Testing Letters | This Week in Virology

From Charles: Dear GOP Senator; When I have written to you in the past I have tried to see both sides of an issue. When it comes to our national response to SARS-COV-2, I can only see a needlessly failed policy. If you disagree, please explain the graph at: https://flic.kr/p/2jo9bxq It is a comparison of how we are doing with respect to the rest of the G8 countries. The graph has been normalized for population differences. I truly believe that the results are indefensible, but if you disagree, please try to convince me. We cannot go back in time, so I am not going to dwell on what we did wrong. Looking forward it is obvious we need more testing, a lot more. I see that the FDA approved Quest’s COVID-19 test for ‘pooled’ samples just yesterday. That is a step in the right direction, but it is not nearly enough. We need Warp Speed/ACTIV to put money into really cheap and fast testing that does not require a lot of training to administer. These tests just need to be good enough to catch those that are shedding infectious amounts of virus. As Dr. Fauci said during a recent interview (link below) about this exact topic, “don’t let the perfect be the enemy of the good”. According to Dr. Michael Mina (an Assistant Professor of Epidemiology at Harvard), testing often with fast turnaround is much more important than accuracy (links below). Bottom line, we need all of Congress to get involved in pushing/funding Warp Speed/ACTIV to develop SARS-COV-2 testing that can be performed by untrained or at the very most minimally trained personal, without special equipment, with the test performed on saliva, with results in about 10 minutes and cost of $1.00. This is not pie in the sky. We can do this and when we do, we can safely open businesses, schools and places of worship. We have very competent federal and university research labs that can take on a large part of the development that private enterprise may not want to. We are at war with SARS-COV-2 and we must bring all guns to bear on the virus. It is not acceptable to allow so many to die and for the economy to be destroyed when we can prevent it. Thanks, Charles Dr. Fauci link (13 minute mark): https://www.youtube.com/watch?v=a_Vy6fgaBPE Dr. Mina links: https://www.nytimes.com/2020/07/03/opinion/coronavirus-tests.html and (all of it is really good, but if you are in a hurry skip to the 22 minute mark) https://www.youtube.com/watch?v=kDj4Zyq3yOA From Lisa: Subject: Rapid, daily, inexpensive, at home, COVID-19 test exists. Solves safe school/economyreopening Hello, I am one of your constituents. Thank you for all of your hard work. The most pressing issue we all face today has to do with COVID-19. The technology for a rapid, inexpensive, at home, spit on paper, COVID-19 test (hereinafter referred to as the “rapid test”) exists and millions of tests can easily bemanufactured and distributed. This cheap, easy-to-use test, allows for frequent testing of a large percentage of the population and therefore, solves the problem of how to safely reopen schools and the economy. I am writing to ask you to please insist that: the FDA [or insert your country’s version of the FDA such as Health Canada]immediately license [use the word “authorize” instead of ‘license’ in Canada] therapid test andthe government immediately begin manufacturing and distributing the rapid tests. Background The rapid test can easily be taken at home. The test requires spit on paper and is simple to run. Results are given within minutes. (No blood, laboratory equipment or medical professionals are needed to run the test).At $1 per test, you can take a test every day. (Exact cost for the test will depend on a number of factors but a price this low is possible). Life could safely return to ‘normal’. For example, before going to work/school in the morning or attending a family gathering, everyone could test themselves.Several companies have developed the technology for a rapid test (and it is ready to be manufactured), but they are not asking the FDA [or insert your country’s version of the FDA such as Health Canada] to license [use the word “authorize” instead of ‘license’ in Canada] the rapid test because it is less sensitive than the current nasopharyngeal swab PCR (polymerase chain reaction) test. We do not need a test as sensitive as the gold standard PCR test to stop the spread of SARS-CoV-2. The PCR test is so sensitive that it can detect viral RNA at very low levels. At these low levels it is unlikely that people are actually transmitting the virus to others, i.e., at low levels, the PCR test may just be detecting leftover bits of RNA (not virus). The rapid test is accurate when the virus is present at high levels, i.e., when people are transmitting the virus to others. Because the rapid test is simple enough and inexpensive enough that it can be administered daily/frequently, it can identify the majority of people while they are capable of transmitting the virus to other people. This means that people can immediately self-isolate and stop the spread of SARS-CoV-2.The gold standard PCR test often fails to identify people during the short window of time (usually a few days to a week) in which they are capable of transmitting the virus to other people. This is due to the fact that the gold standard PCR test is usually only administered once due to its high cost, testing shortages, and logistics (it requires a testing