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

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

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.

MeSH terms

  • Betacoronavirus / genetics
  • Betacoronavirus / isolation & purification*
  • COVID-19
  • Coronavirus Infections / diagnosis*
  • Coronavirus Infections / virology
  • Humans
  • Nasopharynx / virology
  • Pandemics
  • Pneumonia, Viral / diagnosis*
  • Pneumonia, Viral / virology
  • Reagent Kits, Diagnostic
  • Real-Time Polymerase Chain Reaction / methods*
  • SARS-CoV-2
  • Sensitivity and Specificity

Substances

  • Reagent Kits, Diagnostic