FDA Grants EUA for OTC Triple Test for COVID-19, Flu A & B

The FDA has granted emergency use authorization (EUA) for an over-the-counter (OTC) triple combination antigen test for influenza and COVID-19.¹ The test, intended for use at home or at the point of care, can simultaneously detect COVID-19, influenza A, and influenza B in 15 minutes, according to medical diagnostics company Watmind USA.¹

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Watmind USA developed the SpeedySwab COVID + FLU A&B Antigen Self-Test in partnership with the National Institutes of Health's Rapid Acceleration of Diagnostics Independent Test Assessment Program, an initiative that aims to accelerate innovation, development, regulatory approval, and commercialization specifically of COVID-19 testing technologies.^2,3

"Receiving the EUA for our SpeedySwab test marks a significant milestone in our commitment to advancing public health," Dan Davis, CEO of Watmind, said in a press announcement.¹ "As we navigate the ongoing challenges of COVID-19 and influenza A&B strains, our goal is to provide accessible and rapid at-home testing solutions that empower individuals to proactively manage their health from the comfort of their homes, while minimizing the spread of such diseases.”¹

The SpeedySwab test is authorized for self-administration by adults and for use by adults for children aged 2 years and older who have symptoms of COVID or flu. Antigen detection is accomplished using lateral flow assay, a simple low-cost technology used widely in rapid, portable detection devices.⁴ The step-by-step process for in-home testing mirrors that for COVID-19 home antigen tests currently available.¹ The test kits are produced in 1, 2, 4 and 25-pack options, Watmind said in the press release.¹

The test will detect the presence of proteins from SARS-CoV2 variants and subvariants but will not discriminate among them.

According to data from the CDC, the COVID-19 test positivity rate in the United States was 4.2% for the week ending May 25, up .8% from the previous week.⁵ Additionally, the emergency department visit rate for the same time period was .4%, up 5.1% from the week before.4 While COVID-19 cases are down substantially from the height of the pandemic, the disease still represents a threat to public health due to emerging variants.⁵

On May 1, 2024, the CDC noted on its COVID Data Tracker webpage that hospitals in the US are no longer required to report COVID-19 hospital admissions, hospital capacity, or hospital occupancy data to HHS through CDC’s National Healthcare Safety Network, although the agency still encourages voluntary reporting of hospitalization data.⁵

References

1. Watmind USA™ receives FDA emergency use authorization for SpeedySwab 15-minute at-home 3-in-1 antigen test for COVID-19, Flu A & B. News Release. Watmind. May 31, 2024. Accessed May 31, 2024. https://www.prnewswire.com/news-releases/watmind-usa-receives-fda-emergency-use-authorization-for-speedyswab-15-minute-at-home-3-in-1-antigen-test-for-covid-19-flu-a--b-302160165.html
2. Independent test assessment program (ITAP). National Institutes of Health. Accessed June 3, 2024. https://www.nibib.nih.gov/covid-19/radx-tech-program/ITAP
3. Rapid acceleration of diagnostics (RADx). National Institutes of Health. Accessed June 3, 2024. https://www.nih.gov/research-training/medical-research-initiatives/radx
4. Koczula KM, Gallotta A. Lateral flow assays. Essays Biochem. 2016 Jun 30;60(1):111-20. doi: 10.1042/EBC20150012. PMID: 27365041; PMCID: PMC4986465.
5. Centers for Disease Control and Prevention. COVID Data Tracker. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2024. Updated May 10, 2024. Accessed June 3, 3024. https://covid.cdc.gov/covid-data-tracker