Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: a systematic review and meta-analysis

OBJECTIVE: To systematically assess the diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children under real-life conditions. DESIGN: Systematic review and meta-analysis. DATA SOURCES: MEDLINE, Embase, Cochrane Database for Systematic Reviews, INAHTA HTA database, preprint servers (via Europe PMC), ClinicalTrials.gov, WHO ICTRP from 1 January 2020 to 7 May 2021; NICE Evidence Search, NICE Guidance, FIND Website from 1 January 2020 to 24 May 2021. REVIEW METHODS: Diagnostic cross-sectional or cohort studies were eligible for inclusion if they had paediatric study participants and compared rapid point-of care tests for diagnosing current SARS-CoV-2 infections with reverse transcription polymerase chain reaction (RT-PCR) as the reference standard. The Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool was used to assess the risk of bias and the applicability of the included studies. Bivariate meta-analyses with random effects were performed. Variability was assessed by subgroup analyses. RESULTS: 17 studies with a total of 6355 paediatric study participants were included. All studies compared antigen tests against RT-PCR. Overall, studies evaluated eight antigen tests from six different brands. Only one study was at low risk of bias. The pooled overall diagnostic sensitivity and specificity in paediatric populations was 64.2% (95% CI 57.4% to 70.5%) and 99.1% (95% CI 98.2% to 99.5%), respectively. In symptomatic children, the pooled diagnostic sensitivity was 71.8% (95% CI 63.6% to 78.8%) and the pooled diagnostic specificity was 98.7% (95% CI 96.6% to 99.5%). The pooled diagnostic sensitivity in asymptomatic children was 56.2% (95% CI 47.6% to 64.4%) and the pooled diagnostic specificity was 98.6% (95% CI 97.3% to 99.3%). CONCLUSIONS: The performance of current antigen tests in paediatric populations under real-life conditions varies broadly. Relevant data were only identified for very few antigen tests on the market, and the risk of bias was mostly unclear due to poor reporting. Additionally, the most common uses of these tests in children (eg, self-testing in schools or parents testing their toddlers before kindergarten) have not been addressed in clinical performance studies yet. The observed low diagnostic sensitivity may impact the planned purpose of the broad implementation of testing programmes. PROSPERO REGISTRATION NUMBER: CRD42021236313.