NOLA Public Schools suspended mobile testing programs Friday after learning state provided tests could result in false negatives, the district said in a press release.
“The COVID-19 test kit, provided through the [Louisiana Department of Health’s] partnership with Curative, Inc., is under review following a recent safety communication from the FDA about the potential for it to produce false negative results,” the district said.
The district said they were contacted by the state on Thursday regarding the review and immediately suspended its use. Test kits from Curative, Inc. will remain out of use until the Louisiana Department of Health completes its review.
“NOLA-PS was informed Thursday, Jan. 21, that the Louisiana Department of Health (LDH) is reviewing the effectiveness of a COVID-19 test that has been used in the initial rollout at NOLA-PS’s mobile testing units. Out of an abundance of caution, NOLA-PS immediately suspended the use of this test until the LDH can complete its review,” the release said.
On January 4, the U.S. Food and Drug Administration published a safety advisory alerting health care providers of “the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test.”
“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,” according to the FDA.
The FDA guidance does not ask providers to stop using the tests, but instructs them to confirm negative results in asymptomatic patients using a different PCR test.
Curative, Inc. is a Southern California based startup that claims to have processed more than 13 million tests nationally. Following the FDA’s advisory, many clients, which include states, countries and school districts are exploring alternatives or breaking ties with the company.
According to the FDA’s advisory, Curative tests should only be administered to people with COVID-19 symptoms while under the supervision of healthcare workers.The district had planned to administer these tests as part of its asymptomatic testing strategy, an approach common among Curative clients.
The district began offering regular testing to staff and students earlier this month through a partnership with LDH and grant funding. Three vans were set to circulate between 45 schools, providing individuals with testing every other week.
Previously, district-supported testing was only available when a student or staff presented symptoms or was identified as having close contact with a positive case.
Testing for asymptomatic and symptomatic individuals continues to be available through the City of New Orleans.
