Kroger Receives FDA Emergency Approval for COVID-19 Home Test Kits

CINCINNATI – Kroger Health has received FDA approval for COVID-19 home testing.

In a press release on Wednesday, Kroger Health hopes to work with Covington-based Gravity Diagnostics to conduct 60,000 tests per week by the end of July.

The new test model combines “comfort at home with telehealth technology, with most results confirmed in less than 72 hours”.

Kroger Health is the health division of The Kroger Co. FDA approval was granted in accordance with the agency’s guidelines for emergency approval. According to the FDA’s website, an EEA allows the FDA officer to approve unapproved medical devices or unapproved uses of approved medical devices in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions.

Kroger Health announced that the COVID-19 home collection kits will be available for frontline workers starting this week, based on medical needs. The company hopes to expand the availability of home tests to other companies and organizations in the coming weeks through a partnership with Gravity Diagnostics.

“During the COVID-19 pandemic, the safety of our employees and our customers remains a 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 have found that some people do not have access to transportation or live near these community test sites. Um To reduce this burden and ensure better accessibility, we first offer our employees a home test solution, followed by other companies and organizations. “

According to Kroger Health, the COVID-19 test kits work as follows:

• The home collection is carried out under the supervision of a licensed medical professional. The process is simple and available free of charge to eligible patients who meet established clinical criteria for likely COVID-19 infection or exposure.

• Patients are given access to a website where they can answer screening questions, enter their organization’s performance code and a unique code such as an employee ID, and complete a clinical evaluation. When a patient qualifies, a healthcare professional will write a prescription and the house collection kit will be sent to their home within 24 to 48 hours.

• The Home Collection Kit contains a nasal swab, a transport vial, an instruction sheet, a prepaid shipping label and packing material for returning the sample to the laboratory.

• After receiving the home collection kit, a healthcare professional leads the home collection process via telemedicine – a bidirectional video chat. Direct observation helps ensure that the correct sampling technique is used.

• The patient then sends their sample to the lab for processing overnight, which takes an average of 24 to 48 hours.

• In the laboratory, the collection is subjected to 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 for active infection are negative, the results are posted to the patient’s electronic health record portal. Alternatively, patients can be called if they do not agree to use the portal. For a patient whose test result is positive, a healthcare professional will contact them by phone to find a recommended treatment.

• The test results are only available to the patient and are only shared with his organization if the patient approves the publication of his results. All results are reported to state health authorities 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 more states will be added in the coming weeks.