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Performance evaluation of Revohem ™ FVIII chromogenic and Revohem ™ FIX chromogenic in the CS‐5100 autoanalyser
Author(s) -
Suzuki Atsuo,
Suzuki Nobuaki,
Kanematsu Takeshi,
Shinohara Sho,
Arai Nobuo,
Kikuchi Ryosuke,
Matsushita Tadashi
Publication year - 2019
Publication title -
international journal of laboratory hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.705
H-Index - 55
eISSN - 1751-553X
pISSN - 1751-5521
DOI - 10.1111/ijlh.13083
Subject(s) - chromogenic , chemistry , coagulation , reagent , chromatography , microbiology and biotechnology , medicine , biology
Chromogenic substrate assay (CSA) reagents Revohem ™ FVIII and Revohem ™ FIX are now available as in vitro diagnostic reagents for autoanalysers in Japan. In this study, we evaluated the performance of these reagents in the CS‐5100 automated coagulation analyser. Methods We assessed within‐run and between‐day imprecision, on‐board stability and frozen‐storage stability of Revohem FVIII and FIX. Sensitivity to lupus anticoagulant (LA) was examined using LA‐positive patient plasma. Correlations were analysed using plasma samples from normal individuals and patients with haemophilia A (HA) or B (HB) or von Willebrand disease (VWD). Results Imprecision was <2% for Revohem FVIII and <6.5% for Revohem FIX. On‐board storage of Revohem FVIII resulted in a <10% decrease in FVIII levels from baseline at 24 hours, whereas Revohem FIX showed a >10% decrease at 8 hours. Revohem FVIII showed good stability while frozen for 22 days. Although Revohem FIX showed degradation due to freeze‐thawing, a new calibration improved stability up to 22 days. Interference from LA was not observed with Revohem FVIII or FIX. The FVIII CSA‐CSA correlation was excellent in normal ( r = 0.9924), HA ( r = 0.9945) and VWD ( r = 0.9914). The FVIII CSA‐OSA correlation was good in normal ( r = 0.8468) and excellent in HA ( r = 0.975) and VWD ( r = 0.9936). The FIX CSA‐OSA correlation was fair in normal ( r = 0.4791) and excellent in HB ( r = 0.9501). Conclusion Revohem FVIII and FIX both showed excellent performance in the CS‐5100 analyser. These reagents could be useful in routine laboratory testing for diagnosing and treating haemophilia.