Analytical Performance of Different Laboratory Methods for Measuring Susoctocog-Alfa
Cristina Novembrino,
Ilaria Quaglia,
Angelo Claudio Molinari,
Alessandra Borchiellini,
Antonio Coppola,
Rita Carlotta Santoro,
Massimo Boscolo-Anzoletti,
Eleonora Galbiati,
Ezio Zanon,
Alessandra Valpreda
Affiliations
Cristina Novembrino
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, 20122 Milan, Italy
Ilaria Quaglia
Center for Thrombosis and Hemorrhagic Diseases, IRCCS Humanitas Research Hospital Rozzano, 20089 Milan, Italy
Angelo Claudio Molinari
Regional Reference Center for Inherited Bleeding Disorders, Istituto Giannina Gaslini, 16147 Genova, Italy
Alessandra Borchiellini
Regional Reference Center of Thrombotic and Hemorrhagic Disorders of the Adults, Department of Oncology and Hematology “Città della Salute e della Scienza”, 10100 Turin, Italy
Antonio Coppola
Regional Reference Center for Inherited Bleeding Disorders, University Hospital of Parma, 43125 Parma, Italy
Rita Carlotta Santoro
Hemostasis and Thrombosis Unit, Regional Reference Centre for Hemophilia, and Inherited Bleeding Disorders, AOPC, 88100 Catanzaro, Italy
Massimo Boscolo-Anzoletti
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, 20122 Milan, Italy
Eleonora Galbiati
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, 20122 Milan, Italy
Ezio Zanon
Haemophilia Centre-General Medicine, Padua University Hospital, 35128 Padua, Italy
Alessandra Valpreda
Regional Reference Center of Thrombotic and Hemorrhagic Disorders of the Adults, Laboratory Department “Città della Salute e della Scienza”, 10100 Turin, Italy
Recombinant porcine factor VIII (rpFVIII) is indicated for treating bleeding episodes in acquired haemophilia A, but there are few data regarding laboratory methods to adequately monitor treatment. This study involving three Italian laboratories aimed to evaluate the analytical performance of different assays for measuring rpFVIII. Five spiked rpFVIII samples (0.5–1.5 IU/mL) were analysed on three days, in triplicate, with eleven combinations of reagents (Werfen, Boston, MA, USA: SynthasIL and SynthaFax for one-stage assay, Chromogenix Coamatic FVIII for chromogenic assay), FVIII depleted plasmas (with or without von Willebrand factor—VWF) and calibrators (HemosIL human calibrator plasma, porcine calibrator diluted in FVIII deficient plasma with or without VWF). The assays were performed on ACL TOP analysers (Werfen, Boston, MA, USA). Intra- and inter-assay and inter-laboratory Coefficient of Variation (CV%) were calculated together with percentage of recovery (% recovery) on the expected value. The results showed that the reagent combinations reaching satisfactory analytical performance are: SynthasIL/human calibrator/deficient plasma+VWF (total recovery 99.4%, inter-laboratory CV 4.04%), SynthasIL/porcine calibrator/deficient plasma+VWF (total recovery 111%, inter-laboratory CV 2.75%) and Chromogenic/ porcine calibrator/deficient plasma+VWF (total recovery 96.6%, inter-laboratory CV 8.32%). This study highlights that the use of porcine standard (when available) and FVIII deficient plasma with VWF should be recommended.
