Evaluation of a chemiluminescent enzyme immunoassay‐based high‐throughput SARS‐CoV‐2 antigen assay for the diagnosis of COVID‐19: The VITROS® SARS‐CoV‐2 Antigen Test

Abstract

Abstract A high‐throughput, fully automated antigen detection test for SARS‐CoV‐2 is a viable alternative to reverse‐transcription polymerase chain reaction (RT‐qPCR) for mass screening during outbreaks. In this study, we compared RT‐qPCR for viral load and the VITROS® SARS‐CoV‐2 Antigen Test with reference to the results of the LUMIPULSE® SARS‐CoV‐2 Ag Test. Of 128 nasopharyngeal swab specimens taken from patients suspected of being infected with SARS‐CoV‐2, 49 were positive and 79 were negative according to RT‐qPCR. Consistent dose‐dependent detection with VITROS® assay was successfully achieved when using nasopharyngeal swab specimens with Ct values of 32.0 or lesser, whereas the CLEIA‐based LUMIPULSE® assay was able to detect lower viral loads compared with the VITROS® assay. Our results show that the performance of the VITROS® assay was satisfactory for the diagnosis of contagious COVID‐19 patients in the clinical setting. Highlights The performance of the VITROS® SARS‐CoV‐2 Antigen Test was sufficient for the diagnosis of contagious COVID‐19. This test showed high sensitivity and specificity in the detection of SARS‐CoV‐2 in samples with a Ct value of 32 or less.