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

Acute gastroenteritis (AGE) remains a global health concern, particularly affecting children under five. While mortality rates have declined in industrialized countries, AGE continues to pose a significant burden on healthcare systems and remains a major threat in developing regions. This study evaluates the diagnostic performance of two commercial molecular assays for enteric viruses, GastroIntestinal (GI) Viral PLUS ELITe MGB® and GI Norovirus PLUS ELITe MGB®, for the detection of a broad panel of viral genotypes associated with AGE. A total of 222 archived stool samples, previously characterized by reference biomolecular methods, were analyzed. These included 50 rotavirus (RVA)-positive, 57 norovirus (NoV)-positive, 39 adenovirus (AdV)-positive, 45 astrovirus (HAstV)-positive samples, and 10 co-infections. Both assays showed excellent agreement with reference methods (κ ≥ 0.95), with sensitivity ranging from 99.4 % to 100 % and specificity from 98.1 % to 100 %, confirming their ability to detect a broad spectrum of circulating viral genotypes. Minor discrepancies were observed in NoV GII.6 strains, misclassified as Genogroup I (GI), likely due to overlapping annealing profiles. These findings support the use of GI Viral PLUS and GI Norovirus PLUS ELITe MGB® assays as reliable tools for rapid and accurate genotypic diagnosis of viral AGE. Their implementation may enhance patient management, reduce inappropriate antimicrobial use, and support timely outbreak containment, especially in healthcare settings.