What you need to know about the Kroger test that has just been approved by the FDA

HOUSTON – The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization for the Kroger-brand COVID-19 Test Home Collection kit, the supermarket chain announced Wednesday.

Here’s how the Kroger Health COVID-19 Home Evidence Collection Kit works, as described by the company:

• Home collection is done under the supervision of a licensed healthcare professional. The process is simple and available at no cost to eligible patients who meet the established clinical criteria for possible infection or exposure to COVID-19.
• Patients will have access to a website where they will answer screening questions, enter their organization’s benefit code and an individual code, such as an employee ID, and complete a clinical evaluation. If a patient qualifies, a healthcare professional will issue a prescription and the home collection kit will be delivered to your home within 24-48 hours.
• The home collection kit includes a nasal swab, a transport vial, an instruction sheet, a prepaid shipping label, and packaging materials for shipping the sample to the laboratory.
• Upon receiving the home collection kit, a healthcare professional guides the home collection process through telehealth, a two-way video chat. Direct observation helps to ensure that the proper technique is used for sample collection.
• The patient will then send their sample overnight to the laboratory for processing, which will take an average of 24 to 48 hours.
• In the laboratory, the collection undergoes a molecular diagnostic test, a test that detects parts of the SARS-CoV-2 virus and can be used to diagnose an active infection with the SARS-CoV-2 virus.
• If the test results are negative for an active infection, the results are submitted to the patient’s electronic medical records portal. Alternatively, patients can be called if they do not consent to use the portal. For a patient whose test result is positive, a healthcare professional will contact you by phone to provide a recommended course of care.
• Test results will only be accessible to the patient and will only be shared with their organization if the patient authorizes the publication of their results. All results are reported to government health agencies as required by law.

A press release said the home kit will be available to “front-line associates across the Kroger Family of Companies, based on medical need,” starting this week. The company did not elaborate on the term “based on medical necessity.”

The Kroger Health COVID-19 Home Test Collection Kit will initially be available in Arizona, Colorado, Georgia, Indiana, Kansas, Kentucky, Michigan, Montana, Nevada, New Mexico, Ohio, Tennessee, Utah, and Virginia. Kroger noted that additional states will be added in the coming weeks.

To process the tests, Kroger said he is partnering with Gravity Diagnostics, a clinical laboratory located in Covington, KY, in an effort to expand the availability of the home collection kits to other companies and organizations in the coming weeks, with The goal is to process up to 60,000 tests per week in late July.

“As our country experiences an increase in COVID-19 cases, physical distancing, wearing protective masks, and testing remain paramount in flattening the curve,” said Jim Kirby, senior director, Kroger Health. “We know that accessible and flexible testing options, like home solutions that leverage telehealth technology, are critical to accelerating America’s reopening and recovery.”