STANDARD M10 Evaluation

The data included in this research were collected regarding the outburst of COVID-19 and the need of fast and accurate diagnosis of SARS-CoV-2 . For this reason we compared a point of care analyzer, STANDARD M10 with three accurate real time RT-PCR tests. The aim of our study is to understand and delineate the use of STANDARD M10 in the laboratory routine and how it can actually affect the diagnostic result. The data collected, were 106 nasopharygeal samples under COVID-19 suspicion from patients arrived to the emergency departement of our hospital. In addition, samples were processed from sample identification stage to genetic material extraction to end up at the final validation of SARS-CoV-2 diagnosis. In this procedure three real time RT-PCR assays were compared with the STANDRD M10 point of care assay. 36 samples were proceeded, according to EnzyQuest assay, 18 positive and 18 negative, 74 samples were processed according to Sacace assay, 28 positive and 46 negative and 106 samples were reviewed by Primer Design, 54 positive and 52 negative samples. Finally, we collected and analysed our results by calculating the efficiency of the tested assay through the following paramteres; sensitivity, specificity, negative/positive predictive value and accuracy.