Comparison of efficacy and reliability of six commercial COVID-19 diagnostic PCR kits

Abstract

All countries have been deeply affected by the coronavirus disease 2019 pandemic, both economically and in situations that strain health systems, such as workforce and workload. Therefore, various measures should be taken to control the disease and prevent its spread. Since the disease onset, real-time PCR tests have been used as the gold standard for disease diagnosis. Owing to the rapid progress of the pandemic and the spread of the disease, validation, consistency, and optimization tests of some commercial kits have been conducted directly in the field. Therefore, it is important to compare the results of these kits and improve the existing ones. We compared five kits (Bioexen, Polgen, Coronex, Diagen, and Anatolia) donated to the TOBB Economics and Technology University Hospital PCR laboratory with the KrosGen kit to detect severe acute respiratory syndrome coronavirus 2. A total of 244 samples were selected and analyzed using five different severe acute respiratory syndrome coronavirus 2 PCR detection kits. Positive and negative results from the six kits were compared using the working protocols of the kits, primers, and cycle threshold (Ct) values. Five of the six kits have reliable compatibility for Ct<30 but decreases for Ct≥30. Therefore, it is important to evaluate the performance of these kits for reduced viral loads. Using a suitable kit with high compatibility for Ct≥30 is important for detecting patients with a low viral load and helping prevent disease spread.