[Evaluation of the quality of the principal kits to identify HBs antigen used in French blood transfusion centers. "Viral hepatitis" group of the SNTS].

The aim of this study is the evaluation of the main kits used for the HBs Ag screening in French blood donors. Eight ELISA or RIA kits were evaluated. The specificity was assessed by testing samples from unselected blood donors. Repeatedly reactive sera were confirmed by a neutralisation test using an anti-HBs polyclonal antibody. The specificity expressed by the false positive reactions was lower than 0.1% for the ELISA and RIA kits. Sensitivity was assessed by the study of a panel of 16 HBs Ag specimens (ad and ay subtypes) with titres ranging from 0.05 to 1.80 ng/ml; all were tested in duplicate. Differences in sensitivity were observed according to the kits and procedures used. Some kits have a better sensitivity than RIA which is no longer the most sensitive technique. Such a study and a permanent control of each lot of HBs Ag commercial kit allow an improvement of reagents quality.