Introduction: Acute gastroenteritis is the second main cause of morbidity and mortality in the developing world, with about 2 million deaths in children under the age of five recorded each year. Mortality is lower in developed countries, but morbidity and economic consequences are high. Therefore, rapid and accurate detections of enteric pathogens is vital for effective treatment. This study evaluated and demonstrated effective detection of the most prevalent enteric viral pathogens, using the EasyScreenTM Enteric Viral Detection Kit EV002, a multiplex real-time PCR detection system.
Aim: To evaluate the clinical performance of the EasyScreenTM Enteric Viral Detection Kit EV002.
Methods: Clinical samples (N=241) were sourced retrospectively from several Sydney hospital and diagnostic services. These included Norovirus GII (N=164), Norovirus GI (21), Adenovirus (18, including 4 Adenovirus 41), Rotavirus A (10), Astrovirus (7), Enterovirus (3), Sapovirus (1), and 17 negative stool samples. Nucleic acids were extracted from the blinded raw stool samples using the EasyScreenTM Sample Processing Kit and the KingFisher Flex robot in batches of 96. The eluted nucleic acids were screened using the EV002 real-time PCR kit in 384 well format. Discordants or co-infections were investigated by alternate PCR assays and DNA sequencing.
Results: For the detection of Astrovirus, Adenovirus, Enterovirus, Rotavirus A, Sapovirus, and negative samples, 100% concordance between reference and EV002 was observed. In Norovirus GI samples, EV002 resulted in 95% sensitivity (20/21) and 100% specificity. Similarly, 96% sensitivity (158/164) and 100% specificity was observed for Norovirus GII. EV002 identified some apparent dual infections that were not tested for in the reference set, which are being further investigated.
Conclusion: The EasyScreenTM Enteric Viral Detection Kit EV002 demonstrated an overall 97% concordance in this dataset, and can provide rapid detection of enteric viruses within 5 hours from sample to result.