Global Health Effects on Markets and Mining Stock

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As was noted in an earlier post, confusing case-fatality rate with mortality is not a valid predictive model. Such early prediction based on limited data collection lacks widespread testing of the population. Added to the confusion is the so-called “death rate” that is properly a retrospective percentage of the population that was infected, and usually not available until some years after an outbreak is fully analyzed. As more and more data is collected, multiple problems requiring input with multiple variables will deliver a variety of more accurate solutions. The predictive models are changing daily with the increasingly more complexity, so stay tuned to reliable sources of information.

Note that Abbott’s rapid testing platform that is becoming widely available is an RT-PCR viral test. We were clearly behind on our available testing, but rapidly catching up. We have yet to have available the other half of the solution, a rapid antibody testing platform that is needed to separate the sick, from the recovered sick with antibodies that eliminate the virus, and those that have not yet caught the COVID-19 virus in the population. Such an antibody test is being developed through collaborative efforts around the world. Here is an excerpt from a very long article why the most common method of testing, RT-PCR tests, are not always reliable. Read the entire article if you would like to understand the full context:

COVID-19 testing

The RT-PCR tests are just one way to test for the virus – and it only detects it when people are still acutely infected, and the virus is still making all that RNA to make all the proteins it needs to make more of itself and infect more cells.

Once the virus is “conquered” by a person’s immune system, that viral RNA isn’t there anymore; however, evidence of the proteins made from it is – the immune response that allowed the body to fight off the virus involved making little proteins called antibodies that recognize specific pieces of the viral proteins as “foreign” and trigger an immune response.

After the initial infection, it takes a while for the body to develop antibodies against it – the process involves the viral proteins getting chopped up and their pieces placed “on display,” held by proteins jutting out from immune cells. Your body goes through a random “trial and error” approach to making antibodies that recognize (bind to) those viral protein pieces and then make more of the matching antibodies. More here: Antibodies – production, types & uses in the lab – The Bumbling Biochemist

Some of these antibodies stick around after the infection’s over to “keep watch” so that, if that same virus tries again, the immune system doesn’t have to go through the trial and error phase of finding an appropriate antibody. So, tests that look for antibodies can see if someone previously had the virus, even after they’ve recovered, and this can be used to trace cases back to see the line of transmission even if the transmitters are no longer symptomatic and don’t have the RNA that the RT-PCR tests could detect.

The antibody tests are quicker and they’re typically done on blood samples, but a downside with them is that, since they come from the immune response finally gaining some ground on the virus, they can’t detect the virus as early in an infection, while the RT-PCR way can.

COVID-19 testing – The Bumbling Biochemist

There’s another fascinating story that I’ll post a link to for those who may be interested on how RT-PCR testing was even developed. Here is some excerpts from “the story” with the link included and a brief explanation of how it works:

Key ingredient in coronavirus tests comes from Yellowstone’s lakes
Today, those enzymes are a key component in polymerase chain reaction, or PCR, a method used widely in labs around the world to study small samples of genetic material by making millions of copies. This technique, which would have been impossible without the discovery of heat-resistant bacteria more than half a century ago, is now being used to boost the signal of viruses in most of the available tests for COVID-19.

As the novel coronavirus sweeps around the world, testing has become the crux of tracking—and hopefully slowing—the pandemic’s advance. While authorities have been slow in making COVID-19 tests widely available in the U.S., the PCR process that is the vital backbone of the test is relatively simple and quick, thanks to a cluster of bacteria thriving in the thermal pools of Yellowstone.

Since the discovery of DNA’s elegant double helix in 1953, scientists have grappled with the challenge of studying these tiny genetic molecules. To see and understand different types of DNA, scientists needed large scale samples.

For years, PCR testing was “super laborious, it took forever,” says Julie Huber, an oceanographer at Woods Hole. “But now it’s so easy and routine.”

The COVID-19 test uses this same process—but with a few additional steps. The genetic material of the novel coronavirus is RNA, rather than DNA, which is similar but encodes its genetic instructions with different building blocks in just a single strand. The RNA of the virus is converted to DNA first. The test also includes a fluorescent tag that highlights the copies of the virus’ genetic material in a nasal swab. The more copies that are made with PCR, the brighter the sample.

