Evaluation of the diagnostic performance of nine commercial RT-PCR kits for the detection of SARS-CoV-2 in Colombia

J Med Virol. 2021 Sep;93(9):5618-5622. doi: 10.1002/jmv.27051. Epub 2021 May 3.

Abstract

The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has led to the design and development of multiple reverse-transcription polymerase chain reaction kits aimed to facilitate the rapid scale-up of molecular testing for massive screening. We evaluated the diagnostic performance of nine commercial kits, which showed optimal performance and high discriminatory power. However, we observed differences in terms of sensitivity, specificity, and E gene Ct Values and discuss these results in light of the influence of SARS-CoV-2 genetic variability and its potential impact in current molecular diagnostic assays.

Keywords: RT-PCR; SARS-CoV-2; commercial kits; molecular diagnosis; performance.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19 / diagnosis*
  • COVID-19 / virology
  • COVID-19 Testing
  • Colombia
  • Humans
  • Molecular Diagnostic Techniques
  • Reagent Kits, Diagnostic / standards*
  • Reverse Transcriptase Polymerase Chain Reaction / methods*
  • SARS-CoV-2 / genetics*
  • SARS-CoV-2 / isolation & purification*
  • Sensitivity and Specificity

Substances

  • Reagent Kits, Diagnostic