... “Testing, Testing, Testing,” again playing a very dangerous political game. States, not the Federal Government, should be doing the Testing - But we will work with the Governors and get it done. This is easy compared to the fast production of thousands of complex Ventilators!— Donald J. Trump (@realDonaldTrump) April 20, 2020
All testing materials, being medical equipment and/or medicine, are regulated and governed by the Food and Drug Administration. All tests have been authorized, or authored, by the Centers for Disease Control. The CDC screwed up the testing in February by not following its own protocols. The entire blame for lack of testing materials, and lack of valid testing in the first place, lies with the Trump administration. Which has led to this:
Two U.S. companies — Premier Biotech of Minneapolis and Aytu Bioscience of Colorado — have been distributing the tests from unapproved Chinese manufacturers, according to health officials, FDA filings and a spokesman for one of the Chinese manufacturers. Many of the unapproved tests appear to have been shipped to the U.S. after the FDA relaxed its guidelines for tests in mid-March and before the Chinese government banned their export just over two weeks later.We are literally in free-fall, and Trump keeps looking for someone else to blame.
If COVID-19 antibody tests are unreliable, they can produce false results, either negative or positive, health officials said. The use of such tests has been widely discussed as a way to ensure that employees are healthy enough to go back to work and to find COVID-19 survivors who may be able to provide blood plasma to severely ill patients.
Officials at the Association of Public Health Laboratories have expressed concern about the reliability of the numerous antibody tests being sold or used across the country with little scrutiny. Scott Becker, the association's chief executive, told NBC News that FDA officials are working with the Centers for Disease Control and Prevention, the National Institutes of Health and the Biomedical Advanced Research and Development Authority to evaluate the performance of the tests.
In the meantime, Becker said, any U.S. companies that are selling tests to public health agencies should push to have the FDA evaluate them in the multi-agency study.
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