New, small portable COVID-19 testing device in development, awaiting FDA approval

Posted at 6:19 AM, Aug 20, 2020
and last updated 2020-08-20 07:39:43-04

HILLSBOROUGH COUNTY, Fla. — Several Tampa Bay area organizations are working together to create a new portable COVID-19 testing device, the Rapid Biofluid Analyzer 2 or RBA-2.

Kaligia Biosciences, a medical device company, says it’s partnering with AdventHealth, the USF College of Pharmacy, the USF College of Medicine and Tampa General Hospital to collect positive and negative COVID-19 saliva samples.

“They’re all collaborating together to get us the samples that we need so that we are able to give results that will be accurate, they’ll be non-invasive, and they will be quick,” said Fazal Fazlin, CEO of Kaligia Biosciences.

The device will be the size of a shoebox and will use saliva to test for COVID-19.

People will spit into a little funnel that goes into a tube. Then they use a laser to scan the saliva to digitize it.

Once the information from the saliva is in the machine, they apply it to the special algorithm to be able to detect if there’s COVID-19 or not.

“I want them to say that this is accurate, this was easy, and this was quick. So people would not be afraid to get themselves tested for it,” said Fazlin.

Kaligia Biosciences tells ABC Action News it’s been working around the clock for months, getting the device ready.

Right now, they’re getting an accuracy rate of around 90% for negative COVID-19 tests, and around 87% for positive COVID-19 tests.

Project leaders say they’re working to improve those numbers.

“Our number one priority is accuracy. For that, getting all these readings are really helping us become a lot better than we were,” said Fazlin.

The device now requires much less saliva than it did a few months ago.

Officials say they’ve also shaved off the amount of time it takes to get test results. It was around 3 minutes, but now it can give you results in about 60 seconds.

Fazlin says they submitted the device to the Food and Drug Administration for approval, and are hoping to get in in the next few days.

In anticipation of that, they company says it has been working with vendors to ramp up production so they can deploy it out into the community.

Some medical institutions say this device could be an important part of healthcare and public health moving forward.

Project leaders say the reopening of the economy relies on easy and accessible COVID-19 screening, and they believe this new device will be the key.

“It brings us back to the new normal, whatever that is. People are going to feel safe knowing that most of our population has been tested and that they do not have COVID-19,” said Fazlin.

Fazlin says the device could be used before people head into places like schools, businesses, restaurants and board meetings.

Fazlin wants people to feel better about going on an airplane, a cruise ship or into a theater knowing everyone has been tested.

“They’ll have that instrument over there at the airport where people can put their saliva into the tube, get tested, and you’ll be able to tell if that person is positive or not for COVID-19,” said Fazlin.