title: Novel evolved immunoglobulin (Ig)-binding molecules enhance the detection of IgM against hepatitis C virus.
abstract: Detection of specific antibodies against hepatitis C virus (HCV) is the most widely available test for viral diagnosis and monitoring of HCV infections. However, narrowing the serologic window of anti-HCV detection by enhancing anti-HCV IgM detection has remained to be a problem. Herein, we used LD5, a novel evolved immunoglobulin-binding molecule (NEIBM) with a high affinity for IgM, to develop a new anti-HCV enzyme-linked immunosorbent assay (ELISA) using horseradish peroxidase-labeled LD5 (HRP-LD5) as the conjugated enzyme complex. The HRP-LD5 assay showed detection efficacy that is comparable with two kinds of domestic diagnostic kits and the Abbott 3.0 kit when tested against the national reference panel. Moreover, the HRP-LD5 assay showed a higher detection rate (55.9%, 95% confidence intervals (95% CI) 0.489, 0.629) than that of a domestic diagnostic ELISA kit (Chang Zheng) (53.3%, 95% CI 0.463, 0.603) in 195 hemodialysis patient serum samples. Five serum samples that were positive using the HRP-LD5 assay and negative with the conventional anti-HCV diagnostic ELISA kits were all positive for HCV RNA, and 4 of them had detectable antibodies when tested with the established anti-HCV IgM assay. An IgM confirmation study revealed the IgM reaction nature of these five serum samples. These results demonstrate that HRP-LD5 improved anti-HCV detection by enhancing the detection of anti-HCV IgM, which may have potential value for the early diagnosis and screening of hepatitis C and other infectious diseases.
authors.affiliation: Department of Microbiology, Shanghai Key Laboratory of Medical Biodefense, Second Military Medical University, Shanghai, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Cao
authors.forename: Qiuli
authors.initials: Q
authors.lastname: Chen
authors.forename: Huaqun
authors.initials: H
authors.lastname: Zhang
authors.forename: Peipei
authors.initials: P
authors.lastname: Qi
authors.forename: Chao
authors.initials: C
authors.lastname: Liu
authors.forename: Xufang
authors.initials: X
authors.lastname: Yang
authors.forename: Niansong
authors.initials: N
authors.lastname: Wang
authors.forename: Baohua
authors.initials: B
authors.lastname: Qian
authors.forename: Jinhong
authors.initials: J
authors.lastname: Wang
authors.forename: Shaohua
authors.initials: S
authors.lastname: Jiang
authors.forename: Hua
authors.initials: H
authors.lastname: Yang
authors.forename: Shuhan
authors.initials: S
authors.lastname: Sun
authors.forename: Wei
authors.initials: W
authors.lastname: Pan
mesh_terms: D015374:Biosensing Techniques; D004797:Enzyme-Linked Immunosorbent Assay; D016174:Hepacivirus / Q000276:immunology*; D006801:Humans; D007075:Immunoglobulin M / Q000097:blood* / Q000276:immunology / Q000378:metabolism; D011485:Protein Binding
chemical_list: D007075:Immunoglobulin M