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FDA Cracks Down On Antibody Tests For Coronavirus

Deputy Chief Patricia Cassidy of the Jersey City Police Department has blood drawn to test for coronavirus antibodies in Jersey City, N.J., on Monday.; Credit: Seth Wenig/AP

Richard Harris | NPR

The Food and Drug Administration is stiffening its rules to counteract what some have called a Wild West of antibody testing for the coronavirus.

These tests are designed to identify people who have been previously exposed to the virus. The FDA said more than 250 developers have been bringing products to the market in the past few weeks.

In a rush to make antibody tests available as quickly as possible, the FDA had set a low standard for these tests. Manufacturers were supposed to submit their own information about the accuracy of their wares, but the agency had no standards for what would be acceptable. Companies weren't allowed to claim the tests were authorized by the FDA, under initial guidance issued in mid-March.

Now the FDA is telling manufacturers that if they want their tests to remain on the market, they must meet minimum quality standards and submit a request for emergency use authorization, a temporary route to market for unapproved products when others aren't available. The EUA involves a lower standard than the usual FDA clearance or approval.

The FDA said 12 manufacturers have already opted to request EUA's for their products. More than 100 other producers have been talking to the agency about using this process, said FDA Commissioner Stephen Hahn. He spoke on a press call Monday. Companies have 10 days to submit that request.

"Our expectation is that those who can't [meet the new standard] will withdraw their products from the market and we will be working with them to help them do that," he said.

These tests are now so widespread that people can order them from lab giants Quest or LabCorp. The tests can cost more than $100. Though the FDA's original guidance calls for these tests to be run by a certified lab, the kits themselves are simple to use and have been readily available.

Despite the enthusiasm surrounding these tests, they have substantial limitations. Though people who test positive for antibodies have in most cases been exposed to the coronavirus, scientists don't know whether that means those people are actually immune from the coronavirus, and if so for how long.

"Whether this is the ticket for someone to go back to work [based solely on an antibody test result], my opinion on that would be no," Hahn said.

The tests may be more useful when combined with information from a standard coronavirus diagnostic test, or in someone who has symptoms, or if the results have been confirmed with a different antibody test. That "would dramatically increase the accuracy of those tests," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health

Antibodies are a potentially valuable research tool, and can be used to determine the prevalence of a disease in a population. In that circumstance, individual false results are less important. New York State used antibody tests to determine that about 20 percent of people in New York City have already been exposed to the coronavirus.

In California, researchers have attempted to measure the prevalence of the coronavirus in Los Angeles County and Santa Clara County in the Bay Area. Those unpublished results have garnered criticism because even a test that's more than 99 percent accurate can produce many false positive results when used to survey hundreds or thousands of people.

In the face of this criticism, the authors of the Santa Clara study have posted revised results acknowledging the high degree of uncertainty in their findings. Those findings haven't been peer-reviewed.

The emergency use authorization is only valid during the time of the national emergency. "Once the national emergency ends, the EUA authorizations end as well," Shuren said. Companies that want to keep marketing these tests will need to get them approved through the regular, more stringent FDA process.

FDA officials say they will continue to crack down on companies that falsely claim their tests are approved by the FDA, or that market them for home use, which isn't currently allowed.

You can contact NPR Science Correspondent Richard Harris at rharris@npr.org.

Copyright 2020 NPR. To see more, visit https://www.npr.org.

This content is from Southern California Public Radio. View the original story at SCPR.org.




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Child Sexual Abuse Reports Are On The Rise Amid Lockdown Orders

; Credit: Fanatic Studio/Gary Waters/Science Photo Library/Getty Images

Anya Kamenetz | NPR

There has been a rise in the number of minors contacting the National Sexual Assault Hotline to report abuse. That's according to RAINN, the Rape, Abuse and Incest National Network, which runs the hotline.

By the end of March, with much of the country under lockdown, there was a 22% increase in monthly calls from people younger than 18, and half of all incoming contacts were from minors. That's a first in RAINN's history, Camille Cooper, the organization's vice president of public policy, tells NPR.

Of those young people who contacted the hotline in March, 67% identified their perpetrator as a family member and 79% said they were currently living with that perpetrator. In 1 out of 5 cases where the minor was living with their abuser, RAINN assisted the minor in immediately contacting police.

"As a result of looking at the information that we had from those sessions, it was clear that the abuse was escalating in both frequency and severity," Cooper says. "So a lot of the kids that were coming to the hotline were feeling pretty vulnerable and traumatized. And it was a direct result of COVID-19, because they were quarantined with their abuser. The abuser was now abusing them on a daily basis."

Lockdown orders are first and foremost public health and safety measures. But statistically speaking, home is not the safest place for every young person. RAINN reports that about 34% of child sexual abusers are family members. Closing schools and canceling youth activities like sports removes children from the watchful eyes of "mandatory reporters" — those trusted adults, like teachers, nurses and child care providers, who are required by law in most states to report suspicions of child abuse or neglect.