location, medical professionals, and a laboratory to run). Furthermore, testing delays often mean that people who test PCR positive for SARS-CoV-2 often get the results days after they have stopped transmitting the virus to others.In order to stop the spread of SARS-CoV-2, we must change our testing strategy from the current method of infrequently testing with the gold standard PCR test to the frequent use of the rapid test so we can identify and isolate people when they are actually transmitting the virus.A large scale, daily/frequent, rapid test, testing strategy is very cost-effective. It’s much cheaper than a shut down.Current PCR nasopharyngeal swab testing is much more expensive and requires a laboratory to complete.It would eliminate the need for most contact tracing since people would be testing themselves daily so they would know if they had the virus.Not everyone needs to be tested daily. If a person is staying at home or lives in an area without (or with little) COVID-19, they may be able to test themselves less often. A large scale, daily/frequent, rapid test, testing strategy is very cost-effective. It’s much cheaper than a shut down.Current PCR nasopharyngeal swab testing is much more expensive and requires a laboratory to complete.It would eliminate the need for most contact tracing since people would be testing themselves daily so they would know if they had the virus. Not everyone needs to be tested daily. If a person is staying at home or lives in an area without (or with little) COVID-19, they may be able to test themselves less often. To learn more about the rapid test and its benefits, listen to the interview with Dr. Michael Mina on the podcast, This Week in Virology, episode #640 (specifically minutes 22-33). This podcast was released on July 16, 2020. (https://www.microbe.tv/twiv/twiv-640/). Dr. Mina is Assistant Professor, Harvard T.H. Chan School of Public Health, Center for Communicable Disease Dynamics, Department of Epidemiology. Dr. Mina cowrote, along with economist Laurence Kotlifoff (professor of economics at Boston University), an op-ed piece on this subject that was published in the New York Times on July 3, 2020. https://www.nytimes.com/2020/07/03/opinion/coronavirus-tests.html This Week in Virology is an outstanding podcast and I highly recommend all of the episodes. During the pandemic, they have done an excellent job of explaining issues related to COVID-19 in a manner that is accessible to both scientists and non-scientists. If you have any questions, please feel free to contact me. Thank you, [Insert your name] [Insert your address – so they know that you’re one of their constituents] P.S. It’s not just about reopening schools and businesses. It’s also about equity and accessibility. Firstly, the rapid test is more accessible because it’s inexpensive and it doesn’t require access to a medical professional. Secondly, the rapid test would also be extremely helpful to members of vulnerable populations, such as people over 70 and to people who are disabled, immunocompromised or have a non-COVID-19-related health condition. Many of these people have been unable to receive the homecare and/or healthcare that they need during the pandemic. From Jocelyn: Subject: paper strips printed with monoclonal antibodies for fast, frequent, cheap testing — we CAN open our economy, our schools safely Dear State Epidemiologists,This Week in Virology recently had a fascinating and helpful explanation & forum discussion with Dr. Michael Mina (Harvard School of Public Health) about how frequent and fast and inexpensive tests are more important than test sensitivity to stop the spread of SARS Cov2. The virologists and immunologists from Columbia University, University of Michigan, DREW, etc, on the panel were blown away, and I was too (a layperson). The technology has been available since early May but need to be scaled up quickly. If we can spotlight this proposal, it may get attention from the FDA, NIH and CDC and hopefully we can get governmental authorities to act.Here is the forum discussion with Dr. Michael Mina on This Week in Virology (TWiV):https://www.microbe.tv/twiv/twiv-640/ Here’s the written opinion from Drs. Laurence Kotlikoff and Michael Mina on those points: https://www.nytimes.com/2020/07/03/opinion/coronavirus-tests.html And finally, here is the MedCram episode (viewed by many in healthcare) that provides a summary and background of the This Week In Virology forum discussion: https://www.youtube.com/watch?v=h7Sv_pS8MgQ&feature=youtu.be If these tests become widely available and affordable, they can support to a great extent our schools’ and our states’ ability to safely re-open. Malcolm Gladwell said this about Dr. Mina’s proposal:”This is hands down the best and smartest and most hopeful (maddening) thing I have encountered since COVID began. Please listen.” (And Malcolm Gladwell links the TWiV episode #640): https://twitter.com/Gladwell/status/1284843069427388416 Dr. Seheult (co-founder of Medcram.com) closed the Medcram episode with these comments: “What you have here, potentially, is a test like this that’s pretty cheap, that you could pick up, that you could test daily and find out whether you’re infective. And if you were [infective], you could stay home and prevent infection to other people. This may be a way, potentially, to get out and get kids back to school, which is obviously the ideal situation. One of the reasons