By Zoë McLaren, associate professor, Public Policy, UMBC

On Aug. 26, the Food and Drug Administration granted an Emergency Use Authorization to a new rapid antigen test for COVID-19 called the BinaxNOW test.

I study public health policy to combat infectious disease epidemics. Testing is one of the most powerful tools available to fight the spread of COVID-19. The new test is inexpensive, rapid and easy to use. It will massively scale up access to testing, but hurdles remain in achieving widespread, frequent COVID-19 testing.

The Abbott BinaxNOW rapid antigen test claims to give results in 15 minutes. Abbott

What type of test is BinaxNOW?

The credit-card-sized test is an antigen test that detects a specific viral protein from SARS-CoV-2. It costs US$5 and doesn’t require a lab or a machine for processing.

Performing the test is simple. A health care worker or technician would use a swab to collect a sample from less than 1 inch inside the nostril. They would then combine the sample with a few drops of chemicals inside the test card. Within 15 minutes, the test strip would show a positive or negative result. The test is also paired with an app that produces a digital code that can be scanned to show proof of a recent negative COVID-19 test.

The FDA granted emergency use authorization for the test, but only for use on patients with symptoms of COVID-19. AP Photo/Andrew Harnik, File

What does the Emergency Use Authorization allow for?

The BinaxNOW test is currently only authorized for patients who have had COVID-19 symptoms for seven days or less, which is when virus levels in the body are likely to be high. It must be prescribed by a physician and performed by a trained technician or other health care worker.

The PCR test for COVID-19 is currently widely used and considered the gold standard, but requires patient samples to be sent to a lab and can take days to provide results. The new antigen test is designed to be a cheap and quick alternative to PCR testing for diagnostic purposes in a medical setting. It would add critical capacity to an overstretched testing system.

The emergency use authorization provides preliminary authorization for doctors to prescribe the antigen test while the full FDA approval process is ongoing. The authorization could be revoked if the test is not as accurate or reliable as expected.

How accurate is this test?

Abbott, the health technology company that produces the test, reports that when patients had symptoms the test was in agreement with PCR testing for 97.1% for COVID-19 positive cases and 98.5% for COVID-19 negative cases. This is high enough for diagnostic settings where accuracy is critical.

However, the true accuracy could be lower because the performance testing group was only 102 people and the accuracy hasn’t been validated by the FDA as part of the full approval process. There will inevitably be some false negatives and false positives with the BinaxNOW test since accuracy isn’t 100%, but the FDA will monitor the data to make sure the test meets the reported accuracy.

Long lines and slow turnaround times have limited access to testing, but the new Abbott test should be far easier and faster. AP Photo/Nati Harnik

Can this test be used for widespread screening?

The BinaxNOW test is cheap, rapid, able to be mass-produced and easy to use outside a lab. This makes it a promising candidate for widespread screening. However, the test is currently only authorized for people with COVID-19 symptoms.

This is an obstacle because an estimated 40% of all COVID-19 cases are asymptomatic and these people likely don’t know that they’re contagious. To maximize the effectiveness of any COVID-19 screening program, it is important to test people whether they have symptoms or not.

Health care providers are able to prescribe the BinaxNOW test for asymptomatic patients for off-label use, but health officials don’t yet know how accurate the test is when performed on asymptomatic people.

Is this test a game-changer?

The massive expansion of testing access made possible by the BinaxNOW test will almost surely outweigh the downsides of a small number of inaccurate results. Abbott plans to manufacture 50 million tests per month starting in October. This will quickly exceed the 76 million COVID-19 tests the U.S. has performed over the last six months.

Widespread, frequent testing is effective at slowing the spread of the coronavirus. The new testing capacity made possible by the authorization of this rapid antigen test represents a major advance in bringing the pandemic under control.

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Zoë McLaren, Associate Professor of Public Policy, University of Maryland, Baltimore County

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Header image: AP Photo/Elaine Thompson

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Fall 2020 Operations During COVID-19

Essential Travel Preamble

In an effort to mitigate the spread of COVID-19, UMBC Transit is encouraging riders to PLEASE USE TRANSIT FOR ESSENTIAL TRAVEL ONLY. Transit defines essential travel as trips to and from campus, grocery stores, work, banks, hospitals, pharmacies, providing care for family members, food distribution centers such as Retriever Essentials, and other similar destinations. All Transit buses will be operating at reduced capacity to encourage social distancing. By reducing unnecessary travel, it is our hope that we have adequate space on our shuttles for those who depend on it to get to their classes safely.

Health and Safety

UMBC’s COVID19 safety protocols are in effect aboard buses and at bus stops. Aboard buses, distancing is accomplished by removal of half of the available seating. Unavailable seats are marked with signage. Facial masking is required aboard buses and at stops. Bus operator cabins are temporarily separated by clear removable sheeting. Should you need to inform the operator of a concern, please do so respecting social distancing guidelines.

Your ID is Your Ticket to Ride

Your campus ID is required to be presented upon boarding. You will be swiping your card to validate enrollment and to create a ridership report per route. These ridership reports are available to approved health agencies conducting tracing efforts. No visitors are permitted on Transit buses at this time.

Routes

UMBC Transit is providing its customary routes Monday through Friday with one exception: Courtney Road coverage is absorbed by the Paradise Route. Operational hours are limited to 6:30 a.m. – 6:30 p.m. Evening and weekend routes are suspended. However, retail business destinations and public transportation transfer points are incorporated into the modified Monday – Friday routes.

Route Frequency

Route frequency is different per route – some are hourly, some are midday only. Please see the Transit website for specific hours and route schedules. The bus locator system (Transit Tracker) is available for determining the real-time location of specific buses on route. The app is also used to send updates and messages to the ridership. The smart phone application is available for download from the Transit website.

Delays, Emergency Notification, and Communication

Multiple methods are used by Transit to communicate with our ridership:

·       Transit Tracker Alerts - umbc.transloc.com

·       Website Alerts - umbc.edu/transit

·       Transit Text Alerts - Text “Transit” to 79516

·       Transit Groups - myUMBC Alerts

·       Social Media

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Contact Us

The Transit office is closed to public access. For assistance please call the Transit Help Line at 410-455-2454 or email Transit Operations at transit@umbc.edu Phone calls will be answered by Transit staff during operational hours and by email as soon as possible from remote work sites.