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

Abstract

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. Study design: Multiple bibliographic databases including MEDLINE and Embase, clinical trial registries and further information sources were systematically searched for literature (last bibliographic search: May 7, 2021). Diagnostic cross-sectional or cohort studies that included paediatric study participants and evaluated rapid point-of care tests for diagnosing current SARS-CoV-2 infections against RT-PCR as the reference standard were eligible for inclusion. QUADAS-2 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: We included 17 studies with a total of 6355 paediatric study participants. All included studies compared antigen tests against RT-PCR. 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%-70.5%) and 99.1% (95% CI: 98.2%-99.5%), respectively. In symptomatic children, the pooled diagnostic sensitivity was 71.8% (95% CI: 63.6%-78.8%) and the pooled diagnostic specificity was 98.7% (95% CI: 96.6%-99.5%). The pooled diagnostic sensitivity in asymptomatic children was 56.2% (95% CI: 47.6%-64.4%) and the pooled diagnostic specificity was 98.6% (95% CI: 97.3%-99.3%). Conclusions: Performance of current antigen tests under real-life conditions varies broadly. Policymakers should especially be aware of the low diagnostic sensitivity of current antigen tests. Results should be interpreted with caution since risk of bias was predominantly judged as unclear due to poor reporting. Study Registration: CRD42021236313 (PROSPERO).

Diagnostic accuracy of SARS-CoV-2 rapid antigen test from self-collected anterior nasal swabs in children compared to rapid antigen test and RT-PCR from nasopharyngeal swabs collected by healthcare workers: A multicentric prospective study

“…As compared with the HCW-RAT, for which a positive test result is often associated with live viral culture ( 17 ), the diagnostic accuracy of the SCANS-RAT is similar in both sensitivity and specificity. If we consider all positive tests independent of Ct number, as compared with HCW-PCR, the SCANS-RAT had excellent specificity but relatively moderate sensitivity under the minimum performance requirements as recommended by the World Health Organization ( 6 ). However, HCW-PCR have been reported to remain positive up to 5 weeks after infection while live virus is usually isolable only during the first week ( 5 ).…”

“…and was the subject of a meta-analysis (6). No test included fully satisfied the performance requirements recommended by the World Health Organization, and the diagnostic accuracy of the HCW-RAT under real-life conditions varied broadly (6).…”

“…The diagnostic accuracy of HCW-RAT for diagnosing SARS-CoV-2 infection in children has been assessed in several studies and was the subject of a meta-analysis ( 6 ). No test included fully satisfied the performance requirements recommended by the World Health Organization, and the diagnostic accuracy of the HCW-RAT under real-life conditions varied broadly ( 6 ).…”

“…The diagnostic accuracy of HCW-RAT for diagnosing SARS-CoV-2 infection in children has been assessed in several studies and was the subject of a meta-analysis ( 6 ). No test included fully satisfied the performance requirements recommended by the World Health Organization, and the diagnostic accuracy of the HCW-RAT under real-life conditions varied broadly ( 6 ). A recent French study in an emergency department found good sensitivity of the HCW-RAT in real life for symptomatic children, and when focused on high viral load, the sensitivity was excellent ( 7 ).…”

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

“…The protocol for this systematic review was registered with PROSPERO (ID: CRD42021236313) 12. The reporting adhered to the Preferred Reporting Items for Systematic reviews and Meta-Analyses of DTA studies (PRISMA-DTA) guideline13 and two relevant extensions ‘PRISMA-DTA for Abstracts’14 and ‘PRISMA-S for Reporting Literatures Searches in Systematic Reviews’ 15…”