
If testing was performed more than two weeks ago, and there is no reason to suspect current SARS-Cov-2 infection, it is not necessary to retest. Health care providers: Consider retesting your patients using a different test if you suspect an inaccurate result was given recently by the Curative SARS-Cov-2 test.A negative result does not exclude the possibility of COVID-19. A negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions.Specimen collection must be directly observed and directed during the sample collection process by a trained health care worker at the specimen collection site.Collection of nasal swabs and oral fluid specimens is limited to symptomatic individuals within 14 days of COVID-19 symptom onset.Be aware of the important information regarding the use of the Curative SARS-Cov-2 test, which is described in the test’s authorized labeling, including the following:.Important Recommendations for Health Care Providers, Patients, and Caregivers 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. To reduce the risk of false negative results, it is important to perform the test in accordance with its authorization and as described in the authorized labeling, e.g., the Fact Sheet for Healthcare Providers. 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. Food and Drug Administration (FDA) is alerting patients and health care providers of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. The test that is the subject of this safety communication is no longer being offered and is no longer authorized for emergency use by the FDA. Curative-Korva SARS-Cov-2 Assay) Emergency Use Authorization was revoked at the company’s request effective July 15, 2021, because the company is now using different EUA-authorized tests for the testing offered at its laboratories. Please visit these companies' websites to learn more about their efforts to provide timely and accessible COVID-19 testing or to schedule an appointment.The Curative, Inc., Curative SARS-Cov-2 Assay (originally authorized as the Korvalabs, Inc. Expand testing to communities across the United States, especially those that are under-tested and socially vulnerable.Protect healthcare personnel by eliminating direct-contact with symptomatic individuals.Provide Americans with faster, less invasive and more convenient testing.


These companies are coordinating with state and local governments to: HHS has partnered with pharmacies and retail companies to accelerate testing for more Americans in communities across the country. Please call the health center to ask about the availability of low- or no-cost testing. If there are costs to the patient, health centers may provide sliding fee discounts based on income and family size.įind a health center near you.

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Health centers provide free or low-cost COVID-19 tests to people who meet criteria for testing. Contact your health care provider or your state or local public health department for more information. Low- or no-cost COVID-19 tests are available to everyone in the U.S., including people who are uninsured, at health centers and select pharmacies.