However, Cooper says her organization has confirmed with authorities around the country that the child welfare system is still operating during the pandemic. That is, an official report of current and ongoing abuse will still trigger an investigation, and, if necessary, a child will be removed from the home.

"[Child welfare workers] will be coming to the home in person and proceeding with a formal investigation and a child forensic interview and things like that," she says. If the abuse is farther in the past and the child is not quarantined with the accused, Cooper says, the interview may take place over video chat.

In the meantime, RAINN and other child welfare organizations are lobbying to make it easier for children to report abuse. Cooper says, "One of the solutions we came up with that we are now currently working directly with the leadership in Congress on is to get all of the online learning platforms that children are interacting with to have a reporting function on that platform in plain sight for children."

Copyright 2020 NPR. To see more, visit https://www.npr.org.

This content is from Southern California Public Radio. View the original story at SCPR.org.




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When After-School Is Shut Down, Too

; Credit: LA Johnson/NPR

Kavitha Cardoza | NPR

When Jessyka Bagdon set out to move her tap dancing classes online, big questions started popping up right away: What about kids who don't own their own tap shoes? How to tap dance at home without ruining the floor?

And then came the really big challenge: Online programs like Zoom are designed for meetings, not dance classes. "They're made to pick up voices," she explains, not the clickety clack of tap-dancing shoes. "So how do we make the system not filter out our tap sounds as background noise?"

So Blagdon, an instructor at 'Knock on Wood Tap Studio' in Washington, D.C., set about problem-solving. No tap shoes? Turns out Mary Jane flats work well. Saving the floor? A piece of plywood does the trick.And that muffled sound over Zoom? Blagdon says fiddling around with some computer settings can help.

In the nation's capital, like the rest of the country, kids cooped up at home for weeks now are craving both physical activity and the mental and creative challenges that extracurricular activities bring. And ballet instructors, soccer coaches and piano teachers — just to name a few — are finding the shutdown every bit as complicated as schools moving academic lessons online.

As their counterparts in schools are finding every day, it's really difficult to explain — watching on a screen — to children in a painting class exactly how to hold the brush to get the right effect. Or to align a young karate student's body just so, for a proper sidekick.

Nevertheless, coaches and instructors are finding creative ways of keeping children active and engaged.

Weeks in, Bagdon says she still has the occasional bump but not always because of technology.

"Emmy, how come you're not dancing with us, my friend?" she asks one 5-year-old who has wandered off screen during class. Her student Emeline has a perfectly valid response, "Sometimes I go to drink a glass of milk!"

For student athletes looking ahead to a summer of meets, games and matches, and the companionship of their friends and teammates, the shutdown is frustrating.

Ava Morales, 16, of Bethesda, Md., was excited about showing off her skills this month in front of hundreds of college recruiters. But instead of being in Arizona, she's stuck at home and can't even see her teammates.

"We're all best friends," she says. "So it's heartbreaking we can't spend time together and that our season is basically cancelled." The online activities are comforting, she says, because it helps keep all her team motivated.

In the Washington area, 60 local soccer clubs have joined together in a new group called DMV United. And they've made a pledge that, during the shutdown, coaches won't engage in recruiting activities.

Tommy Park, with the Alexandria Soccer Association in Virginia, says coaches have shared different online workouts as well as apps that focus on specific soccer skills.

"The apps allow you to log how many juggles you have on the ball in a row and then log that," Park explains. "Maybe you can only get five the first time and then you see your teammates at eight. So try to get nine and you see all of your teammates progress."

Some players are reviewing championship games on video, or making Instagram videos of soccer tricks; others are reading about sports psychology.

But Matt Libber with the Maryland SoccerPlex is clear, this can never replace the adrenaline rush of actually being on the field.

And he worries about some of those bigger lessons kids are missing out on, like the importance of losing sometimes.

"Competing online or through Instagram, yeah, you're losing but you're not losing," he says. A big part of what he and other coaches teach, he says, are "some of those life lessons that, you know, if you learn them as a kid, it makes being an adult so much easier."

Copyright 2020 KQAC-FM. To see more, visit KQAC-FM.

This content is from Southern California Public Radio. View the original story at SCPR.org.




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Windows 10 is out and available immediately via the Windows 10 Download Tool




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The Breakdown is moving

(Stock photo); Credit: Meathead Movers/flickr Creative Commons

As of today, KPCC is moving Breakdown coverage to our main business page, where you will find KPCC’s ongoing news and information about Southern California business and the economy.

As a result, the Breakdown blog will no longer be updated. All previous Breakdown posts will remain available here as an archive.

Please let us know if there are issues you feel merit coverage. You can comment below, by email, on our Facebook page or on our Twitter feed (just "@" mention @KPCC).

This content is from Southern California Public Radio. View the original story at SCPR.org.




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