Remember Me
Or use your Academic/Social account:


Or use your Academic/Social account:


You have just completed your registration at OpenAire.

Before you can login to the site, you will need to activate your account. An e-mail will be sent to you with the proper instructions.


Please note that this site is currently undergoing Beta testing.
Any new content you create is not guaranteed to be present to the final version of the site upon release.

Thank you for your patience,
OpenAire Dev Team.

Close This Message


Verify Password:
Verify E-mail:
*All Fields Are Required.
Please Verify You Are Human:
fbtwitterlinkedinvimeoflicker grey 14rssslideshare1
Kitchen, S.; Jennings, I.; Makris, M.; Kitchen, D.P.; Woods, T.A.L.; Walker, I.D. (2016)
Publisher: Wiley
Languages: English
Types: Article
Introduction\ud \ud Although the variability in factor VIII (FVIII):C measurement is well recognized, this has not been widely reported for post-FVIII infusion samples.\ud Aim/Methods\ud \ud Three samples from haemophilia A patients were distributed in a UK National External Quality Assessment Scheme survey, each after treatment with either ReFacto AF, Kogenate FS or Advate. Fifty-two UK haemophilia centres performed FVIII assays using one-stage (n = 46) and chromogenic (n = 10) assays. Centres calibrated assays with the local plasma standard and with ReFacto AF laboratory standard for the ReFacto AF sample.\ud Results/Conclusions\ud \ud Chromogenic assays gave significantly higher results than one-stage assays (P < 0.0001, 32% difference) in the post-Kogenate sample but not in the post-ReFacto AF (11% higher by chromogenic assay, ns) or post-Advate samples (3% lower by chromogenic, ns) when assays were calibrated with plasma standards. Twenty centres used all Instrumentation Laboratory (IL)-activated partial thromboplastin time reagents (Synthasil)/IL deficient plasma/reference plasma) in the one-stage assay and 15 used all Siemens reagents (Actin FS/Siemens deficient plasma/reference plasma); this made a significant difference to results post-ReFacto AF (41% higher by IL reagents, P < 0.0001) and Advate (39% higher by IL reagents, P < 0.0001), but not Kogenate (7% higher by IL, ns) when calibrated with plasma standards. Differences between results obtained with different one-stage assay reagents for monitoring Advate have implications for dosing patients. Furthermore, there was considerable inter-laboratory variation as indicated by CVs in the range 15–26% for chromogenic assay and 12–19% for one-stage assay results. This study suggests that external quality assessment schemes should offer participation in post-FVIII infusion schemes where haemophilic patients are monitored.
  • The results below are discovered through our pilot algorithms. Let us know how we are doing!

