MANATEE COUNTY – As people recover from the coronavirus, they develop antibodies. A Suncoast company develops a new test for those antibodies.
There are two types of tests available for COVID–19: the molecular and serological, according to Epidemiologist and CEO of CliniLinc Diagnostics, Dr. Scott Hopes. He says the one we’re most familiar with is the molecular test.
“It test for the presence of the actual virus in the respiratory system,” Dr. Hopes said.
And the serology test, tests for two different types of COVID–19 antibodies.
“IgG antibodies are those antibodies that your body produces to a particular foreign agent, in this case the SARS–CoV–2 virus,” Dr. Hopes said. “And then there’s another type of antibody that’s called IgM antibodies. Those are the antibodies your body is producing at the height of the infection when you’re fighting off the infection.”
CliniLinc Diagnostics and Livzon Diagnostics developed a new serological test.
CliniLinc Diagnostics, based in Manatee County, is a global healthcare technology company with offices in the USA, Dublin Ireland, and Taipei Taiwan. Dr. Hopes, says Food and Drug Administration is allowing its serological test to be marketed and distributed.”We’ve done the clinical trials on the serology test,” Dr. Hopes said. We did it in four hospitals in Asia, a hospital in Houston, and Tampa General.”
It tests for the immunity of the virus. Dr. Hope says it’s like a pregnancy test. You just use a drop of blood with a diluent in a little cassette and wait for about two minutes.
“You get a bar that the test was reliable, and then you’ll get a colored bar indicating the presence of the IgG antibodies, and a bar indicating the presence or the absence of IgM antibodies to the COVID–19 virus,” Dr. Hopes said.
Dr. Hope says the company is producing about 75,000 test kits a day. They’re distributing all around the world so he hopes to ramp up production.
CliniLinc Diagnostics plans to roll out the new tests in the coming week.
While the FDA has allowed for the test to be marketed and distributed, Dr. Hopes says he’s still waiting on the actual FDA’s Emergency Use Authorization before he distributes the test with unlimited access in the United States.
