FDA is recalling hundreds of thousands of covid tests to be done at home. Excess of false positives
The Food and Drug A DMINISTRATION Member Unit i drew domestic COVID-19 counter the Ellume companies calling test as a matter of class 1, the most serious type of recall, after the Australian producer of diagnostic tests has removed some of the its tests from the market last month.
Ellume had cited higher than acceptable false positive test results for SARS-CoV-2 as the reason for the recall. That is, the test indicated that a person was infected even if, in reality, there was no trace of a virus.
The antigen test, which detects SARS-CoV-2 virus proteins from a nasal sample, is available without a prescription for use by people over the age of two with or without symptoms of COVID-19.
The agency said Wednesday that there have been 35 antigen test complaints that have given false positive results, but no test-related deaths have been reported. It is estimated that more than 200,000 tests have been withdrawn from the market.
In the US this type of do-it-yourself test is very widespread , to the point that the NYT has talked about cases of "Obsession" with home tests, which are done too often. Among other things, these tests are appreciated by doctors because they reduce the waiting issues of normal PCRs. Also for some psychologists they are very useful …
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The FDA article calls up hundreds of thousands of covid tests to be done at home. Excess of false positives comes from ScenariEconomici.it .
This is a machine translation of a post published on Scenari Economici at the URL https://scenarieconomici.it/fda-richiama-centinaia-di-migliaia-di-test-covid-da-fare-a-casa-eccesso-di-falsi-positivi/ on Fri, 12 Nov 2021 07:00:07 +0000.