Leander woman receives negative COVID-19 result for test she never took
LEANDER, Texas - A Leander woman received a negative COVID-19 test result for a test she never took.
On Christmas Eve, Elizabeth Evans traveled to a COVID-19 testing site in Pflugerville, where private medical company DAVACO, who is contracted by the Texas Division of Emergency Management, administers Curative tests. Evans says she scanned a QR code on the front door and set up a same-day appointment.
"There were a whole bunch of people in line behind us and all of a sudden somebody said ‘oh heck, they just posted on their website that they’re closed today.’" she explained.
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Evans left without a test, after realizing the appointment she booked was not going to happen. To her surprise, this Sunday, she received what appeared to be her test results from Curative. "I opened it up and entered my date of birth and it opened up to the results, and said ‘whew! You’re negative yay!’"
Evans contacted Curative. Their response implied she had incorrectly received someone else’s results. It read:
"Thank you for contacting Curative and flagging this issue to us. We sincerely apologize for the confusion. We have removed your email address from appointment ........... and are working to contact the patient associated with this appointment to confirm their email address."
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Evans says the email "still didn’t make [her] feel any more comfortable about their process."
Evans received her incorrect results, Sunday, January 3 and on Monday, January 4, the FDA put out a vague safety notice warning of false, particularly false-negative Curative test results. The release had no information as to why or how false results were being produced and whether the information could apply to someone like Evans, who never got a test.
The notice said the test should be performed in accordance with its authorization or authorized labeling. This confused many in the medical industry, as all tests should be performed in accordance with their authorization or authorized labeling. The notice said medical providers who suspect a patient recently received inaccurate results using a Curative COVID-19 test, should re-test said patient. FOX 7 Austin is awaiting clarification from the FDA.
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Curative provided FOX 7 Austin with this statement:
"Curative’s test has been validated and is being offered during the pandemic under an Emergency Use Authorization, and is labeled with specific warnings, precautions, and limitations that FDA reiterated in the Safety Communication. The test performance and labeling, however, have not changed, nor has the company observed any changes in test performance. We have been working with the agency to address their concerns and these limitations, and we will continue to work interactively with FDA through the Emergency Use Authorization process.
We understand that the Safety Communication seeks to ensure that Curative’s test is administered and performed according to the labeling and limitations in the EUA.
Curative will continue to work actively with FDA to provide additional data required to address the limitations and precautions. Curative remains committed to following FDA and CMS regulations in the development, testing, and use of our Emergency Use Authorized test, and in providing medical devices and services that meet or exceed our customer's expectations operating in accordance with these requirements."
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A TDEM spokesperson told FOX 7 Austin they were working with Curative to get to the bottom of Evans’ case, and provided FOX 7 Austin with this statement:
"As you know, Curative is only one of the multiple COVID-19 tests utilized by the state pursuant to the FDA’s Emergency Use Authorization. As the FDA described in their notice, and as is the case with all COVID-19 tests utilized under an EUA, it is important to perform the test in accordance with its authorization and as described in the authorized labeling. We will continue to monitor any findings and data released by Curative and the FDA."
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A Curative spokesperson told FOX 7 Austin they believe the error was caused by DAVACO and was looking into whether similar errors were made. DAVACO’s COO Jason Melvin said they would look into the matter with Curative.
"I really have no explanation. I can’t even begin to guess." Evans said.
Still, she hopes her story will not fan the flames of "conspiracy theorists." "By all means get tested, and get your vaccination," she said.