Evaluation of a new immunochromatographic assay kit for the rapid detection of norovirus in fecal specimens

Ann Lab Med. 2012 Jan;32(1):79-81. doi: 10.3343/alm.2012.32.1.79. Epub 2011 Dec 20.

Abstract

Rapid and accurate detection of norovirus is essential for the prevention and control of norovirus outbreaks. This study compared the effectiveness of a new immunochromatographic assay kit (SD BIOLINE Norovirus; Standard Diagnostics, Korea) and real-time reverse transcription-PCR (RT-PCR) for detecting norovirus in fecal specimens. Compared with real-time RT-PCR, the new assay had sensitivity, specificity, positive predictive value, and negative predictive value of 76.5% (52/68), 99.7% (342/343), 98.1% (52/53), and 95.5% (342/358), respectively. The sensitivity of the assay was 81.8% (18/22) for GII.3 and 75.7% (28/37) for GII.4. None of the 38 enteric virus-positive specimens (3 for astrovirus, 5 for enteric adenovirus, and 30 for rotavirus) tested positive in the cross-reactivity test performed by using this assay. The new immunochromatographic assay may be a useful screening tool for the rapid detection of norovirus in sporadic and outbreak cases; however, negative results may require confirmatory assays of greater sensitivity.

Keywords: Immunochromatographic assay; Norovirus; Sensitivity; Specificity.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Caliciviridae Infections / diagnosis*
  • Child
  • Child, Preschool
  • Feces / virology*
  • Gastroenteritis / diagnosis*
  • Gastroenteritis / virology
  • Humans
  • Immunoassay*
  • Infant
  • Middle Aged
  • Norovirus / genetics*
  • Norovirus / isolation & purification
  • RNA, Viral / analysis
  • Reagent Kits, Diagnostic
  • Reverse Transcriptase Polymerase Chain Reaction
  • Sensitivity and Specificity

Substances

  • RNA, Viral
  • Reagent Kits, Diagnostic