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WHO International Standards for the diagnosis and treatment of bleeding and thrombotic disorders

Global harmonisation in the diagnosis and treatment of bleeding disorders relies on the availability of WHO International Standards (IS) which define the International Unit (IU) for coagulation factors and related therapeutics. NIBSC has a long history in this area beginning in the 1970s with the establishment of the WHO 1st IS for Factor VIII Concentrate which was developed to quantify and harmonise the potency of concentrated preparations of coagulation factor VIII. Since then over 40 different WHO IS have been established to support diagnostics and therapeutics in all areas of haemostasis.

Enquiries on WHO International Standards: enquiries@nibsc.org Standards catalogue: https://www.nibsc.org/products/brm_product_catalogue.aspx

Newly Established Standards in 2017-19

  • Activated Factor X (FXa), human purified – WHO Reference Reagent (15/102) >
  • Factor XII (activity and antigen) in plasma (15/180) - WHO 1st International Standard
  • Activated Factor IX (FIXa), human, purified (14/316) – WHO 2nd International Standard
  • Factor V (activity and antigen) in plasma (16/374) – WHO 2nd International Standard
  • von Willebrand factor:GPIb binding (GPIbR and GPIbM methods) (07/316) – WHO 1st International Reference Reagent (plasma)
  • Streptokinase (16/358) – WHO 4th International Standard
  • Factor XIII B subunit (total), plasma (02/206) – WHO 1st International Standard

Established WHO International Standards

WHO International Standards and Reference Reagents - therapeutics and purified coagulation factors

NameVersionCodeAnalytesResponsible scientist
Alpha-1-antitrypsin 1st IS 05/162 activity Craig Thelwell
Ancrod 1st IS 15/106 activity Craig Thelwell
Antithrombin, Concentrate 3rd IS 06/166 function; antigen Elaine Gray
Batroxobin RR 15/140 function Craig Thelwell
Beta Thromboglobulin, Human 1st IS 83/501 antigen Elaine Gray
C1-Inhibitor, Concentrate 1st IS 08/256 function Craig Thelwell
Factors II & X, Concentrate 4th IS 11/126 activity: FII, FX Elaine Gray
Factor VII, Concentrate 2nd IS 10/252 activity: clotting; chromogenic Craig Thelwell
Activated Factor VII (FVIIa), Concentrate 2nd IS 07/228 clotting activity Craig Thelwell
Factor VIII, Concentrate 8th IS 07/350 FVIII:C Sanj Raut
Factor IX, Concentrate 5th IS 14/148 FIX:C Elaine Gray
Activated Factor IX (FIXa) 2nd IS 14/316 activity Elaine Gray
Activated Factor XI (FIXa) 1st IS 13/100 activity Elaine Gray
Activated Factor X (FXa), human IRR 15/102 activity Craig Thelwell
Fibrinogen, Concentrate 2nd IS 09/242 clottable & total protein Sanj Raut
High Molecular Weight Urokinase 2nd IS 11/184 activity Colin Longstaff
Low Molecular Weight Heparin for Molecular Weight calibration 2nd IS 05/112 MW distribution Elaine Gray
Low Molecular Weight Heparin 3rd IS 11/176 activity: anti-IIa; anti-Xa Elaine Gray
Plasmin 4th IS 13/206 activity Colin Longstaff
Platelet Factor 4, Human 1st IS 83/505 antigen Elaine Gray
Prekallikrein Activator 2nd IS 02/168 activity Colin Longstaff
Protein C, Concentrate 1st IS 04/252 function; antigen Elaine Gray
Streptodornase 2nd IS 08/230 activity Colin Longstaff
Streptokinase 4th IS 16/358 activity Colin Longstaff
Thrombin, Human 2nd IS 01/580 activity Colin Longstaff
Thromboplastin, Rabbit, Plain 5th IS RBT/16 International Sensitivity Index 1.21 Craig Thelwell
Thromboplastin, Human, Recombinant 5th IS RTF/16 International Sensitivity Index 1.11 Craig Thelwell
Tissue Plasminogen Activator, plasma 1st IS 94/730 antigen Colin Longstaff
Tissue Plasminogen Activator, recombinant 1st IS 98/714 activity Colin Longstaff
Unfractionated Heparin 6th IS 07/328 activity: anti-Xa; anti-IIa; APTT Elaine Gray
Von Willebrand factor, Concentrate 2nd IS 09/182 VWF:RCo; VWF:Ag; VWF:CB Craig Thelwell

WHO International Standards and Reference Reagents - diagnostic

NameVersionCodeAnalytesResponsible scientist
ADAMTS13, plasma 1st IS 12/252 activity; antigen Craig Thelwell
Antithrombin, plasma 3rd IS 08/258 function; antigen Elaine Gray
C1 Inhibitor, plasma 1st IS 08/262 function Craig Thelwell
Factors II, VII, IX, X, plasma 4th IS 09/172 FII:C; FVII:C; FIX:C; FIX:Ag; FX:C Craig Thelwell
Factor V, plasma 2nd IS 16/374 FV:C; FV:antigen Craig Thelwell
Factor VIII and von Willebrand factor, plasma 6th IS 07/316

FVIII:C, FVIII:Ag, VWF:Ag, VWF:RCo, VWF propeptide VWF:collagen binding

Craig Thelwell
Factor XI, plasma 2nd IS 15/180 activity; antigen Elaine Gray
Factor XII, plasma 1st IS 15/180 activity; antigen Elaine Gray
Factor XIII, plasma 1st IS 02/206 A2B2 activity; antigen; total B subunit antigen Sanj Raut
Fibrinogen, plasma 3rd IS 09/264 mass by Clauss assay Sanj Raut
Lupus Anticoagulant, plasma 1st IRP 13/172 negative, moderate positive, strong positive Elaine Gray
Plasminogen Activator Inhibitor-1 (PAI-1), plasma 1st IS 92/654 t-PA, u-PA neutralisation Colin Longstaff
Protein C, plasma 2nd IS 02/342 function; antigen Elaine Gray
Protein S, plasma 2nd IS 03/228 function; total & free antigen Elaine Gray
von Willebrand factor:GPIb binding (GPIbR & GPIbM) IRR 07/316 binding to recombinant GPIb (GPibR & GPIbM) Craig Thelwell

IS – International Standard; IRP – International Reference Panel; RR – Reference Reagent

British Standards and NIBSC Reference Materials

NameVersionCodeAnalytesResponsible scientist
FEIBA – Factor Eight Inhibitor By-passing Activity 2nd NIBSC Ref Std 13/242 activity Sanj Raut
Factor VIII Concentrate 13th BS 10/188 FVIII:C Sanj Raut
Factors II, IX, X Concentrate 7th BS 15/182 FII:C; FIX:C; FX:C Elaine Gray
Reteplase NIBSC Reagent 10/104 activity Colin Longstaff
Staphylokinase NIBSC Reagent 94/718 activity Colin Longstaff
Single chain urinary-type plasminogen activator (SCuPA), recombinant, non-glycosylated NIBSC Reagent 95/564 activity: clot lysis; chromogenic Colin Longstaff
Single chain urinary-type plasminogen activator (SCuPA), recombinant, glycosylated NIBSC Reagent 95/668 activity: clot lysis; chromogenic Colin Longstaff
SSC/ISTH Secondary Coagulation Standard Lot#5 ISTH Reference SSCLOT5 21 analytes – supply restricted to manufacturers Anthony Hubbard
 
 
 
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