Key ingredient in coronavirus tests comes from Yellowstone’s lakes

But what I really wanted to post is a major part of the “game changer” by Abbott labs. One should also note the system we had in place until very recently was tightly controlled centrally by the CDC, which is largely a data collection agency and policies regulated by the FDA. It is now decentralized into FDA certified commercial labs (private enterprise) and state health agencies, which are proving to be a much more efficient and logical solution for rapid large scale population testing:

ABBOTT LAUNCHES MOLECULAR POINT-OF-CARE TEST TO DETECT NOVEL CORONAVIRUS IN AS LITTLE AS FIVE MINUTES

  • The Abbott ID NOW™ COVID-19 test brings rapid testing to the front lines

  • Test to run on Abbott’s point-of-care ID NOW platform - a portable instrument that can be deployed where testing is needed most

  • ID NOW has the largest molecular point-of-care installed base in the U.S. and is available in a wide range of healthcare settings

  • Abbott will be making ID NOW COVID-19 tests available next week and expects to ramp up manufacturing to deliver 50,000 tests per day

  • This is the company’s second test to receive Emergency Use Authorization by the FDA for COVID-19 detection; combined, Abbott expects to produce about 5 million tests per month

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in as Little as Five Minutes - Mar 27, 2020

Apologies again for a much too long post, but I have not had access to my home computer for some time! There is so much information available and things are going to scare the daylights out of much of the uniformed public, as well as those who are informed! Much of the “information” is just opinion and unreliable. I urge all of you to stay well informed, take precautions, and stay safe.

One more if you care to watch an investigative youtube from an Australian 60 Minutes feature, it is very scary!:

https://www.bing.com/videos/search?q=Journalist+goes+undercover+at+"wet+markets"%2C+where+the+coronavirus+statred+60+minutes+australia&docid=608033735093913698&mid=2FC875BAAB66F7644E7E2FC875BAAB66F7644E7E&view=detail&FORM=VIRE

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Who?? that decided that the World Health Organization’s decision to name the disease caused by the virus, COVID-19. The name does not clearly designate its origin in China, allowing the Chinese regime to whitewash its bungled response to this outbreak.
**… Don’t be afraid to call this virus for what it is, The CCP virus.

*** Let’s all remember ** Throughout history, the key events of a crisis are thought by those living through them in the moment to be indelibly seared into everyone’s minds. In reality, though, it is often the case that even in the most cataclysmic of times, many people forget some of the most important facts.!!! Sure, historians who study this in the future will recount that it was the Chinese government that bears the lion’s share of culpability for the 2020 Covid-19 pandemic.
But there is no reason to assume that the preeminent view among these historian will translate automatically to the common knowledge — “now or in the future”.
This is why it is so important, to reinforce this essential fact in the casual terminology we use to describe the disease: By calling it the “CCP Coronavirus,” people will never forget whose malevolent negligence it was that started the fire that eventually engulfed the entire world.
C.S.

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You might find this interesting. Discovery of Patient Zero in Wuhan and China’s sloppy attempts at covering it up. I Found The Source of the Coronavirus - YouTube

The bat virus research center 280 meters from the wet market in Wuhan is well documented.(Is there any possible way that this could be a coincidence?) Here is a mainstream story about the bat lady who worked there but who has since retired. I believe a researcher hired to replace her is Patient Zero. (She and others were splashed with urine/blood samples from the bats.) https://www.scientificamerican.com/article/how-chinas-bat-woman-hunted-down-viruses-from-sars-to-the-new-coronavirus1

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Good point C.S. Before the virus was first given it’s official cover-up name it was referred to as the Wuhan virus. It’s a result of a decision in 2015 by our not so wonderful WHO to be PC. The WHO wanted to discourage names that refer to geographic places in order to avoid stigmatizing a region or it’s people. “CCP Coronavirus” is a much more appropriate name than COVID-19. Now try to get that put into a peer reviewed paper or scientific journal!

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I liked the American astrophysicist Neil deGrasse Tyson’s ad into to your media clip. Very good video report!

Did anyone catch the following coming out of the general media, or am I so bored at home that I’m the only one that still scans the “news” and media? What passes as news and which is actually fact?

Despite previous reports that coronavirus had been traced to bats, most likely the kind that could be found in wet markets like the one in Wuhan, a new report from Botao Xiao and Lei Xiao of the South China University of Technology suggests that there’s a more likely scenario — a leak from a lab.

The report detailed the tracing of COVID-19 to the intermediate horseshoe bat — a bat that they confirmed was not available at the Wuhan wet market and did not live locally. In fact, the report noted that native populations were no closer than 600 miles away from the first known cases, making a natural transmission from bat to human appear more unlikely.

The only place those particular bats existed locally was inside a research facility — which was just several hundred yards from the Wuhan wet market — and the paper’s ultimate conclusion was that the coronavirus pandemic had likely been the result of a leak from the lab: “The killer coronavirus probably originated from a laboratory in Wuhan.”

The U.S. Intelligence Community reportedly presented President Donald Trump with a highly classified report last week that confirmed that communist China lied to the world about the number of cases and deaths it’s suffered from the novel coronavirus, COVID-19, which originated in China.

