Fauci warns: Many antibody tests aren't fully validated yet

Will expanded testing capacity be needed to get Americans back into the public square — and if so, what kind of testing? Dr. Anthony Fauci told ABC’s George Stephanopolous on Good Morning America that viral-identification testing has enough capacity to handle a Phase 1 start, although Fauci would like to see more of it and more efficient access by states to capacity now. However, the talk about antibody testing and by extension “immunity certificates” based on it is way too early.

In the first place, Fauci says, we aren’t even sure that exposure to COVID-19 confers immunity yet. If not, antibody testing might end up being superfluous even if it proved reliable — and we’re not there yet on that point either (via CNN):

“The problem is that these are tests that need to be validated and calibrated, and many of the tests out there don’t do that. So even though you hear about companies flooding the market with these antibody tests, a lot of them are not validated,” Fauci told ABC’s George Stephanopoulos.

“There’s an assumption – a reasonable assumption – that when you have an antibody that you are protected against reinfection, but that has not been proven for this particular virus. It’s true for other viruses,” said Fauci, director of the National Institute of Allergy and Infectious Diseases.

“But we don’t know how long that protection, if it exists, lasts. Is it one month? Three months? Six months? A year? So the assumption that with the tests that are out there, if you have an antibody positivity, you’re good to go – unless that test has been validated and you can show there’s a correlation between the antibody and protection, it is an assumption to say that this is something that we can work with,” Fauci said. “We still have a way to go with them.”

Fauci intends this as a warning specific to the antibody tests that are set to flood the marketplace now. Until they are validated and calibrated, there’s not a lot of value in them, unlike the viral-identification tests that show acute infection of COVID-19. The New York Times also offers a big warning to those hoping that antibody testing is the shortcut out of our economic thicket. They’re not accurate, they’re not being used properly, and there aren’t enough of them to matter in terms of making go/no-go decisions.

Oh, and the “Made in China” label should be a warning all on its own these days:

Officials fear the effort may prove as problematic as the earlier launch of diagnostic tests that failed to monitor which Americans, and how many, had been infected or developed the disease the virus causes. Criticized for a tragically slow and rigid oversight of those tests months ago, the federal government is now faulted by public health officials and scientists for greenlighting the antibody tests too quickly and without adequate scrutiny.

The Food and Drug Administration has allowed about 90 companies, many based in China, to sell tests that have not gotten government vetting, saying the pandemic warrants an urgent response. But the agency has since warned that some of those businesses are making false claims about their products; health officials, like their counterparts overseas, have found others deeply flawed.

Tests of “frankly dubious quality” have flooded the American market, said Scott Becker, executive director of the Association of Public Health Laboratories. Many of them, akin to home pregnancy tests, are easy to take and promise rapid results.

And the federal guidance that does exist is so confusing that health care providers are administering certain tests unaware that they may not be authorized to do so. Some are misusing antibody test results to diagnose the disease, not realizing that they can miss the early stages of infection.

“People don’t understand how dangerous this test is,” said Michael T. Osterholm, an infectious disease expert at the University of Minnesota. “We sacrificed quality for speed, and in the end, when it’s people’s lives that are hanging in the balance, safety has to take precedence over speed.”

While we wait to see whether infection confers immunity and for validation of antibody tests, we will have to set public policy on massively accessible viral-ID testing and some guesswork on how to manage the public square for the short term. That’s really the biggest question we face for the longer-term implications of reopening, which will happen regardless but for which we must prepare in some fashion. If exposure confers immunity, then antibodies mean safety for those who go back out in public — for themselves, anyway. Are they still capable of spreading COVID-19, though? And if they’re not immune from re-infection, then how do we get back to normal?

That matters more than just in policy. To recover from the Great Hunkering Down, we need people to be confident that they won’t get sick from public economic engagement. That’s not going to be as easy as yelling olly olly all in free after the shelter-in-place orders are lifted, as Ashley Parker points out in the Washington Post:

“I’ve been saying over and over to businesses: ‘What are you doing to make people comfortable to show up?’ Because ultimately all the governors and Trump can say, ‘Yeah, you can go,’ but I think people will still be very cautious,” said Sen. Rick Scott (R-Fla.).

Referring to the more than 1 million jobs in his state tied to tourism, Scott added: “How are we going to make all these people feel comfortable coming back?”

Indeed, more than any edict from a leader — from the president to the nation’s governors to local mayors — people must feel confident returning to their pre-coronavirus existence before the economy can truly recover, according to many politicians, business leaders and consumer experts.

“The full restoration of consumer confidence will be more difficult and will take longer to complete than following any other recession since the Great Depression,” Richard Curtin, director of Michigan’s Institute for Social Research, wrote in Friday’s report on the hurdles to economic recovery. “Residual fears of exposure to some virus may still limit people’s willingness to be in crowds at sport stadiums, theaters, airplanes, cruises, large shopping malls, or even shake hands at the workplace or social events.”

Ya think? Until people see that they have some resistance or immunity to COVID-19 and that they are no threat to spread it to family members, they won’t be in much of a mood to travel, or to go to crowded venues at all. Validated antibody tests with confirmed conferred immunity would go a long way toward creating the necessary market psychology to recover from this imposed recession, but it might take a proven-effective vaccine to really close that sale with a large sector of the public. That could take a year or more, which portends a very long dry spell for the economy — if we can’t validate the antibody-testing option.