Phlebotomists process specimens of people getting tested for coronavirus antibodies in Spring Valley. ; Credit: Yana Paskova/Getty Images

As of Tuesday afternoon, L.A. County has at least 1,314 deaths and 27,836 confirmed cases of coronavirus.

New confirmed infections per day in the U.S. exceed 20,000, and deaths per day are well over 1,000,000 according to figures from Johns Hopkins University. And public health officials warn that the failure to flatten the curve and drive down the infection rate in places could lead to many more deaths — perhaps tens of thousands — as people are allowed to venture out and businesses reopen. From the marbled halls of Italy to the wheat fields of Kansas, health authorities are increasingly warning that the question isn’t whether a second wave of coronavirus infections and deaths will hit, but when — and how badly. President Donald Trump said his COVID-19 task force would keep working but focus more on rebooting the economy. According to the Orange County Register, more OC beaches received approval to open with limited hours.

Today on AirTalk, we get the latest on COVID-19. Do you have questions for our infectious disease specialist? Join the conversation by calling 866-893-5722. 

With files from LAist and the Associated Press 

Guest: 

Peter Chin-Hong, M.D., infectious disease specialist and professor of medicine at the UCSF Medical Center; he tweets @PCH_SF

This content is from Southern California Public Radio. View the original story at SCPR.org.

Deputy Chief Patricia Cassidy of the Jersey City Police Department has blood drawn to test for coronavirus antibodies in Jersey City, N.J., on Monday.; Credit: Seth Wenig/AP

The Food and Drug Administration is stiffening its rules to counteract what some have called a Wild West of antibody testing for the coronavirus.

These tests are designed to identify people who have been previously exposed to the virus. The FDA said more than 250 developers have been bringing products to the market in the past few weeks.

In a rush to make antibody tests available as quickly as possible, the FDA had set a low standard for these tests. Manufacturers were supposed to submit their own information about the accuracy of their wares, but the agency had no standards for what would be acceptable. Companies weren't allowed to claim the tests were authorized by the FDA, under initial guidance issued in mid-March.

Now the FDA is telling manufacturers that if they want their tests to remain on the market, they must meet minimum quality standards and submit a request for emergency use authorization, a temporary route to market for unapproved products when others aren't available. The EUA involves a lower standard than the usual FDA clearance or approval.

The FDA said 12 manufacturers have already opted to request EUA's for their products. More than 100 other producers have been talking to the agency about using this process, said FDA Commissioner Stephen Hahn. He spoke on a press call Monday. Companies have 10 days to submit that request.

"Our expectation is that those who can't [meet the new standard] will withdraw their products from the market and we will be working with them to help them do that," he said.

These tests are now so widespread that people can order them from lab giants Quest or LabCorp. The tests can cost more than $100. Though the FDA's original guidance calls for these tests to be run by a certified lab, the kits themselves are simple to use and have been readily available.

Despite the enthusiasm surrounding these tests, they have substantial limitations. Though people who test positive for antibodies have in most cases been exposed to the coronavirus, scientists don't know whether that means those people are actually immune from the coronavirus, and if so for how long.

"Whether this is the ticket for someone to go back to work [based solely on an antibody test result], my opinion on that would be no," Hahn said.

The tests may be more useful when combined with information from a standard coronavirus diagnostic test, or in someone who has symptoms, or if the results have been confirmed with a different antibody test. That "would dramatically increase the accuracy of those tests," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health

Antibodies are a potentially valuable research tool, and can be used to determine the prevalence of a disease in a population. In that circumstance, individual false results are less important. New York State used antibody tests to determine that about 20 percent of people in New York City have already been exposed to the coronavirus.

In California, researchers have attempted to measure the prevalence of the coronavirus in Los Angeles County and Santa Clara County in the Bay Area. Those unpublished results have garnered criticism because even a test that's more than 99 percent accurate can produce many false positive results when used to survey hundreds or thousands of people.

In the face of this criticism, the authors of the Santa Clara study have posted revised results acknowledging the high degree of uncertainty in their findings. Those findings haven't been peer-reviewed.

The emergency use authorization is only valid during the time of the national emergency. "Once the national emergency ends, the EUA authorizations end as well," Shuren said. Companies that want to keep marketing these tests will need to get them approved through the regular, more stringent FDA process.

FDA officials say they will continue to crack down on companies that falsely claim their tests are approved by the FDA, or that market them for home use, which isn't currently allowed.

You can contact NPR Science Correspondent Richard Harris at rharris@npr.org.

This content is from Southern California Public Radio. View the original story at SCPR.org.

Source: Streetwise Reports   05/06/2020

Testing has been an Achilles heel of the coronavirus pandemic, but ProMIS Neurosciences Inc. (PMN:TSX; ARFXF:OTCQB) has partnered with Dr. Hans Frykman and the BC Neuroimmunology Lab to use its unique technology to create a more accurate antibody test for SARS-CoV-2, the virus that causes Covid-19.

