Saturday, May 21, 2022

    Quick Covid tests are not accurate with Omicron, US regulator says in a wave of lawsuits

    The U.S. Food and Drug Administration (FDA) said Tuesday that Rapid Covid is more likely to give a false negative with a heavily-modified Omicron variant in a home test than the previous strain.

    The news comes as the country faces a huge surge in cases where experts say the test crisis has led to a long wait for more accurate PCR tests and low-supply home kits.

    In a statement, the FDA said it was collaborating with the National Institutes of Health (NIH) to study the effectiveness of home tests against patient samples containing live versions of the Omicron variant, also known as the “antigen” test.

    “Preliminary data suggest that antigen tests may detect omikron variants but may reduce sensitivity,” the agency said.

    Sensitivity is a measure of how positive a test is to detect.

    Previous experiments focused on samples of heat-inactivated viruses rather than live viruses that are better, and a drop-off in performance has not been seen so far, the statement added.

    The FDA says it will continue to approve the use of antigen testing – which works by identifying proteins on the surface of the coronavirus – and will continue to use them as directed by individuals.

    For example, some quick tests instruct users to take two tests at regular intervals to confirm a negative one.

    If a person tests negatively through a quick test and is thought to be likely to be covid due to symptoms or their exposure, he or she is still advised to perform a “gold standard” molecular test – such as PCR.

    These identify the genetic material of the virus. These are even more accurate because they can make millions of copies of the virus’s RNA, so even small amounts become identifiable.

    Read all the latest news, breaking news and coronavirus news here.


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