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iDiagnostics® for All
The Handheld Future of Precision Medicine
This project is developed
by TIRF Labs
This blog invites you to share your opinions and ideas on emerging, propagating, combating and preventing epidemics and pandemics, such as COVID19. The ongoing COVID19 crisis demonstrated that U.S.needs a reliable national infrastructure, agencies, technologies, industries, tools and protocols that will help to prevent, isolate and combat invisible micro enemies, viruses and microbes that are capable of making damages, comparable or exceeding the explosion of nuclear bombs in metropolitan areas. Americans should create a biosafety infrastructure, capable of preventing and combating such biothreats as COVID-19 by efficient and affordable manners.
3-23-2020. Dr. William Haseltine, who recently returned from Wuhan, where he chaired the 9th US-China Health Summit, wrote:
“Someday there will be another lethal coronavirus epidemic. There will also be another highly lethal and transmissible strains of influenza, a global spread of antibiotic-resistant tuberculosis and antibiotic-resistant bacteria. The biological threats we face are not unknown - just like the current coronavirus outbreak was not unexpected among scientists. This outbreak is yet another lesson from the natural world - one we have ignored in the past and ignore in the future at our peril. If you live in an earthquake zone, you build earthquake-proof houses. If you live near a volcano, you pay close attention to the local seismometer and clear out when it goes off. Now we are on the alert today to take actions to protect ourselves against a dangerous virus. But will we forget again tomorrow? We will we ready for the next viral epidemic or pandemic? It is up to us to hold our leaders accountable now and in the future to step in and bring lifesaving drugs to market when others won't or can't.”
Dr. William Haseltine is a former Harvard Medical School professor and founder of the university's cancer and HIV/AIDS research departments. He also serves as Chair and President of the global health think tank, ACCESS Health International. Dr. Haseltine was at the heart of the United States response to the HIV/AIDS and anthrax crises.
3-18-2020. The Coronavirus COVID19 pandemic spectacularly manifested that our life environment, prosperity and lifestyle critically depend on our own knowledge, our swift and intelligent responses, as opposed to late and useless moves. We also critically depend on our local and national governments, their intelligence and their abilities to obtain true and correct information. The ability to obtain critically important correct information about the pandemic and to design efficient response depend on diagnostics. Without accurate, precise and rapid diagnostics you find yourself in a situation, which is similar to driving a car while you are a blind person.
Currently, in the US, a country which is bragged to have the most advanced healthcare, the first responders are suffering from severe deficiency of diagnostics. Many of COVID19 carriers are asymptomatic. Even if you have some severe symptoms, but do not exhibit the entire spectrum yet, most likely, will be denied to perform the COVID19 testing due to irrational shortage of the tests. The iDiagnostics will perform COVID19 testing in a matter of several minutes at the cost $1-2 dollars, using fresh samples taken in situ. Compare with the current most common PCR test, which takes approximately 5 hours to perform and costs ~$400 or more and requires shipping the perishable sample to the centralized lab.
The questions arise:
- What is the burden on national economy of such testing?
- How many under-diagnosed and un-diagnosed carriers are walking around to spread the virus?
- How to know that you are one of them, if your symptoms are not covering the entire spectrum of the official symptoms?
- Children do not die from COVID19? But recent studies show that COVID19 damages their lungs and other organs badly.
- If you have recovered, how to know that you do not carry COVID19 anymore and can go to work and social gatherings?
FDA Stops At-Home Tests
by Alex Tabarrok March 24, 2020 at 7:37 am in Current Affairs Law Medicine
…the U.S. Food and Drug Administration (FDA) has updated its Emergency Use Authorization guidelines to private labs that specifically bar the use of at-home sample collection. This means startups, including Everlywell, Carbon Health and Nurx, will have to immediately discontinue their testing programs in light of the clarified rules.
The FDA issued the updated guidance on March 21, and though some of the companies had already begun to ship their sample collection kits to people, and even begun to receive samples back to their diagnostic laboratory partners, even any samples in-hand will not be tested, and will instead be destroyed in order to compel with the FDA’s request
The tests are collected at home but the tests themselves are done in certified labs under quality-control standards (CLIA). It is of course possible, even likely, that tests collected at home are not as accurate as those collected by a trained nurse. But we don’t want trained nurses to be testing everyone–they have other things to do right now. Furthermore, some of these errors will be detected at the lab and can be fixed with a retest. False negatives are possible but going to a hospital or standing in line to get a test also comes with risk. False negatives will also become apparent to the extent that symptoms worsen at which time patients can seek medical assistance. Yes, of course, delay and false reassurance are also not without risk. Welcome to the world of tradeoffs. But at this point in time we need to unleash American ingenuity and enterprise and evolve our way to the frontier as conditions improve.