SAFETY HARBOR, Fla. – Changing international COVID-19 testing rules, lax state regulations and rapidly evolving technology have created confusion when it comes to PCR testing, the most accurate type of test often required for work or travel.
During the height of the pandemic, ABC Action News’ I-Team uncovered a local medical clinic promoting a COVID testing service that experts said was good to be true.
Paul Gelsleichter was on his way to a trip of a lifetime, a river cruise in Europe, when he received bad news at Tampa International Airport.
“I went to the Delta Airlines ticket counter 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 clinic in Safety Harbor that an airline employee had recommended.
No mask, no gloves, but results in minutes
Advertised on the front was “Rapid PCR Tests…results in 15 minutes”.
“It was a medical clinic and there was a dog there,” Gelsleichter said.
The dog is owned by Advanced Practice Registered Nurse Tracy Greene, who owns the business
“I told her I came over from the airport. She said oh I’ll take you in and out right away so you don’t miss your flight,” Gelsleichter said.
He said Greene wiped his nose and took the sample to another room while he filled out the paperwork.
“She wasn’t wearing a mask or gloves,” Gelsleichter said. “Five to seven minutes later she said let me check. So she went back there and said it’s fine, you’re fine. She said the positive results are immediate. She said the negatives take a while.”
Greene gave him a travel certificate and a note on a prescription pad stating that he tested negative on a PCR test and was safe for the trip.
“We were traveling. And the driver said, oh, you were only in there eleven minutes,” Gelsleichter said.
A Canadian citizen we contacted had a similar experience.
In an email, she said she did three rapid PCR tests at the clinic and they all took “15 minutes… as promised.”
Experts say claiming the sign is impossible
dr Scott Witherow, a professor of biochemistry at the University of Tampa, said PCR testing is too complicated to get results that quickly.
“The genetic material in the cycle is amplified and in each cycle this genetic material doubles. So you can start with one copy of it and then have a billion copies of it over about 30 cycles,” Witherow said.
The manual for the fastest PCR test on the market states that samples are collected, labeled and placed in a chemical compound. Then the solution is placed on a cassette that is inserted into a machine that performs dozens of continuous cycles.
Witherow said he believes there is currently no technology that would allow health professionals to do a PCR test in 15 minutes.
“To perform these amplification steps and still give your patient a result, I just don’t see how that’s possible,” Witherow said.
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Steve Weiner owns a business that offers expedited PCR test results in 45 to 90 minutes at two Tampa locations.
He charges up to $199 for his fastest PCR tests. He said the cost of his equipment and materials is far more expensive than the rapid antigen test kits consumers can buy in pharmacies.
“Basically, PCR is state of the art. PCR is 99% effective. It’s a much broader, more complicated process,” Weiner said.
Witherow says PCR tests can detect COVID-19 days earlier than rapid tests.
“The rapid test might not pick it up, while the PCR test would,” Witherow said.
For this reason, many countries require PCR test certificates for foreign travel.
A $125 rapid PCR test and a dog named “Johnny Cash”
The ABC Action News I team decided to look at the tests. We went to Remedies, called the number and asked Greene to come into the parking lot to do a PCR test.
Greene emerged without a mask or gloves, collected a sample with a swab and took it back inside.
“I would think that any type of licensed nurse or practitioner would have what we call PPE, personal protective equipment … at least a mask, gloves,” Witherow said.
“I haven’t seen a testing site anywhere where the testers weren’t wearing gloves and masks,” said USF Healthcare vice president Jay Wolfson, a public health physician and attorney.
He said Greene should also have checked ID and had the person who administered the test sign a document confirming their identity and the exact time and date of the test. That didn’t happen.
“They need to know who they’re testing. You have to verify that you really are you,” Wolfson said.
Less than two minutes after the swab was taken, Greene returned for payment and a general form asking for name, address, date of birth, email address, phone number and allergies.
She carried the same dog, which 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 this with PCR.”
Weiner said the incubation time is longer for the fastest PCR test available. This does not include the time required to label the sample, mix it with solution, load it onto a cassette, run the required number of cycles, and interpret the results.
“So now you’re talking about 35 minutes,” Weiner said.
Greene issued a certificate with a false date of birth showing the COVID-19 test was negative.
Later we confronted them about their testing practices. She said she can do the testing quickly because she can do the testing on site. We asked to see the lab.
“No, you can’t. There’s HIPAA information in there,” Greene said.
“HIPAA prevents you from sharing your personal health information with anyone else and making your files available. It has nothing to do with them showing you the machine,” Wolfson said.
We also asked them about the 15 minute claim on their sign. She blamed her sign maker for the mistake that made it months earlier.
“There has to be a comma. There should be a comma on the tag. PCR…comma…rapid test,” Greene said.
“I can go out there with a Sharpie and put a comma. PCR and Rapid because there are two tests,” she said.
When we came back the next day, the word “and” was inserted between the words “rapid” and “PCR” in lower case.
“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 considers himself lucky that he was actually negative for COVID-19.
“This could have been catastrophic if I had been positive,” he said.
State records show the clinic never reported COVID test results
Records showed that Greene had received a certificate called a “CLIA waiver” from the CDC that allowed her to perform PCR testing at Remedies.
We contacted the Florida Department of Health to find out how many test results she had reported to the state. A department spokesman said the Florida Department of Health has no records showing the clinic has ever reported COVID test results, which are required by law.
Greene reportedly moved from her Safety Harbor location after we confronted her with the tests. She runs another clinic in Palm Harbor.
If you have a story for the I-Team to investigate, email us at [email protected].