Kroger granted FDA approval to use COVID-19 Test Home Collection Kit

Coronavirus

DENVER (KDVR) — The U.S. Food and Drug Administration (FDA) granted Kroger Health Emergency Use Authorization for the COVID-19 Test Home Collection Kit on July 1.

According to the press release on the company’s website, “The testing solution combines the safety and convenience of at-home sample collection with the expert guidance of a telehealth consultation to help improve the quality of the collection process.”

Kroger Health is the healthcare division of the Kroger Company, which is the parent company for King Soopers and City Market in Colorado.

The COVID-19 Test Home Collection Kit is immediately available to all frontline employees across Kroger’s family of companies, based on medical need.

“Throughout the COVID-19 pandemic, the safety of our associates and our customers has remained our top priority. Kroger Heath remains committed to helping people live healthier lives through our multi-disciplinary team of licensed, trained and experienced healthcare providers,” Colleen Lindholz, president of Kroger Health, said.

“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.”

In partnership with Gravity Diagnostics, Kroger Health plans to expand the availability of the home collection kits to other companies and organizations in the next few weeks. Their goal is to process up to 60,000 tests per week by the end of July.

Per the press release, here’s an outline of how the test 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. 
  • 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 Kroger Health COVID-19 Test Home Collection Kit will initially be available in Arizona, Colorado, Utah, and several other states. The company says additional states will be added in the coming weeks.

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