FDA Authorizes First COVID-19 Test

FDA Authorizes First COVID-19 Test for Patient At-Home Sample Collection

The UNITED STATE Food and Drug Administration approved the very first diagnostic COVID-19 test with an option of home sample collection. To allow testing of self-collected samples by patients in the house using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit, FDA authorized the kit by re-issuing the emergency use authorization for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test.

Stephen M. Hahn, M.D, Commissioner, FDA said, “We have been helping with test development to make people access the accurate diagnostics including supporting the development of reliable and accurate at-home sample collection options during this pandemic”. “The Firm is working round the clock from the beginning of this outbreak. With more than 350 test developers, their hard work has resulted in the approval of more than 50 diagnostic tests and engagements. We collaborated with LabCorp to guarantee that at-home sample collection data showed is as secure and exact as sample collection at other testing sites or hospitals. This kit is a hassle-free and trustworthy option for sample collection at the comfort of home”.

The test kit contains saline and nasal swabs that allows collecting the sample from the

person’s nose. The sample is collected by self-swabbing their nasal and is sent for testing in an insulated package to a LabCorp lab. In the coming weeks, LabCorp plans to make the kit readily available to consumers in most states – with a physician’s prescription.

The kit consists of a Q-tip-style cotton swab to collect the sample. Other cotton swabs should not be used with this test as of now because of concerns about sterility as well as cross-reactivity due to inherent genetic material in the cotton swabs. FDA is working with test designers to establish whether, with various other tests, Q-tip-style cotton swab can be used safely as well as efficiently.

This permission only applies to the tests using the Pixel by LabCorp COVID-19 home collection kit. It is essential to keep in mind that this is not basic permission for at-home collection of samples using various other collection swabs, media, or tests, or for totally at-home tests.

FDA protects the general public health by guaranteeing the safety, efficiency, human security, vet medications, vaccinations, and various other biological products for human use, as well as medical tools. The firm is also in charge of the security and safety of our country’s food supply, nutritional supplements, cosmetics, products that emit electronic radiation, and tobacco products regulation.

Source

Author: Sruthi S