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Kroger Health gets FDA emergency approval for COVID-19 at-home collection test kit

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Posted at 5:02 PM, Jul 03, 2020
and last updated 2020-07-03 17:09:03-04

CINCINNATI — Kroger Health recently received emergency approval for a COVID-19 at-home test collection kit.

The kits will first be available to frontline employees at Kroger brand stores based on medical need, according to a press release from Kroger. The company hopes to expand the kits to other organizations and companies in the coming weeks.

Kroger Health's collection sample test kits will be available to Kroger brand associates in Arizona, Colorado, Georgia, Indiana, Kansas, Kentucky, Michigan, Montana, Nevada, New Mexico, Ohio, Tennessee, Utah, and Virginia, according to the release.

The U.S. Food and Drug Administration granted the emergency authorization on Tuesday.

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Kroger Health received emergency approval for a home COVID-19 test sample collection kit. The tests will be available to Kroger brand associates in several states at first.

Gravity Diagnostics, a laboratory in Covington, Kentucky, is working with Kroger Health and hopes to be able to process nearly 60,000 cases a week, according to the release.

According to the press release, here's how the home test kits work:

  • 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 be accessible only 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.

"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," Colleen Lindholz, president of Kroger Health, said in the press release. "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.”

On April 21, LabCorp was the first company to receive emergency authorization from the FDA for an at-home COVID-19 test sample collection kit, according to a press release from the FDA.