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

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 (R) SARS-CoV-2 Antigen Test with reference to the results of the LUMIPULSE (R) 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 (R) assay was successfully achieved when using nasopharyngeal swab specimens with Ct values of 32.0 or lesser, whereas the CLEIA-based LUMIPULSE (R) assay was able to detect lower viral loads compared with the VITROS (R) assay. Our results show that the performance of the VITROS (R) assay was satisfactory for the diagnosis of contagious COVID-19 patients in the clinical setting.