EUA withdrawal for CDC COVID-19 PCR test is due to the development of new tests that save time and resources, not because the test is faulty

FULL CLAIM: The COVID-19 PCR test is inaccurate; COVID-19 PCR tests will no longer be used; COVID-19 PCR test cannot differentiate influenza and COVID-19

MEET AGAIN

COVID-19 PCR testing has been a critical tool in identifying infections and reducing the spread of the virus by supporting contact tracing efforts and quarantining those infected. But this key role has also turned it into a hotbed of disinformation, as those who oppose public health measures like mask wear, containment and vaccination seek to discredit the test in order to cast doubt on the seriousness of the test. pandemic and in turn the need to implement such measures. Complaints related to COVID-19 PCR testing were previously handled by Health Feedback here, here, and here.

Another claim on the same theme took advantage of a Lab alert of July 21, 2021 issued by the United States Centers for Disease Control and Prevention (CDC) Center for Surveillance, Epidemiology, and Laboratory Systems. In short, the Lab Alert announced:

“After December 31, 2021, the CDC will withdraw from the United States Food and Drug Administration (FDA) the Emergency Use Authorization (EUA) request from the CDC Real-Time RT-PCR Diagnostic Panel 2019- Novel Coronavirus (2019-nCoV), the test first introduced in February 2020 for the detection of SARS-CoV-2 only”.

This was then interpreted by some as validation of previous false claims that COVID-19 PCR tests are inaccurate (see Example). Still others asserted that the COVID-19 PCR test cannot differentiate SARS-CoV-2 from the influenza virus, citing this statement in the Lab Alert: “CDC encourages laboratories to consider adopting a multiplexed method that can facilitate the detection and differentiation of SARS-CoV -2 and influenza viruses ”.

In total, these allegations received tens of thousands of interactions across multiple social media platforms, including Facebook, Instagram and Twitter, with a political commentator. Candace Owens and former US Representative Robert Fraser among those who share such claims. Notably, the two shared a tweet from the UK Medical Freedom Alliance group. This tweet has since been deleted but has been archived here.

This was then interpreted by some as validation of previous false claims that COVID-19 PCR tests are inaccurate (see Example). Still others asserted that the COVID-19 PCR test cannot differentiate SARS-CoV-2 from the influenza virus, citing this statement in the Lab Alert: “CDC encourages laboratories to consider adopting a multiplexed method that can facilitate the detection and differentiation of SARS-CoV -2 and influenza viruses ”.

In an email to Health Feedback, CDC spokesperson Jasmine Reed explained the reason for the withdrawal:

“Given the availability of commercial options for the clinical diagnosis of SARS-CoV-2 infection, including multiplexed and high-throughput options, the CDC intends to discontinue support for the panel. CDC 2019 real-time RT-PCR diagnostic of novel coronavirus (2019 nCoV), the test first introduced in February 2020 for the detection of SARS-CoV-2.

While the 2019 CDC Novel Coronavirus (2019 nCoV) real-time RT-PCR diagnostic panel addressed a significant unmet need during its development and deployment and has demonstrated no performance issues, demand for this test has declined with the emergence of other higher tests. -flow and multiplexed dosages. CDC is encouraging public health laboratories (PHLs) to adopt the CDC Influenza SARS-CoV-2 (Flu SC2) multiplex test to enable continuous surveillance for influenza and SARS-CoV-2, which will save costs. time and resources for PHL.“

In other words, the performance of the CDC’s RT-PCR test for detecting COVID-19 has not suffered any problems. However, assays capable of processing more samples in a given time (higher throughput) and detecting more than one pathogen (multiplex) have since been developed and, as such, are the preferred alternatives in the interest. time and resources.

It should be noted that the lab alert is only for the CDC’s own COVID-19 diagnostic PCR test, specifically the 2019-nCoV real-time RT-PCR diagnostic panel – it does not affect others COVID-19 PCR tests developed by other parties. , many of which still remain under Emergency Use Authorization (EUA), according to the United States Food and Drug Administration (FDA) website. Therefore, it is wrong to claim, as some have done, that the lab alert means that COVID-19 PCR testing in general will be discontinued.

Finally, the claim that the COVID-19 PCR test cannot distinguish between SARS-CoV-2 and influenza virus is false and has been addressed in a previous review by Health Feedback. In short, the influenza virus and the SARS-CoV-2 coronavirus belong to completely different families of viruses. The COVID-19 PCR test specifically detects the presence of SARS-CoV-2 genetic material. The genetic sequence of the influenza virus is different from the SARS-CoV-2 virus and would not be detected by a COVID-19 PCR test.

Overall, these bogus claims about COVID-19 PCR testing are repeats of already debunked claims about the accuracy of the test, based on embellishments from an official CDC communication that are not grounded in scientific evidence. .