Robust Automation and Point of Care IDentification of COVID - Hospital Costa del Sol
Description
he objetive of the study was the testing of a Point of Care (PoC) device, capable to sample to result in under 60 minutes. This device shall act as a front-line screening diagnostic for patients suspected of having SARS-CoV-2 infection and others pathogens, such as Influenza A and Influenza B. This device should be fully automated for sample extraction DNA/RNA amplification (“PCR”) and detection/data analysis steps. This solution will allow for effective triage of patients outside of central testing laboratories, including remote locations, A&E in hospitals, pandemic surveillance centres and border control disease detection centres. All samples were pre-diagnosed using the Xpert Xpress SARS-CoV-2 (Cepheid, Sunnyvale, CA USA), this is a comparator test with a similar response time and handling characteristics. Data was also collected on the limit of detection, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and reproducibility. The conclusions drawn from this study were that the global and stratified specificity were, in all cases, greater than 99%. The overall sensitivity of the EasyNAT SARS-CoV-2 Assay, when compared to the comparator assay, was 79.1%, which is considered as suboptimal. When stratifying the assay by type of preanalytical preservation it was found that the POC assay had a much greater sensitivity when testing fresh or recently extracted samples rather than samples which have been frozen. The concordance evaluation highlighted discordant results against the comparator assay, particularly when the comparator Ct values were high and therefore viral load is low, or if the samples are frozen. The Xpert Xpress SARS-CoV-2 failed to detect pathogens in these cases. The EasyNAT SARS-CoV-2 Assay could therefore be recommended for use with samples that have been drawn recently, kept refrigerated during transport, and is suspected of containing a high viral load (symptoms compatible with SARS-CoV-2 infection or have a recent positive antigen test).The assay is also favorable for carrying out rapid screening in patients with symptoms compatible with SARS-CoV-2 infection, including centers far from hospitals or in areas of difficult access, and health professionals or professionals from important sectors with a previous positive result and without current symptoms.