title: Development and evaluation of rapid point-of-care tests for detection of Enterovirus 71 and Coxsackievirus A16 specific immunoglublin M antibodies.
abstract: Two colloidal gold immunochromatographic assays (CGIAs) for detection of EV71- and CA16- immunoglobulin M (IgM) were developed and evaluated. A total of 1465 sera collected from children with hand, foot, and mouth disease (HFMD), non-HFMD patients and healthy children. The sensitivity of IgM CGIA tests for EV71 and CA16 were 97.6% (330/338) and 91.6% (296/323) respectively, compared to those who were viral RNA positive by PCR. Their performances were comparable to those of commercial ELISA kits, with agreement of 98.1% for EV71-IgM and 97.3% for CA16-IgM. In addition, for EV71- and CA16-IgM CGIAs, the results of whole blood samples were 99.6% (248/249) and 100% (191/191) concordant to those with serum samples, respectively. As rapid point-of-care (POC) tests, the two CGIAs were suitable to be used in community clinic units, especially in resource-poor areas and will facilitate the control of HFMD.
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Cellular Stress Biology, School of Life Sciences, Xiamen University, Xiamen, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Zhang
authors.affiliation: State Key Laboratory of Molecular Vaccine and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen, China.
authors.forename: Zuxing
authors.initials: Z
authors.lastname: Weng
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Cellular Stress Biology, School of Life Sciences, Xiamen University, Xiamen, China.
authors.forename: Hailian
authors.initials: H
authors.lastname: Du
authors.affiliation: State Key Laboratory of Molecular Vaccine and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen, China.
authors.forename: Feihai
authors.initials: F
authors.lastname: Xu
authors.affiliation: Xiamen Center for Disease Control and Prevention, Xiamen, China.
authors.forename: Shuizhen
authors.initials: S
authors.lastname: He
authors.affiliation: State Key Laboratory of Molecular Vaccine and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen, China.
authors.forename: Delei
authors.initials: D
authors.lastname: He
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Cellular Stress Biology, School of Life Sciences, Xiamen University, Xiamen, China.
authors.forename: Tong
authors.initials: T
authors.lastname: Cheng
authors.affiliation: State Key Laboratory of Molecular Vaccine and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Zhang
authors.affiliation: State Key Laboratory of Molecular Vaccine and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen, China. Electronic address: sxge@xmu.edu.cn.
authors.forename: Shengxiang
authors.initials: S
authors.lastname: Ge
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Cellular Stress Biology, School of Life Sciences, Xiamen University, Xiamen, China.
authors.forename: Ningshao
authors.initials: N
authors.lastname: Xia
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D002846:Chromatography, Affinity / Q000379:methods*; D003955:Diagnostic Tests, Routine / Q000379:methods; D004770:Enterovirus / Q000276:immunology*; D029821:Enterovirus A, Human / Q000276:immunology*; D006232:Hand, Foot and Mouth Disease / Q000175:diagnosis*; D006801:Humans; D007075:Immunoglobulin M / Q000097:blood*; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D000914:Antibodies, Viral; D007075:Immunoglobulin M
keywords: CA16; Colloidal gold immunochromatographic assay; EV71; IgM