Curative testing sites are available at many locations in the Texas, including the Houston, Austin and Dallas areas. The tests are self-administered, according to the Curative website.
The FDA statement said the way the test is administered can be key to the test’s accuracy.
“To reduce the risk of false negative results, it is important to perform the test in accordance with its authorization and as described in the authorized labeling,” according to the FDA release. “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.”
In a statement, Curative said its test has been validated and is being offered under emergency use authorization. The company said the tests are labeled with the warnings, precautions and limitations reiterated by the FDA in its safety communication.
“The test performance and labeling ... have not changed, nor has the company observed any changes in test performance,” according to the statement. “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.”
Instructions on the Curative website show the test is collected by the patient by means of a mouth swab.
Curative said in a statement that Dr. Brian P. Monahan, the U.S. Congress’s attending physician, has noted that the issues cited by the FDA are not unique to the test Curative is using.
The FDA statement said the risk of false results includes delayed or lack of supportive treatment; a lack of monitoring for symptoms among those infected, their households and their contacts; and an increased risk of spread.
The FDA recommends that patients talk to their health care providers if they have concerns about their test results and that problems, such as suspected inaccurate results, be reported to the FDA.
