Yritän etsiä linkin tai kuvakaappauksen kun aikaa.
''The real reason for withdrawing the EUA request
The first Facebook post we referenced quoted from and linked to a
July 21 CDC laboratory alert that informed labs that as of Dec. 31 the agency would withdraw its emergency use authorization request for the CDC 2019
Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel or, for short, the CDC 2019-nCoV RT-PCR.
It is standard practice for the Food and Drug Administration to issue temporary
emergency use authorizations for tests and other medical products that have not yet undergone the FDA’s full approval process but need to be used in an emergency to diagnose, treat or prevent serious diseases.
The FDA issued the EUA for the CDC’s 2019-nCoV RT-PCR in
February 2020. At that time, no other tests were available in the U.S. to determine whether someone had COVID.
But it’s important to remember that what the CDC developed and submitted for its EUA request was not a tangible product but rather a protocol for how to test for COVID, said
Susan Whittier, a professor of pathology and cell biology at Columbia University Irving Medical Center. That means the CDC wrote out directions specifying which reagents were needed to test the laboratory samples for the presence of the COVID virus. The CDC does not distribute COVID tests.
“It’s not like they have a test that laboratories can purchase. We borrow their protocol and use the reagents that they say,” said Whittier, who recently retired as director of the clinical microbiology lab at Columbia. So withdrawing the EUA request just “means that protocol will no longer be available.”
In the lab alert, the CDC said it was withdrawing the EUA request because, rather than testing only for the COVID virus, it wants labs to test people for multiple viruses simultaneously, using what is known as “a multiplexed method.” The CDC’s 2019-nCoV RT-PCR panel tests only for COVID-19.
“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,” noted the alert regarding the multiplexed method.
Dr. Christopher Polage, an associate professor of pathology at Duke University, said his take on the CDC’s message is that, because flu season is on the horizon, a patient might come in with respiratory symptoms that could be attributed to either COVID-19 or the flu. Laboratories need to start testing for both COVID and various flu viruses.
But the lab alert does not mean the CDC’s test cannot differentiate between COVID-19 and the flu.
In fact, the CDC’s test was developed to look for the presence of a nucleic acid found only in the COVID virus, said
Kelly Wroblewski, director of infectious disease programs at the Association of Public Health Laboratories.
“It is not remotely accurate that the CDC test doesn’t differentiate between flu and SARS-CoV-2. It doesn’t detect influenza. It only detects SARS-CoV-2,” said Wroblewski. “If flu and COVID are both circulating, you would be able to detect only SARS-CoV-2 and not flu.”
How the PCR test (or any other PCR test) works, Wroblewski said, is that primers, which are little bits of a genetic material, are used to identify specific viruses. In this case, the primer is built to identify a nucleic acid found only in the COVID virus.''
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