FDA authorizes first COVID-19 self-collection test kit for at-home sample collection

Coronavirus

A nurse holds swabs and test tube to test people for COVID-19 at a drive through station set up in the parking lot of the Beaumont Hospital in Royal Oak, Mich., Monday, March 16, 2020. (AP Photo/Paul Sancya)

ALBUQUERQUE, N.M. (KRQE) – The U.S. Food and Drug Administration has authorized the first COVID-19 diagnostic test that allows for patients to collect samples at home. LabCorp plans to make the tests available to consumers in the coming weeks and will be available online for $119.

The FDA has re-issued the emergency use authorization for the Laboratory of America COVID-19 RT-PCR Test to allow testing of samples that are self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 home test collection kit. The reissued EUA for LabCorp’s test allows testing of a sample that is collected from a patient’s nose.

Patient’s will be able to collect their own nasal sample and then mail it in an insulated package to a LabCorp to be tested. The company plans to make the Pixel by LabCorp COVID-19 test home collection kits available to patients in most states with a doctor’s order in the upcoming weeks.

The kit includes a specific cotton swab for patients to use to collect their sample. The FDA reports that due to sterility concerns and cross reactivity due to inherent genetic material in cotton swabs, other swabs should not be used with this test.

The FDA authorization is only applicable to the LabCorp COVID-19 RT-PCR Test for at hoe collection of nasal swab specimens using the Pixel by LabCorp COVID-19 home collection kit. The FDA states this is not a general authorization for at-home collection of patient samples using other collection swabs, tests, media, or fully conducted tests at home.

LabCorp says these kits will initially be made available to first responders and healthcare workers who have symptoms of COVID-19.

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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