“China’s public reporting on cases and deaths is intentionally incomplete,” Bloomberg News reported, according to three U.S. officials that it spoke to. “Two of the officials said the report concludes that China’s numbers are fake.”

“The reality is that we could have been better off if China had been more forthcoming,” Vice President Mike Pence told CNN in an interview on Wednesday. “What appears evident now is that long before the world learned in December that China was dealing with this, and maybe as much as a month earlier than that, that the outbreak was real in China.”

CNN’s Jake Tapper highlighted a report yesterday from Radio Free Asia that stated that the number of deaths that China reported is significantly lower than the truth. RFA reported:

Wuhan resident Chen Yaohui told RFA that city officials have been handing out 3,000 yuan in “funeral allowances” to the families of the dead in exchange for their silence.

“There have been a lot of funerals in the past few days, and the authorities are handing out 3,000 yuan in hush money to families who get their loved ones’ remains laid to rest ahead of Qing Ming,” he said, in a reference to the traditional grave tending festival on April 5.

Chen said nobody in the city believes the official death toll.

“The official number of deaths was 2,500 people … but before the epidemic began, the city’s crematoriums typically cremated around 220 people a day,” he said.

“But during the epidemic, they transferred cremation workers from around China to Wuhan keep cremate bodies around the clock,” he said.

Bloomberg News’ report comes after The Daily Mail reported last week that scientific advisers reportedly told British Prime Minister Boris Johnson that the communist China downplayed the true extent of the coronavirus outbreak in their country and that the real number could be “15 to 40 times” higher than what China has reported.

“Mr Johnson has been warned by scientific advisers that China’s officially declared statistics on the number of cases of coronavirus could be ‘downplayed by a factor of 15 to 40 times,’” The Daily Mail reported. “And [the British government] believes China is seeking to build its economic power during the pandemic with ‘predatory offers of help’ [to] countries around the world.’”

A recent Washington Post analysis warned against viewing the numbers out of China as being truthful. The Washington Post reported:

An article in the journal Science estimates that 86 percent of Hubei’s cases were undocumented by the time authorities extended the lockdown to Wuhan and other cities on Jan. 23.

It is also likely that officials reported lower numbers of deaths from covid-19, the disease caused by the coronavirus. Especially once the central government’s propaganda mission to win the “people’s war” against the virus became clear, numbers shifted to achieve that vision. Such shifts would probably be subtle — not hundreds or thousands of hidden deaths, but instead excluding deaths that could be attributed to other types of pneumonia or heart failure, for instance.

China also has a history of lying about epidemics that originate within its borders.

On April 21, 2003, during the SARS outbreak, The New York Times reported that China admitted to under-reporting the total number of SARS cases:

In a rare public admission of failure, if not deception, the Chinese government disclosed today that cases of a dangerous new respiratory disease were many times higher than previously reported, and stripped two top officials of their power. […]

Admitting to the existence of more than 200 previously undisclosed SARS patients in military hospitals, the official, Deputy Health Minister Gao Qiang, said that as of Friday Beijing had 339 confirmed cases of SARS and an additional 402 suspected cases.

Ten days ago, Health Minister Zhang Wenkang said there were only 22 confirmed SARS cases in Beijing. Last Wednesday, the World Health Organization caused a stir here by estimating that there could be as many as 100 to 200 cases.

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If anyone is looking for a good book to read while in lockdown.
It has to do with “Effect on markets”. Stealth War

How China Took Over While America’s Elite Slept

by Robert Spalding

Narrated by Ray Porter

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When will this end? When will the economy restart? What might be lurking around the corner?

The virus prediction models that have been floating around lately have been modeled around the initial first wave this Spring and don’t show what will happen next winter. What happens if you run them till they complete? These all show a super second wave to hit next Winter. The author of this article suggests that the several months of social distancing will actually cause the peak to be much worse next Winter as it would have been otherwise muted by seasonality effects if the peak had occurred over the Summer. The virus will not stop till everyone is infected or a vaccine is produced. See link below. The peak being experienced now is barely a blip compared to what is coming next Winter?! How long can people stay locked in their homes to prevent the second wave without the economy falling back to the stone age?https://medium.com/@wpegden/a-call-to-honesty-in-pandemic-modeling-5c156686a64b https://medium.com/@wpegden/a-call-to-honesty-in-pandemic-modeling-5c156686a64bgraphfile

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194M total infections? certainly a much smaller number than the previous Billions of infections that were being projected a few weeks/months ago.

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Just for the U.S. i.e. 194 million out 327 million to become infected unless a vaccine becomes available sooner than expected.

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Daily case growth rate
Daily case growth rate1278×1364 186 KB
![Daily
Daily Growth Rate of Deaths
Daily Growth Rate of Deaths1270×1296 106 KB

Source is NYT - is recent spike in NY deaths possibly due to very restricted access of Dr’s ability to prescribe hydroxychloroquine on a compassionate need basis?

