Abstract Number: PB0589
Meeting: ISTH 2020 Congress
Background: Introduction of new coagulation factor concentrates may confront laboratories with technical problems in selecting suitable test batteries. The study involves 11 centres and examines the test behaviour of three new factor preparations (two half-life-prolonged factor concentrates rurioctocog alfa pegol (rPEGVIII; Adynovi), nonacog beta pegol (rPEGFIX; Refixia) and vonicog alpha (rVWF; Veyvondi).
Aims: The influence of test methods available in the laboratories for factor recovery, APTT based one stage clotting assay (OSA), or by chromogenic assay (CSA), if available, and for rVWF, VWF:Ag and VWF:Akt assay (if established VWF:RCo and VWF: CB – collagen binding), respectively, should be determined.
Methods: Factor deficient human plasmas were mixed by the manufacturers of the products in different concentrations and sent to the participating laboratories with information on the spiked factor concentrations but without further information.
Results: rPEGFVIII: Using OSA all laboratories achieved comparable results to the target
(max. < 25%). Combinations of the CS-5100 analyzer with Pathromtin SL (Siemens) and ACL Top with SynthAsil (Werfen), respectively, showed the best results. With both CSA tests Biophen FVIIIc, (Hyphen) and FVIIIc chromogenic assay (Siemens)) an overestimation of the recovery (>20%) was seen.
rPEGFIX: Using OSA only with SynthaFAx (Werfen) a recovery with an overestimation of maximum 25% was seen; all other APTTs Actin FS, Pathromtin SL, SynthAsil, C.K.Prest® (Stago) showed significant underestimations as well as massive overestimations of the recovery. CSA by Biophen FIX (Hyphen) showed a good agreement with the spiked concentrations.
rVWF: VWF:Akt tended to be >20% above the spiked concentrations; only HemosIL VWF:Act (Werfen) showed good agreement. Both VWF:Ag and VWF:RCo values (Siemens and Werfen) were within an acceptable range of +/- 20%.
Conclusions: Selecting appropriate test batteries are crucial. Supply of spiked plasma samples by manufactueres facilitates evaluation of the assays. The final study results are expected for mid 2020.
To cite this abstract in AMA style:Stuebler M, Seier J, Wimmer E, Cadmuro J, Fraunberger P, Griesmacher A, Irsara C, Hauer R, Prueller F, Quehenberger P, Radek J, Schlagenhauf A, Sussitz-Rack S, Tomasits J, Haushofer AC. Laboratory Analysis of Half-Life-Prolonged Coagulation Factors VIII Rurioctocog Alfa Pegol and IX, Nonacog Beta Pegol and of rVWF – Vonicog Alpha in Spiked Human Plasma Samples – First Results of a Multicentre Study by the Austrian Laboratory Societies ÖGLMKC and ÖQUASTA [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/laboratory-analysis-of-half-life-prolonged-coagulation-factors-viii-rurioctocog-alfa-pegol-and-ix-nonacog-beta-pegol-and-of-rvwf-vonicog-alpha-in-spiked-human-plasma-samples-first-results-of-a-mu/. Accessed November 26, 2021.
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