Rapid COVID Test Results Reduce Spread

The role of BinaxNOW in community testing. 

Rapid COVID Test Results Reduce Spread
Diagnostics Testing | Apr. 21, 2021

In the heart of San Francisco is a community called the Mission District. The largely Latinx population was hit hard in the early months of the COVID-19 pandemic and looked to widespread testing to help slow the spread of the virus.

However, not all communities have equal access to COVID-19 testing. A recent study in the Mission District showed how portable, reliable and fast testing through our BinaxNOW COVID-19 test can enable fast detection of people who are likely to be infectious to isolate them and prevent further spread.

A partnership between UCSF and the Latino Task Force for COVID-19 called Unidos En Salud collaborated with the City and County of San Francisco, SFMTA (the San Francisco Municipal Transit Agency) and BART (Bay Area Rapid Transit) to provide COVID-19 testing to the public.

As part of the initiative, research from University of California San Francisco (UCSF) and Chan Zuckerberg Biohub found our BinaxNOW COVID-19 rapid antigen test provided test results in minutes, allowing people to isolate quickly and help slow the spread of the virus.

The initiative used one nasal swab for polymerase chain reaction (PCR) testing — considered to be the "gold standard" of COVID-19 testing due to its high sensitivity — and another for BinaxNOW rapid antigen testing to compare the two results and gauge the performance of tests on the ground, outside of professional settings.

The study ultimately found that BinaxNOW displayed:

  • 93.3% sensitivity — identifying 14/15 individuals who were likely to be infectious.
  • 99.9% specificity — identifying 855/856 individuals who were likely to not be infectious.
  • That it can help test more people and identify more positives than could have been done otherwise.
  • That its ease of use and portability allows it to be easily brought into any areas in need of testing.

Rapid antigen tests such as BinaxNOW are able to quickly identify individuals with or without symptoms or other epidemiological evidence to suspect COVID-19 infection within minutes and enable fast isolation, as opposed to waiting days for a lab result. A BinaxNOW test can be conducted anytime, anywhere (including a BART train station), making it critical in testing underserved communities where seeking lab-based testing may be more difficult.

"The ability to quickly identify people who are likely to be infectious and enable them to quarantine and seek appropriate care immediately is paramount as we aim to slow the spread of COVID-19," said Mary Rodgers, Ph.D., Abbott principal scientist. "Not all communities have had the same experience in accessing COVID-19 testing. The portability, affordability and speed of BinaxNOW tests allow testing to reach more people in more places, making it a critical tool in keeping communities safe."

Underserved communities have experienced unique barriers to COVID-19 testing such as lack of testing resources, less testing sites in their area, costs associated with seeking testing and more. We're dedicated to breaking these barriers down.

That starts with making BinaxNOW tests even more accessible. We also recently announced authorization for BinaxNOW Self Test, which will be available at major retailers over-the-counter, without the need for a prescription or an online test proctor. The self-use tests will be affordable, simple and user-friendly, aiming to knock down those barriers that may have prevented the masses from getting their COVID-19 status.

No single test may be able to do it all, but BinaxNOW is the test communities need in this moment.

IMPORTANT SAFETY INFORMATION

The BinaxNOW COVID-19 Ag 2 Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swab samples from COVID-19 symptomatic individuals tested twice over three days with at least 36 hours between tests within the first seven days of symptom onset.

This test is authorized for use with direct anterior nasal (nares) swab samples from individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested twice over three days with at least 36 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 36 hours between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older.

The BinaxNOW COVID-19 Ag tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. The tests have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.