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2020-08-27| COVID-19

COVID-19: USFDA Approves Abbott’s $5 Test, BinaxNOW™ for Rapid Diagnosis

by Sahana Shankar
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On August 26th, the agency approved a new rapid antigen test developed by Abbott Diagnostics under its EUA (emergency use authorization). The results of the test can be read directly from a testing card.

By Sahana Shankar, Ph.D. Candidate &

Rajaneesh K. Gopinath, Ph.D.

The biotech industry is racing against time not only to make vaccines against COVID-19 but also to bolster the overwhelmed healthcare system with more accessible diagnostic kits and patient management systems to screen and identify new cases. The agency has now approved a new rapid antigen test, BinaxNOW™ developed by Abbott Diagnostics Scarborough Inc. under its emergency use authorization.

 

BinaxNOW™ COVID-19 Ag Card

Abbott’s BinaxNOW™ COVID-19 Ag Card provides a fast and efficient diagnosis with a simple nose swab and a testing card containing the required reagents. Much like a pregnancy kit, one line indicates a negative case, and two lines mean a positive result. This will bring much relief to healthcare providers, point-of-care settings, emergency rooms, and other places where people need to be tested periodically, without the requirement of sophisticated equipment and long turnaround times.

Under FDA EUA, the BinaxNOW™ COVID-19 Ag Card is available for use by healthcare professionals and can be used in point-of-care settings that are qualified under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Doctors, nurses, medical assistants, technicians, pharmacists, employer occupational health specialists, and many more authorized personnel can conduct the test upon a patient prescription.

The test is highly portable, about the size of a credit card, and is estimated to cost $5. Abbott plans to make up to 50 million tests per month in the US by October 2020. The BinaxNOW COVID-19 Ag Card demonstrated a sensitivity of 97.1% and specificity of 98.5% in patients suspected of COVID-19 by their healthcare provider within seven days of symptom onset. It is useful to screen infected people and prevent clusters of infection by isolating positive cases, at a fraction of time compared to molecular tests such as RT-PCR.

 

NAVICA™, a First-of-a-Kind Mobile Application

The company will also launch NAVICA™, a free of cost mobile application for both iPhone and Android users. This pioneering app, will allow people who test negative for COVID-19 avail a temporary digital health pass which could be renewed after every test, facilitating their entry into workplaces. In turn, organizations will also be able to view and verify a person’s test information on a mobile device.

“We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives,” said Robert B. Ford, President, and CEO of Abbott. “BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a complimentary digital health tool to help us have a bit more normalcy in our daily lives.”

BinaxNOW™ COVID-19 Ag Card and Companion Digital Health Tool, NAVICA™

These developments can also help take some load off testing labs that are operating at full capacity. However, since antigen tests have comparatively lower sensitivity than molecular tests, negative results may need to be confirmed with a molecular test based on the clinical context of patient history and epidemiology. Abbott says it will ship tens of millions of tests in September, and increase it to 50 million tests per month, starting October.

The approval of the rapid test comes at a time when debates about keeping businesses and schools open are raging on. Hopefully, this decision could provide governing bodies, a means to keep the pandemic under control.

Related Article: AstraZeneca Initiates Phase 1 Trial of COVID-19 Antibody Treatment in the UK

References
  1. https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-authorizes-first-diagnostic-test-where-results-can-be-read-directly-testing-card
  2. https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Receives-FDA-Emergency-Use-Authorization-Mobile-App-Displays-Test-Results-to-Help-Our-Return-to-Daily-Life-Ramping-Production-to-50-Million-Tests-a-Month
  3. https://www.abbott.com/corpnewsroom/product-and-innovation/upping-the-ante-on-COVID-19-antigen-testing.html

 

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