Abstract
Increasing transmission of SARS-CoV-2 infection in successive waves may strain the capacity of laboratories performing molecular diagnostic testing. Alternative testing approaches may offer additional diagnostic capacity. A high throughput chemiluminescent antigen assay (Ortho VITROS SARS-CoV-2 antigen test) was evaluated using both an inactivated virus preparation and prospective clinical samples (nasopharyngeal swabs in virus transport medium). The limit of detection of the assay was approximately 0.5 TCID 50 /ml, equivalent to a Ct value of 33. The assay was linear over a wide range. When 528 clinical samples were tested with the antigen assay, the sensitivity was 84.2% and the specificity was 100% (positive predictive value 100% and negative predictive value 97.7%). High volume antigen tests might be used to supplement molecular diagnostic testing capacity.
Keywords: COVID-19; SARS-CoV-2; antigen detection.
【저자키워드】 COVID-19, SARS-CoV-2, antigen detection., 【초록키워드】 SARS-COV-2 infection, Infection, diagnostic, virus, Predictive value, Laboratory, Antigen, clinical samples, sensitivity, specificity, Positive predictive value, nasopharyngeal swabs, nasopharyngeal, limit of detection, diagnostic testing, Ct value, Swab, SARS-CoV-2 antigen, molecular, antigen detection, inactivated, Negative predictive value, transport medium, transport medium), Volume, TCID, successive waves, offer, transmission of SARS-CoV-2, virus transport medium, approach, Ortho Vitros, clinical sample, tested, evaluated, linear, Increasing, successive wave, 【제목키워드】 Antigen, Volume,