CINCINNATI — Kroger Health has received FDA approval for at-home COVID-19 tests.
In a news release Wednesday, Kroger Health said it hopes to process 60,000 tests per week by the end of July in partnership with Covington-based Gravity Diagnostics.
The new testing model combines “at-home convenience with telehealth technology, with most results confirmed in less than 72 hours.”
Kroger Health is the healthcare division of The Kroger Co. The FDA approval was granted under the agency’s “Emergency Use Authorization” guidelines. According to the FDA’s website, an EUA allows the FDA commissioner to permit unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions.
Kroger Health said the COVID-19 home collection kits will be available to frontline associates, based on medical need, across the Kroger families of companies starting this week. It said it hopes to expand availability of the home tests to other companies and organizations in the coming weeks by partnering with Gravity Diagnostics.
"Throughout the COVID-19 pandemic, the safety of our associates and our customers has remained our top priority," 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."
Here’s how the COVID-19 test kits will work, according to Kroger Health:
- 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.
- 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.
The home test kits will initially be available in Arizona, Colorado, Georgia, Indiana, Kansas, Kentucky, Michigan, Montana, Nevada, New Mexico, Ohio, Tennessee, Utah and Virginia. Kroger Health said additional states will be added in the coming weeks.