Roche gets go ahead for their serology test I am trying to get this confirmed, but I believe that PMN's serology test uses a different science. This approval gives a person a good idea what the inteneded uses are for these tests
1- to verify the effectiveness of the new vaccine
2- to assist to identify potential donors for expermental blood plasma transfer of plasma from recovered covid victims to people being treated for covid infection. Not alot know about this process, but in one European country, they have collected 2200 litres of blood from recovered covid patients, as they investigate this possible treatement .
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Emma Court December 1, 2020, 11:20 AM MST
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Roche Holding AG test that detects the presence and level of coronavirus antibodies inside people was cleared by the U.S. Food and Drug Administration for emergency use.
The test, known as the Elecsys Anti-SARS-CoV-2 S, identifies antibodies tied to the virus’s distinctive spike protein, a target for several of the leading vaccines in development. The test could be used to evaluate how well the shots work, including over time, Roche said in a
statement announcing the approval.
Like other antibody tests, it could also be used to identify potential plasma donors. The use of so-called convalescent plasma to treat people hospitalized with Covid-19 was granted emergency authorization by the FDA earlier this year.
Similar tests from
Siemens Healthineers AG, cleared by the FDA in
late July, were the first such tests to get a green light in the U.S.
Roche will begin shipping the new antibody test to U.S. laboratories in the next week, where it will be processed using a Roche automated platform that produces results in about 18 minutes.
Laboratory Corp of America Holdings will be the first to offer the tests.