Peter Schorsch
With a lack of testing kits and medical personnel to screen individuals for COVID-19 across the country, multiple federal officials are calling for increasing antibody screenings to rapidly determine if someone has contracted the virus and is now immune, even if they have previously shown no symptoms.
Thankfully, one South Florida-based company is already producing antibody tests for COVID-19 and rolled out thousands of screenings across Miami-Dade County last week.
Disaster Management Group (DMG) launched its 15-minute COVID-19 antibody test last week. The DMGtest is a serological test that detects antibodies in the blood to determine if the body has been exposed to COVID-19, whether or not the candidate ever experienced symptoms.
The DMGtest received an FDA waiver after meeting accuracy guidelines and is expecting full FDA approval soon. These rapid antibody tests are more cost-effective and the results are quicker than current COVID-19 diagnostic testing techniques, which detect the DNA of the virus in the body.
“Rapid and widespread COVID-19 testing is one of the critical components to get the country to move forward into recovery,” said Tom Rubio, DMG CEO. “The DMGtest can provide quick results from a screening that has been scientifically validated against COVID-19 positive blood.”
DMG’s lab partner, Florida-based Vista Clinical, tested the validity of the DMGtests against live COVID-19 blood. Vista Clinical found a very high accuracy rate in the sampling used. The lab has been solicited by about 10 other antibody test producers, and none have the lab-tested accuracy of the DMGtests.
“We evaluate the samples against known positive patients, positive blood samples that were confirmed through PCR testing,” said Davian Santana, president of Vista Clinical. “This test will be critical to showing that you have had COVID-19, that you are immune to it, and that you can now go back to work. There is no other way of validating this immunity than the antibody test.”
The FDA has provided a waiver to allow the use of antibody screenings for COVID-19. The DMGtest is operating under the waiver but is also one of the few tests with full clinical lab validation.
“The majority of tests on the market right now are not reliable. It’s like the Wild West.,” Santana said. “The end-user would have no way of knowing whether the test is accurate unless it has been validated in a lab. It’s a very confusing environment right now. We are trying to do the right thing by our patients and help the country begin to recover.”
Officials at all levels of government have urged for more testing of COVID-19. In recent weeks, the White House’s daily coronavirus updates have included details about expanding serologic, or antibody screening, across the country. Vice President Mike Pence specifically asked companies to increase the availability of serologic testing in order to screen more Americans.
And last week, the FDA provided an update regarding antibody testing, including information on how companies can market and sell the tests after following FDA guidelines, with no need to be FDA approved, a lengthier process that would delay getting the tests on the ground to areas in need.
“Serological tests can play a critical role in the fight against COVID-19 by helping health care professionals to identify individuals who have overcome infection in the past and have developed an immune response,” the FDA update reads. “In the future, this may potentially be used to help determine, together with other clinical data, that such individuals are no longer susceptible to infection and can return to work.”
Governments and health care providers continue to open drive-thru testing facilities across the state to conduct PCR tests, which detect the DNA of the virus in the body and may take up to two weeks for results. These tests are used to confirm if residents have COVID-19 after experiencing symptoms or being exposed to other COVID-positive patients. Unlike the PCR tests, the antibody tests produced by DMG do not use a swab or send a specimen to a lab for testing.
Miami-Dade was the first to expand testing. On May 3, Mayor Carlos Gimenez announced the purchase of 20,000 DMGtests to screen first responders and support a survey of the county’s population. This represents the largest testing survey in the nation since COVID-19 was first detected.
12 comments
Michael O'Rourke
April 18, 2020 at 9:48 am
It’s remarkable that of all the articles that come through the FLAPOL email system this article, which could be the most important story to come about during this COvid 19 crisis, has only this one comment. I guess people don’t want to comment unless political red-meat is thrown in their direction.
Michael O'Rourke
April 18, 2020 at 10:04 am
Now for my important comments.
This serological test is the breakthrough that we have been looking for during this crisis. The current data on this pandemic is woefully inadequate because the only testing programs being done only test those who have serious symptoms but doesn’t tell if there were asymptomatic infections. Because of that ALL the data collected is irrelevant and at least highly suspect since we have NO IDEA of how many people have actually been exposed to this virus. The new test will show that a person either has the antibodies and is unlikely to be infected again, or it will show that the person has the virus, or finally, that the person has not had the virus and would be at risk.
Armed with this information the CDC would be able to properly evaluate the risk of spread of this virus. That way we can get our economy back on track and move beyond this devastating health and economic crisis.
Thank you Peter for bringing this information to us. You always seem to be the most level headed journalist on this site.
Leslie A Goebel
April 18, 2020 at 11:05 am
I was sick the 1st week of march. How can I get one of these test ?
Gary D Moll
April 19, 2020 at 6:02 pm
On May 3rd?
Patrick W. Geiger
April 20, 2020 at 7:42 am
“received an FDA waiver”
What type of waiver? EUA?
Patrick W. Geiger
April 20, 2020 at 7:46 am
“Vista Clinical found a very high accuracy rate in the sampling used”
Very high- sounds like marketing hype, 10% is relatively high to 0%
Anne Melissa Dowling
April 20, 2020 at 12:55 pm
When will these tests be available to the SW coast of Florida, Naples? I am certain I had and recovered from COVID after three weeks of this horrible virus. I’d like to verify that and be able to donate plasma and begin volunteering.
Therese
April 20, 2020 at 2:30 pm
Where can we go to get tested?
Therese
April 20, 2020 at 2:32 pm
Not a very good article if we’re not given info on where to get tested.
Steven Reznick MD
April 23, 2020 at 1:11 pm
This is one of ninety tests permitted by the FDA onto the market without testing based on the manufacturers say so of accuracy.Is this test detecting IgG against corona virus causing Covid-19 or is it detecting antibodies to the many common cold corona virus infections humans get and shrug off? Of course we dont know. All we know is we took the company word on it, bought it, used it on critical first responders and will expect them to believe that they are immune if they get a positive test. Perfect logic for FloriDUH
Sandra Knight
April 25, 2020 at 9:46 am
I was sick, very sick, with all the Covid 19 symptoms the last week of February after attending a baseball game in Miami with 3000+ people from all over Florida. Our whole family subsequently became sick with the same symptoms in the coming weeks. I was diagnosed with “a virus” by our local ER doctor and given heavy antibiotics and steroids to avoid pneumonia and recovered in 10 days or so. I live in Naples, FL. Where can I be tested to see if I had Covid 19? There was no test available in February. I was tested for the flu. That was negative.
Katy
May 3, 2020 at 10:23 am
I had a strange cold at the end of Feb- little congestion but my glands were sore on and off for 2 weeks. Can I have the antibody test for Covid-19. I worked un St Pete and live in Redington.
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