Source YouTube Video: First rapid concussion blood test approved by FDA - WGN News (video)
According to the news release:
"Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.” "
Read the full news release:
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The U.S. Food and Drug Administration (FDA), in response to requests from the U.S. Centers for Disease Control (CDC) and Prevention, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test, reports this FDA news release, "FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans." In essence, this authorizes the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products, made possible by this determination and declaration of emergency, provided certain criteria are met. The authorization ends when the declaration of emergency is terminated or the authorization revoked by the agency.
The FDA Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories is intended to enhance the quality and reliability of test results submitted by importers to demonstrate that their products meet the FDA's requirements. The guidance advises importers how to use accredited -- rather than non-accredited -- laboratories and makes recommendations about the quality and type of test data and information that these laboratories should produce in support of test results submitted to the FDA. The draft guidance is also intended to reduce the likelihood that an importer will select only favorable test results to submit to the FDA. This draft guidance supports the FDA's import strategy emphasizing prevention of harm, intervention when risks are identified, and rapid response after harm has occurred.
The statistics make me nervous. Your personal safety might be at risk, reports this excellent Health Care Blog post, The MRI Safety Gap. If you're headed for an MRI, you'll want to bone-up on the safety risks. It seems that more accidents and harm are happening in the MRI suite. The blog post tells the full story of flying missiles, getting burned, and more. If you're one of approximately 30 million folks (per year) getting an MRI, read the post.
For more detailed information:
JCAHO Sentinel Event Alert: Preventing accidents and injuries in the MRI suite
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Way cool! Now you can connect an alcohol breathalyzer to your iPod or iPhone, reports this LA Times news article, "Blow into the iBreath and your iPod plays a blood-alcohol alert. Measure your blood alcohol level, and avoid driving while you're drunk. For about $80, you buy the iBreath from David Steele.com. How would you use the iBreath?
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This recent Journal of Urology abstract, "Clinical and Consumer Trial Performance of a Sensitive Immunodiagnostic Home Test That Qualitatively Detects Low Concentrations of Sperm Following Vasectomy, concludes that SpermCheck Vasectomy, a simple and reliable immunodiagnostic test, can provide evidence of vasectomy success or failure, and offers a useful alternative to improve compliance with post-vasectomy sperm monitoring. It is currently the only FDA-approved test for this purpose. Monitoring is important because vasectomies are not 100 percent successful, and men who have had them can experience recanalization, or spontaneous healing, leading to restored fertility. Traditionally, after a vasectomy has been performed, the monitoring process involves bringing semen samples to a doctor's office or laboratory at two- and three-month intervals after the procedure. This at-home test is designed to help couples monitor and confirm that post-vasectomy sperm concentrations have reached infertile levels and avoid any surprises. The device is undergoing commercialization through a start-up company.
Updated May 24, 2016 - broken elements removed
This brings back memories of my days working in the emergency room. This is the ongoing saga of who's gaming whom, read this news article found on the CBS website, "Drug-Test Cheats Try New Tricks - Experts Say Internet And Household Products Bring New Challenges To Drug Testing." In my opinion, it's a leap-frog phenomenon. The tests and testers get better, then the cheaters get craftier, and on and on it goes.
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Creating test data for clinical computing or software is always a challenge. I found this interesting and helpful article on the 21 CFR Part 11 blog, "Protecting test data privacy when testing protocol amendments," which describes how to mask real data. This is important for a couple reasons. First, it's all so important to guard protected health information (PHI). Therefore, it's critical to avoid the easy path of testing with real live, production information about people. Second, creating meaningful, usable, test data from scratch can be an arduous task. Protect the privacy of the health information, and happy testing.
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