"Evidence gaps identified in this systematic review demonstrate current research needs to support evidence-based decision making," they wrote. The researchers concluded that the real-world performance of rapid antigen tests in children varied widely, only a few tests had relevant data, and the risk of bias was unclear due to poor reporting. Of the 12 peer-reviewed studies in journals and 5 published on preprint servers, only 1 was at low risk of bias. Specificity, on the other hand, is the ability to identify those who don't have a condition the higher the specificity, the lower the risk of false-positive results. Sensitivity is the probability that a test correctly identifies all positive cases the higher the sensitivity, the lower the likelihood of false-negative results. For reference, WHO and FDA performance standards for rapid antigen tests specify a minimum sensitivity of 80% and a minimum specificity of 97%. In children with symptoms, diagnostic sensitivity and specificity were 71.8% and 98.7%, respectively, and in those without symptoms, sensitivity and specificity were 56.2% and 98.6%, respectively. Overall pooled diagnostic sensitivity and specificity of the rapid tests were 64.2% and 99.1%, respectively. The studies assessed eight tests from six different brands.
In the first meta-analysis of its kind, a team led by University of Manchester researchers in the United Kingdom evaluated 17 studies involving 6,355 children that compared rapid antigen test results with those from the gold-standard: reverse transcription polymerase chain reaction (RT-PCR) test.
Many people will get a negative result and go to dinner with Grandma and Grandpa." Poor sensitivity, acceptable specificity "The average consumer isn't going to know what this means. Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, publisher of CIDRAP News, calls interpreting negative test results "a huge challenge." "I think an important point to remember is that with rapid antigen tests, positive results are generally meaningful, but negative results have to be taken with a grain of salt," Kelly Wroblewski, MPH, director of infectious diseases at the Association of Public Health Laboratories, told CIDRAP News. While experts say these nasal-swab tests-sold under brand names such as BinaxNOW and BD Veritor-have some value in disrupting virus transmission, it's important to understand their limitations-especially amid the current surge of cases caused by the highly transmissible and evasive Omicron (B.1.1.529) variant. Amid scarcity of the over-the-counter tests, US households can now order four such tests from a US government website for free. A meta-analysis published this week in BMJ shows that COVID-19 rapid antigen tests for children don't meet minimum performance standards set by the World Health Organization (WHO) and the US Food and Drug Administration (FDA).Īlready shown to be far less sensitive in adults than their manufacturers report, rapid antigen tests, also called lateral flow tests, are widely used in children to screen for COVID-19 in schools, homes, and healthcare settings.
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