title: A novel double antibody sandwich-lateral flow immunoassay for the rapid             and simple detection of hepatitis C virus.
abstract: The objective of this study was to screen for antigens of the hepatitis C virus (HCV) to establish a new double antibody sandwich-lateral flow immunoassay (DAS-LFIA) method for testing the presence of anti-HCV antibodies in human serum or plasma. A series of different recombinant HCV proteins in Escherichia coli cells were constructed, expressed, purified and the new DAS-LFIA strip was developed. The sensitivity and specificity of new the DAS-LFIA strip were evaluated by detecting 23 HCV-positive sera, a set of quality control references for anti-HCV detection that contain known amounts of anti-HCV antibodies, and 8 HCV-negative sera. A total of 300 clinical serum samples was examined by both the new DAS-LFIA strip and enzyme-linked immunosorbent assay (ELISA). Data were analyzed using SPSS 11.5 software. The sensitivity and specificity of the new DAS-LFIA strip were 100%. The lowest test line of the HCV DAS-LFIA strips was 2 NCU/ml. Additionally, the concordance between the new DAS-LFIA strip and ELISA methods was 94.33%. In conclusion, our new testing method is rapid, simple, sensitive and specifically detects the presence of anti-HCV antibodies in human serum or plasma. Therefore, it may be used for monitoring HCV.
authors.affiliation: Molecular Oncology and Epigenetic Laboratory, The First Affiliated Hospital of Chongqing Medical University, Chongqing, PR China.
authors.forename: Tingxiu
authors.initials: T
authors.lastname: Xiang
authors.forename: Zheng
authors.initials: Z
authors.lastname: Jiang
authors.forename: Jian
authors.initials: J
authors.lastname: Zheng
authors.forename: Chaoyu
authors.initials: C
authors.lastname: Lo
authors.forename: Harry
authors.initials: H
authors.lastname: Tsou
authors.forename: Guosheng
authors.initials: G
authors.lastname: Ren
authors.forename: Jun
authors.initials: J
authors.lastname: Zhang
authors.forename: Ailong
authors.initials: A
authors.lastname: Huang
authors.forename: Guoqi
authors.initials: G
authors.lastname: Lai
mesh_terms: D000956:Antigens, Viral / Q000096:biosynthesis / Q000235:genetics / Q000276:immunology; D002846:Chromatography, Affinity / Q000379:methods*; D003001:Cloning, Molecular; D004926:Escherichia coli; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology*; D006526:Hepatitis C / Q000097:blood / Q000175:diagnosis* / Q000276:immunology; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D007159:Immunologic Tests; D011485:Protein Binding; D011994:Recombinant Proteins / Q000096:biosynthesis / Q000235:genetics / Q000276:immunology; D012680:Sensitivity and Specificity; D014764:Viral Proteins / Q000096:biosynthesis / Q000235:genetics / Q000276:immunology
chemical_list: D000956:Antigens, Viral; D018937:Hepatitis C Antibodies; D011994:Recombinant Proteins; D014764:Viral Proteins