A Houston health care startup has begun testing people in their homes for COVID-19 after becoming one of the first companies to receive federal approval for distributing at-home test kits.

The company, imaware, has partnered with the Houston Health Department as part of an effort to increase the number of people getting tested for the disease spread by the novel coronavius. The at-home tests — at least for now — are allocated for those who are “symptomatic, exposed and high-risk individuals who are unable to leave their own home,” the Houston Health Department said.

Unlike other at-home test kits that are designed to be self-administered, the swabs used to take specimens are administered by medical assistants and nurses to comply with federal regulations barring a patient from collecting their own samples.

Imaware’s test could help alleviate test shortages as the country tries to bring the pandemic under control and bring the exams to those who can’t access drive-thru testing sites — whether because they’re bedridden or don’t have a way to get to the testing sites.

“Who we want to catch is anybody who feels like they haven’t had a chance to be tested or screened,” said imaware co-founder Jani Tuomi said.

Driven by demand

The appetite for the tests is high — as of Tuesday morning, more than 23,500 people had taken imaware’s online screening quiz for coronavirus. But CDC guidelines on who can get tested — hospital workers, first responders, people 65 and older, nursing home residents and people with underlying conditions with COVID-19 symptoms — and a limited amount of personal protective equipment is keeping the company from administering it widely.

Tuomi estimates that about 1 percent of people who take the online screening quiz are high-risk, meaning they fall in the CDC’s priority groups. A clinician from Wheel, an Austin-based telemedicine company, video calls the prospective patient to confirm the symptoms, then orders the test.

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Medical professionals from temporary employment firms such as Pulse Staffing take the test kit to a person’s home, where they insert a nasal swab that reaches into the upper throat, and then deliver the sample to a location operated by its partner, Clinical Pathology Labs of Austin. The results are available within 72 hours, and the imaware notifies public health authorities.

Some possible COVID-19 patients who call the City of Houston’s triage line will get tested for free this way, the Health Department said. Five people so far — usually elderly or otherwise home-bound residents — have been tested with the imaware kits. The company allocated 125 to the health department, and another 125 kits to the city’s emergency medical services.

Imaware is also administering tests privately for $135.

Five Pulse medical assistants and phlebotomoists slip into head-to-toe protective gear to administer the tests. Each medical professional can test up to six patients a day. To date, imaware’s tests have reached more than 150 high-risk people in the Greater Houston region.

“The patients and their families are grateful they’d come out, subject themselves to active COVID-19 patients and be willing to take their swab,” said Bruce Mowry, Pulse’s owner.

The hurdles

Other at-home testing kits have yet to get approval from the Food and Drug Administration because they would be self-administered, rather than given by trained medical assistants.

“It is more likely that the sampling process will be done properly if professionals are involved directly in the sampling,” said Dr. Jeffrey Cirillo, director of Texas A&M University’s Center for Airborne Pathogen Research and Tuberculosis Imaging Resources.

The swabs hit an uncomfortable spot in the upper throat, where signs of infection are present at both early and late stages of the virus, Cirillo said. Most people won’t be able to hit that hard-to-reach spot.

Medical assistants from Pulse handle the swabbing process, which is approved by the FDA.

The problem now is getting those test kits to those who need it. The city is only using at-home tests for those who have no way of getting to a drive-thru testing stadiums.

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”We’re trying to kind of stretch out our amount,” said Dr. Letosha E. Gale Lowe, chief physician of the Houston Health Department.

As with other companies, imaware is frustrated by the shortage of personal protective equipment, nasal swabs and slow-changing federal guidelines around test kits, which are used both to confirm that someone has coronavirus and when they’re no longer sick.

For now, Tuomi will keep looking for supplies of swabs and face masks to get more medical assistants and nurses out there. The initial goal was to acquire 10,000 nasal swabs to create imaware’s sample collection kits by the end of April; imaware did not want to disclose the number of swabs it now has, but said it numbers “in the thousands.”

“I’m glad we can test high-risk people,” Tuomi said, “but I’m disappointed we only have limited supplies and we can’t get any more tests for people to get cleared to go back to work.”

gwendolyn.wu@chron.com

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