Version 1: Performance comparison of the miDiagnostics COVID-19 PCR Test with the GeneXpert SARS-CoV-2, Seegene Allplex Sars-CoV-2 and Aries Sars-CoV-2 assays

‘We compared the miDiagnostics COVID-19 PCR Test in an acute regional Hospital setting to the standard of care Covid-19 testing at the time: GeneXpert SARS-CoV-2, Seegene Allplex Sars-CoV-2 and Aries Sars-CoV-2 assays. Nasopharyngeal swabs were collected from 200 symptomatic and asymptomatic patients. A standard of care swab and a study swab were collected in a randomized fashion.
In this pooled analysis, 165 swabs were compared to Seegene, 28 to GeneXpert and 5 to Aries. On a total of 198 paired samples, the miDiagnostics test correctly classified 49 samples as positive and 127 samples as negative when compared to the standard of care method. This resulted in a sensitivity of 90.74% and a specificity of 88.19%. The miDiagnostics COVID-19 PCR Test is a viable diagnostic platform for very fast direct PCR diagnosis of Sars-CoV-2. Further studies are still needed to evaluate the performance in other settings and against other test platforms.’