21029749
not annotated - annotated - LINNAEUS only
Double-antigen sandwich ELISA for the detection of anti-hepatitis C virus antibodies.
A double-antigen sandwich ELISA was developed a detection of HCV antibodies by a recombinant multi-epitope HCV antigen and a biotin-streptavidin amplification system. Three plasma specimens from 1708 individuals who were suspected previously to be HCV-positive using an HCV antibody diagnostic kit (Chuangxin, Xiamen, China) displayed negative results when using the ELISA. These results were validated by a recombinant immunoblotting assay (two were negative, and one was indeterminate). Among 889 blood specimens donated for clinical evaluation, 246 were positive and 630 were negative using the ELISA. The sensitivity and specificity of the ELISA were 98.7% and 100%, respectively. In 43 donors and 14 patients with chronic hepatitis C, the detectable rates for HCV IgM by both ELISA and the HCV anti-IgM detection reagents (Huimin, Shenyang, China) were 100%, and the detectable rate for HCV IgG using an indirect HCV-antibody detection kit (GWK, Beijing, China) was 98.3%. Thus, the double-antigen sandwich ELISA exhibits strong specificity and sensitivity and has been approved by the China State Food and Drug Administration (SFDA). The performance of the double-antigen sandwich ELISA was similar to the Ortho ELISA 3.0. It did not give false-negative results otherwise IgM was undetectable using an indirect HCV-antibody detection kit. This ELISA provides another method for the detection of HCV antibodies.
Ann file
T1 Species 56 73 hepatitis C virus
N1 Reference T1 Taxonomy:11103
T2 Species 149 152 HCV
N2 Reference T2 Taxonomy:11103
T3 Species 195 198 HCV
N3 Reference T3 Taxonomy:11103
T4 Species 336 339 HCV
N4 Reference T4 Taxonomy:11103
T5 Species 358 361 HCV
N5 Reference T5 Taxonomy:11103
T6 Species 853 856 HCV
N6 Reference T6 Taxonomy:11103
T7 Species 883 886 HCV
N7 Reference T7 Taxonomy:11103
T8 Species 980 983 HCV
N8 Reference T8 Taxonomy:11103
T9 Species 1006 1009 HCV
N9 Reference T9 Taxonomy:11103
T10 Species 1405 1408 HCV
N10 Reference T10 Taxonomy:11103
T11 Species 1489 1492 HCV
N11 Reference T11 Taxonomy:11103
#1 AnnotatorNotes T1 TODO check ("anti-")