Annex 1
Update notice: This Annex was updated following the issue of Change Notification 02 - 2009
Standards available
at the National Institute for Biological Standards and Control (NIBSC)
The following details
some of the various standards and reference materials available from NIBSC relevant
to transfusion medicine. A catalogue is available from NIBSC on request and on the
website www.nibsc.ac.uk.
Table A1.1 Serological, virological
and other preparations
| Serological |
Status |
Code |
| Anti-Human Platelet Antigen-1a minimum potency reagent |
IRR |
05/106 |
| Anti-Human Platelet Antigen-5b minimum potency reagent |
IRR |
99/666 |
| Anti-Human Platelet Antigen-3a minimum potency reagent |
IRR |
03/190 |
Anti-Human Platelet Antigen-1a Intended for quantitation of anti-HPA-1a in International units |
IS |
03/152 |
| Anti-A minimum potency for blood grouping reagents |
IS |
03/188 |
| Anti-B minimum potency for blood grouping reagents |
IS |
03/164 |
Anti-D minimum potency for blood grouping reagents Intended to be used as the reference preparation for minimum acceptable potency of anti-D blood grouping reagents |
IS |
99/836 |
Anti-D (Rho) antibodies, human Intended to be used in the assay of plasma/serum anti-D levels by automated haemagglutination |
B† |
73/515 |
| Anti-c incomplete blood typing serum, human |
IS |
W1007 (67/160) |
Anti-c serum, human Intended to be used in the assay of plasma/serum anti-c levels by automated haemagglutination |
B† |
84/628 |
| Anti-C complete blood typing serum, human |
IS |
W1004 |
| Anti-E complete blood typing serum, human |
IS |
W1005 |
Anti-D for operator proficiency* Intended to be used to assure the efficacy of red cell washing prior to the addition of an anti-globulin reagent, and to assess operator variability in the detection of weak, macroscopic agglutination in the spin-tube anti-globulin test |
B |
95/784 |
| Anti-human globulin |
ICSH/ISBT |
96/666 |
| Papain preparation for use with anti-D preparation 91/562* |
ICSH/ISBT |
92/658 |
Anti-D for use with papain preparation 92/658* Intended to check the efficacy of enzyme preparations |
ICSH/ISBT |
91/562 |
Anti-D immunoglobulin, human Intended for use in anti-D potency assays of anti-D immunoglobulin products |
IS |
01/572 |
Anti-D immunoglobulin control* Intended for use as a control in anti-D potency assays of anti-D immunoglobulin products to monitor assay consistency |
NR |
99/728 |
Biotinylated Brad-5 (Bio-Brad-5)* Intended for use in the competitive enzyme-linked immunoassay of potency of anti-D immunoglobulin products |
NR |
99/698 |
Negative control for FCXM* For use in flow cytometry cross matching (FCXM) and anti-HLA serology |
B† |
02/282 |
Minimum potency positive control for FCXM* For use in flow cytometry cross matching (FCXM) and anti-HLA serology |
B† |
07/214 |
Virological |
| Anti-HAV Immunoglobulin |
IS |
97/646 |
| Anti-HBc |
IS |
95/522 |
| Anti-HBs Immunoglobulin |
IS |
07/164 |
| Anti-measles serum (for use in neutralization assays only) |
IS |
97/648 |
| Anti-parvovirus B19 serum (IgG), human |
IS |
01/602 |
| Anti-VZ Immunoglobulin |
IS |
W1044 |
| Anti-poliovirus serum, types 1, 2 and 3 |
IS |
82/585 |
| Anti-rubella serum |
B† |
67/182 |
| Hepatitis B surface antigen (HBsAg) (subtype adw2, genotype A) |
IS |
00/588 |
| Hepatitis A virus RNA |
IS |
00/560 |
| Hepatitis C virus RNA |
IS |
06/100 |
| HCV genotype panel |
NR |
02/202 |
| Hepatitis B virus DNA |
IS |
97/750 |
| HIV-1 p24 antigen |
IRR |
90/636 |
| HIV-1 RNA for NAT |
IS |
97/650 |
| HIV-1 RNA genotype reference panel |
IRR |
01/466 |
| Anti-HIV-1 British Working Standard (1 in 5 dilution)* |
B† |
99/710 |
| Low level control materials for HBsAg and anti-HCV |
B† |
See NIBSC catalogue for current batches |
| Anti-HIV-1 British Working Standard* |
B† |
99/750 |
