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.

1. Inventory Newsflash
August 2014
New Products
Disease State Plasma
Capabilities
New Inventory
Clinical Samples
Capabilities
New Inventory
Specialty blood products
Capabilities
Inventory correct at time of publication

2.  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 ?
Quick Links
Latest news >
New Product >
Disease State Plasma
Our Capabilities >
New Inventory Items >
Clinical Samples
Our Capabilities >
New Inventory Items >
Speciality Blood
Our Capabilities >
How to order >

3. 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.

4. 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

5. New Inventory: Disease State Plasma
Autoimmune Disease
Biomarker Product Code
Quantitative
results
Volume 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

6. New Inventory: Disease State Plasma
Disease
Type
Product Code
Quantitative 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 Code
Quantitative 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

7. “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.

8. 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
4
8
12
16
20
0 5 10
s/coIndexValue
Dilution Factor
Abbott Architect
Batch 1
Batch 2
Batch 3
Positive Control
Negative control
0
4
8
12
16
20
0 5 10
s/coIndexValue
Dilution Factor
Siemens Immulite
Batch 1
Batch 2
Batch 3
Positive Control
Negative control
0
4
8
12
16
20
0 5 10
s/coIndexValue
Dilution Factor
Roche COBAS
Batch 1
Batch 2
Batch 3
Positive Control
Negative control
0
4
8
12
16
20
0 5 10
s/coIndexValue Dilution Factor
BioMerieux VIDAS
Batch 1
Batch 2
Batch 3
Positive Control
Negative control

9. 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
sales@bbisolutions.com or +44 (0) 2920 767 499

10. Our Capabilities: Clinical Samples
Infectious Disease Autoimmune Thyroid Diabetes
Chlamydia pneumoniae IgA/IgG ASO Free T3 (Triiodothyronine) HbA1c
Chlamydia 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/Impairment
HCV IgG Anti-GBM Renal Failure
HBsAg / Anti-HBs Anti-Nuclear Antibodies (Includes: Pregnancy Hepatic Impairment
HBc IgM / Total Ab SS-A/Ro, SS-B/La, Sm, RNP hCG
HBeAg / HBeAb Jo-1, PM-SCL, KU, Centromere, Pre-eclampsia Oncology
HEV AMA-M2, RIB-P, RO52) Pregnancy serum AFP
HIV 1 / 2 / O Anti-Tg CA 125
HTLV-1 / HTLV-2 Anti-TPO Cardiac CA 15-3
Malaria ANCA (Anti-MPO / Anti-PR3) Cholesterol CA 19-9
Measles IgG Celiac Disease CK-MB CEA
Mycoplasma pneumoniae Crohn’s Disease D Dimer CYFRA
Parvovirus B19 Gliadin Antibodies IgA / IgG HDL PSA
Rubella IgM / IgG / Negative HAMA Hypertension
Sepsis Histone Antibodies LDL Endocrine
Syphilis IgG / IgM Rheumatoid Factor Myoglobin Cortisol
Toxo IgG / IgM / Negative SLE NT proBNP FSH
Yersinia IgG / IgM Tissue Transglutaminase Abs Triglyceride LH
Troponin I Oestradiol
Biochemistry Neurological Progesterone
Vitamin D Alzheimer’s Disease Drugs of Abuse Prolactin
Bilirubin (Total) NSE Urine SHBG
Calcium CDT Testosterone
Potassium Allergy
CRP Raised Specific IgE

11. 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

12. 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.

13. How to Order
info@bbisolutions.com
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