CLEVELAND (WJW)– A Cleveland company said it has developed new technology for first-of-its-kind at-home COVID-19 testing.
IdentifySensors Biologics said its saliva test is fast, accurate and inexpensive, and will soon go before the U.S. Food and Drug Administration for emergency approval.
Current tests usually involve a nasal swab performed by a health care worker.
According to the FDA, RT-PCR tests are highly accurate, but results can take days, and rapid antigen tests are less accurate. Such a test led to a presumed false positive for Ohio Gov. Mike DeWine earlier this year.
“We’re a very accurate test. We look for the genes of the virus, and if the test is positive, we know the virus is there,” IdentifySensors Biologics founder and CEO Dr. Gregory Hummer said.
Like the RT-PCR test, the IdentifySensors test is molecular, but it uses a saliva sample from spit. A test reader with a sensor uses an electric current to detect COVID-19 from the sample.
“Ours is a self test done at home without any of these other reagents. You don’t need a machine, you don’t need a lab tech, it’s very inexpensive and it can be done daily as many times as you need to,” Hummer said.
He said the test will use a Bluetooth signal to provide accurate results within minutes to users’ smart phones and to health agencies, as legally required.
“We’re expecting the accuracy to be the same as the gold standard, the RT-PCR test, which is 95 to 97 percent accurate,” Hummer said.
The company is working with Purdue University to develop the test by repurposing sensors first designed to detect things like salmonella in the food supply.
IdentifySensors said its reusable test reader will cost about $130, and each test cartridge is expected to cost less than $25.
“That’s really inexpensive and it’s accurate, and it lets you know if you’re contagious and can go to work or not,” Hummer said.
He said the company plans to seek Emergency Use Authorization from the FDA within 30 to 60 days, and with approval, the test may be available over the counter within six months.
The company said it plans to use the same technology to expand the test for other viruses, including influenza.
“It will be like having a laboratory in your medicine cabinet,” Hummer said.
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