CRANSTON, R.I. (WPRI — A false negative COVID-19 test sandwiched between two positive results left a Cranston woman emotionally drained and stuck in quarantine in Rhode Island.
Stephanie Buono was already battling Multiple Sclerosis when she suddenly felt unfamiliar, excruciating body aches around Easter.
There was no relief for the pain.
“I couldn’t stand the hot water, the cold water. The heating pad. Nothing,” Buono said. “It was that intense. My clothes hurt.”
Buono was examined on Easter Sunday with the standard COVID-19 test involving a swab inserted deep into the nasal passage.
“It did not hurt that much,” Buono said. “But that is the one that people say is painful.”
Even though Buono did not have many of the common coronavirus symptoms, she tested positive for the virus and was instructed to quarantine.
By the middle of May, about four weeks after testing positive, Buono hoped to get the all clear from medical professionals, so she got retested at the Lincoln CVS site that administers the Abbott ID Now test. Buono’s result was back in about 15 minutes.
She was virus free, according to the test, but skeptical.
‘”My mom was happy. My family was happy,” Buono said. “But my gut feeling was, how sure is this test?”
Buono’s “gut” prompted another test last Monday with the conventional, long swab.
The result: positive.
“I was defeated,” Buono said. “I was truly defeated. This is over seven weeks. It’s awful. I go to do something around the house, I got to sit down. I try to make myself useful, I have to sit down.”
Buono said her doctor could not determine whether she’s had the virus since Easter, or somehow contracted it a second time. Either way, Buono is concerned about anyone relying on the rapid test results.
“There are so many people walking around, thinking they’re negative but I feel that it’s not accurate,” Buono said. “They shouldn’t let the test go on if they really want the virus to stop.”
The ID Now test has been approved for emergency use, but is still being tested by the Food and Drug Administration.
On May 15, the day after Buona was tested at the CVS site, the FDA issued an alert that the ID Now test may give false-negative results.
Abbott spokesperson Kimberly LaFleur said the company released a clinical study that indicates ID Now is “95 percent or better” in accuracy.
“Our customers are telling that they’re seeing positivity rates from ID Now testing at or above local community infection rates,” LeFleur said. “Which means ID Now is detecting the virus at the same level as lab-based testing.”
CVS spokesman Mike DeAngelis said there are not indications false negatives are an issue at the company’s testing locations.
“The percentage of positive tests in Lincoln and at our four sites in other states using the rapid test has been higher than state averages, so there hasn’t been a red flag for false negatives,” DeAngelis said.
Based on her experience, however, Buono said she’s discouraging others from considering the rapid testing site.
“I’m begging them not to do that,” she said. “I’m not a scientist, but I just don’t think it’s accurate.”
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