Molecular detection of Rotavirus in children with gastroenteritis: A comparative study of RT-PCR and rapid diagnostic tests

Abstract

Rotavirus an infection in the gastrointestinal tract is a leading cause of severe diarrhea globally in infants aged under 1 years and younger aged five years. This study evaluated the diagnostic accuracy of a modern antigen-based Rapid Diagnostic Test for the detection of RVA in stool samples, employing reverse transcription-quantitative as the reference diagnostic method from September 2022 and Aug. 2023. This study performed a cross-sectional evaluation involving 55 children under the age of 5 years, with 35 exhibiting diarrheas, while 20 showed no symptoms. The analysis of stool samples involved testing for the non-structural protein 4 gene tests through rapid diagnostic test (RDT) and RT-qPCR, alongside genotyping for viral protein 4 and viral protien7. The RDT exhibited a sensitivity of 70% for symptomatic patients; however, its accuracy declined to 68% in asymptomatic cases, with performance further diminishing at elevated Ct values. The RT-qPCR analysis indicated that the most prevalent strains in the study population were RVA G12P (53.6%), G1P (26.8%), and G8P (19.5%). In contrast, the RDT demonstrated detection rates of only 55% for G12P, 30% for G1P, and 15% for G8P. The rapid RVA screening capability of RDT, which is resource-efficient, should be complemented by confirmatory testing through RT-qPCR, given that its lower diagnostic accuracy required validation of results in clinical practice .This research demonstrated the ability of RDT to detect RVA through preliminary assessments; it indicated reduced efficacy in cases of symptoms or low viral load situations. The testing method requires further optimization to improve reliability ratings prior to broader implementation.