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Still have strong doubts about the usefulness of hydroxychloroquine. Note that its usage has been widespread in Italy so certainly no miracle cure. I think controlled studies will show that it has little or no benefit for severe cases but probably it will show benefit in resolving less severe cases quicker which helps with hospital overcrowding. I believe its usage for the H1N1 flu was hyped at one time as well before controlled tests showed 0% benefit. Still, if I come down with the virus, I would hope they give it to me. Not much else, is there?

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I think you are correct, it is most useful the earlier it is used in one who has been exposed or infected. For those more severe cases, or those already on a ventilator, a plasma infusion (or gamma globulin) is the best available therapy, which is also available under compassionate use.

Here’s an excerpt from WebMD on an explanation of how it works:

In the UK, Robin May, Professor of Infectious Disease at the University of Birmingham, explained that there is a scientific rationale for the use of hydroxychloroquine in the treatment of COVID-19, based on its mode of action in malaria.

In a statement through the Science Media Centre, he explained that, as chloroquine is a “weak base” and so helps to neutralise acids, it makes the environment “less suitable” for the malaria parasite to live in when it diffuses into red blood cells.

While the mode of action against COVID-19 is not established, Prof May said, he pointed out that many viruses enter host cells via endocytosis, as a result of which they are initially taken up into an intracellular 'compartment that is "typically fairly acidic”.

"Chloroquine would alter the acidity of this compartment, which can interfere with the ability of viruses to escape into the host cell and start replicating.”

He continued: "Another possibility is that chloroquine may alter the ability of the virus to bind to the outside of a host cell in the first place,” adding that the drug "has subtle effects on a wide variety of immune cells…and it may be that one of these effects helps stimulate the body’s ability to fight off COVID-19.”

Crucially, the drug is also “cheap and relatively easy to manufacture” and so could easily be put into clinical trials and, eventually, treatment, May underlined.

A very simple retrospective analysis could be done to see if it has preventative or curative effects. The highest risk group, seniors, are also the group most likely to be taking the drug hydroxychloroquine for Lupus or or Rheumatoid Arthritis. Medicare and Medicaid has an Rx list of those under these programs who have been receiving this drug. The rerospective study would answer the question; “Is the incidence of CCP Coronavirus been reduced from the general population, especially in the Nation’s hot spots?” This study to date has not been undertaken.

Also, part of the rationale for not promoting this drug may be to assure that there was not a shortage. Hydroxychloroquine should be available for those already with an Rx for medical reasons. There is now more availability to use this drug for more than Lupus and Rhematoid Arthritis. For compassionate use an Rx is still needed by a physician. New York is not allowing it’s use for the CCP Coronavirus without going to an Emergency Room first!

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Are certain states neglecting seniors by prohibiting appropriate use of Hydroxychloroquine? At least they finally reversed a “bad” decision by their Board of Pharmacy. (Read the entire article, please.) The following is selected excerpts only:

Malaria drug used to treat coronavirus patients at Oregon veterans home

After hearing that hydroxychloroquine could be effective, Dr. Rob Richardson began treating eight of the veterans with it and an antibiotic called azithromycin, also known as Z-Pak.

“I was using it to give them a fighting chance,” Richardson told The Associated Press in a telephone interview.

A doctor at the veterans home in Lebanon used a malaria drug to treat eight patients there for coronavirus, but said a state rule enacted last month would prevent him from treating any more veterans there.

The Oregon Board of Pharmacy had adopted a temporary emergency rule March 25 prohibiting the dispensing of chloroquine and hydroxychloroquine “for presumptive treatment or prevention of COVID-19 infection.”

The board said it took the action to preserve supplies for treatment of malaria, inflammatory conditions, and documented COVID-19 infection in hospitalized patients.

But after pushback against the Oregon Board of Pharmacy’s March 25 rule, the board amended it on Wednesday to allow the drug to be used not only in hospitals for confirmed COVID-19 cases, but also long-term care facilities like the Edward C. Allworth Veterans’ Home.in the second week of March, the first cases of the coronavirusbegan emerging at the veterans home, when two men fell ill with COVID-19. Then more got sick.

Among those treated appears to be William Lapschies, one of the first two confirmed cases. Lapschies celebrated his 104th birthday Wednesday at the veterans home and doctors have declared him fully recovered, said his daughter, Carolee Brown of Lyons.

