Assessing the Effectiveness of Fast-Track Diagnostic Kit for Detecting Viral Gastroenteritis Agents

Clin Lab. 2025 Jan 1;71(1). doi: 10.7754/Clin.Lab.2024.240821.

Abstract

Background: Viral gastroenteritis is a significant global health concern. An effective, rapid, and easy-to-use diagnostic tool is essential for screening causative viruses.

Methods: Forty-eight samples, known to be infected with one of the following viruses: norovirus, group A rotavirus, astrovirus, adenovirus, and sapovirus determined by reverse transcription-PCR and nucleotide sequencing, were evaluated by the Fast Track Diagnostics (FTD) viral gastroenteritis assay.

Results: The assay demonstrated 100% specificity for all viruses and matched the RT-PCR sensitivity for norovi-rus GI, classic human astrovirus, adenovirus, and sapovirus. It identified norovirus GII and rotavirus with 87.5% and 85.7% sensitivity, respectively. However, its sensitivity for detecting novel human astrovirus MLB and VA was lower, at 35%.

Conclusions: The FTD viral gastroenteritis assay can effectively screen simultaneously for norovirus GI, GII, group A rotavirus, adenovirus, and sapovirus in clinical settings. The study also suggests that improved detection methods are necessary for novel astrovirus strains.

MeSH terms

  • Feces / virology
  • Gastroenteritis* / diagnosis
  • Gastroenteritis* / virology
  • Humans
  • Norovirus / genetics
  • Norovirus / isolation & purification
  • Reagent Kits, Diagnostic
  • Reverse Transcriptase Polymerase Chain Reaction / methods
  • Rotavirus / genetics
  • Rotavirus / isolation & purification
  • Sapovirus / genetics
  • Sapovirus / isolation & purification
  • Sensitivity and Specificity

Substances

  • Reagent Kits, Diagnostic