Comparative Evaluation of RT-PCR Kits Available in Sri Lanka for Diagnosis of SARS-CoV-2

Real-time reverse transcriptase-PCR (RT-PCR) is considered as the gold standard method for severe acute respiratory syndrome coronavirus-2 (SARS CoV-2) diagnosis. However, the performances of the commercial RT-PCR kits used in Sri Lanka have not been evaluated adequately. Performance of the five RT-PCR kits selected for this study was compared individually using known SARS-CoV-2 positive (62) and negative (32) respiratory samples. The sensitivity, specificity, Cohen’s kappa coefficient, positive and negative predictive values (PPV and NPV) were analyzed. Comparison of the Ct value of the five commercial kits revealed heterogeneity. Among them, the TaqPathTM RT-PCR kit showed the highest sensitivity (98.4%), and inter-rater reliability (0.976). The Hybribio COVID-19 RT-PCR kit showed the lowest sensitivity (91.9%), specificity (93.7%) and inter-rater reliability (0.838). Although the five RT-PCR kits exhibited varying sensitivity, specificity, and Ct values, all of them are suitable for the routine diagnosis of COVID-19 as all values are above 90 %.