The most widely used test for the diagnosis of SARS-CoV-2 infection is a PCR test. PCR has very high sensitivity and is able to detect very low amounts of RNA. However, many individuals receiving a positive test result in a context of a PCR-based surveillance might be infected with SARS-CoV-2, but they are not contagious at the time of the test. The question arises regards if the cost effective, portable rapid antigen tests (RATs) have a better performance than PCR in identification of infectious individuals. In this direction, we examined the diagnostic performance of RATs from 14 different manufacturers in 400 clinical samples with known rRT-PCR cycles threshold (cT) and 50 control samples. Substantial variability was observed in the limit of detection (LOD) of different RATs (cT = 26.8–34.7). The fluorescence-based RAT exhibited a LOD of cT = 34.7. The use of the most effective RATs leads to true positive rates (sensitivities) of 99.1% and 90.9% for samples with cT ≤ 30 and cT ≤ 33, respectively, percentages that can guarantee a sensitivity high enough to identify contagious patients. RAT testing may also substantially reduce the quarantine period for infected individuals without compromising personal or public safety.
【저자키워드】 viral infection, Diagnostic markers, 【초록키워드】 quarantine, SARS-COV-2 infection, Infection, diagnostic, RNA, sensitivity, rRT-PCR, PCR, rapid antigen test, Surveillance, limit of detection, Fluorescence, PCR test, threshold, positive rate, patients, RAT, Quarantine period, leads, test result, infected individual, infected individuals, individual, RATs, Variability, Positive test, positive test result, sensitivities, contagious, effective, clinical sample, identify, detect, examined, receiving, exhibited, question, reduce, individuals, arise, diagnosis of SARS-CoV-2, infected with SARS-CoV-2, percentage, 【제목키워드】 SARS-CoV-2, Efficacy, rapid antigen test, COVID-19 patient,