Abstract
Point-of-care antigen tests are an important tool for SARS-CoV-2 detection. Antigen tests are less sensitive than real-time reverse transcriptase PCR (rRT-PCR). Data on the performance of the BinaxNOW antigen test compared to rRT-PCR and viral culture by symptom and known exposure status, timing during disease, or exposure period and demographic variables are limited. During 3 to 17 November 2020, we collected paired upper respiratory swab specimens to test for SARS-CoV-2 by rRT-PCR and Abbott BinaxNOW antigen test at two community testing sites in Pima County, Arizona. We administered a questionnaire to capture symptoms, known exposure status, and previous SARS-CoV-2 test results. Specimens positive by either test were analyzed by viral culture. Previously we showed overall BinaxNOW sensitivity was 52.5%. Here, we showed BinaxNOW sensitivity increased to 65.7% among currently symptomatic individuals reporting a known exposure. BinaxNOW sensitivity was lower among participants with a known exposure and previously symptomatic (32.4%) or never symptomatic (47.1%) within 14 days of testing. Sensitivity was 71.1% in participants within a week of symptom onset. In participants with a known exposure, sensitivity was highest 8 to 10 days postexposure (75%). The positive predictive value for recovery of virus in cell culture was 56.7% for BinaxNOW-positive and 35.4% for rRT-PCR-positive specimens. Result reporting time was 2.5 h for BinaxNOW and 26 h for rRT-PCR. Point-of-care antigen tests have a shorter turnaround time than laboratory-based nucleic acid amplification tests, which allows for more rapid identification of infected individuals. Antigen test sensitivity limitations are important to consider when developing a testing program.
Keywords: Abbott BinaxNOW SARS-CoV-2 Ag Card; COVID-19; SARS-CoV-2; antigen test; viral culture.
【저자키워드】 COVID-19, SARS-CoV-2, antigen test, viral culture., Abbott BinaxNOW SARS-CoV-2 Ag Card, 【초록키워드】 Symptom, virus, Symptoms, Predictive value, Antigen, nucleic acid, SARS-CoV-2 detection, sensitivity, rRT-PCR, PCR, Positive predictive value, symptomatic, Cell culture, Community, antigen tests, nucleic acid amplification, viral culture, nucleic acid amplification tests, disease, specimens, questionnaire, Demographic variables, Abbott, reverse transcriptase, Pima, symptom onset, infected individuals, symptomatic individuals, participant, limitation, positive, SARS-CoV-2 test, Administered, real-time reverse transcriptase, upper respiratory, Result, highest, analyzed, collected, less, demographic variable, swab specimen, symptomatic individual, 【제목키워드】 Test, Testing, PCR, performance, Site,