JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

Annex 1: Standards available from the National Institute for Biological Standards and Control

This annex lists some of the various standards and reference materials available from the National Institute for Biological Standards and Control (NISBC) that are relevant to transfusion medicine. Further details of these preparations as well as the complete product catalogue are available on the website www.nibsc.ac.uk.

Table A1.1 Serological, virological and other preparations

  Status Code

Serological and related preparations

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-Human Neutrophil Antigen-1a minimum potency reagent

IRR

09/284

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 sensitivity of routine antibody screening methods, to assess operator competence in performing and reading antiglobulin tests, to assure the efficacy of red cell washing prior to the addition of an antiglobulin reagent, and as an internal control for antibody titrations

B

07/304

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†

09/112

Minimum potency positive control for FCXM*
For use in flow cytometry cross matching (FCXM) and
anti-HLA serology

B†

07/214

Anti-HLA Control
Negative control for Luminex-based anti-HLA serology

B†

10/142

HLA Class II positive control for anti-HLA serology
Positive control for Luminex-based anti-HLA Class II serology

B†

08/148

RHD/SRY plasma DNA sensitivity standard
For use in fetal RHD testing using maternal blood

IRR

07/222

RBC1 gDNA
For blood group genotyping

IRR

10/232

RBC4 gDNA
For blood group genotyping

IRR

10/236

RBC5 gDNA
For blood group genotyping

IRR

10/238

RBC12 gDNA
For blood group genotyping

IRR

10/234

Blood Group Genotyping Reference Panel
One ampoule of each of 10/232, 10/234, 10/236 and 10/238 above

IRR

11/214

HLA-A Genotyping Reference Panel
24 samples for use in DNA-based HLA typing

NR†

05/208-001

HLA-DRB1 Genotyping Reference Panel
39 samples for use in DNA-based HLA typing

NR†

10/136-001

Virological preparations

Anti-HAV Immunoglobulin

IS

97/646

Anti-HBc

IS

95/522

Anti-HBs Immunoglobulin

IS

07/164

Anti-measles serum (for use in neutralisation 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 (currently awaiting a replacement)

NR

See NIBSC catalogue

Hepatitis B virus DNA

IS

97/750

HIV-1 p24 antigen

IRR

90/636

HIV-1 RNA for NAT

IS

10/152

HIV-2 RNA for NAT

IS

08/150

HIV-1 NAT Subtype Reference Panel

IRR

12/244

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 Genotype 1

IS

99/802

Parvovirus B19 genotype panel (Genotypes 1, 2 and 3)

IS

09/110

NAT working reagent for HAV RNA*

NR

01/488

NAT working reagent for HBV DNA*

NR†

11/182

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 for B19 DNA*

NR†

11/208

NAT working reagent for multiplex (HCV, HBV, HBV, HIV, B19)*

NR

99/732

Endotoxin

IS

94/580

Tetanus antitoxin

NR

76/589

Anti-HIV 1: Quality Control Serum: Sample 1

QCRHIV1QC1

 

Anti-HIV 1: Quality Control Serum: Sample 2

QCRHIV1QC2

 

Anti-HIV 1: Quality Control Serum: Sample 3

QCRHIV1QC3

 

Anti-HIV 1: Quality Control Serum: Sample 5

QCRHIV1QC5

 

HIV1 p24 Antigen : Quality Control Serum: 1

QCRHIV1P24QC1

 

HIV1 p24 Antigen : Quality Control Serum: 2

QCRHIV1P24QC2

 

Anti-HIV 2: Quality Control Serum: Sample 2

QCRHIV2QC2

 

Anti-HIV 2: Quality Control Serum: Sample 3

QCRHIV2QC3

 

Anti-CMV Quality Control Serum: Sample 1

QCRCMVQC1

 

Anti-VZV Quality Control Serum: Sample 1

QCRVZVQC1

 

Anti-Syphilis Quality Control Serum: Sample 1

QCRSYPHQC1

 

Anti-Syphilis Quality Control Serum: Sample 2

QCRSYPHQC2

 

Anti-Rubella Quality Control Serum: Sample 1

QCRRUBQC1

 

Anti-Rubella Quality Control Serum: Sample 2

QCRRUBQC2

 

Anti-Rubella IgM Quality Control Serum: Sample 1

QCRRUBIgMQC1

 

Anti-Toxoplasma Quality Control Serum: 1

QCRTOXOQC1

 

Anti-HSV1 Quality Control Serum: Sample 1

QCRHSV1QC1

 

Anti-HSV2 Quality Control Serum: Sample 1

QCRHSV2QC1

 

Anti-Malaria Quality Control Serum: Sample 1

QCRMALQC1

 

Anti-HCV Quality Control Serum: Sample 1

QCRHCVQC1

 

Anti-HBs Quality Control Serum: Sample 1

QCRHBsQC1

 

HBsAg Quality Control Serum: Sample 1

QCRHBsGQC1

 

HBsAg Quality Control Serum: Sample 2

QCRHBsGQC2

 

Anti-HBe Quality Control Serum: Sample 1

QCRHBEQC1

 

Total Anti-HBc Quality Control Serum: Sample 1

QCRTHBcQC1

 

Total Anti-HBc Quality Control Serum: Sample 2

QCRTHBcQC2

 

Total Anti-HAV Quality Control Serum: Sample 1

QCRTHAVQC1

 

IgM Anti-HBc Quality Control Serum: Sample 1

QCRHBcIgMQC1

 

IgM Anti-HAV Quality Control Serum: Sample 2

QCRHAVIgMQC2

 

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 Hematology/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

 

 

08/258

ATIII

 

 

06/166

Fibrinogen

 

 

09/264

Fibrinogen

 

 

09/242

II

 

 

09/172

II

 

 

11/126

IX

 

 

09/172

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

 

 

09/172

VIIa

 

 

07/228

VII

 

 

10/252

VIII

 

 

07/316

VIII

 

 

07/350

VWF

 

 

07/316

VWF

 

 

09/182

X

 

 

09/172

X

 

 

11/126

XI

 

 

04/102

XIII

 

 

02/206

Table A1.3 Coagulation preparations – British Standards

Preparation Code

Blood Coagulation Factor VIII, Concentrate, Human (13th BS)*

10/188

Blood Coagulation Factors II, IX, X, Concentrate, Human (6th BS)*

07/326

FEIBA Concentrate, Human (1st NIBSC Working Reference Standard)*

06/172

* 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 is GB £70 per ampoule/vial.

Those preparations identified as ‘working standards’ are supplied as multiples of five with a current handling charge of GB £90 per five ampoules/vials. HLA genotyping panels are £675 each or £900 for both panels; other panels are £140. See the NIBSC website (www.nibsc.ac.uk) for prices of quality control reagents. NIBSC periodically adjusts the handling charge. Any changes to the handling charge are detailed on the website.

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, UK

Fax: +44 (0) 1707 641064

E-mail: standards@nibsc.hpa.org.uk

Telephone: +44 (0) 1707 641467

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, NIBSC must have a contact name along with both contact telephone and fax numbers
     
  • your e-mail address or fax number. NIBSC will acknowledge receipt of your order. NIBSC 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 the website www.nibsc.ac.uk.