Malaria drug used to treat coronavirus patients at Oregon veterans home - oregonlive.com

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This just came out…no evidence of benefit in severe cases: No evidence of rapid antiviral clearance or clinical benefit with the combination of hydroxychloroquine and azithromycin in patients with severe COVID-19 infection - ScienceDirect

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Are virus base or acid ?
.https://drsircus.com/general/viruses-are-ph-sensitive/ ;

…Now of course you’ll find the negative Nancy postings calling him a quack . Every doctor that went against the established Big Pharm gets labeled that.

The first person that questioned that maybe the body had electrical currents going through it was labeled a quack also. Nobody thinks that of a EKG now.

**A person can test themselves with test PH test strips bought on line, if, you want to see where your body is at.

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Who Makes Generic Plaquenil?

Generic hydroxychloroquine is made by many different companies, including:

  • Mylan Pharmaceuticals
  • Sandoz
  • Teva Pharmaceuticals
  • Watson Laboratories.
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A new treatment regimen was used by Dr. Mohammud Alam (an infectious disease specialist) for treating the elderly with CCP Coronavirus. The use of hydroxychloroquine with doxycycline instead of azithromycin is receiving greater attention. Again, read the full article for context, as I extracted only a few details for brevity:

Long Island doctor tries new twist on hydroxychloroquine for elderly COVID-19 patients

“Since we’re talking about the elderly being the most vulnerable, or people with underlying conditions, there is a theoretical benefit of doxycycline over azithromycin because doxycycline is not associated with cardiovascular disease,” said Dr. Sten H. Vermund, the dean of the Yale School of Public Health.

Alam began treating his patients, 45 of whom had tested positive for the coronavirus after they developed a high fever, shortness of breath and cough.

His patients were under long-term acute care and had comorbidities such as hypertension, coronary artery disease, chronic obstructive pulmonary disease or congestive heart failure.

The FDA has warnings that azithromycin “can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm.”

“Doxycycline is an anti-inflammatory with properties similar to azithromycin but without the safety concerns and without cardiac toxicity,” he said.

“So I decided why not choose that?” added Alam, a board-certified internist, who shared the results of an observational report consisting of 47 patients he treated.

Again, these patients had tested positive for CCP Coronavirus. It has been shown that patients are best treated with a regimen of hydroxychloroquine in the earlier stages of infections. With elderly patients there can be a very rapid onset of the disease leading to a severe cytokinetic storm. It may be too late in the disease process for hydroxychloroquine to be effective in patients at this stage of the disease. Hospitalization in the ICU for these late stage severe cases may find that convalescent plasma is of greater benefit and may additionally necessitate the use of a ventilator.

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Wide-spread mass testing needs to occur, and soon!

A few days ago I started to write a response to several things in the thread, but new information and new models were appearing so rapidly! I was going to start by simply stating that the contagion factor for CCP corona virus is incredibly high. Controlling the rate of how quickly it spreads is useful to model solutions in formulating strategy, policy and treatments. The goal is to minimize the total number of deaths while not exceeding the ability of the healthcare system to treat those who are ill. This must be accomplished without overwhelming the system. Allowing more patients to arrive at the same time than the hospitals can support would destroy healthcare. The public health policies need to concentrate the efforts primarily in the metropolitan areas where the highest population densities exist, and focus on elder care facilities to protect the most vulnerable.

Models are multivariate, focusing on specific areas, and therefore attempt to explain different aspects of the same problem while working towards solutions. This approach results in many models depending on which assumptions predominate. It is now thought that the “COVID-19” corona virus is 3X more contagious than seasonal flu (1.3 RO seasonal flu vs 5.7 RO “COVID-19” - median value from Los Alamos National Lab). It is thought that there are many factors that have slowed the spread of the virus including social distancing, therapeutic measures, and testing to verify presence of the virus, to name but a few. Original unmitigated models showed more than a million deaths in US. With mitigation and other factors, the resulting data predicts fewer deaths from “COVID-19”. The newer IHME model estimates 60K deaths by end of August.

Many models start out by looking at historical data to see if a similar pattern emerges. I’ve looked at how the CDC/FDA had an inaccurate model of the H1N1 virus, but it took years to show how inaccurate this early model was as revealed in their written report three years later.

“The clearest sign of the progress in modeling comes from flu forecasts in the U.S.” Disease modelers gaze into computers to see future of Covid-19 - STAT

This reminds me of a multi-year graph of hospitalizations from seasonal flu just released by the CDC:

CDC Seasonal Flu Hospitalizations2011-2020
CDC Seasonal Flu Hospitalizations2011-2020524×616 83.5 KB

Much of the attention lately has significant misinformation concerning the early use of hydroxychloroquine. That has already been covered ad nauseam, but do look at the previous post and link!

