APR 23, 2020 2:07 PM PDT

FDA Approves At-Home Sample Collection Diagnostic Test for COVID-19

WRITTEN BY: Lawrence Renna

The coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Many Americans are wondering when or if they should get tested for COVID-19; or even if it is possible for them to get testing. Currently, state and local public health departments have received tests from the Centers for Disease Control and Prevention (CDC), and medical providers are able to get diagnostic tests from commercial manufacturers. The CDC’s guidance on how to decide if you should be tested is that not everyone needs to be tested for COVID-19. The CDC says: “Most people have mild illness and are able to recover at home without medical care. They may not need to be tested,” however, the “decisions about testing are at the discretion of state and local health departments and/or individual clinicians.”

Currently, testing for COVID-19 is done at designated testing sites, doctors’ offices, and hospitals. While the supplies for these diagnostics are increasing, it may still be challenging to find a place to get tested. The U.S. Food and Drug Administration (FDA) recently approved, via the Emergency Use Authorization (EUA), an at-home test for COVID-19. The tests, called Pixel, will be sold by Laboratory Corporation of America (LabCorp) and use a technique called real-time reverse transcription-polymerase chain reaction (RT-PCR) to amplify the virus’ nucleic acid signal from upper and lower respiratory swabs. Doctors can order the diagnostic test kits, and then patients can collect the samples on their own, at home, and then mail the collected samples to LabCorp. The test kits provide materials for sample collection and supplies to mail the samples to an authorized laboratory safely. The test kits should be available in most states in the coming weeks.

As testing, in general, for COVID-19 is limited, adding another diagnostic to the market will help healthcare professionals gain better insight into the disease, its spread, and its morbidity. In particular, home sample collection allows for the collection of data on COVID-19, without having to expose the community to potentially positive patients. Also, at-home tests, like this one, can help prevent the over-exposure of healthcare workers to SARS-CoV-2. Although many companies have publicly announced that they will be selling at-home tests for COVID-19, the FDA had thus far only authorized the test kits from LabCorp.

 

Sources: CDC, FDA, MobiHealthNews, WRAL

About the Author
  • Hello! I am a scientist currently living in Southern California, although I am originally from the east coast. I received my B.S. in Chemistry from Northeastern University in 2012, and my Ph.D. in Chemistry from the University of Massachusetts Amherst. I also had a postdoctoral appointment at the University of California, Irvine. I have written 25+ peer-reviewed articles, several patents, and one book chapter. I am a reviewer for scientific manuscripts, and a freelance editor and writer. Outside of science, I enjoy spending time with my family, training Jiu-Jitsu, and baking sourdough bread. I am happy to be writing for LabRoots.
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