Development and evaluation of rapid point-of-care tests for detection of Enterovirus 71 and Coxsackievirus A16 specific immunoglublin M antibodies

J Virol Methods. 2016 May:231:44-7. doi: 10.1016/j.jviromet.2016.01.015. Epub 2016 Feb 18.

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.

Keywords: CA16; Colloidal gold immunochromatographic assay; EV71; IgM.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Viral / blood*
  • Chromatography, Affinity / methods*
  • Diagnostic Tests, Routine / methods
  • Enterovirus / immunology*
  • Enterovirus A, Human / immunology*
  • Hand, Foot and Mouth Disease / diagnosis*
  • Humans
  • Immunoglobulin M / blood*
  • Point-of-Care Systems*
  • Sensitivity and Specificity
  • Time Factors

Substances

  • Antibodies, Viral
  • Immunoglobulin M