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

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.

Automated summary

The study evaluated the diagnostic performance of nine commercial reverse-transcription polymerase chain reaction kits for SARS-CoV-2 testing, showing optimal performance and high discriminatory power. Variability in sensitivity, specificity, and E gene Ct Values was observed among the kits, potentially influenced by genetic variability of the virus.