Curative Covid-19 Tests May Return False Negative Warns FDA
The FDA has stated that the Covid tests administered by Curative may return false negatives if performance is not “in accordance with its authorization or as described in the authorized labeling.”
According to the Curative website tests are administered via mouth swab however they are authorized for use on “respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider”.
The FDA has stated that there is a risk with tests registering as false-negatives. Those who are asymptomatic may not register a positive result with the test, resulting in a delay in needed medical attention. The FDA states once testing providers adhere to the guidelines outlined in the authorization material less false negatives will surface.
Providers and patients who feel that their results are inaccurate should pursue testing via another method for extra assurance.
The FDA also stated:
“A negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19,” the FDA says on its website.
These Curative tests range nationwide and are used largely in the Greater Los Angeles area and the city of San Antonio. Dr. Colleen Bridger who is leading the charge in San Antonio stated the city is only using the Curative tests for recipients who are symptomatic. The larger area of concern seems to be stemming from the City of Los Angeles.