Now to what this post was really going to be about in the first place!
There is a great deal of attention turning to the subject of testing and Abbot’s new testing platform. Abbott’s new m2000 RealTime System received U.S. Food and Drug Administration approval for use in hospitals and molecular laboratories to diagnose the infection. Unfortunately this system is not yet widely being used, or on line, yet. There are 120 certified labs that have this system and test kits, but only 87 are on-line and reporting to the CDC/FDA! According to Dr. Birx, that is being addressed and corrected. So how have approximately 1 million tests or more already been run?

The RT-PCR (reverse transcription-polymerase chain reaction) test is widely used, can be run on a variety of available test kits, and on the older and slower ID Now platforms (Abbott). The ID Now platform is the most common point-of-care test currently available in the U.S., with more than 18,000 units spread across the country. It is widely used to detect influenza, strep throat and other respiratory viruses. Both systems are rapidly ramping up for wide-spread population testing and data collection. Results need to be on line and sent to the CDC to have a comprehensive database!

Between the two platforms, Abbott expects to produce about five million tests per month. It is an RT-PCR type test kit with reagent. The test takes a short segment of RNA and amplifies it to identify the viral pathogen specific to “COVID-19”. Use of the RT-PCR technique identifies the RNA nucleic acids from a nasal swab or nasal wash samples, thereby detecting the active virus, but does not test for the presence of anti-bodies.

You may have already heard there is one Colorado town that has taken a first step into seeing who in their town has the presence of antibodies.

Colorado ski town will test everyone for coronavirus

By Rachael Rettner - Senior Writer

The town will offer coronavirus testing to all 8,000 of its residents, for free.

Town officials will use so-called ELISA tests, which detect antibodies against the new coronavirus in people’s blood. When a person is infected with the new coronavirus, called SARS-CoV-2, their immune system typically develops long-lasting antibodies against the virus within 10 days, ABC news reported. This means antibody tests can reveal what percentage of the population has ever been infected with the virus, even if those tested aren’t currently infected. In contrast, tests used to diagnose the new coronavirus disease, COVID-19, look for SARS-CoV-2’s genes in samples taken from people’s noses and throats, which indicate that a person is actively infected with the virus.

Colorado ski town will test everyone for coronavirus | Live Science

So, with so much new information, do not confuse the RT-PCR Viral test with the antibody tests. The antibody tests are actually quite widely available and being used. These are not yet approved by the FDA for “COVID-19”, although applications have been submitted. There are two methods in use for detecting antibodies. The lateral flow device (LTD) and the enzyme-linked immunosorbent assay (ELISA) have a similar quantitative result. Both are established technologies for detecting DNA in protein specific antibodies. Most of the companies that have IVDs are in the universities or held by private enterprise (corporations).

The FDA Regulates In Vitro Diagnostic Device (IVD) Studies

Updated USFDA guidance issued on March 16, 2020, allows the distribution of many of these types of test kits product for diagnostic use in laboratories or by healthcare workers at the point-of-care.

https://www.fda.gov/media/135659/download

Test kits for the qualitative detection of CCP Coronavirus (“SARS-CoV-2 / COVID-19”) N-Protein IgM / IgG antibodies in human serum, plasma, or whole blood are the gold standard sought for rapid testing. These run on widely available industry standard platforms used mostly for allergen testing in the manufacturing of various products. These antibody tests detect both early marker and late marker, IgM/IgG antibodies in human finger-prick (capillary) or venous whole blood, serum, and plasma samples. This is the basis for the well-known and established ELISA test for detecting components of the immune system. They are investigative at this point for “COVID-19”, but may become widely available relatively soon. Already, there have been 70 submissions for approval to the FDA specifically for “COVID-19” antibody tests that have been developed.

Early investigation shows the highest positive rate of the antibodies against the virus appears 21 - 40 days after the onset, and may have a positive result for years. The IgM is a shorter-lived component that shows up early, and the IgG component remains much longer and is responsible for immunity that may last for years. A titer level, the quantitative concentration of an antibody, is not yet established for “COVID-19” that assures immunity, but is presently being investigated. It is desired that both the RT-PCR and ELISA tests are run together showing if a person has both immunity and no active disease. It is thought that such a ”recovered person” could donate "convalescent” plasma safely and this hypothesis is actively being investigated. Additionally, this dual antigen and anti-body testing would assure that a person could safely return to the work place. Companies could use both these testing methods, RT-PCR and ELISA/LTD, to recommend the appropriate precautions to take in allowing employees to return to work. (The above information is loosely paraphrased from various public sources and some referenced excerpts.)

The nation’s public health policy decisions must first address the issues of containment, treatment and immunity while incrementally allowing an economic recovery to return as quickly and safely as is possible.

Do continue to use safe practices for self and others. Stay well!

