Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

To assess the diagnostic accuracy of point‐of‐care antigen and molecular‐based tests for diagnosis of SARS‐CoV‐2 infection. We consider accuracy separately in symptomatic and asymptomatic population groups. Seventy-eight study cohorts were included (described in 64 study reports, including 20 pre-prints), reporting results for 24,087 samples(7,415 with confirmed SARS-CoV-2). Studies were mainly from Europe (n = 39) or North America (n = 20), and evaluated 16 antigen andfive molecular assays.We considered risk of bias to be high in 29 (37%) studies because of participant selection; in 66 (85%) because of weaknesses in thereference standard for absence of infection; and in 29 (37%) for participant flow and timing. Studies of antigen tests were of a highermethodological quality compared to studies of molecular tests, particularly regarding the risk of bias for participant selection and the indextest. Characteristics of participants in 35 (45%) studies differed from those in whom the test was intended to be used and the delivery of theindex test in 39 (50%) studies differed from the way in which the test was intended to be used. Nearly all studies (97%) defined the presenceor absence of SARS-CoV-2 based on a single RT-PCR result, and none included participants meeting case definitions for probable COVID-19.