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Performance evaluation of Revohem™ FVIII chromogenic and Revohem™ FIX chromogenic in the CS-5100 autoanalyser.

Authors
  • Suzuki, Atsuo1
  • Suzuki, Nobuaki2
  • Kanematsu, Takeshi3
  • Shinohara, Sho4
  • Arai, Nobuo4
  • Kikuchi, Ryosuke1
  • Matsushita, Tadashi2, 3
  • 1 Department of Medical Technique, Nagoya University Hospital, Nagoya, Japan. , (Japan)
  • 2 Department of Transfusion Medicine, Nagoya University Hospital, Nagoya, Japan. , (Japan)
  • 3 Department of Laboratory Medicine, Nagoya University Hospital, Nagoya, Japan. , (Japan)
  • 4 Sysmex Corporation, Kobe, Japan. , (Japan)
Type
Published Article
Journal
International journal of laboratory hematology
Publication Date
Oct 01, 2019
Volume
41
Issue
5
Pages
664–670
Identifiers
DOI: 10.1111/ijlh.13083
PMID: 31271527
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

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. 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). 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). 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. © 2019 John Wiley & Sons Ltd.

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