9/7/2023 0 Comments Covid testing norcoPlease refer to each test’s Instructions for Use (IFU ) for specific interpretation. These tests’ results may be presumptive and require confirmation by NAAT. Other diagnostic tests may be used to detect SARS-CoV-2 from non-traditional respiratory specimens, such as breath.Please see FDA guidance on the use of at-home COVID-19 antigen tests. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. As noted in the labeling for authorized over-the-counter antigen tests: Negative results should be treated as presumptive (meaning that they are preliminary results).Antigen tests are available for at-home testing (self-testing), at the point of care, or in a laboratory. Most antigen tests are less expensive than NAATs and can provide results in minutes. Because antigen tests have lower sensitivity, FDA recommends negative antigen tests be repeated up to three times, with each test 48 hours apart to confirm a negative result. Antigen tests generally have high specificity, similar to NAATs, but are less sensitive than most NAATs. A positive test indicates current infection. Antigen tests are immunoassays that detect the presence of specific viral proteins, called antigens.Most NAATs produce qualitative (positive/negative) results. Most NAATs need to be performed in a laboratory, although some are performed at the point-of-care. Therefore, NAATs should not be used to test someone who has tested positive in the last 90 days. Viral RNA may stay in a person’s body for up to 90 days after they test positive. PCR tests are the most common type of NAAT used for COVID-19 testing.
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