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Analytical Performance of Different Laboratory Methods for Measuring Susoctocog-Alfa
Cristina Novembrino1, Ilaria Quaglia2, Angelo Claudio Molinari3
1Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, 20122 Milan, Italy.
Diagnostics (Basel, Switzerland)
|August 26, 2022
Summary
Accurate laboratory monitoring of recombinant porcine factor VIII (rpFVIII) for acquired haemophilia A is crucial. This study identified optimal assay combinations, recommending porcine standards and VWF-containing plasma for reliable rpFVIII measurement.
Area of Science:
- Clinical Chemistry
- Haematology
- Laboratory Medicine
Background:
- Recombinant porcine factor VIII (rpFVIII) treats acquired haemophilia A.
- Limited data exist on laboratory methods for monitoring rpFVIII treatment efficacy.
- Standardization of rpFVIII assays is needed for accurate patient management.
Purpose of the Study:
- To evaluate the analytical performance of different laboratory assays for measuring rpFVIII.
- To identify optimal reagent and calibrator combinations for rpFVIII quantification.
- To assess inter-laboratory variability in rpFVIII measurement.
Main Methods:
- Three Italian laboratories analyzed spiked rpFVIII samples (0.5-1.5 IU/mL) using eleven reagent combinations (one-stage and chromogenic assays).
- Assays utilized FVIII-depleted plasmas (with/without VWF) and human or porcine calibrators on ACL TOP analysers.
- Intra- and inter-assay/laboratory Coefficients of Variation (CV%) and percent recovery were calculated.
Main Results:
- Satisfactory analytical performance was achieved with SynthasIL/human calibrator/deficient plasma+VWF (99.4% recovery, 4.04% inter-lab CV).
- SynthasIL/porcine calibrator/deficient plasma+VWF showed high recovery (111%) and low inter-lab CV (2.75%).
- Chromogenic/porcine calibrator/deficient plasma+VWF yielded 96.6% recovery and 8.32% inter-lab CV.
Conclusions:
- The study identified reliable assay configurations for rpFVIII measurement.
- Using a porcine standard and FVIII-deficient plasma with VWF is recommended for accurate rpFVIII quantification.
- Optimized laboratory monitoring can improve treatment outcomes for acquired haemophilia A.
