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Abbott’s BinaxNOW COVID-19 Antigen Self Test, which requires no lab processing and yields results within 15 minutes, has received emergency use authorization from the FDA.

Kroger to roll out OTC rapid antigen COVID-19 self-test kit to stores

Abbott’s BinaxNOW test can be conducted at home without prescription

The Kroger Co. plans to sell an over-the-counter, rapid COVID-19 self-testing kit from health care products giant Abbott at its stores.

Kroger Health, the Cincinnati-based retailer’s health services arm, said yesterday that Abbott’s BinaxNOW COVID-19 Antigen Self Test will be available for purchase at all Kroger retail locations and, soon, at Kroger.com. Because BinaxNOW doesn’t require a prescription from a health professional, customers can perform the test in their own home as well as receive results within 15 minutes, since there’s no laboratory processing, Kroger Health noted.

Each BinaxNOW box contains two nasal swab tests, to be used twice over three days and with at least 36 hours between tests. Kroger Health said, adding that the test is designed for people with or without symptoms, or other epidemiological reasons to suspect COVID-19 infection. Abbott’s OTC SARS-CoV-2 rapid antigen test has received emergency use authorization (EUA) for self-testing from the Food and Drug Administration.

“The U.S. has made tremendous strides in the battle with COVID-19, with vaccination efforts proving successful, yet testing continues to be a critical pillar in the fight against this public health crisis,” Kroger Health President Colleen Lindholz said in a statement. “We know Americans will greatly benefit from having access to affordable, at-home testing to support diagnostic needs, and Kroger Health is grateful that we can continue to be part of the solution by providing access to diagnostic testing as well as administering COVID-19 vaccines.”

Rapid antigen tests detects protein fragments specific to the COVID-19, while the more common molecular PCR (viral) test actually detects genetic material (RNA) specific to the virus. Though both tests employ nasal or nasalpharyngeal swabs, the molecular PCR test is considered the “gold standard” in COVID-19 detection. The rapid antigen test delivers results quickly but can yield false positives, and negative results may need to be confirmed with a molecular test, according to the FDA. Results can take up to a week for the molecular PCR test, yet it’s typically highly accurate and usually doesn’t need to be repeated, the agency said.

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Each BinaxNOW box contains two nasal swab tests, which are used twice over three days and with at least 36 hours between tests.

Serial testing can raise the chances of detecting asymptomatic infection and offers schools, worksites, communities and other venues new options to screen for COVID-19, the FDA reported.

“This virus remains unpredictable, which is why we can’t let our guard down on testing, especially as people get back to seeing more of each other in a variety of spaces like workplaces, schools and family events,” according to Andrea Wainer, executive vice president of Abbott’s rapid and molecular diagnostics business. “Abbott will continue making its BinaxNOW COVID-19 Antigen Self Test available in more national retail settings like Kroger so that people can quickly and easily find the test and get back to living their pre-pandemic lifestyles with more assurance.”

Kroger Health has continued to expand its coronavirus testing options. In February, the company announced plans to offer what it called the first smartphone-enabled, at-home rapid antigen test for COVID-19. The Gauss COVID-19 Rapid Antigen Test Kit — still awaiting EUA from the FDA — can be performed using a smartphone and a lateral flow assay (similar to an at-home pregnancy test) without involving a lab, a telemedicine visit or specialized electronics. Once cleared by the FDA, the Gauss test is slated to become available for purchase on Kroger.com and over the counter at its 2,200 pharmacies nationwide.

Plans call for Kroger Health to add at-home COVID-19 antigen testing to its employer-focused health and wellness solutions. The company said employers or organizations can use these tests to help reopen workplaces by providing regular, low-cost testing.

Kroger Health’s range of COVID-19 testing solutions includes viral and antibody testing. Designed for employers and launched in August, COVIDCare+ comprises Kroger Health’s FDA-authorized COVID-19 Test Home Collection Kit, which became available in July, and access to clinical services for primary care. Viral, rapid antigen and rapid antibody testing also is available at Kroger Co. pharmacies and The Little Clinic in-store clinics. Kroger rolled out rapid antibody testing to all pharmacies and clinics starting last fall. Rapid antibody testing informs patients if they previously have been infected with SARS-CoV-2, the virus that causes COVID-19. 

Overall, Kroger Health has 2,200 pharmacies and 220 clinics in 35 states serving more than 14 million customers with a team of 22,000 health professionals, ranging from pharmacists and nurse practitioners to dietitians and technicians. Kroger said that, as  a national partner in the Federal Retail Pharmacy Program for COVID-19 Vaccination, its health care workforce has administered more than 3.5 million vaccinations.

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