UK Blood Transfusion & Tissue Transplantation Services
Guidelines for the Blood Transfusion
Services in the UK


   Print friendly version

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 yes

93/768
ATIII
yes
06/166
Fibrinogen yes

98/612
Fibrinogen
yes
98/614
II yes

99/826
II
yes
98/590
IX yes

99/826
IX
yes
07/182
IXa

yes 97/562
Protein C yes

02/342
Protein C
yes
04/252
Protein S yes

03/228
Thrombin

yes 01/580
V yes

03/116
VII yes

99/826
VIIa
yes
07/228
VII
yes
97/592
VIII yes

02/150
VIII
yes
99/678
VWF yes

02/150
VWF
yes
00/514
X yes

99/826
X
yes
98/590
XI yes

04/102
XIII yes

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.