Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: A systematic review and meta-analysis
Authors: Fujita-Rohwerder Naomi , Beckmann Lars , Zens Yvonne , Verma Arpana 
Published: August 2021

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 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

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 was only identified for about 1% of antigen tests with market access in Europe. The results should be interpreted with caution since risk of bias in studies was predominantly judged as unclear due to poor reporting. Further, the most common paediatric use cases (e.g., self-testing in schools or toddlers getting tested by their parents before leaving for kindergarten) have not been addressed in clinical performance studies yet. Policymakers should scrutinise whether the observed low diagnostic sensitivity may impact the planned purpose of antigen tests and are encouraged to require the evaluation of tests in the intended setting prior to the broad implementation of testing programmes.

Systematic review registration

CRD42021236313 (PROSPERO).

SUMMARY BOXES

What is already known on this topic?

During the current SARS-CoV-2 pandemic, antigen tests are widely used to detect children with current SARS-CoV-2 infection in schools and kindergarten despite an ongoing debate on potential benefits and harms.

A recent Cochrane review showed that sensitivity estimates of antigen tests in adult populations vary broadly and are substantially lower as reported by manufacturers; however, test performance in paediatric populations remained unknown.

What this study adds?

A systematic literature search and comprehensive author queries allowed to include 17 studies evaluating the diagnostic accuracy of antigen tests in children.

Based on the results of the bivariate meta-analysis, the real-life performance of current antigen tests for professional use in paediatric populations is below the minimum performance criteria set by WHO, the US FDA, or the MHRA in the UK.

Considering the unclear risk of bias in most studies due to poor reporting, the performance of antigen tests for professional use in paediatric populations is similar to what has been reported previously for adult populations.

There is an urgent need to evaluate the performance of antigen tests for the most common paediatric use cases since the impact of context-specific factors, e.g., sample collection in toddlers by laypersons or self-testing performed by children, on the diagnostic test accuracy – and most notably on the diagnostic sensitivity – remains unknown.

How might it impact clinical practice in the foreseeable future?

The results presented in this systematic review may support the development and improvement of testing programmes in schools and kindergarten.

The evidence gaps identified in this systematic review demonstrate current research needs in the context of rapid point-of-care testing for SARS-CoV-2 infection in paediatric populations to support evidence-based decision making.