Evaluation of two commercial multiplex RT-PCR tests for broad genotypic detection of viral gastroenteritis

Chiara Filizzolo1, Mariangela Pizzo1, Marika Munacò1

  • 1Dipartimento di Promozione della Salute, Materno-Infantile, di Medicina Interna e Specialistica di Eccellenza "G. D'Alessandro", Università degli Studi di Palermo, Italy.

PubMed

Insights

Two molecular assays accurately detect multiple enteric viruses causing acute gastroenteritis (AGE) in children. These reliable diagnostic tools aid in patient management and outbreak control for viral AGE.

Area of Science:

  • Clinical Microbiology
  • Virology
  • Molecular Diagnostics

Background:

  • Acute gastroenteritis (AGE) is a significant global health issue, especially in children under five.
  • While mortality has decreased in developed nations, AGE remains a substantial healthcare burden and threat in developing regions.
  • Accurate and rapid diagnosis of viral pathogens is crucial for effective management and control.

Purpose of the Study:

  • To evaluate the diagnostic performance of two commercial molecular assays: GastroIntestinal (GI) Viral PLUS ELITe MGB® and GI Norovirus PLUS ELITe MGB®.
  • To assess the assays' ability to detect a broad range of viral genotypes responsible for AGE.
  • To compare the performance of these assays against established reference biomolecular methods.

Main Methods:

  • Analysis of 222 archived stool samples previously characterized by reference methods.
  • Testing included samples positive for rotavirus (RVA), norovirus (NoV), adenovirus (AdV), astrovirus (HAstV), and co-infections.
  • Performance evaluation based on sensitivity, specificity, and agreement (κ value) with reference results.

Main Results:

  • Both GI Viral PLUS and GI Norovirus PLUS ELITe MGB® assays demonstrated excellent agreement with reference methods (κ ≥ 0.95).
  • High sensitivity (99.4–100%) and specificity (98.1–100%) were observed for the detection of various viral genotypes.
  • Minor misclassification of specific norovirus strains (GII.6) was noted, potentially due to primer binding site similarities.

Conclusions:

  • The GI Viral PLUS and GI Norovirus PLUS ELITe MGB® assays are reliable tools for rapid and accurate genotypic diagnosis of viral AGE.
  • These assays can effectively detect a wide spectrum of circulating viral pathogens associated with gastroenteritis.
  • Implementation of these molecular assays can improve patient care, reduce unnecessary antibiotic use, and facilitate timely outbreak containment.