[Evaluation of one of the third generation reagents for anti-HCV antibody measurement in comparison with three second generation methods].
It is important to measure anti-HCV antibody(HCV.Ab) in blood to diagnose and treat viral hepatitis C patients. We evaluated one of the third generation reagents, Entymun-Test anti-HCV(Boehringer mannheim), which was developed to minimize false-positive reactions, and compared these results to findings obtained with three second generation tests for HCV.Ab. Coefficients of variation in the Entymum-Test assay were good(within-run, 1.1 approximately 1.8%; between-run, 2.5 approximately 7.5%). Four interfering substances(bilirubin C, bilirubin F, lipid and hemoglobin) hardly affected the HCV.Ab measurement. The HCV.Ab indices of healthy donors(n = 61) were distributed below the cut-off index(C.O.I). Sensitivity of the third generation test was the same as that of second generation tests, calculated from the results of dilution tests. Index of the dilution test in the third generation test formed a plateau until four-fold dilution, but there was no prozone phenomenon. Among the third generation test and three second generation tests, the former had the lowest positive percentage in serum HCV.Ab. Moreover, findings of HCV-RNA agreed more with the results of the third generation test among the four tests. As a result, the third generation test appeared to minimize false-positive results and improve specificity.
Kobayashi
J
J
Department of Clinical Laboratory, Kanazawa University Hospital.
Nishibu
M
M
Hashimoto
T
T
D005069:Evaluation Studies as Topic; D006526:Hepatitis C / Q000175:diagnosis; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D007124:Immunoenzyme Techniques; D011933:Reagent Kits, Diagnostic / Q000592:standards*
D018937:Hepatitis C Antibodies; D011933:Reagent Kits, Diagnostic