BALTIMORE — It could be the future of COVID-19 testing, requiring just a a pin-prick of blood. Results come in minutes, with a mark on a stick showing positive or negative, similar to a pregnancy test.
"Simply requires a pipette, a fingerprint, and a couple drops of blood on the ID strip, add the reagent, wait five minutes and you get an answer." said Robert Guy, CEO of Stonebridge Defense, a Baltimore-based company with the exclusive deal to distribute this particular COVID-19 test – if it's approved by the Food and Drug Administration.
The tests are manufactured in Singapore. They're made by the British company BioSysAI. Maryland's Stonebridge Defense is the distributor for the U.S. and six other countries.
Antibody tests, including this one, can detect if your body is currently fighting a coronavirus infection or if you already were infected, but showed no symptoms. That's according to University of Maryland scientists, who tested and passed the BioSysAI product in a small pilot study in mid-March. That study found the test had the federally required accuracy of at least 95%.
"That's a result of it looking for both the IgG and IgM antibodies in your blood," explained Guy.
Two weeks ago, WUSA9 showed how Germantown-based Qiagen is assembling COVID-19 test kits. But those kits, and most others around the world, require nasal swabs with samples taken to labs, and take days for people to find out if they are infected with COVID-19.
"We want to get these kits in the hands of clinicians and government agencies," Guy said.
The new test is now approved by CE, the safety mark for the European Union. Records show this new COVID=19 test is under review by the FDA for "emergency use authorization."
WUSA9 asked the FDA over the past few days for updates on when that final authorization is expected, but has not received a reply.
"We're currently working with the University of Maryland. Right now we have a number of kits that are inbound. Those are en route," Guy said about how quickly the tests could be in health professionals' hands. "We expect University of Maryland to have those next week."
Once approved by the FDA, the Singaporean manufacturer that Maryland's Stonebridge Defense is working with says it can make 300,000 test kits a day. Individually, the test is priced at more than $75, with prices going down for wholesale bulk orders expected from government and medical clinics.