous

analytes:

HbSAg Hep B Core IgM Ab Hep B Core Total Ab Hep B e Ag Hep B e Ab

Page 6: Disease State Plasma

On-going autoimmune disease state plasma screening programme Regular supply - screening programme

to characterise over 40L of autoimmune disease state plasma every month

High quality products - collect under ethics approval, and carry out viral testing

The best results - test for numerous markers and provide extensive characterisation data

Customisation for bulk - pool process units and QC to meet defined specifications

Current Inventory:

A-GBM

ANCA (Anti-PR3 / Anti-MPO)

A-RNP / A-SS-A

SAA / CRP

RF

Celiac Disease

Crohn’s Disease

A-Tg

A-TPO

Page 7: Disease State Plasma

Infectious Disease Autoimmune Cardiac Chlamydia IgG / IgM

Anti-GBM Anti-RNP / Anti-SSA

Cholesterol

CMV IgG / IgM / Negative ANCA (Anti-MPO / Anti-PR3) HDL EBV IgG / IgM Celiac Disease Hypertension H. Pylori Crohn’s Disease LDL HAV IgG / IgM Gliadin Antibodies IgA / IgG Triglyceride HCV IgG HAMA HBsAg Rheumatoid Factor Organ Failure / Impairment HBc IgM / Total Ab SLE Renal Failure HBeAg / HBeAb Tissue Transglutaminase Abs Kidney Transplant HIV 1 Liver Transplant HIV 2 Autoimmune Thyroid Disease HIV O Anti-Tg Drugs of Abuse HSV 2 IgG / IgM Anti-TPO CDT HTLV-1 Graves Disease HTLV-2 Hashimoto’s Disease Pregnancy HEV Amniotic Fluid Lyme IgG / IgM Diabetes Pregnancy Serum Malaria Glucose Chronological Bulk Urine Parvovirus B19 HbA1c Rubella IgG / Negative Diagnosis (Type I / II) Syphilis IgG / IgM Other Biomaterials Toxoplasma IgG / IgM / Negative Inflammation / Allergy CSF

CRP UrineBiochemistry SAA Saliva Vitamin D Specific IgE (Allergy) Cord Serum

Our capabilities | Disease State Plasma

Page 8: Disease State Plasma

Infectious disease clinical sample panels

Our clinical sample panels are readily available - saving you time when validating your assay

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

HIV Positive Panel

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

HBsAg Positive Panel

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

Page 9: Disease State Plasma

Our capabilities | Clinical SamplesInfectious Disease Autoimmune Cardiac Chlamydia pneumoniae IgA/IgG ASO Cholesterol Chlamydia trachomatis IgA/IgG Anti-Cardiolipin CK-MB CMV IgG / IgM / Negative Anti-CCP D Dimer EBV Anti-dsDNA HDL HCV IgG Anti-GBM Hypertension HBsAg / Anti-HBs Anti-Nuclear Antibodies (Includes: LDL HBc IgM / Total Ab SS-A/Ro, SS-B/La, Sm, RNP, Scl-70, Myoglobin HBeAg / HBeAb Jo-1, PM-SCL, KU, Centromere, NT proBNP HEV AMA-M2, RIB-P, RO52) – NEW Triglyceride HIV 1 Anti-Tg Troponin I HIV 2 Anti-TPO HIV O ANCA (Anti-MPO / Anti-PR3) Neurological HTLV-1 Celiac Disease Alzheimer’s Disease HTLV-2 Crohn’s Disease NSE Malaria Gliadin Antibodies IgA / IgG Measles IgG HAMA Diabetes Mycoplasma pneumoniae Histone Antibodies HbA1c Parvovirus B19 Rheumatoid Factor Diagnosis (Type I / II) Rubella IgM / IgG / Negative SLE Sepsis Tissue Transglutaminase Abs Organ Failure/Impairment Syphilis IgG / IgM Renal Failure Toxoplasma IgG / IgM / Negative Oncology Hepatic Impairment Yersinia IgG / IgM AFP

CA 125 EndocrinePregnancy CA 15-3 Cortisol hCG CA 19-9 FSH Pre-eclampsia CEA LH Pregnancy serum (1st/2nd/3rd trimesters) CYFRA Oestradiol

PSA ProgesteroneBiochemistry Prolactin Vitamin D Thyroid SHBG Bilirubin (Total) Free T3 (Triiodothyronine) Testosterone Calcium Free T4 (Thyroxine) Potassium Parathyroid Hormone (PTH) Drugs of Abuse CRP TSH Urine

CDTAllergy Raised Specific IgE

Page 10: Disease State Plasma

Custom Plasma collection – Custom anticoagulant, capabilities of >500L per month

“Packed” red cells available in bulk

Access to various normal patient samples demographics to allow representative testing cohorts

Custom control of the pre-analytical phase available

“Looking for something specific? We offer custom collections to meet your

inclusion/exclusion criteria”

Our capabilities | Normal Blood Products