SAFETY HARBOR, Fla. — Changing international COVID-19 testing rules, lax governmental regulation, and rapidly developing technologies have created confusion when it comes to PCR testing, the most accurate type of test often which is required for work or travel.
During the height of the pandemic, the ABC Action News I-Team uncovered a local medical clinic advertising a COVID testing service experts said was good to be true.
Paul Gelsleichter was leaving for a trip of a lifetime, a river cruise in Europe when he got bad news at Tampa International Airport.
“I went to the ticket counter at Delta Airlines and was told by the agent that my test had expired,” Gelsleichter said.
In a panic, he took an Uber to Remedies Health and Wellness, a small Safety Harbor clinic recommended by an airline employee.
No mask, no gloves, but results in minutes
The sign out front advertised “Rapid PCR Tests …results in 15 minutes.”
“It was a medical clinic and there was a dog there,” Gelsleichter said.
The dog belongs to Advanced Practice Registered Nurse Tracy Greene, who owns the business
“I told her I came over from the airport. She said oh, I’ll get you right in and out so you don’t miss your flight,” Gelsleichter said.
He said Greene swabbed his nose and took the sample to another room while he filled out paperwork.
“She was not wearing a mask or gloves,” Gelsleichter said. “Five to seven minutes later, she said let me check it. So she went back there and she said it’s fine, you’re fine. She said the positives show right away. She said the negatives take a while.”
Greene gave him a travel certificate and a note on a prescription pad saying he tested negative on a PCR test and was safe for travel.
“We were on our way. And the driver said oh, you were in there only eleven minutes,” Gelsleichter said.
A Canadian citizen we contacted had a similar experience.
In an email, she said she took three rapid PCR tests at the clinic and all took “15 minutes…as promised.”
Experts say claim on the sign not possible
University of Tampa biochemistry professor Dr. Scott Witherow said PCR tests are too complicated to get results that quickly.
“The genetic material in the cycle is amplified and each cycle, that genetic material doubles. So you can start with one copy of that and then through about 30 cycles, have a billion copies of that,” Witherow said.
The manual for the fastest PCR test on the market said samples are collected, labeled, and placed in a chemical agent. Then the solution is introduced onto a cassette, which is placed in a machine that performs dozens of continuous cycles.
Witherow said he believes no technology currently exists which allows health professionals to conduct a PCR test in 15 minutes.
“To do those amplification steps and then still get a result to your patient, I just don’t see how that’s possible,” Witherow said.
Steve Weiner owns a company that offers expedited PCR test results in 45 to 90 minutes at two locations in Tampa.
He charges up to $199 for his fastest PCR tests. He said the costs of his equipment and materials are far more expensive than the test kits associated with rapid antigen tests, like the ones consumers can purchase at pharmacies.
“PCR is basically state of the art. PCR’s 99% effective. It’s a much more comprehensive, complicated process,” Weiner said.
According to Witherow, PCR tests can detect COVID-19 days earlier than rapid tests.
“The rapid test might not pick it up, whereas the PCR test would,” Witherow said.
That is why many countries require PCR testing certificates for foreign travel.
A $125 rapid PCR test and a dog named “Johnny Cash”
The ABC Action News I-Team decided to check out the testing. We went to Remedies, called the phone number, and asked Greene to come into the parking lot to perform a PCR test.
Greene showed up without a mask or gloves, collected a specimen with a swab, and took it back inside.
“I would think that any kind of licensed nurse or practitioner would have what we call PPE, personal protective equipment… a mask, gloves at a minimum,” said Witherow.
“I have not seen a testing site anywhere that I’ve been where the testers were not wearing gloves and masks,” said USF Healthcare Vice President Jay Wolfson, who's a doctor of public health and an attorney.
He said Greene also should have checked an ID and had the person taking the test sign a document confirming their identity and the specific time and date of the test. That did not happen.
“They gotta know who they’re testing. They’ve got to verify that you’re you,” Wolfson said.
Less than two minutes after performing the swab, Greene returned to collect payment and a general form requesting name, address, date of birth, email address, phone number, and allergies.
She was carrying the same dog who she introduced as “Johnny Cash.”
We started a timer and 27 minutes later, Greene called to say the result of the COVID test was negative.
Witherow said, “27 minutes… none of the devices or instruments or protocols or techniques that I’ve seen have been able to do that using PCR."
Weiner said the incubation period for the most rapid PCR test available on the market takes longer than that. That doesn’t include the time it takes to label the sample, mix it with solution, introduce it onto a cassette, conduct the required number of cycles and interpret the results.
“So now you’re talking about 35 minutes,” Weiner said.
Greene issued a certificate with the wrong date of birth which said the COVID-19 test was negative.
We later confronted her about her testing practices. She said she was able to do testing quickly because she was able to process the testing on-site. We asked to see the lab.
“No, you can’t. There’s HIPAA information in there,” Greene said.
“HIPAA prevents them from sharing your personal health information with other people and making your files available. It doesn’t have anything to do with them showing you the machine,” Wolfson said.
We also asked her about the 15-minute claim on her sign. She blamed the error on her sign maker, who she said made it months earlier.
“There should be a comma. There should be a comma in there on the sign. PCR… comma… rapid test,” Greene said.
“I can go out there with a Sharpie and put a comma in. PCR and Rapid, because there’s two tests,” she said.
When we returned the next day, the word “and” was added in small letters between the words “rapid” and “PCR.”
“People who are positive could have gotten on a flight and flown and maybe infected other people,” Gelsleichter said.
He is 80 years old and counts himself lucky that he really was negative for COVID-19.
“This could have been a disaster had I been positive,” he said.
State records show clinic never reported COVID testing results
Records showed Greene received a certificate from the CDC called a “CLIA waiver,” which allowed her to conduct PCR tests at Remedies.
We contacted the Florida Department of Health to find out how many test results she had reported to the state. A department spokesperson said the Florida Department of Health has no records showing the clinic has ever reported any COVID testing results, which are required by law.
Greene reportedly moved out of her Safety Harbor location after we confronted her about the testing. She operates another clinic in Palm Harbor.
If you have a story you’d like the I-Team to investigate, email us at email@example.com.