FDA warns of false negatives with test used in Houston
The U.S. Food and Drug Administration this week warned that a type of COVID-19 test used at Minute Maid Park and other sites in Houston could lead to false negative results when used on asymptomatic people.
The FDA alerted providers that Curative tests should be used only for people who are experiencing symptoms within 14 days of the test, as prescribed in the government’s authorization for the test’s emergency use.
“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,” the FDA wrote in its alert. “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 Texas Department of Emergency Management has not required symptoms for tests at Minute Maid Park. Seth Christensen, an agency spokesman, said it is aware of the guidance and will continue to monitor findings, though he did not say whether itwould begin requiring symptoms at the site.
“Our continued goal is to ensure that Texans have access to a wide variety of COVID-19 testing options across our state,” Christensen said.
Curative tests are used in at least six other sites in the Houston area, including at Memorial Park Conservancy and several Kroger stores.
Curative was alerting some customers Friday that they are not eligible for the test, depending on a questionnaire about symptoms and possible exposures.
Curative told providers it has not observed any changes in test performance and has been working with the FDA to address its concerns.
“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,” wrote Amy Vanden Berg,
an executive with the company.
“Due to FDA questions about the study design for this additional data, FDA’s Safety Communication remindsHealthcareProviders of the existing precautions and limitations that remain in place at this time.”
Curative said the government’s safety guidance stressed parameters that already were in place.
“We are confident in our data, and we are working with the FDA closely on the matter,” Curative CEO and co-founder Fred Turner said. “Testing sensitivity and accuracy on behalf of our patients is at the heart of our work.”
Health officials with Houston and Harris County said they are aware of the problem, but neither uses the tests at their own sites. The city health department said there is a chance of false results with all tests, and it encourages people to get tested multiple times.
“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,” said Scott Packard, the health department’s communications director. “Curative tests are not used at any health department-operated testing sites.”
In Los Angeles, where the city uses Curative tests at its sites, officials defended the company. Mayor Eric Garcetti told reporters Thursday that the company helped catch 92,000 cases in asymptomatic people, about a third of the positive results.
“This is something that has saved lives, will continue to save lives,” Garcetti said, the Los Angeles Times reported. “If we move away fromit, I fearwewouldhave a lot fewer people diagnosed, and even more spread.”
Congress uses Curative tests, as well. Dr. BrianMonahan, the Capitol physician, said in a memo about the safety guidance that Curative is “the most accurate available” and that the chance of false negatives “is a problem for all coronavirus tests,” Politico reported.