EZ

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OK, here come three in a row. I’ve put off this post for a few days waiting for someone to post something new. I know the CCP virus is still of great importance to those reading this thread as the coronavirus continues to greatly impact all our lives. I understand there is so much information out there it’s not easy to make a lot of sense out of all of it, let alone focusing in on some of it. Sifting through all the opinions, emotions and media coverage creates quite a controversy. Most of the controversies continue to argue weighing and balancing the different possible policies to prevent the CCP coronavirus from overwhelming the health care system and keeping the population safe. Avoiding continuation of the economic devastation that resulted is finally starting to be addressed in a balanced strategic way. Why has it taken so long? Every wonder why there is a two-week quarantine imposed? Why have we had the 30 day “shelter at home” recommendation imposed nation-wide? Why has there not been wide-spread population testing? Is it reasonable to expect a full implementation of both viral (RT-PCR) testing and antibody (primarily ELISA) testing to allow the economy to recover before resuming most normal activities? I hypothesize the following to answer some of those questions:

Initially, testing and widespread containment measures were imposed with the intent of preventing the healthcare system from collapsing. That goal has largely been achieved. I have some skepticism as to whether this was needed in many of the more rural areas of the country. As best I can tell, several “time targets” are being used to test different hypotheses and set public health policies accordingly. Because “experts” believe there is a maximum and minimum amount of time needed to test whether a potential exposure will result in expression of symptoms that differs from merely the expression of anti-bodies, testing is now moving forward. To be sure, the capability for this testing did not exist, but is rapidly under development.

After an initial exposure the immune system may identify the virus as an “invader” and start producing anti-bodies almost immediately, but not always. The viral RT-PCR test takes as little as 2 days or as many as 10 days to test positive and identifies the presence of the virus. There is some evidence that an additional 3 days past clinical recovery is needed to assure the virus is not still being shed. So how does one test if that is true? What is the quantitative concentration of antibody that attains a protective level? Testing should first be applied to all individuals with symptoms of the flu and Covid-19 in order to distinguish the appropriate diagnosis and treatment.

First, I hope I didn’t over emphasize the need for mass population testing. It probably isn’t necessary, nor is it possible to repeatedly test the entire population as some have suggested. Targeted and intensive testing should be aimed at those areas identified as the most likely vulnerable populations. Results would indicate appropriate measures to prevent and identify potential outbreaks. Small random testing of non-symptomatic populations would map the viral spread. There are major differences between viral RT-PCR testing and the antibody IgM/IgG (ELISA) tests, and what each is actually testing and identifying. The antibody tests actually aren’t that useful for population risk modeling until after the peak hospitalization has started to decline. That “time target” has apparently been reached in many areas. It now makes sense to use and actively perform ELISA testing for the presence of antibodies. Investigators need to determine a titer level that offers protection. How long this protective titer persists also needs to be determined by repeated sampling over extended periods of time.

The risk of an outbreak will be different in different areas of the country. For instance, Idaho on average has a population density of 20 per sq.mi, whereas New Jersey registers 1,200 (List of States By Population Density ). Should the same containment measures be applied in all states for the same length of time? The utility of using these two different tests for mass testing is multi-fold, but may be applied differently regionally. Multivariate analysis will be used to model and consider different variables that may be correlated with each other. It makes sense for both tests to be performed within the workplace for each employee to safely return to work. Both antigen (viral RT-PCR) and anti-body (IgM/IgG, ELISA) tests should first be given to all those currently working and prioritized for healthcare works, first responders, law enforcement, those in public transit work, and other essential jobs.

An anti-body test gives some assurance (in conjunction with a negative RT-PCR test) that a person has “recovered” and can safely return to work. But this broad statement is not entirely true in many instances! What about the individual that had a minor exposure to the virus and successfully creates enough anti-bodies to dispose of the viral invasion quickly? Would this result in a case where the RT-PCR antigen test is negative (no virus) and the ELISA test is positive for the presence of anti-bodies? Is it possible that someone with a very responsive immune system that is repeatedly exposed to low levels of the virus (i.e. some health care workers, average food shopper in metropolitan areas) have increasingly higher levels of anti-bodies due to repeated low-level exposures to the virus? How would we test for this?

The additional information from doing both tests shows how wide-spread the virus has penetrated in the population. However, it does not identify those who have expressed the disease and recovered from those who have only been exposed. Some individuals that have been exposed and produced antibodies have not had a clinical expression of the disease. It may not positively show immunity for those that have had a mild case of the disease. The antibody level in some individuals may not register a sufficient concentration to be protective to future exposures. Multiple small population testing is currently underway and looking to see just how wide-spread the virus exposure is in different parts of the country. We know metropolitan areas are at greater risk of wide-spread contagion than some of the less populated areas.

