Discrepancy between PCR based SARS-CoV-2 tests suggests the need to re-evaluate diagnostic assays

Abstract Objective We investigated the discrepancy between clinical and PCR-based diagnosis of COVID-19. compared results ten patients with mild to severe Respiratory samples from all cases were tested on Roche SARS-CoV-2 (Cobas) assay, Filmarray RP2.1 (bioMereiux) TaqPath™ COVID19 (Thermofisher) PCR assays. Results Laboratory records COVID-19 examined. Initially, respiratory as negative ® assay. Further investigation using BIOFIRE assay identified pathogen in cases. To investigate possible discrepancies assays, additional testing was conducted PCR. Eight positive for TaqPath Further, Spike gene target failures (SGTF) three these eight Discrepancy assays could be due variation efficiencies amplification reactions or, at primer binding sites. Strains SGTF indicate presence new variant strains. Regular modification targets diagnostic may necessary maintain robustness accuracy avoid reduced case detection, under-surveillance, missed opportunities control.