Recently, the US Centers for Disease Control and Prevention (CDC) has “announced” that after December 31, 2021, it will withdraw the Emergency Use Authorization (EUA) application related to testing for COVID-19 by RT-PCR method (first done in February 2020 only to detect corona virus) to the US Food and Drug Administration (FDA), to switch to using test that can diagnose both COVID-19 and the flu.
CDC USA headquarters in Atlanta. (Photo: Jim Gathany/Wikimedia/Muff)
The CDC said the agency announced the decision nearly five months in advance to give clinical laboratories enough time to select alternative testing methods that have been approved by the FDA. The US federal health agency did not explain the reason for this announcement, but some believe the accuracy of the RT-PCR method may be to blame.
In addition, CDC also urges laboratories to save time and resources by using test kits that can detect and distinguish between corona virus and other influenza viruses in the context of the approaching flu season. .
Laboratories and testing sites should conduct validation of the selected test method in their facility prior to commencing clinical testing.