FDA grants EUA for at-home specimen collection kit

July 7, 2020

The U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for a COVID-19 at-home specimen collection kit, which is designed for consumers to use while being observed by a healthcare provider through a two-way video chat.

The agency granted the EUA to Kroger Health, a division of The Kroger Co., which said the COVID-19 Test Home Collection Kit will be available to frontline associates across Kroger's companies, based on medical need, beginning this week.

The company plans to expand availability of the home collection kits to other companies and organizations in the coming weeks, with a goal of processing up to 60,000 tests per week by the end of July.

Kroger said it is working with Gravity Diagnostics, a full-service clinical laboratory located in Covington, KY, which will provide testing services to detect SARS-CoV-2 RNA.

“Over the past few months, Kroger Health has been providing Americans with access to COVID-19 testing through community test sites across the country; however, we've observed some individuals do not have access to transportation or live near these community testing locations,” said Colleen Lindholz, president of Kroger Health.

The home collection kit includes a nasal swab, transport vial, instruction sheet, prepaid shipping label, and packing materials for return shipment of the sample to the laboratory. Patients answer screening questions on a website, and if they qualify, a healthcare professional will write a prescription for the home collection kit, which is then shipped to the patient in 24-48 hours.

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