Kroger Health receives FDA clearance for COVID-19 at-home test
The Food and Drug Administration has granted Emergency Use Authorization for Kroger’s at-home COVID-19 test that will begin with availability to frontline associates across the Kroger company and expand after that to other organizations.
Kroger Health, the healthcare division of Kroger, developed the Kroger COVID-19 Test Home Collection Kit to be a way to test workers at home in concert with a telehealth consultation to improve the quality of the collection process.
Working with Gravity Diagnostics, a full-service clinical laboratory located in Covington, Ky., Kroger Health plans to rapidly expand the 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.
For now, the tests are for associates, but as Kroger Health has worked to make testing sites available and working to serve customers in underserved areas, it seems possible to expand to more patients.
"Kroger Heath remains committed to helping people live healthier lives through our multi-disciplinary team of licensed, trained and experienced healthcare providers," said Colleen Lindholz, president of Kroger Health. “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. To help ease this burden and provide greater accessibility, we will be offering a home testing solution to our associates first followed by other companies and organizations."
Kroger outlined the following as keys to how the home kit works:
- The home collection is performed under the supervision of a licensed healthcare professional. The process is simple and is available at no cost to eligible patients who meet established clinical criteria for likely COVID-19 infection or exposure;
- Patients will be provided access to a website where they will answer screening questions, input their organization's benefit code and an individual code, like an employee ID, and complete a clinical assessment. If a patient qualifies, a healthcare professional will issue a prescription and the home collection kit is shipped to their home within 24-48 hours;
- 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;
- Upon receipt of the home collection kit, a healthcare professional guides the home collection process via telehealth – a two-way video chat. The direct observation helps to ensure the proper technique is used for sample collection;
- The patient will then overnight ship their sample to the laboratory for processing, which on average will take 24-48 hours;
- At the laboratory, the collection undergoes a molecular diagnostic test – a test which detects parts of the SARS-CoV-2 virus and can be used to diagnose active infection with the SARS-CoV-2 virus;
- If test results are negative for an active infection, results are released to the patient's electronic medical record portal. Alternatively, patients may be called if they do not consent to use of the portal. For a patient whose test result is positive, a healthcare professional will contact them via phone to provide a recommended course of care; and
- Test results will only be accessible to the patient and only shared with their organization if the patient authorizes the release of his or her results. All results are reported to government health agencies as required by law.
"As our country experiences an increase in COVID-19 cases, physical distancing, wearing protective masks and testing remains paramount to flattening the curve," said Jim Kirby, senior director of Kroger Health. "We know flexible, accessible testing options like home solutions that leverage telehealth technology are critical to accelerating America's reopening and recovery."
The Kroger Health COVID-19 Test Home Collection Kit will initially be available in Arizona, Colorado, Georgia, Indiana, Kansas, Kentucky, Michigan, Montana, Nevada, New Mexico, Ohio, Tennessee, Utah and Virginia. Additional states will be added in the coming weeks.
Kroger Health launched public drive-thru and walk-up COVID-19 testing sites in April. Since then, Kroger Health has administered more than 100,000 tests across 19 states.