The US Food and Drug Administration is warning the public that Curative COVID-19 tests can provide false negative results.
According to the agency, a patient who receives a false negative COVID-19 test result may not get the supportive treatment they need.
Without monitoring infected individuals, their households, and their close contacts, there is also a heightened risk that the virus will spread further through the community.
“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 said.
The Curative COVID-19 tests are only for use by symptomatic individuals, according to the agency, and must be used within 14 days of symptom onset. The collection of specimens must be “directly observed and directed” by a trained healthcare worker.
Curative COVID-19 testing kiosks allow people to collect their own oral fluids using a swab. The swabs are then tested for COVID-19, and results are delivered electronically to the patient within 48 hours.
“A negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions,” the FDA said.
A representative from Curative reached out to Daily Hive, releasing the following statement on January 18:
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. The Curative test must be observed and directed by a healthcare worker and self-collected by the patient. To view the process, please see the sample collection video here. Please see the EUA statement here for our COVID-19 test and the patient factsheet here. As noted in the EUA, the Curative test is 100% clinically sensitive and 100% specific relative to the CDC assay.
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.