Performance Evaluation of Seven Commercial Real-Time Polymerase Chain Reaction Assays for SARS-COV-2 Detection

Abstract

Background / Aim: Since the emergence of the severe acute respiratory syndrome-coronavirus-2 (SARS-COV-2) pandemic in Wuhan, China, several efforts are being focused on the development of fast and reliable diagnostic molecular tests. Real-time polymerase chain reaction (RT-PCR) based assay on respiratory specimens was recommended by the World Health Organization as the gold standard for early diagnosis of infection spread. Our study aimed to compare the analytical performance of seven commercially available RT-PCR assays. Materials and Methods: A total of 33 nasopharyngeal swabs were analyzed by: Da An, PerkinElmer, Norgen, Prestige, PhoenixDX, Bio-Speedy, and Xpert Xpress RT-PCR assays. Sensitivity and detection rates of SARS-COV-2 target genes were analyzed. Results: Da An and Xpert Xpress assays showed the highest detection rate and percentage for SARS-COV-2 target genes; (16/33) 48.5%, followed by PerkinElmer and Norgen kits (13/33) 39.4%, (10/33) 30.3%, respectively. However, Prestige, PhoenixDx, and Bio-speedy displayed the same performance (6/33) 18.2%. Conclusion: The analyzed assays showed inconsistent analytical performance. Overall, findings reported in our study may not be applicable to other RT-PCR assays or thermocyclers; analytical sensitivities and positive-negative cut-off values should be locally validated.