BinaxNOW Performance, From Studies in the Field

Researchers at leading academic institutions find BinaxNOW is a reliable way to detect COVID-19 including variants.

Diagnostics Testing|Feb.23, 2022

Rapid antigen tests have become a critical tool to detect COVID-19 in people who are infectious — allowing those who need to quarantine to do so, and those who don’t, to continue to do the things they love. 

BinaxNOW has become America's leading rapid antigen test, trusted by tens of thousands of schools and universities, long-term care facilities and nursing homes, workplaces, state testing programs and millions of families.

As the developers of BinaxNOW, we have deep history in healthcare and know the importance of having the data and science to back technologies. In addition to our research, leading academic institutions have conducted research and showed BinaxNOW is effective at detecting the virus — including Omicron and other variants of concern — and remains an essential tool to the world’s COVID-19 response.

Here's the latest research on rapid antigen tests in general and on BinaxNOW specifically:

University of California San Francisco — Omicron Detection

A real-world study from the University of California San Francisco showed BinaxNOW can detect the Omicron variant in the vast majority of people who are infected and carrying high levels of the virus.

  • Study conducted via a walk-up community testing site in San Francisco
  • 731 participants
  • Simultaneous nasal rapid antigen testing (BinaxNOW) and PCR testing was performed
  • A single BinaxNOW rapid antigen test detected 95% of high viral load omicron cases

Brigham and Women's Hospital and Harvard Medical School — Omicron Detection

A study from Brigham and Women’s Hospital and Harvard Medical School found that BinaxNOW detects Omicron at rates comparable to previous variants.

  • Participants were found after testing positive for COVID-19 through PCR tests at an academic medical center
  • BinaxNOW was able to detect Omicron and Delta viral concentrations of 100,000 copies per swab or greater
  • Study shows that BinaxNOW rapid antigen tests can detect the Omicron variant

Johns Hopkins School of Medicine — Test Accuracy in Kids

Researchers from Johns Hopkins School of Medicine found that BinaxNOW had 92.7% sensitivity and 98% specificity among the 1,054 pediatric study participants.

  • Study was focused on testing children as they can be significant spreaders of the disease and the inability to detect infections can disrupt in-person education
  • Delta was the predominant variant during testing period
  • Determined that highly accurate rapid antigen tests may be vital to containing the spread of COVID-19 and minimizing detrimental effects

University of California San Francisco — Asymptomatic Detection

A real-world study from the University of California San Francisco showed BinaxNOW detects COVID-19 among people regardless of symptoms

  • Study conducted at a public plaza site during ongoing community transmission in September 2020
  • 878 participants
  • Study found that BinaxNOW demonstrated a sensitivity of 93.3% and specificity of 99.9% in high viral load samples

With the ability to provide reliable COVID-19 results when and where they're needed most, individuals can quarantine appropriately and help minimize the spread — something even more crucial with the current Omicron variant.



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 24 hours (and no more than 48 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 Card has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. It has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is 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.