The Food and Drug Administration (FDA) has given emergency approval to America’s first at home COVID-19 testing kit by LabCorp known as ‘Pixel.’ The new at-home coronavirus testing kit comes with a nasal swab for sample collection, which patents can then send to LabCorp’s lab for examination using the shipping package included in the pack.
FDA, on Tuesday, has entitled Emergency Use Authorization (EUA) to the Laboratory Corporation of America’s molecular RT-PCR Pixel testing kits to detect the presence of the pandemic influenza. The official letter says that LabCorp’s testing kit draws a qualitative test for the detection of coronavirus.
Stephen M. Hahn, FDA Commissioner, said that the organization has been working around the clock to ease the testing procedures. More than 50 diagnostic tests were authorized with the help of over 350 test developers. Including all these test development facilities, FDA ensures that patients get easy access to accurate diagnostics, which is reliable and comes with at-home sample collection options.
“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 a patient sample collection from the comfort and safety of their home,” said Hahn.
Adam Schechter, CEO of LabCorp, said that “LabCorp continues to develop new ways to help patients and healthcare providers fight the COVID-19 crisis through our leading testing capabilities and deep scientific and research expertise. Our at-home collection kits designed to make it easier and safer to test healthcare workers and first responders during this important time.”
For coronavirus tests, according to a study in France, the nasal swabs are less accurate for sample collection as compared to the gold standard specimen collection, which involves inserting a long swab up through the nose into the back of the throat that health providers perform.
However, the FDA believes that the data LabCorp had submitted shows the Pixel at-home test kits results are as accurate as a sample collection at a doctor, hospital, or other testing sites.
The authorized LabCorp’s Pixel COVID-19 RT-PCR test
The people having Coronavirus symptoms can use the nasal swabs to self-collect the samples at home. The samples are then supposed to be mailed to an accredited LabCorp laboratory for testing safely. To get accurate results, individuals must follow all specimen collection and mailing instructions provided in the kit.
FDA authorized coronavirus diagnostic tests in March for emergency use by a health care provider. The FDA revised the authorization on Monday to allow the home specimen collection method. FDA said in its release that “It is important to note that this [at-home testing] 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 COVID-19 RT-PCR Pixel test kit uses the materials that are commercially sourced. Also, it requires other authorized ancillary reagents commonly used in clinical laboratories for the authorized procedures as prescribed by the EUA. The reissued letter provides a list of controls that generates valid results.
The ‘Pixel’ test kit will be available to consumers in most states by the coming week, with a doctor’s prescription. The new testing kit would be available first to health care workers and emergency workers who are working on the frontline and may be exposed to the virus or have symptoms.
The at-home test kit can be ordered online, subject to eligibility, from the official LabCorp website for $119. Though the Pixel is costly, it is expected still the consumers will pay the money from their pockets, and later get reimbursement from the insurer. Moreover, we hope the federal government will reimburse all COVID-19 tests as the Trump administration has made it easy for people to get the emergency coverage for coronavirus, so they don’t have to bear the expense.
Talking to the New York Times, Dr. Sheldon Campbell, associate director of the Yale School of Medicine’s Clinical Microbiology Laboratory, said: “This is not a game-changer, it’s potentially another piece of the large and rather messy puzzle we’re assembling to test enough people to stop COVID-19,” of the at-home nasal self-swabbing kits. A home-collection testing procedure will support telemedicine and help patients with transportation difficulties and in hard-to-reach places to access testing.”
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