The US Food and Drug Administration (FDA) has revoked a PCR Covid-19 test.
This is not true. The CDC has withdrawn a request for emergency authorisation for one type of PCR test, but not because of any fault. The FDA has recalled one brand of lateral flow test.
A post on Facebook claims that an unspecified test has been “revoked” by the US Food and Drug Administration (FDA).
The post itself doesn’t say exactly what sort of test the post refers to, but the author says it “brought the world to its knees” and describes “sticking [it] up your nose”, which indicates it’s about a Covid-19 test. In a comment on the same post the author posts a screenshot of an announcement from the US Centers for Disease Control and Prevention (CDC) about a type of PCR test.
As we wrote at the time, the CDC announced that it was withdrawing the request for emergency authorisation of one type of PCR test. This, despite claims otherwise, does not amount to the CDC saying the tests don’t work generally, and again they were not revoking all PCR tests.
At the time, a CDC spokesperson told Full Fact that the PCR test in question—the CDC Novel Coronavirus (2019 nCoV) Real-Time RT-PCR—is “a highly accurate test” and the decision to discontinue the request for emergency use authorisation was not due to performance issues but because more PCR tests have become available from commercial manufacturers.
These are “faster, have higher throughput [quicker processing] and are designed to be more efficient” and mean demand for the CDC’s PCR test has “declined significantly”.
The Department of Health and Social Care (DHSC) confirmed to Full Fact in July that the brand of PCR tests in question was not used in the UK.
In a statement published in June, the US government department said it “has significant concerns that the performance of the test has not been adequately established, presenting a risk to health”, and urged people with the tests to either throw them away or send them back to Innova.
As was widelyreported at the time, these are the same tests that have been used widely in the UK for testing in schools, hospitals and care homes. In a statement reported in the Guardian, the Medicines and Healthcare products Regulatory Agency (MHRA) director of devices Graeme Tunbridge said: “The MHRA are reviewing all available information and are working closely with NHS Test and Trace to ensure that a full risk assessment is undertaken, as is our normal process, to understand any implications for products being used in the UK.
“Patient safety is our main priority and we will issue safety information as and when necessary.”
This article is part of our work fact checking potentially false pictures, videos and stories on Facebook. You can read more about this—and find out how to report Facebook content—here.
For the purposes of that scheme, we’ve rated this claim as missing context
because it is true that a specific brand of Covid-19 lateral flow test was recalled by the FDA, but not a PCR test.
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