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Rapid coronavirus antigen tests can give false positives, the FDA warns



The Food and Drug Administration (FDA) has warned of possible false positives when using rapid antigen tests to detect coronavirus, especially if the test is not used correctly. . The regulator said it had received reports of false positives that occurred in nursing homes and other health care facilities.

The agency warns that reading test results before or after the specified time provided in the instructions may result in false positives or false negatives. It also addresses the EUA authorization conditions for the antigen, which requires that the authorized laboratories follow the manufacturer’s instructions for use regarding test performance and readings. fruit.

Mishandling the test or not guaranteeing that it is properly stored before use, can also lead to erroneous results. Handling multiple samples at once can also affect test results, as it can make it difficult to ensure accurate incubation times for each sample.

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“Take care to minimize the risk of cross contamination when testing patient samples, which can cause false positives,”

; the FDA warns. “Inadequate workspace cleaning, incomplete disinfection of tools or the use of inadequate protective equipment (eg, not changing gloves between patients) can increase the risk of cross-contamination. between patient samples with subsequent false positives. “

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The agency also proposed the following Center for Disease Control and Prevention’s recommendations when using antigen testing in nursing homes and considering performing a confirmation test within 48 hours of the results. positive.

“In general, antigen tests are not as sensitive as molecular tests,” the FDA writes. “Due to the potential for decreased sensitivity compared to molecular assays, negative results from antigen tests may need to be confirmed by molecular assays before treatment decisions are made. Negative results from antigen tests should be considered in the context of clinical observations, patient history, and epidemiological information. “

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For its part, the FDA says it is working with test manufacturers to ensure that instructions for use are as clear as possible and to protect the use of COVID testing in nursing homes and facilities. other.


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