FDA warns about ‘false negatives’ with Curative COVID-19 tests

Coronavirus New Mexico

ALBUQUERQUE, N.M. (KRQE) –  The Food and Drug Administration is warning about the risk of ‘false negatives’ on the oral swab COVID-19 tests from the company, Curative. There are 17 testing sites in New Mexico that use the Curative’s testing.

“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 news release. New Mexico health officials said they are confident the tests work when used properly but are still working to get data from the FDA to look into the warning.

“Without knowing whether that difference in what we call sensitivity or the chances that the test will be positive in someone with COVID, without having any idea at all, you know if it goes from 95% down to 20%, well that’s a huge issue. If it goes from 95 to 88 well, that’s still better than almost everything else we’ve got,” said Dr. David Scrase, New Mexico’s Human Services Secretary. “Then we’ve got to think about if we can test 40% more people with a mouth swab, then maybe the benefit of testing more people and identifying more cases is going to outweigh what is potentially a very small decrease in the effectiveness of the test.”

The FDA warns of false negatives with the company’s test but does not give numbers or say how often false negatives may occur. It hasn’t been easy for the state to get detailed data.

“We have not seen the data ourselves, we’ve asked for it. Folks from DOH are having phone calls with Curative and the FDA to get data. The FDA is not forthcoming,” said Dr. Scrase. The Curative test is a PCR test which is considered the ‘gold standard’ of COVID-19 tests.

“The test itself that Curative does is a PCR which is the most accurate test you can get. There’s absolutely no controversy about their machines, with PCR technology itself, that’s not what this is about,” said Dr. Scrase. He explained the question really is whether saliva in asymptomatic people will provide completely accurate results.

Los Angeles County decided to stop using the company’s testing after the FDA warning. Dr. Scrase said there is no plan right now for New Mexico to follow suit.

“The lack of evidence sometimes at least in this pandemic is evidence as well. And so, we’re, we’ve had hours of discussion, we’ve weighed the pros and cons, I was at a number of meetings about it last week, our decision is to stay the course until we get good data,” Dr. Scrase said.

In response to the FDA warning, a spokesperson with Curative sent the following statement to KRQE News 13:

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

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.

As always, the FDA said Curative’s tests are most accurate when taken by a person showing symptoms and within 14 days of getting those symptoms. Dr. Scrase added that all COVID-19 tests are more accurate the more symptomatic a person is. He encourages anyone with COVID-19 symptoms to get tested, stay home, and inform any recent contacts of symptoms.

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