[Virological studies on the usefulness of anti-HCV ELISA assay using recombinant N-14 fusion protein in various liver diseases].
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.
Imamura
S
S
Second Department of Internal Medicine, Faculty of Medicine, Kagoshima University.
D000595:Amino Acid Sequence; D000956:Antigens, Viral; D001483:Base Sequence; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D016174:Hepacivirus / Q000276:immunology*; D006508:Hepatitis Antibodies / Q000097:blood*; D006526:Hepatitis C / Q000175:diagnosis; D018937:Hepatitis C Antibodies; D006801:Humans; D008107:Liver Diseases / Q000175:diagnosis* / Q000276:immunology; D008969:Molecular Sequence Data; D011993:Recombinant Fusion Proteins / Q000737:chemistry; D017361:Viral Nonstructural Proteins / Q000097:blood
D000956:Antigens, Viral; C064544:C100 protein, hepatitis C virus; D006508:Hepatitis Antibodies; D018937:Hepatitis C Antibodies; D011993:Recombinant Fusion Proteins; D017361:Viral Nonstructural Proteins