Assessment of the SD Bioline Rota/Adeno Antigen-Based Test in Infants with Diarrhea by RT-PCR

Abstract

Introduction: Intestinal imbalances cause diarrhoea. Three or more daily loose stools, severe if under 14 days. Chronic diarrhoea has non-infectious causes and severe infections. Rotaviruses, especially RVA genotype G/P, are essential. Affordable RDTs have varying accuracy, but ELISA and RT-PCR are diagnostic procedures. Leukocyte, stool culture, and pH tests pinpoint reasons. C. difficile and E. coli must be tested. Parasite testing improves diagnosis.

Aims and Objective: This study uses RT-PCR and Ct value to evaluate the newly designed antigen test based Rapid Diagnostic Test (RDT) kit for identification of new-born diarrhoea rotavirus A.

Methods: A cross-sectional study from September 2022 to August 2023 used RT-PCR to detect RVA in faeces. Asymptomatic children under five and diarrheal children were sampled. After extracting viral RNA with the RDT, RT-qPCR targeting NSP4 confirmed RVA presence. VP7 and VP4 gene genotyping was performed on samples with Ct < 39, using a CT cut-off of 24 for gastroenteritis assessment.

Results: Table 1 shows baseline characteristics of diarrheal and non-diarrhea patient counts with diarrhoea, high Ct values, and symptoms are shown in Figure 1. RT-qPCR and RDT virus strain identification findings are shown in Table 2. RDT vs. RT-qPCR diagnostics are shown in Figure 2. Table 3 and Table 4 examine RDT's diarrhoea detection and Ct value detection abilities. RT-qPCR and RDT results agree in Figure 3, showing RDT's specificity but lower sensitivity.

Conclusion: The study has concluded that the accuracy of designed RDT is considerable in the presence of diarrhea and can be used by common people in ruling out Rotavirus a infection, but cannot be the ultimate diagnostic tool.