Оно оставляет желать лучшего, тк "планка" для выпуска на рынок, из-за давления обстоятельств (эпидмия), была ФДА установлена низко, да и не все "одобренные "компании соблюдают " отчетность" и "аккредитационные требования".
Months into the outbreak, no one really knows how well many of the screening tests work...
In recent weeks, preliminary findings have flagged potential problems with some COVID-19 tests, including one used daily at the White House. Faulty tests could leave many thousands of Americans with the incorrect assumption that they are virus-free, contributing to new flare-ups of the disease as communities reopen.
The FDA said in a statement that it has already asked multiple test makers to do follow-up accuracy studies, although it didn’t say for how many of the more than 110 authorized screening tests. The agency also said it is tracking reports of problems. Accuracy has also been an issue with blood tests that look for signs of past infections.
No screening test is 100% accurate. So details on accuracy are routinely provided for tests of all types, including seasonal flu, hepatitis, HIV and cancers. For example, rapid flu tests are known to miss 20% or more of all cases, a factor doctors weigh when treating patients who have symptoms but test negative.
For now, most COVID-19 tests in the U.S. don’t give data on real-world performance, including how often the tests falsely clear patients of infection or falsely detect the virus. That information is lacking for all but a few of the roughly 80 commercial screening tests available, according to an Associated Press review.
The government’s emergency authorization process “requires a lower level of evidence,” the agency said. Makers need only show that a test “may be effective” instead of the usual requirement to demonstrate “safety and effectiveness.”
Last month, the FDA warned doctors of a potential accuracy problem with Abbott Laboratories’ rapid ID Now test, which delivers results in roughly 15 minutes. The test has been lauded by President Donald Trump and used to screen the president, his staff and visitors to the White House.
The FDA alert followed a preliminary report by New York University that found Abbott’s test missed between a third to one-half of infections caught by a rival test in patients screened for the virus.
But similar problems with ID NOW’s accuracy have been flagged in preliminary reports by researchers at Stanford University, Loyola University and the Cleveland Clinic.
Dr. Colin West of the Mayo Clinic worries doctors and patients have put too much confidence in the current crop of tests, when an unknown number of patients with COVID-19 are likely receiving false negative results.