    • 1. Srivastava A, Brewer AK, Mauser-Bunschoten EP, Key NS, Kitchen S, Llina A, Ludlam CA, Mahlangu JN, Mulder K, Poon MC Street A. G and Treatment Guidelines Working Group of the World Federation Of Hemophilia. Guidelines for Management of Haemophilia , Haemophilia 2013; 19; 1-47.
    • 2. Keeling D, Tait C, Makris M. Guidelines on the selection and use of therapeutic products to treat haemophilia and other hereditary bleeding disorders. A Uk haemophilia centre doctors
    • 3. Jennings I, Kitchen DP, Woods TAL, Kitchen, S , Walker ID, Preston FE. Laboratory Performance in the World Federation of Hemophilia EQA programme, 2003-2008. Haemophilia 2009 ;15 ; 571-7.
    • 4. F E Preston, S Kitchen, I Jennings, T A L Woods, M Makris SSC/ISTH Classification of Haemophilia A: Can Haemophilia Centre Laboratories achieve the new criteria? Journal of Thrombosis and Haemostasis 2004 ; 2 ;271-4.
    • 5. Lusher JM, Hillman-Wiseman C, Hurst D. In vivo recovery with products of very high purity assay discrepancies. Haemophilia 1998; 4: 641-5.
    • 6. Lee CA , Owens GB, Giangrande P. Collins P. Hay C, Gomperts E, Schroth P. Barrowcliffe T. Pharmacokinetics of recombinant factor VIII (Recombinate) using one stage clotting and chromogenic factor VIII assay. Thromb Haemost 1999: 82; 1644-7.
    • 7. Hubbard AR, Weller LJ. Bevan SA. A survey of one stage and chromogenic potencies in therapeutic factor VIII concentrates B J Haem 2002: 117; 247-8
    • 8. Jennings I, Kitchen DP, Woods TAL, Kitchen S , Walker ID. Emerging Technologies and Quality Assurance: the UK NEQAS perspective. Sem Thromb Haem 2007 ; 33; 243-9.
    • 9. Hubbard AR, Bevan SA , Weller LJ. Potency estimation of recombinant FVIII: effect of assay method and standard. B J Haem 2001: 113; 533-6.
    • 10. Mikaelsson M, Oswaldson U, Sanderg H. Influence of phospholipids on the assessment of factor VIII activity. Haemophilia 1998; 4: 646-50.
    • 11. Morfini M, Cinotti S, Bellatreccia A, Paladino E, Gingeri A, Mannucci PM. A multi-centre pharmacokinetic study of the B-domain deleted recombinant factor VIII concentrate suing different assays and standards. J Thromb Haemost 2003: 1; 2283-2289.
    • 12. Ingerslev J, Jankowski MA, Weston SB, Charles LA. Collaborative field study on the utility of a BDD factor VIII concentrate standard in the estimation of BDD Factor VIII:C activity in hemophilic plasma using the one-stage clotting assay. J Thromb Haemost 2004; 2; 623-628.
    • 13. Santoro C, Iorio A, Ferrante F, PAllotta A, Pignolomi P, Biondo F, Agnelli G, MAzzucconi MG. Peformance of recalibrated ReFacto laboratory standard in the measurement of FVIIII plasma concentration via the chromogenic and one stage assays after infusion of recalibrated ReFacto ( B domain deleted recombinant factor VIII). Hameophilia 2009 : 15; 779- 787.
    • 14. Pouplard C, Caron C, Aillaud MF, Ternisien C, Desconclois C, Dubanchet A, Sobas F. the use of the new ReFacto AF laboratory standard allows reliable measurement of FVIII:C levels in ReFacto AF mock plasma samples by a one stage assay. Haemophilia 2011: 17 e958-62.
    • 15. Cauchie M, Toelen J, Peerlinck K, Jacquemin M. Practical and cost-effective measurement of B-domain deleted and full-length recombinant FVIII in the routine haemostasis laboratory. Haemophilia 2013; 19: e133-8.
    • 16. Mikaelsson M, Oswalksson U, Jankowski MA. Measurement of factor VIII activity of B-domain deleted recombinant factor VIII. Semin Haem 2001; 38: 13-23
    • 17. Viuff D, Barrowcliffe TW, Saugstrup T, Ezban M, Lillicrap D. International comparative field study of N8 evaluating factor VIII assay performance. Haemophilia 2011;17: 695-702.
    • 18. Hubbard AR, Dodt J. Lee T, Mertens K, Seitz R, Srivastava A, Weinstein M and on behalf of . Factor VIII and Factor IX Subcommittee of The Science and Standardisation Committee of The International Society on Thrombosis and Haemostasis. Recommendations on the potency labelling of FVIII and FIX concentrates. J Thromb Haem 2013; 11: 988-9.
    • 19. Jennings I, Kitchen DP, Woods TAL, Kitchen S, Preston FE, walker ID. Stability of coagulation proteins in lyophilised plasma. In J Lab Haem 2015: 37; 495-502.
    • 20. Kitchen S, Signer-Romero K, Key NS. Current laboratory practices in the diagnosis and management of haemophilia . Haemophilia 2015; 21: 550-7.
    • 21. Gomez K Chitlur M Survey of Laboratory tests used in the diagnosis and evaluation of haemophilia A. Thromb Haemost. 2013 ;109:738-43
    • 22. Sommer JM, Moore N, Mcguffie-Valentine B, Bardan S, Buyue Y, Kamphaus GD, Konkle BA, Pierce GF. Comparative field study evaluating the activity of recombinant factor VIII Fc fusion protein in plasma samples at clinical haemostasis laboratories. Haemophilia 2014: 20; 294-300.
    • 23. Kitchen S, Cartwright I, Woods TAL, Jennings I, Preston FE. Lipid composition of seven APTT reagents in relation to Heparin sensitivity. British Journal of Haematology 1999; 106: 801-808.
    • 24. Caron C, Dautzenberg MD, Delahousse B, Droulle C, Pouzol P, Dubanchet A, Rothschild C. A blinded in vitro study with ReFacto mock plasma samples: similar FVIII results between chromogenic assay and a one stage assay when using a higher cephalin dilution. Haemophilia 2002 : 8; 639-643.
  • No related research data.
  • No similar publications.

Share - Bookmark

Cite this article