Update: Jan. 12, 8:50 a.m.
In a statement to The University Star, Chief Medical Officer Emilio Carranco responded to the FDA's recent warning against false negative COVID-19 results from Curutive Inc.
"We are aware of the warning issued by the FDA on January 4th concerning the Korvalabs SARS-CoV-2 test used by Curative. We have contacted Curative and they are working with the FDA to address their concern," Carranco said.
Carranco says the FDA's warning does not merely state that Korovalab's test, the testing lab Curative works with, is not accurate but if the test is not used as authorized, there is an increased risk of false negatives.
Carranco says the university is monitoring the situation and is awaiting the outcome of Curative's efforts to respond to the FDA's concerns.
"While Curative is working to provide the FDA with the additional testing data they need, Texas State will continue to use Curative testing on our campuses," Carranco said.
The test, which is under the FDA's Emergency Use Authorization, is required to include a test fact sheet stating that a negative result "does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions."
"If a healthcare provider had a patient with symptoms of COVID-19 and strongly suspected the infection, the provider should treat the patient as if they might have COVID-19 even if the test is negative. The provider can re-test using a different COVID-19 test if warranted," Carranco said.
The U.S. Food and Drug Administration (FDA) issued a warning this week regarding false negative COVID-19 test results from Curative Inc., the testing company Texas State partnered with to administer on-campus COVID-19 testing to students and staff.
The on-campus kiosk has provided students quick test results through oral swab, allowing them to receive their results in less than 48 hours. The FDA monitors the post authorization use of the tests, including any reports of problems with test performance or results.
"When the test is not performed in accordance with its authorization or as described in the authorized labeling, there is a greater risk that the results of the test may not be accurate," the FDA said in a public statement.
According to the FDA, the risks of a false negative result includes a delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts or other unintended events.
The university has heavily relied on its on-campus Curative site located on the Quad to monitor its COVID-19 cases, as well as cases confirmed by the Student Health Center and community reports to Bobcat Trace.
Texas State also plans to add an additional Curative testing site in the parking lot of the Student Health Center during the upcoming spring semester, according to Health Center Director Emilio Carranco, who referenced the PCR (nasal swab) test as "the gold standard."
The FDA recommends patients to speak with a health care provider if they took a Curative COVID-19 test and suspect their results are inaccurate.
The University Star will continue to update this development as more information becomes available.