1. Among a pediatric cohort, rapid antigen testing for SARS-CoV-2 infection was found to have limited accuracy when compared with reverse-transcriptase polymerase chain reaction testing.
Evidence Level Rating: 2 (Good)
Since the start of the COVID-19 pandemic, reverse-transcriptase polymerase chain reaction (RT-PCR) testing performed on nasopharyngeal swabs has been the most widely used means of establishing the presence of infection. The Panbio™ COVID-19 Antigen (Ag) Rapid Test Device by Abbott is a simple, rapid test that can detect the virus in nasopharyngeal samples in as little as five minutes. There is, however, a paucity of evidence concerning the accuracy of the rapid antigen test in the pediatric population. This study included 1,620 pediatric patients age 0 to 16 years with symptoms compatible with SARS-CoV-2 infection of ≤ 5 days of evolution. Two nasopharyngeal swabs were obtained from each participant, one tested with RT-PCR and the other tested with Abbott’s Panbio™ COVID-19 Ag Rapid Test Device. Among the patients tested, 77 were positive by RT-PCR, 38 by Panbio™ COVID-19 Ag Rapid Test Device, and 35 by both. Discordant results occurred in 45 rapid tests as compared with RT-PCR: 3/1,543 (0.2%) false-positive antigen tests and 42/77 (54.4%) false-negative antigen test results were found. As such, it was determined that evidence of a systemic difference exists between the results of the two testing modalities (p = 1.47 • 10-08); a moderate agreement between the two tests was found (k = 0.6). The overall sensitivity and specificity of the Panbio™ among this pediatric population was 45.4% and 99.8%, respectively. In all, this study showed that the Panbio™ COVID-19 Ag Rapid Test Device has limited accuracy in diagnosing SARS-CoV-2 infection of ≤ 5 days of evolution among children. In particular, the high proportion of false-negative test results may have important public health implications by failing to isolate contagious individuals; initiation of treatment may also be affected by false-negative testing. More work is needed to understand these findings.
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