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!@#$%! · 04.19.2020, 07:49 AM

Dozens of coronavirus antibody tests on the market were never vetted by the FDA, leading to accuracy concerns

Aggressive marketing of the tests could confuse those clamoring for the products to determine who may have developed disease-fighting antibodies

By
Laurie McGinley
April 19, 2020 at 6:30 a.m. MDT

The Food and Drug Administration, which was harshly criticized for being slow in authorizing tests to detect the coronavirus, has taken a strikingly different approach to antibody tests, allowing more than 90 on the market without prior review, including some that are being marketed fraudulently and are of dubious quality, according to testing experts and the agency itself.

Antibody, or serological, tests are designed to identify people who may have overcome covid-19, including those who had no symptoms, and developed an immune response. They are not designed to detect active infections. Some officials tout the blood tests as a way to reopen the economy by identifying individuals who have developed immunity and can safely return to work. But many scientists, as well as the World Health Organization, say evidence is lacking that even high-quality antibody tests can prove someone has immunity to the novel coronavirus.

Now, the emergence of dozens of tests never reviewed by the FDA — many of which are being aggressively marketed — could confuse doctors, hospitals, employers and consumers clamoring for the products, according to critics who say the agency’s oversight has been lax. The questions are taking on special importance as federal and state officials debate various strategies, including using serological testing, to help determine when they can end state and local lockdowns.

“A test is only as good as its results,” said Kelly Wroblewski, director of infectious disease programs at the Association of Public Health Laboratories, which has been urging the FDA to take a close look at the unapproved antibody tests. “Having many inaccurate tests is worse than having no tests at all.”

Prodded by such concerns, the FDA recently has stepped up warnings and is joining other agencies, including the National Cancer Institute, to try to determine whether the unvetted tests actually work.

continues here i think for free:

https://www.washingtonpost.com/healt...avirus-review/

04.19.2020, 07:49 AM	#922
!@#$%! invito al cielo Join Date: Mar 2006 Location: mars attacks Posts: 42,731	Dozens of coronavirus antibody tests on the market were never vetted by the FDA, leading to accuracy concerns Aggressive marketing of the tests could confuse those clamoring for the products to determine who may have developed disease-fighting antibodies By Laurie McGinley April 19, 2020 at 6:30 a.m. MDT The Food and Drug Administration, which was harshly criticized for being slow in authorizing tests to detect the coronavirus, has taken a strikingly different approach to antibody tests, allowing more than 90 on the market without prior review, including some that are being marketed fraudulently and are of dubious quality, according to testing experts and the agency itself. Antibody, or serological, tests are designed to identify people who may have overcome covid-19, including those who had no symptoms, and developed an immune response. They are not designed to detect active infections. Some officials tout the blood tests as a way to reopen the economy by identifying individuals who have developed immunity and can safely return to work. But many scientists, as well as the World Health Organization, say evidence is lacking that even high-quality antibody tests can prove someone has immunity to the novel coronavirus. Now, the emergence of dozens of tests never reviewed by the FDA — many of which are being aggressively marketed — could confuse doctors, hospitals, employers and consumers clamoring for the products, according to critics who say the agency’s oversight has been lax. The questions are taking on special importance as federal and state officials debate various strategies, including using serological testing, to help determine when they can end state and local lockdowns. “A test is only as good as its results,” said Kelly Wroblewski, director of infectious disease programs at the Association of Public Health Laboratories, which has been urging the FDA to take a close look at the unapproved antibody tests. “Having many inaccurate tests is worse than having no tests at all.” Prodded by such concerns, the FDA recently has stepped up warnings and is joining other agencies, including the National Cancer Institute, to try to determine whether the unvetted tests actually work. continues here i think for free: https://www.washingtonpost.com/healt...avirus-review/
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