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. 2020 Jul:128:104454.
doi: 10.1016/j.jcv.2020.104454. Epub 2020 May 22.

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

Byron Freire-Paspuel  1 , Patricio Vega-Mariño  2 , Alberto Velez  2 , Paulina Castillo  2 , Marilyn Cruz  2 , Miguel Angel Garcia-Bereguiain  3
Affiliations

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

Byron Freire-Paspuel et al. J Clin Virol. 2020 Jul.

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.

Keywords: CDC; RT-qPCR; SARS-CoV-2; Validation.

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Conflict of interest statement

Declaration of Competing Interest All authors have no conflict of interest to declare.

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