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 Curative-Korva SARS-Cov-2 Assay) Emergency Use Authorization was revoked at the company’s request effective July 15, 2021, because the company is now using different EUA-authorized tests for the testing offered at its laboratories. You may also contact the FDA at 1-80.The Curative, Inc., Curative SARS-Cov-2 Assay (originally authorized as the Korvalabs, Inc. DO NOT USE any Flowflex tests that have one or more of these issues, as results may be erroneous (false positive or false negative). The authentic Flowflex tests have a 2D-datamatrix without those three boxes. The counterfeit tests may have a QR code containing square shapes within a square box on 3 corners of the code, as shown below. The counterfeit pouches inside the box that contain the test cassette have Lot # COV2015122 and are labeled as “SARS-COV-2 ANTIGEN RAPID TEST (SELF-TESTING),” whereas the authentic Flowflex test cassette pouches are labeled “COVID-19 ANTIGEN HOME TEST.” The plastic test cassette may have a 2D barcode which differs from the one printed on authentic Flowflex tests. The counterfeit tests are missing the Spanish language instructions for use. ACON Laboratories, the manufacturer of Flowflex tests, states that counterfeit white retail boxes are missing the Lot Number / Expiration Date /2-D datamatrix label. We have been notified of counterfeit Flowflex Covid-19 Antigen Home Tests being imported and distributed in the US.
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