31st August 2020 Product update: rapidmicrobiology staff writer
Abbott's Affordable BinaxNOW™ COVID-19 Antigen Test Receives FDA Authorization
Abbott has announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5.
It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider.
With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others.
Abbott will also launch a complementary mobile app for iPhone and Android devices named NAVICA™. This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result.
Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing.
In data submitted to the FDA from a clinical study conducted by Abbott with several leading U.S. research universities, the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 97.1% and specificity of 98.5% in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
Under FDA EUA, the BinaxNOW COVID-19 Ag Card is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, and more with minimal training and a patient prescription.
Currently, AdvaMed (The Advanced Medical Technology Association) estimates that test manufacturers are shipping about 1 million tests per day. Abbott will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October.
The company has invested hundreds of millions of dollars since April in two new U.S. facilities to manufacture BinaxNOW at massive scale.
The BinaxNOW COVID-19 Ag Card can be used as a first line of defense to identify people who are currently infected and who should isolate themselves to help prevent the spread of the disease.
It is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
As a near-person rapid antigen test, BinaxNOW was engineered for point-of-care settings, near-patient, and not for reference labs. Patient samples should be tested immediately and should not be diluted in viral transport media.
NAVICA mobile app will help facilitate return to daily activities
Abbott is also offering a mobile app at no charge that will allow people to display their results obtained through a healthcare 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 about with greater confidence.
The app is supported by Apple and Android digital wallets and will be available from public app stores in the U.S.
If test results are negative, the app will display a digital health pass via a QR code, similar to an airline boarding pass. If test results are positive, people receive a message to quarantine and talk to their doctor.
As they're 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, regardless of whether they use the app. The digital health pass is stored in the app temporarily and expires after the time period specified by organizations that accept the app.
The app's user interface is supported by a back-end digital infrastructure that is cloud-based, scalable and secure. It's been designed to support a very large number of users and enable access from anywhere. The app is not for contact tracing and only collects a person's first and last name, email address, phone number, zip code, date of birth and test results.
About the BinaxNOW COVID-19 Ag Card Test
The BinaxNOW COVID-19 Ag Card is an assay for the qualitative detection of specific antigens to COVID-19 in the human nasal cavity. A simple nasal swab is used to collect specimens from people suspected of having an active infection. No equipment is required to process samples or read test results.
In addition, minimal chemical reagents are required, which lessens exposure to biohazardous materials and improves safety for those administering the test.
The BinaxNOW COVID-19 Ag Card is the sixth test that Abbott is launching in the U.S. 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 molecular point-of-care platform; antibody tests for its high-throughput ARCHITECT® i1000SR and i2000SR and Alinity i laboratory instruments.
Abbott has provided more than 27 million COVID-19 tests in the U.S. to date, including 14 million detection tests and 13 million antibody tests.
Date Published: 31st August 2020
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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.