This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.ĭata Availability: De-identified patient level data cannot be shared publicly because of legal restrictions. Received: AugAccepted: NovemPublished: December 2, 2021Ĭopyright: © 2021 Pollreis et al. PLoS ONE 16(12):Įditor: Shinya Tsuzuki, National Center for Global Health and Medicine, JAPAN (2021) Evaluation of the Abbott BinaxNOW COVID-19 Test Ag Card for rapid detection of SARS-CoV-2 infection by a local public health district with a rural population. Rapid antigen tests, such as the BinaxNOW™ COVID-19 Test Ag Card, may be a more convenient tool in quickly identifying and preventing COVID-19 transmission, especially in rural settings.Ĭitation: Pollreis RE, Roscoe C, Phinney RJ, Malesha SS, Burns MC, Ceniseros A, et al. Although the sensitivity of BinaxNOW™ COVID-19 Test Ag Card was lower than RT-PCR, rapid results and high specificity support its use for early detection of COVID-19, especially in settings where SARS-CoV-2 RT-PCR testing is not readily available. The positive predictive value (PPV) for the BinaxNOW™ COVID-19 Test Ag Card was 100.0% (95% CI: 86.2–100.0%), and the negative predictive value (NPV) was 93.6% (95% CI: 89.1–96.6%). Results between the two tests were 94.4% concordant. Thirty-seven participants (17.3%) had positive RT-PCR results. The median age of participants was 35 and 82.7% were symptomatic. In this validation study, we compared the BinaxNOW™ COVID-19 Test Ag Card with SARS-CoV-2 RT-PCR in 214 participants who sought COVID-19 testing from a local public health district in Idaho, USA. For i-STAT test cartridge information and intended use, refer to individual product pages or the cartridge information (CTI/IFU) in the i-STAT Support area.Ībbott - A Leader in Rapid Point-of-Care Diagnostics.SARS-CoV-2 RT-PCR, the gold standard for diagnostic testing, may not be readily available or logistically applicable for routine COVID-19 testing in many rural communities in the United States. Check with your local representative for availability in specific markets. Not all products are available in all regions. GDPR Statement | Declaration for California Compliance Law. Any person depicted in such photographs is a model. Photos displayed are for illustrative purposes only. Your use of this website and the information contained herein is subject to our Website Terms and Conditions and Privacy Policy. The products and information contained herewith may not be accessible in all countries, and Abbott takes no responsibility for such information which may not comply with local country legal process, regulation, registration and usage. 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. †Abbott conducted a computational analysis of the detection of multiple SARS-COV-2 Strains, including the DELTA and OMICRON variants, and predicts no impact to the performance of our BinaxNOW™ COVID-19 Antigen Self Test.ġ. § 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 SARSCoV-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 Antigen Self Test has not been FDA cleared or approved.
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