Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: an example of the need of validation studies

Abstract Background Several qPCR kits are available for SARS-CoV-2 diagnosis, mostly lacking of evaluation due to covid19 emergency. Objective We evaluated nCoV-QS (MiCo BioMed) kit using CDC kit as gold standard. Results We found limitations for nCoV-QS: 1) lower sensitivity 2) lack of RNA quality control probe. Conclusions Validation studies should be implemented for any SARS-CoV-2 RT-qPCR commercial kit to prevent unreliable diagnosis.