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. 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. The test performance and labeling, however, have not changed, nor has the company observed any changes in test performance. 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. "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 tests are not used at any health department operated testing sites."Ĭurative issued the following statement regarding the FDA's warning: 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. 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. All tests are susceptible to false results. The advisory offers guidance and does not recommend the discontinuation of the tests. "The Houston Health Department is aware of the FDA advisory regarding Curative SARS-Cov-2 tests. The Houston Health Department issued the following statement: The company has administered more than 11 million tests nationwide, including other major cities like Los Angeles, San Francisco, Chicago and Atlanta. "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. 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. "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. HOUSTON, Texas - The Food and Drug Administration is issuing a warning about Curative coronavirus tests, stating the tests carry the risk of false negative results when used on people who are asymptomatic.Ĭurative has seven COVID-19 testing sites in the Houston area, including the popular drive-thru site at Minute Maid Park.
Hit play on the video for a breakdown of coronavirus testing, from the nasal swab to the antibody test. You want to get tested for COVID-19, but there's confusion over the types of tests and what they can actually detect.
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