Consumer-Friendly COVID-19 Testing Now Authorized
The world's leading provider of diagnostic information services based in New Jersey announced that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Quest Diagnostics Self-collection Kit for COVID-19.
The Quest self-collection kit is for individuals to self-collect a nasal specimen at home or in a healthcare setting.
This means individuals can swab the front part of the nostril and then ship their specimen without a frozen cold pack to a testing facility via overnight delivery.
The test results are reported through the myQuest patient portal and mobile app.
Specimens collected using the kit may be tested with the Quest Diagnostics SARS-CoV-2 RT-PCR test that received an FDA EAU in March 2020.
The RT-PCR testing aids in diagnosing infections with SARS-CoV-2, the coronavirus that causes COVID-19.
Quest said it expects to have more than 500,000 kits available by the end of June 2020.
"COVID-19 molecular diagnostic testing has been constrained partly by limited supplies of swabs and trained healthcare professionals to do the specimen collection," said Steve Rusckowski, Quest CEO, in a press statement on May 28, 2020.
"The self-collection kit enables an individual to self-collect at home, and the process is far less invasive and uncomfortable than many traditional methods."
Quest shared data with FDA that indicate that the self-collection kit offers a consumer-friendly approach to high-quality diagnostic testing for COVID-19.
Quest Diagnostics already tested specimens using a similar collection method in real-world settings in a drive-thru and other onsite COVID-19 testing sites across the USA.
The self-collection kit was developed to be very consumer-friendly, with the specimen collected at home and without the need to directly involve a healthcare professional to perform or observe the collection.
The Quest Diagnostics molecular test and self-collection kit have not been FDA cleared or approved, but have been authorized by FDA under an EUA, and have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The test and self-collection kit are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Quest Diagnostics is at the forefront of the response to the COVID-19 pandemic, working to broaden access to laboratory insights to help us all lead healthier lives.
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