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

  1. Byron Freire-Paspuel
  2. Patricio Vega-Mariño
  3. Alberto Velez
  4. Paulina Castillo
  5. Marilyn Cruz
  6. Miguel Angel Garcia-Bereguiain
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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 3) no capacity to quantify viral load.

Conclussions

Validation studies should be implemented for any SARS-CoV-2 RT-qPCR commercial kit to prevent unreliable diagnosis.

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