The NOLA Public Schools district is suspending its new mobile COVID-19 testing program as the Louisiana Department of Health reviews the “effectiveness” of the test it was using, the district announced in a press release Friday.
Earlier this month, the U.S. Food and Drug Administration issued a warning about COVID-19 tests provided by Curative, Inc. — provided to the mobile sites through a partnership with the Louisiana Department of Health — saying there was a risk of false negatives with the tests.
“The COVID-19 test kit, provided through the LDH’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,” a district release stated Friday.
The FDA issued its communication about Curative’s PCR tests on Jan. 4. District leaders first announced the program to board members at a board training session on Jan. 7. Three days later, public health officials in Los Angeles — who were partnering with the same company — announced they would stop using its tests. On Thursday, the Aspen School District announced it would stop using the Curative tests, too.
The FDA guidance didn’t recommend that providers stop using the tests entirely, but that negative results in asymptomatic patients be confirmed via a different PCR test, much like the Centers for Disease Control and Prevention recommends with rapid antigen (non-PCR) tests.
District officials said they were informed of the LDH review of Curative tests on Thursday, the same day district officials announced that a suspension of in-person classes, first announced early this month, would continue through next week. Reliable COVID-19 testing and access to it are one of the three main components of the district’s reopening evaluation. New daily case counts and average percent positivity are the other two.
“Out of an abundance of caution, NOLA-PS immediately suspended the use of this test until the LDH can complete its review,” the district release stated.
At a press conference Thursday, the district didn’t mention anything about the suspension of testing. Asked who was providing testing, the district’s Chief Operations Officer Tiffany Delcour said they were partnering with LDH and other groups but did not provide specifics on the test vendor.
The program provided NOLA-PS with access to three mobile units for on-site, asymptomatic tests for any students, faculty, and families who wanted them. The mobile sites would rotate through schools “on a recurring basis.”
The Curative test uses a self-administered oral swab. Like most COVID tests, it has yet to receive full FDA approval, and is being performed under an emergency use authorization.
That authorization was based on the test’s effectiveness in symptomatic COVID patients. Using it for asymptomatic testing is analogous to using a drug “off-label.” That’s extremely common during the pandemic, as many tests, including the widely used Binax NOW and ID NOW rapid tests, were approved with similar limitations and are well-known to produce more false negatives in asymptomatic people.
PCR tests, like that of Curative, are often referred to as the “gold standard” for COVID diagnosis, because they are more accurate in asymptomatic cases. In essence, PCR tests are more precise at the expense of speed, a benefit that would be lost if negative Curative tests required a second, confirmatory PCR result.
Most PCR tests involve a nasal swab, rather than saliva or an oral swab. According to a report from Buzzfeed, the accuracy of Curative’s test is highly dependent on whether or not someone is closely supervised while providing a sample.
LDH did not immediately respond to questions about the scope or timeline of its review.
According to the Los Angeles Times, Curative was “founded by a 25-year-old British businessman, has administered more than 11 million tests nationwide” as of Jan. 10. It was founded in January 2020.
Another testing provider in New Orleans, Community Organized Relief Effort (CORE), also partners with Curative, Inc. It was not clear whether CORE was involved in the NOLA-PS partnership.
CORE focuses on under-tested neighborhoods and communities, and regularly operates walk-up test sites in New Orleans East and Metairie. It also has provided mobile testing to screen workplaces after a COVID exposure. CORE’s sites are listed on the NOLA Ready Testing calendar. CORE has worked closely with the city health department to provide testing in high-risk environments.
“We have been in contact with CORE and LDH since the FDA concerns were released,” LaTonya Norton, spokesperson for New Orleans Mayor LaToya Cantrell, wrote in an email to The Lens. “LDH has not yet limited or banned the use of these tests in Louisiana, and is working with Curative to better understand the issues. Locally, CORE has been very forthcoming about their strict adherence to proper test procedures, and have been a reliable testing partner since May 2020. We will await definitive guidance from LDH on further use of Curative tests in the future.”
Calls to local CORE leadership and a national CORE spokesperson were not immediately returned.
School district officials said they notified schools that had used the testing program, which began last week. The district did not respond to questions asking which schools had hosted testing and how many tests had been administered.