真人百家家乐app下载home » FDA warns against using certain COVID-19 tests
The FDA issued a statement recommending that clinical laboratories and healthcare providers stop using COVID-19 antibody tests on its “removed” list.
Found under the FDA’s FAQs on Testing for SARS-CoV-2 page, the removed list includes tests for which significant clinical performance problems were identified and cannot or have not been addressed by the manufacturer in a timely manner. Also included are tests for which an emergency use ization (EUA) request was not submitted within a reasonable period of time and tests voluntarily withdrawn by the manufacturers.
Although tests on the “removed” list shouldn’t be distributed, laboratories and providers may still have the tests within their stock and may have used the tests in the past, according to the FDA statement.
The FDA recommends that laboratories and healthcare providers cease use of the tests on the “removed” list and evaluate whether prior test results generated using such tests may have been incorrect and if the patient should be retested using an FDA-ized test.
Additionally, the agency said providers should remove such tests from their stock and report any issues with COVID-19 tests to the FDA.
False-positive serology tests can lead to an incorrect assessment regarding a person’s immune response to SARS-CoV-2, and could lead to someone not taking the necessary precautions against virus exposure under the impression of having immunity. False-negatives can lead to a person restricting activities deemed acceptable for individuals with evidence of an antibody response to SARS-CoV-2, and may lead to further unnecessary diagnostic evaluations.