Evaluation of the AMP rapid test ROTA/ADENOVIRUS for simultaneous detection of rotavirus and adenovirus in stool samples.

Abstract

Background: Rotavirus (RV) and Adenovirus (AdV) gastroenteritis affect children worldwide. The sensitivity and specificity of the AMP Rapid Test ROTA/ADENOVIRUS [AMP-RA] for the detection of RV and AdV were compared against qPCR Allplex™ GI-Virus Assay [Allplex-GI].

Methods: A cross-sectional hospital-based surveillance study was conducted using stool samples from 1,148 patients under the age of five years between July 2023 and May 2024 with gastroenteritis. All samples were tested using the AMP-RA and challenged with the Allplex-GI that detects rotavirus A, enteric adenovirus F, norovirus genogroups GI & GII, sapovirus, and astrovirus. RV samples testing positive by AMP-RA and/or Allplex-GI were subjected to genotyping.

Results: Of the 1,148 stool samples, 123 samples tested positive for RV on AMP-RA while 133 tested positive on the Allplex™ GI. The clinical sensitivity and positive predictive value (PPV) of the AMP-RA for the detection of RV were 92.4% and 100%, respectively, while, the clinical specificity and negative predictive value (NPV) of the AMP-RA kit were 100% and 99%, respectively. The AMP-RA was able to detect all RV genotypes that circulated (G1[P8], G2[P4], G9[P8], G9[P4], G9[P9]). The AMP-RA assay detected 48 positive AdV samples and failed to detect 28 samples. Thus, the clinical sensitivity and PPV were 63.1% and 24.6%, respectively. 147 samples were positive for AdV on AMP-RA and negative by Allplex-GI, indicating a clinical specificity and NPV of 86.2% and 97.1%, respectively.

Conclusion: AMP-RA showed high diagnostic sensitivity and specificity for RV detection. The reliability of detecting AdV was insufficient, emphasizing the need for further adenovirus test improvement.