Diagnostic Accuracy of Rapid Point-of-Care Tests for COVID-19 in Children

Strategic Insights -

New research conducted by the University of Manchester has assessed the diagnostic accuracy of rapid point-of-care tests for diagnosing current SARS-CoV-2 infections in children. The study, published in the BMJ Evidence-Based Medicine journal, analyzed 17 studies involving 6,355 pediatric participants. The results showed that the pooled overall diagnostic sensitivity and specificity in pediatric populations were 64.2% (95% CI 57.4% to 70.5%) and 99.1% (95% CI 98.2% to 99.5%), respectively. However, the study found that the performance of current antigen tests in pediatric populations under real-life conditions varies broadly, and the observed low diagnostic sensitivity may impact the planned purpose of broad testing programs.

Key Takeaways:

  • The study analyzed 17 studies involving 6,355 pediatric participants, comparing antigen tests with reverse transcription polymerase chain reaction (RT-PCR) as the reference standard.
  • The pooled overall diagnostic sensitivity and specificity in pediatric populations were 64.2% (95% CI 57.4% to 70.5%) and 99.1% (95% CI 98.2% to 99.5%), respectively.
  • The study found that the diagnostic sensitivity and specificity in asymptomatic children were 56.2% (95% CI 47.6% to 64.4%) and 98.6% (95% CI 97.3% to 99.3%), respectively.
  • The performance of current antigen tests in pediatric populations under real-life conditions varies broadly, with only one study at low risk of bias.
  • The risk of bias was mostly unclear due to poor reporting, and the most common uses of these tests in children (e.g., 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 broad testing programs.

Statistics:

  • 6,355 pediatric participants were included in the study.
  • 17 studies were analyzed, evaluating eight antigen tests from six different brands.
  • The pooled overall diagnostic sensitivity and specificity in pediatric populations were 64.2% (95% CI 57.4% to 70.5%) and 99.1% (95% CI 98.2% to 99.5%), respectively.
  • The diagnostic sensitivity and specificity in asymptomatic children were 56.2% (95% CI 47.6% to 64.4%) and 98.6% (95% CI 97.3% to 99.3%), respectively.

Sources:

  • NewsRx. University of Manchester Reports Findings in COVID-19 (Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: a systematic review and meta-analysis). Pediatrics Week. February 5, 2022; p 33.
  • BMJ Evidence-Based Medicine. Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: a systematic review and meta-analysis.