| Anti-HIV reference panel |
IRR |
02/210 |
| Anti-HIV-2 Monitor Sample* |
NR† |
99/674 |
| Anti-HTLV-1 Monitor Sample* |
NR† |
03/104 |
| Parvovirus B19 DNA |
IS |
99/800 |
| NAT working reagent for HAV RNA* |
NR |
01/488 |
| NAT working reagent for HBV DNA* |
NR |
05/148 |
| NAT working reagent for HCV RNA* |
NR† |
02/264 |
| NAT working reagent 1 for HIV-1 RNA (medium copy number)* |
NR† |
99/634 |
| NAT working reagent 2 for HIV-1 RNA (high copy number)* |
NR† |
99/636 |
| NAT Working Reagent 3 for HIV-1 RNA (low copy number)* |
NR |
05/158 |
| NAT working reagent for B19 DNA* |
NR |
99/736 |
| NAT working reagent for multiplex (HCV, HBV, HBV, HIV, B19)* |
NR |
99/732 |
| Endotoxin |
IS |
94/580 |
| Tetanus antitoxin |
NR |
76/589 |
See the NIBSC website for details of materials currently available
Key
IRR – International Reference Reagent or Panel
IS – International Standard
ICSH/ISBT – International Committee for Standardization in Haematology/International Society of Blood Transfusion
B – British Standard/Reference Reagent
NR – NIBSC Reagent
* Working Standards supplied as multiples of 5
† CE marked
Table A1.2 Coagulation preparations – WHO International Standards
| Factor |
Plasma |
Concentrate |
Purified |
Code |
| ATIII |
 |
|
|
93/768 |
| ATIII |
|
 |
|
06/166 |
| Fibrinogen |
 |
|
|
98/612 |
| Fibrinogen |
|
 |
|
98/614 |
| II |
 |
|
|
99/826 |
| II |
|
 |
|
98/590 |
| IX |
 |
|
|
99/826 |
| IX |
|
 |
|
07/182 |
| IXa |
|
|
 |
97/562 |
| Protein C |
 |
|
|
02/342 |
| Protein C |
|
 |
|
04/252 |
| Protein S |
 |
|
|
03/228 |
| Thrombin |
|
|
 |
01/580 |
| V |
 |
|
|
03/116 |
| VII |
 |
|
|
99/826 |
| VIIa |
|
 |
|
07/228 |
| VII |
|
 |
|
97/592 |
| VIII |
 |
|
|
02/150 |
| VIII |
|
 |
|
99/678 |
| VWF |
 |
|
|
02/150 |
| VWF |
|
 |
|
00/514 |
| X |
 |
|
|
99/826 |
| X |
|
 |
|
98/590 |
| XI |
 |
|
|
04/102 |
| XIII |
 |
|
|
02/206 |
Table A1.3 Coagulation preparations – British Standards
| Preparation |
Code |
| Blood Coagulation Factor VIII, Concentrate, Human (12th BS)* |
02/122 |
| Blood Coagulation Factors II, IX, X, Concentrate, Human (5th BS)* |
02/162 |
* Working Standards supplied as multiples of 5
How to order
NIBSC does not charge for the reference materials themselves; however, there is a handling charge to part-cover administration and storage costs. The current handling charge (from the 1st April 2008) is GB £58.00 per ampoule/vial. Those preparations identified as 'working standards' are supplied as multiples of five with a current handling charge of GB £75.00 per five ampoules/vials. Panels are £117.50. NIBSC periodically adjusts the handling charge. Any changes to the handling charge are detailed on our website (www.nibsc.ac.uk). This handling charge covers the shipping cost of preparations that can be dispatched by (air) mail.
You can place an order by:
Mail: NIBSC, PO Box 1193, Blanche Lane, South Mimms, Potters Bar, Herts, EN6 3QH, United Kingdom
Fax: +44 (0) 1707 641064
E-mail: standards@nibsc.ac.uk
Telephone: +44 (0) 1707 641467, with 24 hour answer-phone (for enquiries only)
Orders should include the following information:
- your full dispatch address and invoice address (if different).
- your purchase order number.
- for EU customers, your VAT number or VAT exemption certificate.
- for each item ordered, the NIBSC code number, preparation name and number of ampoules/vials required.
- for preparations that are to be sent by courier/air freight, we must have a contact name along with both contact telephone and fax numbers.
- your e-mail address or fax number. We will acknowledge receipt of your order. We would prefer to contact you by e-mail.
In addition, orders for infectious materials must be ordered on an NIBSC order form for infectious materials. These forms are available from our website www.nibsc.ac.uk.