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.