title: A convenient nucleic acid test on the basis of the capillary convective PCR for the on-site detection of enterovirus 71.
abstract: The recent and continuing epidemic of enterovirus 71 in China has affected millions of children and resulted in thousands of deaths. Timely diagnosis and management is essential for disease control. Current enterovirus 71 molecular tests require resources that are unavailable for on-site testing. We have developed a simple-to-operate nucleic acid test, the convenient and integrated nucleic acid test, for local medical institutions. It uses a convective PCR for rapid amplification, a dipstick for visual detection of PCR products, and a simple commercial kit for nucleic acid extraction. By using a specially designed reagent and reaction tube containing a dipstick, the amplification and detection processes are well integrated and simplified. Moreover, cross contamination that may be caused by an open-tube detection system can be avoided. On the basis of the convenient and integrated nucleic acid test, an enterovirus 71 assay for on-site testing was developed. After evaluating known hand, foot, and mouth disease virus stocks of 17 strains of 11 different serotypes, this assay showed a favorable detection spectrum and no cross-reactivity. Its clinical performance was established by testing 141 clinical samples and comparing the results with a nested RT-PCR method. The assay showed a clinical sensitivity and specificity of 98.5% and 100%, respectively. Our results suggest that this convenient and integrated nucleic acid test enterovirus 71 assay may serve as an on-site diagnosis tool.
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Disease, School of Life Science, Xiamen University, Xiamen, China.
authors.forename: Shiyin
authors.initials: S
authors.lastname: Zhang
authors.affiliation: Department of Hepatobiliary Surgery, Zhongshan Hospital of Xiamen University, Xiamen, China.
authors.forename: Yanyan
authors.initials: Y
authors.lastname: Lin
authors.affiliation: Department of Research and Development, Xiamen Innovax Biotech Co, Ltd, Xiamen, China.
authors.forename: Jin
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Research and Development, Xiamen Innovax Biotech Co, Ltd, Xiamen, China.
authors.forename: Penglin
authors.initials: P
authors.lastname: Wang
authors.affiliation: Department of Research and Development, Xiamen Innovax Biotech Co, Ltd, Xiamen, China.
authors.forename: Jieyu
authors.initials: J
authors.lastname: Chen
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Disease, School of Life Science, Xiamen University, Xiamen, China.
authors.forename: Miaoge
authors.initials: M
authors.lastname: Xue
authors.affiliation: Clinical Laboratory, Xiamen Center for Disease Control and Prevention, Fujian, China.
authors.forename: Shuizhen
authors.initials: S
authors.lastname: He
authors.affiliation: Department of Research and Development, Xiamen Innovax Biotech Co, Ltd, Xiamen, China.
authors.forename: Wenbin
authors.initials: W
authors.lastname: Zhou
authors.affiliation: Department of Research and Development, Xiamen Innovax Biotech Co, Ltd, Xiamen, China.
authors.forename: Feihai
authors.initials: F
authors.lastname: Xu
authors.affiliation: Department of Hepatobiliary Surgery, Zhongshan Hospital of Xiamen University, Xiamen, China.
authors.forename: Pingguo
authors.initials: P
authors.lastname: Liu
authors.affiliation: Department of Mechanical Engineering, National Taiwan University, Taipei, Taiwan.
authors.forename: Pinghei
authors.initials: P
authors.lastname: Chen
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Disease, School of Life Science, 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 Disease, School of Life Science, Xiamen University, Xiamen, China.
authors.forename: Ningshao
authors.initials: N
authors.lastname: Xia
mesh_terms: D002648:Child; D002681:China / Q000453:epidemiology; D029821:Enterovirus A, Human / Q000235:genetics / Q000302:isolation & purification*; D004867:Equipment Design; D006232:Hand, Foot and Mouth Disease / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology*; D006801:Humans; D016133:Polymerase Chain Reaction / Q000295:instrumentation* / Q000379:methods; D012367:RNA, Viral / Q000235:genetics / Q000302:isolation & purification; D012680:Sensitivity and Specificity
chemical_list: D012367:RNA, Viral