Sysmex Journal International

2017Vol.27 No.2


Evaluation of HISCL HCV Antibody Reagent and Comparative Examination of HCV Antibody Reagents of Various Manufacturers


Tatsuo SATO

Department of Clinical Laboratory, Kurashiki Medical Center


As a routine screening test for hepatitis C virus (HCV) infection, the HCV antibody test has been used widely. Recently, various manufacturers have developed and released HCV antibody reagents that can be measured automatically using a number of proprietary immunoserological assay systems. Sysmex Corporation has also developed and released HCV antibody reagents that are compatible with the Sysmex HISCL Series chemistry analyzer. HISCL, which adopts chemiluminescence enzyme immunoassay (CLEIA) as the measurement principle, is regarded as a relatively high-speed system requiring a reaction period of only 17 minutes. Recently, we had an opportunity to use the HISCL HCV antibody reagent and evaluated its basic performance. This evaluation was important as both HISCL reagents and other HCV antibody reagents used in routine examinations show inconsistent results due to inter-reagent differences. Sufficient caution should be exercised in interpreting the measurement results because of the differences in the antigens used in the various kits, different performance of reagents themselves, and variability of existing patterns of antibodies in the samples collected from patients. In the present study – in consideration of these actual conditions – we measured panel serum and patient samples using different measurement systems at several facilities. In order to confirm the measurement characteristics of reagents from various manufacturers, we conducted a comparative examination and report the results in this publication.