Curative has seven COVID-19 testing sites in the Houston area, including the popular drive-thru site at Minute Maid Park.
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"Risks to a patient of a false negative result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events," the FDA said in a release.
The FDA emphasized that the issue with many false negative tests boils down to inaccurate performance, where the tests are not administered as directed or administered without supervision.
"When the test is not performed in accordance with its authorization or as described in the authorized labeling, there is a greater risk that the results of the test may not be accurate," the FDA said.
According to Curative's website, tests are administered by having individuals cough deeply into their elbow before swabbing the inside of their mouth in specific regions.
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When signing up for a test, Curative warns recipients of factors that could cause a false result.
"Before your appointment, make sure not to eat, drink, or smoke 20 minutes before swabbing your mouth," Curative warns when booking testing appointments.
Curative has seven testing locations in the Houston area:
- Kroger Bissonnet
- Houston Community College South
- Houston Community College Northeast
- Kroger Voss
- Memorial Park Conservancy
- Minute Maid Park Lot B/C
- Kroger Telephone Rd.
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The company has administered more than 11 million tests nationwide, including other major cities like Los Angeles, San Francisco, Chicago and Atlanta.
The Houston Health Department issued the following statement:
"The Houston Health Department is aware of the FDA advisory regarding Curative SARS-Cov-2 tests. The advisory offers guidance and does not recommend the discontinuation of the tests. All tests are susceptible to false results. That's a reason why the health department encourages people to not rely on one negative test and get tested multiple times, especially after participating in high risk activities. The health department helps Curative identify vulnerable areas of the city to locate the company's testing sites and promotes the sites on its website. Curative tests are not used at any health department operated testing sites."
Curative issued the following statement regarding the FDA's warning:
"As you may be aware, FDA issued a Safety Communication on January 4, 2021, about the Curative SARS-CoV-2 Assay and the potential risk of false negative results for our test, consistent with our FDA authorized labeling. 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. As part of our communication with FDA, Curative recently submitted data from a clinical study that evaluated more than 1,300 subjects and multiple different sample types and comparisons. Due to FDA questions about the study design for these additional data, FDA's Safety Communication reminds Healthcare Providers of the existing precautions and limitations that remain in place at this time. 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. FDA also communicates that a negative result does not exclude the possibility of COVID-19 and that potential inaccuracies, such as increased false negatives can occur in people tested more than 14 days post infection/symptoms and in people who are not observed and directed by a healthcare worker. 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."