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At-home COVID-19 testing approved by FDA

FILE - In this April 2, 2020, file photo a nurse holds a vial and a swab at a drive-up coronavirus testing station at a hospital in Seattle. (AP Photo/Ted S. Warren, File)

The U.S. Food And Drug Administration has authorized the first at-home testing option for COVID-19.

In a statement released Tuesday, FDA Commissioner Stephen M. Hahn says that the agency has been working around the clock to approve more testing.

“Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options.

“The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers. Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing sites.

“With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” he says.

The at-home COVID-19 test was developed by the Laboratory Corporation of America after the FDA re-issued the emergency use authorization (EUA) to permit testing of samples self-collected by patients.

The FDA says that this authorization comes only to the specific LabCorp COVID-19 RT-PCR Test that allows patients to collect a sample from their nose at home using a nasal swab.

“Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing.  LabCorp intends to make the Pixel by LabCorp COVID-19 Test home collection kits available to consumers in most states, with a doctor’s order, in the coming weeks,” the FDA said in their statement.

According to reports from The Verge, the test will first be made available to health care workers and first responders and cost around $119.

 


How To Prevent the Spread of COVID-19Coronavirus

COVID-19 coronaviruses spread from person to person. It is a virus that is similar to the common cold and the flu. So, to prevent it from spreading:

  • Wash hands frequently and thoroughly, with soap and water, for at least 20 seconds.
  • Don’t touch your face.
  • Keep children and those with compromised immune systems away from someone who is coughing or sneezing (in this instance, at least six feet)
  • If there is an outbreak near you, practice social distancing (stay at home, instead of going to the movies, sports events, or other activities.)
  • Get a flu shot.

Local resources

KSL Coronavirus Q&A

Utah’s Coronavirus Information

UtahState Board of Education

Utah Hospital Association

The Church of Jesus Christ of Latter-day Saints

Utah Coronavirus Information Line – 1-800-456-7707

National Resources

Centers for Disease Control and Prevention

Commonly asked questions, World Health Organization

Cases in the United States