![]() ![]() While there is important information to gather from these studies, it should be noted these studies have limitations, including small sample size, potential design biases, or tests that may not have been executed according to the manufacturer’s instructions for use, an important part of scientific research. The agency is aware of some scientific studies that have identified accuracy issues with Abbott ID NOW and is investigating whether it could be due to the types of swabs used or the type of viral transport media (material used to transport the patient’s specimen). No diagnostic test will be 100% accurate due to performance characteristics, specimen handling, or user error, which is why it is important to study patterns and identify the cause of suspected false results so any significant issues can be addressed quickly. The FDA looks at a variety of sources to identify and understand potential patterns or significant issues with the use of the Abbott test. The agency has been working with Abbott to analyze the information gathered to date and has worked with the company on a customer notification letter to alert users that any negative test results that are not consistent with a patient’s clinical signs and symptoms or necessary for patient management should be confirmed with another test. The FDA is sharing early information available about potential inaccurate results in the spirit of transparency. Negative results may need to be confirmed with a high-sensitivity authorized molecular test,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. This test can still be used and can correctly identify many positive cases in minutes. We will continue to study the data available and are working with the company to create additional mechanisms for studying the test. “We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue. Specifically, the test may return false negative results. Food and Drug Administration is alerting the public to early data that suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19. 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.Today, 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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