07/21/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing
Audience: Individuals Performing COVID-19 Testing
Level: Laboratory Alert
After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives.
In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test. CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses. Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season. Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing.
How many people were told they had covid when they had the flu? How many people died of the flu but were deemed to have died with Covid? Is this why the flu disappeared from the stats?
Since the start of the PCR being used for covid testing both the New Zealand government and Ministry of Health have described it as the ‘gold standard‘ for testing people for Covid-19.
“Using the PCR nasopharyngeal swabbing method is considered the gold standard for Covid testing as it detects the virus the most effectively,” said the Ministry of Health on 18 January 2021.
The CDC post also says using a test for covid other than PCR means labs can test for “both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season”.
“CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives,” states the posting.
When will New Zealand’s Ministry of Health make its announcement we wonder.
Those who have questioned the PCR (polymerase chain reaction) test will know the inventor of the test – Kary Mullis (who died in August 2019) – said that with PCR sample amplification you can find anything you want to.