Dr. Mina points why we’re not seeing these [tests] as much is because these companies may be having a little bit of difficulty in terms of thinking how to get passed FDA approval. The FDA really wants to have some rigid standards in terms of how accurate the test is going to be. If [the companies] are working on that, then it’s going to raise the price of these tests. They believe that if there is a viral particle in the patient, the test should turn positive. When in fact, the practical definition of what we’re really looking for here when we’re trying to curb an outbreak is who is infective and who is not infective. And that may be completely different question than who has the viral particles and who doesn’t have the viral particles. Ideally, what you want is a very cheap test that everybody can self administer, that is widely available, and that will tell you whether or not you are infective.” I am cc’ing Dr. Michael Mina from Harvard University here, in case you have questions. Thanks and best regards, From Anonymous: Dear [Town …Person, etc]We need more testing to support reopening business, schools and places of worship. Testing needs to be local, with quality driven key metrics reported centrally to ensure appropriate surveillance and safety of the community. [insert why you are writing to day, eg: The recent case reported by local business is a good example of why we need to test, to reduce exposure risk to the community as we ramp up reopening measures.] Rapid, inexpensive, at home testing: The FDA approved Quest’s COVID-19 test for ‘pooled’ samples. This is a start. We need to put money into really cheap and fast testing that can be performed by the end user (at home)Tests are needed every day with rapid results just good enough to catch those that are shedding infectious amounts of virus. (links below from Dr. Michael Mina, Assistant Professor of Epidemiology at Harvard and Dr. Fauci)We have the technology to manufacture the rapid test that can easily be taken at home. The test requires spit on paper and is simple to run. Results are given within minutes. At $1 per test, you can take a test every day. (See Dr. Mina link below)University and federal research labs can front a large part of the development prior to scale up for manufacturing, which can be done by most companies printing paper. Local labs can be set up easily using equipment sourced from industry Key standardized metrics reporting from a central source allows stable surveillance and supports local risk levels Bottom line, we need to get involved in pushing/funding to develop SARS-COV-2 testing that can be performed by untrained, at home user with results in about 10 minutes and cost of $1.00. We can do this, we have the technology to do this, and when we do, we can safely open businesses, schools and places of worship. It is not acceptable to allow so many to die and for the economy to be destroyed when we can prevent it. Kind regards,[insert Self-Identification] Dr. Fauci link (13 minute mark): https://www.youtube.com/watch?v=a_Vy6fgaBPE Dr. Mina links: https://www.nytimes.com/2020/07/03/opinion/coronavirus-tests.html and (all of it is really good, but if you are in a hurry skip to the 22 minute mark) https://www.youtube.com/watch?v=kDj4Zyq3yOAhttps://www.medrxiv.org/content/10.1101/2020.05.01.20086801v1 Refer to the below podcast for great information on SARS-COV-2 https://www.microbe.tv/twiv/twiv-640/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+twivmp3+%28This+Week+in+Virology+-+MP3+Edition%29 From Jon: A scientifically validated approach — frequent, rapid, cheap paper-strip testing for the SARS-CoV-2 virus — could turn the tide, help reopen schools and businesses safely, and avoid untold deaths and further economic misery. PLEASE, Congresswoman Eshoo, read https://www.nytimes.com/2020/07/03/opinion/coronavirus-tests.html ! The author, Michael Mina, is an epidemiologist, immunologist & physician @ Harvard School of Public Health & Harvard Med School (https://twitter.com/michaelmina_lab) From age 18-65, I almost *never* contacted my representative; I’m determined to be heard now, because so much is at stake. The federal bureaucracy is moving too slowly, and the pandemic is ravaging the U.S. more than any other country. It’s a tragedy. It’s unnecessary. *It can be brought under control*. FREQUENCY is far more important than sensitivity for effective testing, and is absolutely critical to enable schools to reopen safely. Dr. Mina has shown how we can do it. PLEASE help him be heard, and overcome roadblocks from the FDA. I encourage your staff and you to go deeper into the details, e.g. listen to his chat with expert virologists and immunologists at https://www.microbe.tv/twiv/twiv-640/ (“This Week in Virology”, an authoritative, long-running podcast.) I would appreciate your directing your colleagues’ attention to these ideas. I am eager for your reaction, and for suggestions of other officials I should contact. Thank you for your attention! — p.s. I just called and left a message about this at your district office.
— Read on www.microbe.tv/twiv/testing-letters/

AmericaSpeaks TheVoiceOfJoyce 600+ Americans are asking Congress for the Rapid Cheap Frequent in house testing ! We want a scale up of these tests now! Use Charles’ letter as a template for writing to your Congressman. This is our real hope for resuming our lives safely.


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