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FDA warning: Mobile COVID-19 testing van in Milwaukee might produce false results

curative testing van
Posted at 5:46 PM, Jan 11, 2021

MILWAUKEE — One of the COVID-19 tests being administered in the Milwaukee area is now under a safety alert by the Food and Drug Administration. The agency says the test sometimes produces false results.

curative testing van
The Curative mobile COVID-19 testing site operates out of this van in Milwaukee.

The newest COVID-19 test in Milwaukee is run by a company called Curative. They offer mobile COVID-19 tests out of a van, which has been stationed at Barack Obama High School since Dec. 29, 2020. But the FDA released a safety communications saying Curative’s test can give false negative results.

TMJ4 News shared that warning with Kaity, who did not want to give her last name. Kaity got tested by Curative about two weeks ago at the Barack Obama High School testing site.

“It’s kind of disappointing. You went into this, into the test hoping you could get accurate results,” said Kaity.

covid test Kaity
Kaity was tested for COVID-19 by Curative at the mobile Milwaukee testing site at Barack Obama High School.

The Curative test debuted in Milwaukee on Dec. 29. The company operates out of a van and travels to areas where people typically don’t have easy access to COVID-19 tests. The City of Milwaukee hired Curative to administer these tests, which has people do their own nasal swabs.

“Some of the false negatives, we assume, are related more to oral swabs and saliva. The evidence based for using nasal swabs is better, so that is one key point of information to understand at the Milwaukee level,” said Dr. Nick Tomaro from the Milwaukee Health Department.

However, the FDA warns the issue is not how people collect the samples, but authorized use is “limited to people who have shown symptoms of COVID-19.”

Kaity says when she took the test, she was never told she had to have COVID-19 symptoms to get an accurate result. She has now gotten tested at two other COVID-19 testing facilities. She already got back one result, and found out she is negative.

“You just kind of need to go to different places, apparently, that’s what I found out from this,” said Kaity.

curative covid testing
Curative mobile testing van parked in front of Custer Field at Barack Obama High School.

As for Curative, the company released 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.”

We did reach out to the Washington/Ozaukee Health Department, which also uses the Curative test, but TMJ4 News has not heard back from them.

The only place in Milwaukee that uses the Curative test is the traveling mobile site here at Barack Obama High School. The fMiller Park testing site uses a different COVID test.

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