[Virological studies on the usefulness of anti-HCV ELISA assay using recombinant N-14 fusion protein in various liver diseases].Fukuoka Igaku Zasshi 1993; 84(4):138-47FI
An enzyme-linked immunosorbent assay (ELISA) for the detection of HCV antibodies was established, using recombinant N-14 fusion protein, and compared with the results of Ortho's HCV antibody (C-100 Ab) test, in serum samples of 1848 normal blood donors and 248 patients with liver diseases. The following results were obtained. 1) N-14 antibodies and C-100 antibodies were detected in 25 (1.4%) and 17 (0.9%) out of 1848 normal blood donors, respectively. The detection rate was enhanced by 1% by using the N-14 test in addition to the C-100 kit. 2) The prevalence rate of anti-HCV in NANB liver diseases was 119 of 169 patients (70.4%) by the N-14 test and 114 of 169 patients (67.5%) by the C-100 test. 145 (85.8%) patients were positive by either one of the assays. The antibody in patients with chronic hepatitis tends to be detect in higher rate by the N-14 test than the C-100 test (p < 0.01). Reversely the latter could detect in higher rate than the former in patients with liver cirrhosis (p < 0.01). The detection rate of the antibody in patients with HCC was the same level by these two tests. By using both tests the detection rate was increased by 15-18%, up to totally 85.8% when compared with the rate obtained by testing either one of these tests. 3) Among 79 patients with liver diseases unrelated to HCV infections such as chronic hepatitis B and auto-immune hepatitis, 3 cases (3.8%) were detected by the N-14 test and 7 (8.9%) by the C-100 test, suggesting more strict specificity of the N-14 test. History of blood transfusion of the patients gave no difference in the results. In conclusion, the N-14 test for the detection of HCV infection seems to be specific and sensitive for the blood-screening, and the diagnosis of hepatitis C infection.