![]() ![]() Other antigen tests have reported specificities of 100% based on testing tens of specimens, but real-world performance has not supported these estimates ( 15, – 17).Īccurately understanding the trade-off of sensitivity and speed is critical to achieving the right balance of diagnostics used in different settings. Food and Drug Administration (FDA) authorization for the BinaxNOW COVID-19 Ag card. Only six samples with a cycle threshold ( C T) value of >33 were tested as part of the submission for U.S. government for the Abbott BinaxNOW COVID-19 Ag card based on data from just over 100 specimens in the emergency-use authorization (EUA) application ( 12, – 14). However, the demand for antigen testing has outstripped the associated data on its performance, most notably with the $750 million outlay by the U.S. Since the beginning of the pandemic, many have looked to antigen (Ag) tests to provide rapid, inexpensive, and decentralized testing that might potentially reduce transmission with the thought that antigen tests could successfully detect infectious cases ( 10, 11). However, assay sensitivity is critical for detecting additional cases where low viral loads in the nares are present during active lower respiratory tract infection ( 9).ĭespite the current provision of more than 1 million SARS-CoV-2 tests per day in the United States, molecular testing may not be able to scale much further. A double-edged sword of the sensitivity offered by real-time reverse transcription-quantitative PCR (qRT-PCR) is the possibility that the molecular methodology detects RNA copies of virus that may not necessarily correlate with an active infection, especially if the result is a low viral load ( 6, – 8). These analytical sensitivities result in the detection of low-level shedding in patients for weeks to months after initial infection, often with very low viral loads ( 2, – 5). Testing for SARS-CoV-2 has predominantly been performed on molecular platforms with exquisite analytical sensitivities that can detect fewer than 100 viral RNA copies per ml of viral transport medium (VTM) ( 1). Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread in the United States and across the world, causing tens of millions of cases and more than 1 million deaths. ![]() These data indicate that the BinaxNOW COVID-19 Ag card has an analytical sensitivity approximately equivalent to a generic qRT-PCR cycle threshold ( C T) value of 29 to 30. One hundred percent of samples with viral loads of >40,000 copies/swab were detected by rapid antigen testing. We further confirmed this limit of detection with 72 additional clinical samples positive for SARS-CoV-2 in either phosphate-buffered saline or viral transport medium. Initial and confirmatory limits of detection for the BinaxNOW COVID-19 Ag card were determined to be equivalent to 4.04 × 10 4 to 8.06 × 10 4 copies/swab. Here, we evaluated the analytical sensitivity of the Abbott BinaxNOW COVID-19 Ag card using SARS-CoV-2-positive clinical specimens quantified by reverse transcription-droplet digital PCR (RT-ddPCR) and multiple FDA EUA qRT-PCR platforms using RNA standards. Robust analytical sensitivity data in comparison to reverse transcription-quantitative PCR (qRT-PCR) are currently lacking for many rapid antigen tests. Although less sensitive than molecular detection methods, rapid antigen testing offers the potential for inexpensive, quick, decentralized testing. 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.Multiple rapid antigen (Ag) tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have recently received emergency-use authorization (EUA) from the U.S. 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. ![]()
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