CINCINNATI - Kroger on Tuesday announced plans to offer a completely at-home, COVID-19 test with results in 15 minutes to its customers nationwide, part of a push to increase the availability of testing as the nation continues its mass vaccination campaign.
The test, which is pending emergency approval from the U.S. Food and Drug Administration, is performed using a smartphone app and a "lateral flow assay," described as similar to an at-home pregnancy test. Patients follow video instructions on the app to collect a nasal swab, which is included in the kit. The app then prompts the user to scan their test after 15 minutes to see the result.
Since the onset of the coronavirus outbreak, health experts have stressed the need for fast, widespread home testing so that people can screen themselves and avoid contact with others if they have an infection. But the vast majority of tests still require a nasal swab performed by a health worker that must be processed at high-tech laboratories.
The rapid test was developed by the computer vision-focused healthcare company Gauss and submitted to the FDA for approval in late fall 2020.
The rapid COVID-19 test, which can be performed completely at home, was developed by the computer vision-focused healthcare company Gauss and is pending emergency approval from the FDA. (Photo credit: Kroger)
"According to results of a clinical trial submitted to the FDA in support of the solutions EUA application, the testing solution demonstrated a 93% positive agreement and 99% negative percent agreement compared to high-sensitivity, emergency-use-authorized PCR tests," the company said in the announcement.
Kroger Health, the healthcare division of the supermarket giant, said it expects the at-home test to be available on Kroger.com and over-the-counter at its 2,200 pharmacies nationwide if approved.
Kroger operates more than 3,000 stores across the U.S., including Harris Teeter, Ralph’s, and their retail clinic chain, The Little Clinic. It’s among a number of retail pharmacies selected by the federal government to help distribute coronavirus vaccines as quickly as possible to stem the pandemic. The company said it had administered more than 200,000 COVID-19 vaccines as of Feb. 5 — and is offering $100 to all employees who get the vaccine.
Kroger previously received approval for an at-home COVID-19 testing kit, which is then shipped to a lab for processing. In August, the Cincinnati-based company also added hundreds of testing clinics at its stores for both symptomatic and asymptomatic patients.
As vaccines slowly roll out, health experts say the nation could suppress the outbreak and reopen much of the economy by easing regulatory hurdles to allow millions more rapid tests that, while technically less accurate, may actually be better at identifying sick people when they are most contagious.
Earlier this month, the U.S. government announced a $231.8 million contract to an Australian company behind the first fully at-home rapid coronavirus test, which can also be obtained without a prescription. The test, made by Ellume, can similarly show results on the user’s phone within 15 minutes of receiving a sample.
Ellume’s test looks for viral proteins shed by COVID-19, which is different from the gold standard PCR tests that look for the genetic material of the virus.
Like other tests that scan for proteins, FDA officials noted that Ellume’s test can deliver a small percentage of false-positive and false-negative results. People who get a negative result but have coronavirus symptoms should follow up with a health care professional, the agency said.
This story was reported from Cincinnati.