PCR tests have not been revoked by the FDA

16 September 2021
What was claimed

The US Food and Drug Administration (FDA) has revoked a PCR Covid-19 test.

Our verdict

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 The CDC has withdrawn a request for emergency authorisation for one type of PCR test, but not because of any fault.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. 

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PCR tests have not been revoked in the US 

The post on Facebook was published at around the same time we saw a number of posts falsely claiming that an announcement made by the CDC meant that PCR tests were “fraudulent” and “not fit for purpose”. 

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.

The FDA did recall one brand of LFTs 

The FDA has recalled one brand of test—the Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test. 

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 widely reported 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.”

The MHRA has extended the exceptional use authorisation of the Innova tests until 31 January 2022. In a June BMJ article about the authorisation previously being extended to August 2021 it was reported that there had been a “satisfactory outcome” of a review in response to US concerns about the tests. 

The FDA has not revoked all LFTs. Other brands have been approved, such as the Ellume Covid-19 home test

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