Accuracy still unknown for many coronavirus tests
Some want FDA to demand better evidence
WASHINGTON – How accurate are the coronavirus tests used in the U.S.?
Months into the outbreak, no one really knows how well many of the screening tests work, and experts at top medical centers say it is time to do the studies to find out.
When the new virus began spreading, the Food and Drug Administration used its emergency powers to OK scores of quickly devised tests, based mainly on a small number of lab studies showing they could successfully detect the virus.
That’s very different from the large patient studies that can take weeks or months, which experts say are needed to provide a true sense of testing accuracy.
The FDA’s speedy response came after it was initially criticized for delaying the launch of new tests during a crisis and after the Centers for Disease Control and Prevention stumbled in getting its own test out to states.
But with the U.S. outbreak nearly certain to stretch on for months or even years, some experts want the FDA to demand better evidence of the tests’ accuracy so doctors know how many infections might be missed.
There have been more than 2 million confirmed coronavirus cases in the U.S. and more than 115,000 deaths, according to data compiled by Johns Hopkins
University. Cases in nearly half of U.S. states are rising.
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.
“In the beginning, the FDA was under a lot of pressure to get these tests onto the marketplace,” said Dr. Steven Woloshin of Dartmouth College.
“But now that there are plenty of tests out there, it’s time for them to raise the bar.”
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.
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.
Even a modest error rate can have grave consequences during an outbreak like COVID-19. West gives the example of a test that is 95% accurate at detecting the virus and is used on 1 million people. That would still result in 50,000 people being incorrectly told that they don’t have the virus.
“The negative test does not mean that I’m off the hook,” West said. “We just need to maintain that level of vigilance until we have a better sense of how good these tests really can be.”
Chicago group seeks detained immigrants’ release in pandemic
The National Immigrant Justice Center has filed at least 18 federal lawsuits in states including Illinois, Texas and Wisconsin and requested administrative release for at least 44 individuals since mid-March. While two lawsuits were denied, 26 people have been released so far.
The nonprofit argues the outbreak has created unsafe conditions by further delaying proceedings in an alreadybacklogged immigration court system and keeping people detained longer with limited safeguards.
“It’s setting people up for putting them in a really dangerous situation while they sit and wait,” said NIJC’s litigation director Keren Zwick. “It’s literally a life or death situation.”
Since February, roughly 1,800 immigrant detainees nationwide have tested positive for COVID-19 and two have died, according to ICE.
ICE officials argue they’ve taken protective measures to curb the spread, including offering masks and hand sanitizer, spacing out detainees and staggering meal times Because of the pandemic, federal officials say they’re detaining fewer people and have released hundreds of medically-vulnerable detainees they say aren’t a threat to
public safety.
Blind voters fear loss of privacy with shift to mail voting
As election officials plan a major vote-by-mail expansion amid fears of voting in person during the coronavirus pandemic, Ann Byington worries she is being left out.
Blind since birth, Byington welcomed the rise in recent years of electronic voting machines equipped with technology that empowered her and others with disabilities to cast their ballots privately and independently.
When the presidential primary in Kansas was held entirely by mail last month, the 72-year-old Topeka resident had to tell her husband how she wanted to vote so he could fill out the ballot for her.
“I’m back to where we started,” Byington said.
“I’ve lost all my freedom to be independent, to make sure it’s marked how I want it to be marked.”
In recent weeks, advocates for the blind have filed legal actions in Michigan, New York and Pennsylvania seeking access to systems already in place to deliver ballots electronically to military and overseas voters. Blind voters could then use their own computers and assistive technology to read and complete their ballots themselves.
“This is about equality,” said Chris Danielsen with the National Federation of the Blind, one of the groups suing. “If a secret ballot is important to you, it’s important to a blind person, as well.”