As already noted, the RT-PCR test takes a significant amount of time, a minimal of several days, to register a positive test, which is one reason for a false negative early on after an exposure. Symptoms of disease generally show up between 2 and 12 days (average is 5-6 days). RT-PCR is the diagnostic test used to confirm the more severe cases - directly tied to hospital reimbursement initially and used to avoid a severe patient overload to some individual hospital systems. That deserves a much longer discussion, perhaps saved for another day. The diagnostic test could have been used more widely if tests were available (they were not) to prescribe medications for those who stayed home with the flu, or those with milder cases of the CCP corona virus. Up until recently, only the severely ill were tested to diagnose if admission to the hospital was necessary, and determine the appropriate treatment regimen to be followed.

So back to the antibody tests … they really don’t measure significant and persistent levels until the immune system has mostly become effective in clearing the virus, roughly 2 weeks to a month and a half after infection. How far are we into the “stay at home” mitigation? Oh, just a little past the one-month mark! It appears mass testing for antibody tests is now starting with a purpose and strategy. Returning people to work safely and providing a reservoir of donors for convalescent plasma to treat other patients can now start in earnest. It appears most geographic areas have nearly reached or passed peak levels of infection and are declining. Is the planned strategy now being employed? These same “donors” would need to be retested periodically for the next year (or longer) to see when a peak titer (quantitative concentration level) has been reached and sustained. There is a problem with incidental low-level exposures that don’t result in expression of the disease; the concentration of anti-bodies circulating in the blood may not be protective against an acute exposure to the virus. Follow-up testing is needed for recovered patients to show if immunity is sustained as indicated by the maximum levels of IgM/IgG antibodies reached and sustained, and that the RT/PCR test is still negative.

Until now, not only were we unprepared to do these type of tests, the data models were only geared to show the worst possible outcome based on retrospective historical models and limited inaccurate “current” information of this pandemic. Current data changed modeling rapidly and “experts” learned more each day. Public health policies were set accordingly, and now need to be adjusted again based on the increased data available nationally and world-wide. Data is still incomplete, however. Some level of mass testing is required not only for determining the lethality of the CCP virus, but the level of penetration and geographic distribution of the coronavirus in the country. Yes, we are ready for strategically sound effective mass population testing of limited size to start. We still don’t know what proportion of the population had milder forms of the disease or those that were exposed and remained asymptomatic. We’ll hear much more on this the next couple of weeks as the ideal “timing periods” have just been reached and passed.

An excerpt from the author’s conclusion of an article that appeared a couple of weeks ago in the NYT states, “ I am deeply concerned that the social, economic and public health consequences of this near total meltdown of normal life – schools and businesses closed, gatherings banned – will be long lasting and calamitous, possibly graver than the direct toll of the virus itself.” The full article titled, Is Our Fight Against Coronavirus Worse Than the Disease? – There may be more targeted ways to beat the Pandemic. By David L Katz, MD

Control of this coronavirus is well underway. Besides testing, many therapeutic treatments are under investigation and engaged in clinical trials; these include Remdesivir, Chlorquine, Hydroxychloroquine, Leronlimab, EIDD-2801 (Ridgeback Biotherapeutics, LP) and Ivermectin to name but a few. (COVID-19 Treatment Update: Remdesivir, Hydroxychloroquine, Leronlimab, Ivermectin, and More ). Coordinated effort to model and find solutions is being led by the COVID-19 High Performance Computing (HPC) Consortium ; members manage a range of computing capabilities that span from small clusters to some of the largest supercomputers in the world. COVID-19 HPC Consortium

This group is Co-chaired by Paul Dabbar (DOE) and Dario Gil (IBM) and includes groups from Industries, US Federal Agencies, Academia and the Department of Energy and National Labs. There is much more coordination going on than the general media reports. Things are progressing well to find solutions. Defeating the CCP coronavirus and returning the nation back to normal life is a priority of effort by all Americans.

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Note that an antibody report just came out showing 21% have been infected in NYC with 3 or 4% in the rest of the state. They randomly asked people entering grocery stores for tests. There are likely some problems with the test/methodology but might be the best one done to date. I did a quick review of expert opinion on it and it appears mixed but probably a little on the high side of reality. (The commonly used tests have a high rate of false positives with the error compounded by extrapolating it to the population of the whole city.)

One other thing to note, a follow-up study of those on the princess cruise ship showed I think a majority of those that appeared to be asymptomatic actually had visible lung damage per CT scan that is likely permanent. This completely blows out of the water the notion that most will come down with a “mild” case of the disease as it doesn’t make sense to describe something as “mild” that leaves permanent lung damage!

I think a lot of people are going to be surprised that they have indeed already been exposed to the virus after anti-body tests become wide spread. Since my area is a hotbed of infection, and I had a very extended period of coughing back in January/February, it wouldn’t surprise me if I had an early case of it.