Find out why the CDC is withdrawing their authorisation for the COVID-19 RT-PCR test, and what it means for testing COVID-19!
CDC To Withdraw EUA For COVID-19 Only RT-PCR Test
On 21 July 2021, the US CDC (Centers for Disease Control) announced that they would be withdrawing the Emergency Use Authorisation (EUA) for their COVID-19 only diagnostic panel after 31 December 2021.
From 1 January 2022 onwards, laboratories in the United States will no longer be allowed to use the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, which was first introduced in February 2020.
This CDC announcement is meant to spur laboratories and testing sites to transition to “a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses“.
This would allow laboratories to test for both viruses at the same time, saving time and resources, especially when the influenza season begins.
Can Current RT-PCR Test Differentiate Between COVID-19 + Influenza?
At this point, I should take the opportunity to clarify this US CDC move, as it appears that even major news media do not quite understand what they meant.
Yahoo! News, for example, claimed “CDC urges labs to use COVID tests that can differentiate from flu“, which unfortunately suggests that the current RT-PCR test cannot different between SARS-CoV-2 and influenza viruses.
That’s why some people are claiming that the current PCR test is “fake” and “cannot differentiate” between COVID-19 and influenza, or that they are both the same virus.
The current Emergency Use Authorisation was used to allow patients to be tested for a single infectious agent (the SARS-CoV-2 virus) in a given emergency (the COVID-19 pandemic).
But because the signs and symptoms of COVID-19 and other respiratory viral illnesses are similar, the FDA has already authorised multi-analyte panels for RT-PCR tests.
These multi-analyte panels allow laboratories to test for, and differentiate, the genetic data of MULTIPLE pathogens, including the SARS-CoV-2 virus.
As you can tell, these multi-analyte panels will be very useful in :
- conserving resources and laboratory time : instead of requiring multiple tests, the sample can be tested once for multiple pathogens
- helping doctors determine if the patient has COVID-19, or a similar respiratory viral illness, or both.
Now that there are approved multi-analyte panels, there is simply no reason to stick with a single COVID-19 only panel for the RT-PCR test.
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