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Coronavirus update: Abbott's card-sized 15-minute COVID-19 test gets US FDA nod for emergency use

Abbott will also launch a mobile app NAVICA which will allows people to store, access and display their COVID-19 test results.

August 27, 2020 / 09:45 AM IST
Abbott’s BinaxNOW test is about the size of a credit card. The company plans to make 50 million a month starting in October. Source: Abbott Laboratories

Abbott’s BinaxNOW test is about the size of a credit card. The company plans to make 50 million a month starting in October. Source: Abbott Laboratories

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Abbott's 15-minute COVID-19 test. The product, named BinaxNOW, is aimed at eliminating the need for lab tests and thus boosting the nation's capacity to conduct more tests.

The United States is the most-affected country due to the COVID-19 pandemic. It has recorded over 5 million diagnosed cases of COVID-19 and nearly 1,80,000 people have died.

Abbott plans to ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October.

BinaxNOW is the size of a credit card and provides results in 15 minutes. Abbott plans to sell this test for $5 (approx Rs 370), which makes it more affordable than a host of other options. 

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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"BinaxNOW uses a nasal swab to collect specimens from those suspected of having coronavirus and a reactive card to detect COVID-19. No equipment is required to process samples or read test results," Abbott said in a press release on August 27.

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Using the product, COVID-19 test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists with minimal training and a patient prescription, Abbott claimed.

The company will also launch a mobile app NAVICA for iPhone and Android devices. The app allows people to store, access and display their COVID-19 test results and will work as a temporary digital health pass.

"The status will be renewed each time a person is tested through their healthcare provider together with the date of the test result. Organisations 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," it said.

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"While BinaxNOW is the hardware that makes knowing your COVID-19 status possible, the NAVICA app is the digital network that allows people to share that information with those who need to know," said Robert B. Ford, president and chief executive officer, Abbott.

"We're taking our know-how from our digitally-connected medical devices and applying it to our diagnostics at a time when people expect their health information to be digital and readily accessible."

Globally, there have been over 2.40 crore confirmed cases of COVID-19. More than 8.20 lakh people have died so far.

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first published: Aug 27, 2020 09:45 am