Abbott’s Fast, $ 5, 15 Minute, Easy-to-Use COVID-19 Antigen Test Receives Emergency Use Clearance From FDA; The mobile app displays test results to help our return to everyday life; Increased production to 50 million tests per month

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Abbott will also launch a complementary mobile application for iPhone and Android devices called NAVICA ™. This one-of-a-kind app, available for free, will allow people who test negative to display a temporary, renewed digital health pass each time a person is tested through their health care provider with the date of test result. Organizations will be able to view and verify information on a mobile device to facilitate entry into facilities, as well as hand washing, social distancing, enhanced cleaning, and wearing masks.

“We intentionally designed the BinaxNOW test and the NAVICA app to provide a comprehensive testing solution to help Americans feel more confident about their health and their lives,” said Robert B. Ford, President and CEO, Abbott. “BinaxNOW and the NAVICA app provide us with an affordable, easy-to-use and scalable test, as well as a complementary digital health tool to help us achieve a little more normalcy in our daily lives. “In data submitted to the FDA from a clinical study conducted by Abbott with several major US research universities, the BinaxNOW COVID-19 Agricultural card demonstrated a sensitivity of 97.1% (percent agreement positive) and specificity of 98.5% (percent agreement negative) in patients suspected of COVID-19 by their healthcare provider within the first seven days following onset of symptoms.

“The large scale of this test and this application will allow tens of millions of people to have access to rapid and reliable tests,” said Joseph Petrosino, Ph.D., Professor and President, Molecular Virology and Microbiology, Baylor College of Medicine, whose labs have led efforts to provide COVID-19 testing for the college and Harris County. “With the lab tests you get great sensitivity, but you may have to wait days or more for the results. With a rapid antigen test, you get a result immediately, allowing infected people to get off the streets and quarantine them so they don’t. t spread the virus. ”

Under FDA EUA, BinaxNOW COVID-19 Agricultural card is intended for healthcare professionals and may be used in healthcare facilities qualified to have testing performed and operating under a Certificate of Waiver, Certificate of Compliance, or Clinical Laboratory Improvement Amendments (CLIA) Certificate of Accreditation. In these contexts, the test may be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, occupational health specialists from employers, etc. with minimal training and patient prescription.

“Frontline healthcare workers and clinical laboratory staff across our country have been under siege since the start of this pandemic,” said Charles Chiu, MD, Ph.D., professor of laboratory medicine at University of California, San Francisco. “The availability of rapid tests for COVID-19 will help support overworked labs, speed turnaround times and dramatically expand access to people who need them. ”

Currently, AdvaMed (The Advanced Medical Technology Association) estimates that test manufacturers ship approximately 1 million tests per day. Abbott will ship tens of millions of tests in September, rising to 50 million tests per month in early October. The company has invested hundreds of millions of dollars since April in two new U.S. facilities to manufacture BinaxNOW on a large scale.

Le BinaxNOW COVID-19 Agricultural card can be used as a first line of defense to identify people who are currently infected and who should self-isolate to prevent the spread of the disease. It is intended for the qualitative detection of SARS-CoV-2 core protein antigen in nasal swabs of individuals suspected of COVID-19 by their health care provider within the first seven days of symptom onset. .

As a rapid close-to-person antigen test, BinaxNOW was designed for the point of care, close to the patient, not for reference laboratories. Patient samples should be tested immediately and should not be diluted in virus transport medium.

The NAVICA mobile application will facilitate the return to daily activities
Abbott also offers a toll-free mobile app that will allow people to view their results obtained through a health care provider when entering facilities requiring proof of testing. The NAVICA app is optional and an easy-to-use tool that allows people to store, access and display their results with organizations that accept the results so people can move around with more confidence. The app is supported by both Apple and Android digital wallets and will be available in public app stores in the United States.

“While BinaxNOW is the hardware that lets you know your COVID-19 status, the NAVICA app is the digital network that allows people to share that information with those who need to know,” said Ford. “We take our expertise from our digitally connected medical devices and apply it to our diagnostics at a time when people expect their health information to be digital and easily accessible. ”

If the test results are negative, the app will display a digital health card via a QR code, similar to an airline boarding pass. If the test results are positive, people receive a quarantine message and talk to their doctor. As they are required to do for all COVID-19 tests, healthcare providers in all settings will be required to report positive results to the CDC and other public health authorities, whether or not they use it. application. The digital health pass is stored temporarily in the app and expires after the period specified by organizations that accept the app.

The user interface of the application is supported by a cloud-based, scalable and secure back-end digital infrastructure. It was designed to support a very large number of users and allow access from anywhere. The app is not for contact tracing and only collects first and last name, email address, phone number, zip code, date of birth and test results from a no one.

About BinaxNOW COVID-19 Farm card test
Le BinaxNOW COVID-19 Agricultural card is a test for the qualitative detection of specific COVID-19 antigens in the human nasal cavity. A simple nasal swab is used to take samples from people suspected of having an active infection. No equipment is required to process samples or read test results. Additionally, minimal chemical reagents are required, which reduces exposure to biohazardous materials and improves safety for those administering the test.

Le BinaxNOW COVID-19 Agricultural card is the sixth test Abbott is launching in the United States to help fight the coronavirus pandemic. Abbott’s tests are performed on its high volume m2000 ™ and Alinity® m Molecular Laboratory Systems; its ID NOW ™ rapid point-of-service molecular platform; antibody tests for its ARCHITECT® i1000SR and i2000SR and Alinity ™ i high-throughput laboratory instruments.

Abbott has provided more than 27 million COVID-19 tests to the United States to date, including 14 million detection tests and 13 million antibody tests.

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the entire healthcare spectrum, with leading companies and products in diagnostics, medical devices, nutrition and branded generics. Our 107,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The BinaxNOW ™ COVID-19 Ag Test Card UEA has not been approved or approved by the FDA. It has been cleared by the FDA under Emergency Use Clearance for use by licensed laboratories and patient care facilities. The test has only been authorized for the detection of SARS-CoV-2 proteins, not for other viruses or pathogens, and is only authorized for the duration of the declaration of the existence of circumstances justifying the test. ‘authorization of the emergency use of in vitro diagnostic tests for the detection and / or diagnosis of COVID-19 under section 564 (b) (1) of the statute, 21 USC § 360bbb-3 (b) (1), unless the authorization is terminated or revoked earlier.

SOURCE Abbott

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