The performance of cross-current (antigen) testing commonly used to detect COVID-19 infections in children is below the minimum standards set by the World Health Organization (WHO) and device regulators in the United States and the United Kingdom. Find a pooled data analysis of available evidence for eight different tests published in the journal Evidence-based medicine from the BMJ..
Researchers suggest that the findings cast doubt on the effectiveness of their use in extensive school trials.
Immunochromatography (antigen) testing is widely used in schools and kindergartens to pick up children with SARS-CoV-2, the virus that causes COVID-19 infection.
The accuracy of these tests in adults varies greatly and is often significantly lower than those reported by the manufacturer. However, it is not clear how well it works when used on real children.
To bridge this knowledge gap, researchers examined research databases and preprint servers for cross-current antigen and cotton swab (PCR) tests, which were published between 2020 and May 2021, and are considered reference standards. I looked for a study that compared the accuracy. In a child.
They found 17 related studies (12 peer-reviewed journal studies and 5 preprint studies) published in English. These included 6355 children and 8 antigen tests from 6 different brands.
At 11 test In the evaluation, samples were collected from the throat and nose. The remaining samples were collected only from the nose. In one study, a monitored sample was collected. Everything else was related to sample collection by trained staff.
Data from all 17 studies were pooled to measure the diagnostic sensitivity and specificity of these tests. Sensitivity indicates how well the test picks up a person with an illness / infection. Specificity shows how well the test picks up those who are not.
The overall sensitivity of the evaluated tests was just over 64%. The overall specificity was just over 99%. The researchers then limited the analysis to children with and without symptoms.
Based on 3413 children in 13 studies, pooled diagnostic sensitivity was slightly below 72% and pooled diagnostic specificity was slightly below 99% among symptomatic children.
Based on 2439 children in 10 studies, pooled diagnostic sensitivity was just over 56%, while pooled diagnostic specificity was just over 98.5% in asymptomatic children.
The differences in these test results observed between children with and without symptoms indicate that sensitivity and specificity are not unique test characteristics, the researchers say.
They emphasize certain restrictions on their discoveries. Inadequate reporting hampered the quality assessment of most studies. Also, the review was limited to 8 tests. There are over 500 lateral flow tests used by professionals on the market.
None of the studies included have evaluated sample collection or self-testing by untrained people and may worsen performance.And the findings may not be applicable to future SARS-CoV-2 mutants or vaccinations. Children Either, the researcher admits.
But they write: “Sensitivity estimates for antigen testing varied widely from study to study and were significantly lower than those reported by the manufacturer,” but most tests are used only for people with symptoms, so depending on the manufacturer. Reported performance data are usually symptoms, they add.
“The estimates of specificity for the entire study were less variable, and only slight discrepancies with the manufacturer’s claims of performance were observed.”
However, they conclude that: “Given the test-specific pooled results, the tests included in this review do not fully meet the minimum performance requirements recommended by WHO …, the US[FoodandDrugAdministrationortheMedicinesandHealthcareProductsRegulatoryAuthority(MHRA)”Hmm)IntheUK[FoodandDrugAdministration…ortheMedicinesandHealthcareproductsRegulatoryAgency(MHRA)intheUK[食品医薬品局…または医薬品医療製品規制当局（MHRA）が推奨する最小パフォーマンス要件を完全に満たしていません。）イギリスで。[FoodandDrugAdministration…ortheMedicinesandHealthcareproductsRegulatoryAgency(MHRA)intheUK
“This can affect the planned purpose of the broad implementation of the test program.”
The immunoflow test complements the PCR test, expands the test capacity, and is unique when short turnarounds are essential, but it still “decreases diagnostic accuracy, especially lower diagnostics. sensitivityThis increases the risk of missing cases, including patients with presymptomatic infections that are least infectious, “they say.
They add that whether frequent testing can make up for this remains an issue.
Evidence Integration: Rapid Point for Diagnosis of Current SARS-CoV-2 Infection in Children Diagnostic Accuracy of Obcare Tests: Systematic Review and Meta-Analysis, Evidence-based medicine from the BMJ, ebm.bmj.com/doi/10.1136/bmjebm-2021-111828
British Medical Journal
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