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Home » EUA withdrawal for CDC COVID-19 PCR check is because of the improvement of newer checks that assist save time and assets, not as a result of the check is defective

EUA withdrawal for CDC COVID-19 PCR check is because of the improvement of newer checks that assist save time and assets, not as a result of the check is defective

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CLAIM

COVID-19 PCR check is inaccurate, will not be used; COVID-19 PCR check can’t differentiate between flu and COVID-19

DETAILS

Inaccurate: The Lab Alert notified customers that the CDC could be withdrawing its request for emergency use authorization for its COVID-19 PCR diagnostic check after December 2021. This isn’t as a result of the efficiency of the CDC’s RT-PCR check for detecting COVID-19 confirmed any issues, however as a result of checks which might be able to processing extra samples inside a given time and detecting multiple pathogen have since been developed. Such traits make these checks the popular alternate options within the pursuits of time and assets.

KEY TAKE AWAY

COVID-19 PCR checks are extremely delicate and particular for the virus SARS-CoV-2. These checks don’t detect the flu virus, which belongs to a very totally different household of viruses. The U.S. Facilities for Illness Management has determined to discontinue help for its COVID-19 PCR checks because of the improvement of latest diagnostic checks able to processing extra samples at a given time and detecting a number of pathogens together with SARS-CoV-2. These new checks will assist save time and assets.

FULL CLAIM: COVID-19 PCR check is inaccurate; COVID-19 PCR testing will not be used; COVID-19 PCR check can’t differentiate between flu and COVID-19

REVIEW

COVID-19 PCR checks have been a vital software for figuring out infections and lowering the unfold of the virus by supporting contact tracing efforts and quarantine of contaminated people. However this key function has additionally turned it right into a hotbed of misinformation, as these opposing public well being measures like mask-wearing, lockdowns, and vaccination search to discredit the check in an effort to solid doubt on the severity of the pandemic and in flip the need of implementing such measures. Claims associated to COVID-19 PCR testing had been beforehand addressed by Well being Suggestions right here, right here, and right here.

One other declare working alongside the identical theme took benefit of a 21 July 2021 Lab Alert issued by the U.S. Facilities for Illness Management and Prevention (CDC)’s Middle for Surveillance, Epidemiology, and Laboratory Methods. Briefly, the Lab Alert had introduced:

After December 31, 2021, CDC will withdraw the request to the U.S. Meals and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Actual-Time RT-PCR Diagnostic Panel, the assay first launched in February 2020 for detection of SARS-CoV-2 solely”.

This was then interpreted by some as a validation of earlier false claims that COVID-19 PCR testing is inaccurate (see instance). Nonetheless others claimed that the COVID-19 PCR check can’t differentiate between SARS-CoV-2 and the flu virus, citing this assertion within the Lab Alert: “CDC encourages laboratories to contemplate adoption of a multiplexed technique that may facilitate detection and differentiation of SARS-CoV-2 and influenza viruses”.

Different social media customers additionally circulated a doctored picture (see instance), combining the header of the CDC Lab Alert with the contents of an inaccurate article claiming the U.S. Meals and Drug Administration introduced the CDC’s COVID-19 PCR check “failed full assessment”. For a lot of customers, this made it seem as if it was an official message by the CDC. Nevertheless, this declare bears no resemblance to the contents of the unique Lab Alert.

In complete, these claims acquired tens of hundreds of interactions on a number of social media platforms, together with Fb, Instagram, and Twitter, with political commentator Candace Owens and former U.S. Consultant Robert Fraser amongst these sharing such claims.  Notably, each shared a tweet by the group U.Okay. Medical Freedom Alliance. That tweet has since been deleted however has been archived right here.

In an e-mail to Well being Suggestions, CDC spokesperson Jasmine Reed defined the rationale for the withdrawal:

Given the supply of economic choices for medical analysis of SARS-CoV-2 an infection, together with multiplexed and high-throughput choices, CDC intends to discontinue help for the CDC 2019 Novel Coronavirus (2019 nCoV) Actual-Time RT-PCR Diagnostic Panel, the assay first launched in February 2020 for detection of SARS-CoV-2.

Though the CDC 2019 Novel Coronavirus (2019 nCoV) Actual-Time RT-PCR Diagnostic Panel met an necessary unmet want when it was developed and deployed and has not demonstrated any efficiency points, the demand for this check has declined with the emergence of different higher-throughput and multiplexed assays. CDC is encouraging public well being laboratories (PHL) to undertake the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay to allow continued surveillance for each influenza and SARS-CoV-2, which can save each time and assets for PHL.

In different phrases, the efficiency of the CDC’s RT-PCR check for detecting COVID-19 didn’t undergo from any issues. Nevertheless, checks which might be able to processing extra samples inside a given time (higher-throughput) and detecting multiple pathogen (multiplex) have since been developed, and as such, are the popular alternate options within the pursuits of time and assets.

It needs to be famous that the Lab Alert solely pertains to the CDC’s personal COVID-19 diagnostic PCR check, particularly the 2019-nCoV Actual-Time RT-PCR Diagnostic Panel—it has no bearing on different COVID-19 PCR checks developed by different events, of which there nonetheless stay many beneath Emergency Use Authorization (EUA), based on the U.S. Meals and Drug Administration (FDA)’s web site. Due to this fact, it’s false to assert, as some did, that the Lab Alert means COVID-19 PCR testing basically might be discontinued.

Lastly, the declare that the COVID-19 PCR check can’t distinguish between SARS-CoV-2 and the flu virus is fake and was addressed in an earlier assessment by Well being Suggestions. Briefly, the flu virus and the coronavirus SARS-CoV-2 belong to fully totally different households of viruses. The COVID-19 PCR check particularly detects the presence of the genetic materials from SARS-CoV-2. The genetic sequence of the flu virus is totally different from the SARS-CoV-2 virus and wouldn’t be detected by a COVID-19 PCR check.

General, these false claims about COVID-19 PCR testing are repetitions of already-debunked claims concerning the accuracy of the check, primarily based on gildings of an official CDC communication that aren’t rooted in scientific proof.

UPDATE (29 July 2021):

This assessment was up to date to debate an instance of a doctored picture circulated by some social media customers that falsely made it seem as if an official CDC communication confirmed the CDC’s PCR check “failed full assessment”.



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