COVID-19 lateral flow tests provided to children have sensitivity that "varies broadly" and is "substantially lower than reported by manufacturers", researchers warn today.
Researchers led by Dr Naomi Fujita-Rohwerder of the Institute for Quality and Efficiency in Health Care in Cologne, Germany, assessed the diagnostic accuracy of rapid point-of-care tests for COVID-19 in children under real-life conditions.
They explain in BMJ Evidence-Based Medicine today that sensitivity estimates of antigen (antigen) tests in adult populations vary broadly, but "test performance in paediatric populations remains unknown".
A total of 17 studies, published in 2020 and 2021. This covered 6,355 participants and eight antigen tests from six different brands.
They report: “Taking into account test-specific pooled results, no test included in this review fully satisfied the minimum performance requirements as recommended by World Health Organisation, the US Food and Drug Administration, or the Medicines and Healthcare products Regulatory Agency in the UK.
“The observed low diagnostic sensitivity may impact the planned purpose of the broad implementation of testing programmes."
The authors add that, while lateral flow tests extend test capacity, they nevertheless “come at the price of lower diagnostic accuracy, most notably a lower diagnostic sensitivity, which increases the risk of missing cases, including those with pre-symptomatic infection who have yet to enter the most infectious period.”
Despite the roll-out of vaccines, testing continues to be key to pandemic control, so "early identification of outbreaks will remain vital", particularly in populations with low vaccination rates or waning immunity, say the authors.
"Consequently, multi-layered mitigation strategies will continue to involve screening tests of children to avoid further closures. Whether this would still apply in populations with high childhood vaccination rates remains an open point for discussion."
Fujita-Rohwerder, N. et al. Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: a systematic review and meta-analysis. BMJ Evidence Based Medicine 19 January 2022; doi: 10.1136/bmjebm-2021-111828
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