With regards to sample type, highest sensitivity was found for nasopharyngeal (NP) and combined NP/oropharyngeal samples (70.8% ), as well as in anterior nasal/mid-turbinate samples (77.3% ). However, both effects were mainly driven by the Ct-value of the sample. Similarly, sensitivity was higher in symptomatic (76.2% ) compared to asymptomatic (56.8% ) persons. Testing in the first week from symptom onset resulted in substantially higher sensitivity (81.9% ) compared to testing after 1 week (51.8%, 95% CI 41.5 to 61.9). Concordantly, we found the mean Ct-value to be lower for true positive (22.2 ) compared to false negative (30.4 ) results. Sensitivity was markedly better on samples with lower RT-PCR cycle threshold (Ct) values (97.9% and 90.6% for Ct-values <20 and <25, compared to 54.4% and 18.7% for Ct-values ≥25 and ≥30) and was estimated to increase by 2.9 percentage points (95% CI 1.7 to 4.0) for every unit decrease in mean Ct-value when adjusting for testing procedure and patients’ symptom status. When manufacturer instructions were followed, sensitivity increased to 76.3% (95% CI 73.7 to 78.7). Overall, the pooled estimates of Ag-RDT sensitivity and specificity were 72.0% (95% confidence interval 69.8 to 74.2) and 98.9% (95% CI 98.6 to 99.1). We included 194 studies with 221,878 Ag-RDTs performed. To evaluate factors influencing test sensitivity, we performed 3 different analyses using multivariable mixed-effects meta-regression models. Descriptive analyses of all studies were performed, and when more than 4 studies were available, a random-effects meta-analysis was used to estimate pooled sensitivity and specificity with reverse transcription polymerase chain reaction (RT-PCR) testing as a reference. We systematically searched preprint and peer-reviewed databases for publications evaluating the accuracy of Ag-RDTs for SARS-CoV-2 until August 31, 2021. We registered the review on PROSPERO (registration number: CRD42020225140).
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