

It rose to prominence by promising “fast, simple, painless” spit tests that are self-administered.īut last week, the FDA warned that Curative’s tests run “the risk of false results, particularly false negative results.” It cautioned that its tests should only be administered to people with COVID-19 symptoms and under the supervision of healthcare workers.ĭo you have information to share about Curative's COVID-19 testing? You can reach this reporter at or. The Southern California company claims to have processed more than 13 million tests, or 10% of all tests nationwide.

"We have been working with the agency to address their concerns and these limitations and we will continue to work interactively with FDA," the company said.In less than a year, the startup Curative has gone from barely existing to being one of the biggest coronavirus testing providers in the United States. In that alert, the FDA also "reiterated the need to use Curative’s kit strictly in accordance with its label instructions and test people within 14 days of symptoms onset. The test performance and labeling, however, have not changed, nor has the company observed any changes in test performance," the company said. In a statement to The Times-Union, Curative said its test is "being offered during the pandemic under an Emergency Use Authorization approved by the United States Department Health and Human Services, Food and Drug Administration and is labeled with specific warnings, precautions and limitations that FDA reiterated in the Safety Communication." "A negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions," according to the alert. The FDA recommended that collection of nasal swabs and oral fluid specimens be "limited to symptomatic individuals within 14 days of COVID-19 symptom onset … and be directly observed and directed … by a trained health care worker at the specimen collection site." "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 alert. 4 the FDA issued an alert about what it called the "risk of false results, particularly false-negative results, with the Curative test." Because the test is conducted by the patient, there is a greater chance of it not being done properly, the alert said. More: Vaccine scarcity means prepare to wait months for your turn More: Jacksonville's Black leaders want more COVID-19 vaccination, education in minority communities Havana Jax offered its parking lot as a pop-up test site to "ensure that everyone has an opportunity to get tested, regardless of immigration status or insurance," said owner Silvia Pulido. "The entire Curative test is done without having to come into close contact with others, therefore eliminating the need for personal protective equipment changes," according to Curative. Results will be available 24 to 48 hours after the tests are received by the company's labs, at no cost to patients. The virus is then caught in the saliva, the patient then swabs the inside of their cheeks and the roofs of their mouths," according to Curative. The patient then seals their test in a secure container and returns it to one of the van's medical professionals. That "releases virus from the upper and lower respiratory tract. Oral-fluid swab testing, an alternative to nasopharyngeal or brain swabs, requires the recipient to cough. Department of Food and Drug Administration. The van will offer a "self-collected oral fluid swab," a form of COVID-19 test that is the subject of a recent alert from the U.S. "Curative’s goal is to make testing more accessible."Īppointments are encouraged, but walk-ups are welcome.

"Curative is proud to be … a crucial resource for the Southside community area during this pandemic," said Fred Turner, CEO and co-founder of Curative. Monday through Saturday through April 30.
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The Curative van will be at the Havana Jax parking lot at 2578 Atlantic Blvd. 9 a.m.
CURATIVE COVID TEST DEL RIO FREE
Beginning Wednesday a California-based COVID-19 testing startup will deploy a new mobile van in Jacksonville with up to 300 free tests available six days a week.
