FDA COVID-19 antibody tests are pulled from approval

Jun 17, 2020, 7:52 PM
FDA COVID-19 Antibody Tests...
(Picture Credit: Getty Images)
(Picture Credit: Getty Images)

BLUFFDALE, Utah – The FDA has pulled approval of the COVID-19 antibody tests. The decision comes shortly after thousands of Utahns jammed into parking lots in last month to test themselves for COVID-19 antibodies.

It may have been all for nothing.

On Wednesday, the Food and Drug Administration pulled it’s emergency approval of the Chembio Diagnostic System because it was producing a higher than average number of false results. 

Dr. Paul Benson with RapidSolutions, the Utah company who administered the test, said it’s not uncommon for the FDA to pull their approval as quickly as they grant it, but he does not believe anyone had an inaccurate result. 

Even so, Benson says they will be looking at other alternatives. 

“Having one specific test pulled from use means that we simply need to put a little bit more thorough investigation into the other tests we’ve been looking at,” Benson said. 

Benson said they respect the FDA’s decision but are also disappointed because the test is easy to use and doesn’t require a full blood draw like many others. 

Bluffdale City Councilman Jeff Gaston is another person who was caught off guard by the FDA’s decision. 

He says his mother got an accurate result from the test, the results of which came back days before another test also confirmed she had COVID-19 antibodies. 

He also believes his results were accurate. 

“I’ve seen some of the results which matched up with some of the other tests. It gives me a peace of mind knowing I haven’t had the virus, and I need to still be extremely careful,” Gaston said. 

However, other people who paid almost $70 to take the test said there was no paper trail or record they could take home to verify the results. 

The cities are looking at ways to redirect people to other COVID-19 anti-body tests. 

The cities paid for some of their employees to take the test, including first responders, and will likely be reimbursed by CARES Act money for that expense.

However, Bluffdale also fronted nearly $25,000 to get the FDA COVID-19 antibody tests up and running, though Councilman Gaston expects that money will be reimbursed as well. 

Today’s Top Stories

All News

Nichole Thomas, Pioneer Park Coalition member and Latter-day Brides owner, speaks during a Pioneer ...
Mark Jones

Pioneer Park Coalition announces plan to combat crime, homelessness

On Thursday, the Pioneer Park Coalition announced a three-pronged plan to combat homelessness and crime in Salt Lake City.
1 day ago
Salt Lake City police are investigating a shooting Thursday evening, Oct. 6, 2022, at Meadows Park....
Mark Jones

Salt Lake City Police investigating shooting at Meadows Park

One teenager suffered non-life-threatening injuries following a shooting Thursday evening at Meadows Park.
1 day ago
Salt Lake County DA Sim Gill speaking behind a podium...
Devin Oldroyd

Salt Lake County DA discusses Biden’s pardon of marijuana possession

Following President Biden announced pardons for thousands of people convicted of marijuana possession federally, Salt Lake County District Attorney Sim Gill discusses what this means for the Beehive State.
1 day ago
Police in Tooele are looking for an armed robbery suspect that forced three schools into lockdown o...
Mark Jones

Search for wanted fugitive in Tooele is unsuccessful

Law enforcement personnel in Tooele conducted a search for a fugitive on Thursday afternoon. The search was unsuccessful.
1 day ago
Serial Bank Robber...
Mark Jones

FBI seeking information on whereabouts of serial bank robber

The FBI says a serial bank robber has recently robbed a pair of banks in Salt Lake City. Authorities are seeking the public's assistance in locating the individual responsible.
1 day ago
DACA march...
Alejandro Lucero

DACA ruled illegal by court, but current “Dreamers” still protected

Current Dreamers are still protected by the law and can continue to renew their applications, but new applicants are barred.
1 day ago

Sponsored Articles

Young woman receiving laser treatment...
Form Derm Spa

How facial plastic surgery and skincare are joining forces

Facial plastic surgery is not only about looking good but about feeling good too. The medical team at Form Spa are trained to help you reach your aesthetic outcomes through surgery and through skincare and dermatology, too.
large group of friends tohether in a park having fun...
BYU MBA at the Marriott School of Business

What differentiates BYU’s MBA program from other MBA programs

Commitment to service is at the heart of BYU’s MBA program, which makes it stand out among other MBA programs across the country.
a worker with a drill in an orange helmet installs a door in the house...
Price's Guaranteed Doors

Home improvement tip: Increase the value of your home by weatherproofing doors

Make sure your home is comfortable before the winter! Seasonal maintenance keeps your home up to date. Read our tips on weatherproofing doors.
Curb Appeal...
Price's Guaranteed Doors

How to have the best of both worlds for your house | Home security and curb appeal

Protect your home and improve its curb appeal with the latest security solutions like beautiful garage doors and increased security systems.
A paper reading IRS, internal revenue service is pictured...
Jordan Wilcox

The best strategies for dealing with IRS tax harassment | You have options!

Learn how to deal with IRS tax harassment. This guide will teach you how to stop IRS phone calls and letters, and how to handle an IRS audit.
spend a day at Bear Lake...
Bear Lake Convention and Visitors Bureau

You’ll love spending the day at Bear Lake | How to spend a day at Bear Lake

Bear Lake is a place that needs to be experienced. Spend a day at Bear Lake.
FDA COVID-19 antibody tests are pulled from approval