Comparative evaluation of five rapid PCR platforms for respiratory virus detection

Abstract

BACKGROUND: The demand for rapid molecular diagnostics for respiratory viruses has increased substantially. Several point-of-care PCR platforms have become available, yet comparative performance data remain limited. OBJECTIVES: To evaluate the diagnostic accuracy and operational reliability of four rapid PCR platforms for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A and B viruses (IAV, IBV), and respiratory syncytial virus (RSV), in comparison with the GeneXpert (Cepheid, USA) platform. METHODS: Nasopharyngeal swabs from patients with respiratory symptoms were tested using the GeneXpert, positive samples were subsequently analysed on four alternative systems: the 30-minute and 1-hour M10 (SD Biosensor, South Korea) assays, FlashDetect™ Flash10 (Coyote Bioscience, China), Vivalytic (Bosch Healthcare Solutions, Germany), and Galaxy Lite (Igenesis, China). Additional lower viral load samples and cultured IAV/ IBV strains were included. RESULTS: A total of 223 GeneXpert positive samples were prospectively analysed. Flash10 showed 94.6% overall agreement, missing SARS-CoV-2 (n = 4, GeneXpert Cycle threshold (Ct) min-max; 37.7-42.2), IAV (n = 5, 32.8-37.7), and IBV (n = 3, 26.5-36.7). Vivalytic showed 83.0% overall agreement, missing SARS-CoV-2 (n = 16, 30.4-42.2), IAV (n = 9, 26.8-37.7), IBV (n = 9, 27.2-36.7), and RSV (n = 4, 31.5-37.0). Galaxy Lite achieved 88.2% overall agreement but failed in 27.2% of test runs. With a smaller sample size the M10 (30-minute) assay showed 98.6% overall agreement with GeneXpert, missing one SARS-CoV-2 case (Ct 39.7). CONCLUSION: Among four platforms, the M10 (30-min version) and Flash10 platforms demonstrated the highest agreement rates with the GeneXpert. The variability in performance highlights the importance of independent platform evaluation.