This website is governed by applicable U.S. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. FDA Letter "Revisions Related to Serial (Repeat) Testing for the EUAs of Antigen IVDs." November 1, 2022.***Refer to the product package insert for full instructions, clinical data and information on serial testing. Sites performing only waived tests must obtain a Certificate of Waiver by applying for this certification for each location performing testing. ** Before testing patients, federal regulations require testing sites to have a CLIA certificate issued by CMS. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. It has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. It has been authorized by the FDA under an emergency use authorization. *The BinaxNOW COVID-19 Ag Card has not been FDA cleared or approved. Healthcare Provider COVID-19 Fact Sheet.The supplemental data indicates that antigen tests have demonstrated PPA as high as 100% for symptomatic patients (3 serial tests, 2 days after first PCR positive) and as high as 88.9% for asymptomatic patients (3 serial tests, 6 days after first PCR positive). The data shows that repeat COVID-19 antigen testing after a negative test result can increase the chances of detecting COVID-19 in people with and without symptoms. PPA data has been supplemented with the results of a study conducted by the National Institutes of Health (NIH) that pooled the results of several manufacturers’ tests when patients were serially tested. Positive Percent Agreement (PPA): 84.6%.
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