COVID-19 home testing kit approved by FDA

Pixel, a LabCorp subsidiary, has introduced a self--collection test kit for COVID-19. The home test kit costs $119.

Initially, the COVID-19 self-collection kits will be made available to healthcare workers and first responders who may have been exposed to the virus or may have coronavirus symptoms, which is consistent with prioritization guidance issued by the Centers for Disease Control, according to company data, LabCorp representatives said on April 21.


Enabling individuals to self-administer sample collection will help prevent the risk of transmitting the virus to others and will reduce the demand for personal protective equipment (PPE) as the tests do not require a clinician to perform the test collection.


The U.S. Food and Drug Administration authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.


“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,” said FDA Commissioner Stephen M. Hahn, M.D.


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


This reissued EUA for LabCorp’s molecular test permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. 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 LabCorp home self-collection kit includes a specific Q-tip-style cotton swab for patients to use to collect their sample. Due to concerns with sterility and cross-reactivity due to inherent genetic material in cotton swabs, other cotton swabs should not be used with this test at the present time. The FDA continues to work with test developers to determine whether or not Q-tip-style cotton swab can be used safely and effectively with other tests.


This authorization only applies to the LabCorp COVID-19 RT-PCR Test for at-home collection of nasal swab specimens using the Pixel by LabCorp COVID-19 home collection kit. It is important to note that this is not a general authorization for at-home collection of patient samples using other collection swabs, media, or tests, or for tests fully conducted at home.


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Pixel by LabCorp intends to make COVID-19 self-collection kits available to consumers in the coming weeks. To get more information about the Pixel by LabCorp self-collection COVID-19 test kits and sign up to receive email notifications when tests are available to consumers, visit the Pixel by LabCorp COVID-19 test overview page.


FYI

The Pixel by LabCorp at-home COVID-19 test kit may be right for you if you:

  • Are currently experiencing COVID-19 symptoms.

  • Live in or recently traveled to an area with an ongoing spread of COVID-19.

  • Have been in close contact with a person known to have COVID-19.

  • Think you have been exposed to COVID-19.

The Pixel by LabCorp at-home COVID-19 test kit may not be right for you if you:

  • Currently have severe symptoms that limit your daily activities. Seek medical attention right away if this is the case.

  • Do not have symptoms and have not been exposed to COVID-19.

  • Do not have symptoms and have not been to an area with ongoing spread of COVID-19.


How Does the Self-Collection Kit for COVID-19 Testing Work?

The Pixel by LabCorp self-collection kit for COVID-19 testing provides you with a way to get tested for the virus from the comfort and security of your own home. No trip to the doctor’s office or other healthcare provider is required to get COVID-19 testing.

Simply purchase the at-home COVID-19 test kit online after completing a short health screening survey to determine your risk of contracting the disease. Initially, only healthcare workers and first responders will be eligible for testing. Once your order is placed, Pixel by LabCorp will send the COVID-19 test kit to your home.

The self-collection kit includes everything you need to collect your sample, including easy to understand instructions. Watch this nasal sample collection video to learn more about how to collect your sample for the COVID-19 at-home test kit.

After your sample is collected, send it back in the pre-paid packaging for processing. Samples must be dropped in a FedEx drop box BEFORE the last pickup of the day. As with other Pixel by LabCorp lab tests, we have partnered with our leading life sciences parent company, LabCorp, ensuring your COVID-19 sample is sent to a world-class lab for analysis.

You’ll receive an email notification when your results are ready and you can access them online in your secure Pixel by LabCorp account. After receiving your COVID-19 results, you have the opportunity to talk to a licensed physician who can answer questions you may have about your results.

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