Clinical Question

What is the diagnostic accuracy (i.e., sensitivity, specificity, positive predictive value, and negative predictive value) of point-of-care antigen testing for the SARS-CoV-2 virus?

Evidence-Based Answer

SARS-CoV-2 antigen tests have an average sensitivity of 69.3% (95% CI, 66.2% to 72.3%) and specificity of 99.3% (95% CI, 99.2% to 99.3%). Accuracy depends on the presence or absence of symptoms, time from symptom onset, and test brand.¹ (Strength of Recommendation: B, inconsistent or limited-quality patient-oriented evidence.)

Practice Pointers

The development of rapid diagnostic tests for the SARSCoV-2 virus has led to more access to testing. The goals of testing are earlier treatment and reduced transmission. The authors of the Cochrane review evaluated the accuracy of rapid diagnostic tests for SARS-CoV-2 infection.¹

The current review is the first update; the first review was released in 2020 and includes studies published through March 2021. The current review includes 155 cohorts from 166 studies of a single brand of rapid antigen test, and 152 evaluations of 49 different antigen assays were studied. There were 100,462 unique samples, and the presence of the SARSCoV-2 virus was confirmed by polymerase chain reaction testing in 16,822 cases. Most studies (66%) were conducted in Europe, and the remainder were in Asia (11%), North America (10%), South America (9%), and Africa (2%).¹