FDA Grants Emergency Approval for At-Home COVID-19 Testing
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Chapter 1: Introduction to At-Home Testing
The lack of widespread testing significantly hindered the United States as the coronavirus outbreak began to escalate earlier this year. Even today, obtaining a test can be challenging unless one is exhibiting severe COVID-19 symptoms. However, access to testing may soon improve, especially for those willing to invest in at-home testing options. LabCorp has recently announced that its "Pixel" test kit has received the first Emergency Use Authorization (EUA) from the FDA, permitting COVID-19 testing from home.
Several biotech companies are in the process of developing at-home testing solutions for the novel coronavirus. However, the FDA has explicitly prohibited the distribution of these kits until comprehensive evaluations are completed. LabCorp is the first to receive this provisional approval, likely because their product does not function as a full testing kit used at home.
Section 1.1: Understanding the Pixel Test Kit
The COVID-19 test kit from LabCorp is essentially an at-home sample collection kit. Users will collect a sample using a nasal swab, seal it in a designated container, and send it to a LabCorp facility using the included shipping package. The analysis performed on the sample is identical to that conducted in laboratories worldwide. It employs RT-PCR (Reverse transcription-polymerase chain reaction) technology to convert RNA to DNA and search for specific sequences associated with SARS-CoV-2, the virus responsible for COVID-19.
A positive test result indicates an active COVID-19 infection. The FDA validates these results, but it is important to note that results from other at-home tests lacking an EUA are not recognized. The agency is collaborating with various firms to certify additional testing options, including at-home serological tests that detect antibodies in the bloodstream, indicating if an individual has had or currently has COVID-19.
Section 1.2: Availability and Costs
LabCorp also provides at-home collection kits for a range of other tests, including those for cholesterol, diabetes, and colorectal cancer. The most expensive of these kits is priced at $99, while the COVID-19 kit will be offered at $119. Currently, LabCorp has a limited supply of these kits and is prioritizing healthcare workers and first responders. Interested individuals must complete a brief survey on LabCorp’s website before purchasing the kit. The company intends to expand availability in the near future.
Chapter 2: Implications of Reliable Testing
The first video outlines the FDA's approval of the first at-home coronavirus test, discussing its significance in the ongoing pandemic.
The second video elaborates on the FDA's authorization of the first COVID-19 test kit for home use, providing insights into its impact on public health.
With dependable testing solutions, public health officials can effectively utilize contact tracing to pinpoint individuals at higher risk of infection. This advancement could pave the way for a gradual return to normal life.