Factor VIII assay variability in postinfusion samples containing full length and B-domain deleted FVIII

Article English OPEN
Kitchen, S. ; Jennings, I. ; Makris, M. ; Kitchen, D.P. ; Woods, T.A.L. ; Walker, I.D. (2016)
  • Publisher: Wiley

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.
  • References (24)
    24 references, page 1 of 3

    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.

  • Metrics
    views in OpenAIRE
    views in local repository
    downloads in local repository

    The information is available from the following content providers:

    From Number Of Views Number Of Downloads
    White Rose Research Online - IRUS-UK 0 89
Share - Bookmark