![]() ![]() ![]() "A negative result does not exclude the possibility of COVID-19." "A negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions," the agency said. The FDA statement highlighted that use of nasal swabs and oral fluid specimens is limited to symptomatic individuals within 14 days of COVID-19 symptom onset, and specimen collection must be directly observed and directed during the sample collection process by a trained healthcare worker at the specimen collection site. The PCR-based test is authorized for use on throat swab, nasopharyngeal swab, nasal swab, or oral fluid specimens for the detection of nucleic acid from SARS-CoV-2. "When the test is not performed in accordance with its authorization or as described in the authorized labeling, there is a greater risk that the results of the test may not be accurate," the FDA wrote in a safety communication. The agency asserted that the test, to which it granted Emergency Use Authorization in April, must be performed in accordance with its labeling to ensure correct results. NEW YORK – The US Food and Drug Administration on Monday issued an alert to patients and healthcare providers warning them of a risk of false negative results with a SARS-CoV-2 laboratory-based test from San Dimas, California-based Curative. Advances in Clinical Genomics Profiling. ![]()
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