FDA pushed through scores of inaccurate antibody tests without agency review

[babylonsister]

FDA pushed through scores of inaccurate antibody tests without agency review
Some are giving too many false positive results, which could mislead some people into thinking they have already been infected.
By ZACHARY BRENNAN and DAVID LIM
04/27/2020 04:30 AM EDT


The Food and Drug Administration is dealing with a flood of inaccurate coronavirus antibody tests after it allowed more than 120 manufacturers and labs to bring the tests to market without an agency review.

The tests, which look for antibodies that indicate whether a person has been exposed to the virus, have been eyed as a tool to help reopen the country by identifying people who may have immunity. Antibody data could also help determine the true extent of the U.S. outbreak by finding cases that were never formally diagnosed.

Normally, the FDA does its own quality check before allowing tests on the market. Agency leaders have said they tried to create more flexibility for makers of antibody tests to help inform discussions about when people can safely return to work and school, and to identify survivors whose antibody-rich blood could help treat the sick.

But many of the tests available now aren’t accurate enough for such purposes. Some are giving too many false positive results, which could mislead people into thinking they have already been infected.

The problem has gotten so bad that the New York City Health Department warned health providers last week against using the tests to determine whether someone is infected with the coronavirus or has developed immunity through exposure.

Public health experts say the FDA shouldn’t have waived its reviews of antibody tests and are calling on it to crack down. To date, the FDA has granted a formal emergency use authorization, in which it reviews data from manufacturers, to just seven of the tests.

"We're facing a public health epidemic," David Kessler, who led the FDA under Presidents George H.W. Bush and Bill Clinton and is now advising former Vice President Joe Biden on the coronavirus, told POLITICO. "If FDA is not looking at validation studies, then FDA is not doing its job."

more...

https://www.politico.com/news/2020/04/27/reliable-antibody-tests-coronavirus-207589

[procon]

1. Is this how a businessman would run his company!

When your only goal is to "open the country," yes, this is exactly what you would do to push those stats up so you can talk about some new bragging rights.

[Squinch]

2. This will prevent us from being able to answer the question about whether having

the virus imparts immunity. Among other things.

[SWBTATTReg]

3. This is the standard trump MO...nothing ever works, nothing is ever his fault, nothing, period.

[dixiegrrrrl]

4. False negatives are also a problem.

My kid ( he's an adult) twice since Feb. has come down with what we now know are
Civic symptoms, the last time a couple weeks ago.
He got tested this last time, negative for flu, and after a 4 day wait, while still sick,
was negative for Covid.
A friend of his had same symptoms but was tested in another area of the state,
had positive test.

We now know you can get it more than once, and we now know testing is fraught with problems still.

Frankly, I am extremely anxious about my family, even tho they live in the blue side of Washington state.

Believe me when I say that there is no level of Fed.Gov't I trust any longer.I

That's probably a healthy thing nowdays.

[Shermann]

5. Wait I thought when you cleared all the red-tape regulations out of the way things ran smoother? nt

[crickets]

6. He's done this to every department, every agency.