Two main types of tests exist for Covid-19: one that detects the presence of the virus that causes Covid-19, which indicates a person has an active infection, and another that detects antibodies, showing that a person has been exposed to the virus.

The first test that was developed, a test for the presence of the virus, is used mainly to confirm diagnosis of Covid-19 in people who are showing symptoms such as a fever, a dry, persistent cough, difficulty breathing, a sense of restriction in the chest. "They are typical signs of Covid-19, but we would want to know if these are signs of the common flu or a bad cold or Covid-19. We know that Covid can progress really significantly very quickly, especially in individuals with underlying conditions," ProMIS CEO Dr. Elliot Goldstein told Streetwise Reports. "The number of tests is limited, but it's not actually the tests themselves but the reagents and systems you need to run the test that are in short supply."

"Anytime you conduct a test for the virus and get a negative response, the test indicates only that on that day at that time, the person does not have the virus. The person could have had Covid and recovered, or might have had an asymptomatic or very mild case. Or that person could get the virus tomorrow or in three days," Dr. Goldstein explained. "At any point in time the virus test helps indicate the prevalence of the virus—how many people are actually infected—if you test broadly, and at the time you do it, you can determine whether an individual is currently infected or not."

The second type of test, called serological tests or assays, is also known as an antibody test. "When a person is recovering from a viral infection, the immune system makes antibodies—also called immunoglobulins—that are specific to the virus. They neutralize the virus and help clear it out; that's part of the mechanism of why you get better," Dr. Goldstein explained.

One way to see if a person has had Covid is to test for antibodies. "A positive test means you've been exposed to the virus because, in the absence of a vaccine, that's the only way you would have the antibodies. While it's not 100% certain that antibodies neutralize the virus, based on experience with other coronaviruses, it is likely," Dr. Goldstein said. Having the virus neutralized should offer at least some protection against future re-infections.

People who have had positive virus tests know that they have Covid or had Covid and recovered, but many people are asymptomatic or may have had what felt like a light cold, and they want to know if they are at risk, or if they have some protection against the disease. "This is really important for frontline healthcare workers, people working 8-10 hours a day in intensive care or the emergency room with patients known to be very sick with Covid-19; even with protective equipment, they have significant exposure to the virus," Dr. Goldstein explained. "If someone has been through the disease and has natural antibodies, they can't infect someone else. What you want to know on an individual level is am I safe from infection and am I safe for other people."

Generally, antibody testing is a fairly common procedure, Dr. Goldstein explained. When you spin blood in a centrifuge, it separates into three parts: red blood cells, plasma and serum. Serum is where you find antibodies. "ELISA (enzyme-linked immunosorbent assay) is a standard test that looks for antibodies, but it is not specific enough for the Covid-19 virus."

The challenge is there are multiple coronaviruses. "Four different coronaviruses are responsible for the common cold, and then there are others like SARS and MERS. They all have the same sort of halo or corona of protein around the outside of it," Dr. Goldstein said. "They look like the old naval mines used in war. The whole family of coronaviruses look like that. The amino acid sequences of different coronaviruses are not identical but very similar; they share a lot of common structures. There are only really small differences and you can't really pick them up using the usual physical methods."

Studies have shown that up to 90% of individuals in Western countries have been exposed to one or more of the common cold coronaviruses and have antibodies against them. "They look very similar to the coronavirus causing Covid-19. So in Covid-19 antibody tests, the most important thing is it has to be highly specific for the Covid-19 antibodies and doesn't test positive when it identifies a common cold antibody. That is a false positive," said Dr. Goldstein. "It's actually much safer not to have a test that has a lot of false positives because you could base a behavioral decision on faulty information."

Dr. Goldstein cited an example. "If you are testing 1,000 people and there is a 90% prevalence for the cold virus, that means around 900 people have antibodies to the common cold. If the prevalence of the Covid-19 virus is 2%, roughly 20 of the 1,000 would have antibodies to the Covid-19 virus. Let's say the serology test has 95% specificity. That means five times out of 100, it will give a false positive, indicating the presence of Covid-19 antibodies when it is really picking up antibodies against the cold virus. What this means is 5% of 900, or 45 people, will test positive for Covid when they have not had it, and are making decisions based on incorrect information. The consequences of being wrong are dramatic and highlight the need for a very good, high-quality serological test."

How does this relate to Alzheimer's and other neurological diseases that are ProMIS' core competency? "In Alzheimer's, ALS, frontotemporal dementia, Parkinson's disease and other neurological disease, we've been able to use our proprietary, unique technology to identify sites on misfolded proteins that are driving these diseases. Our core technology is the capability to understand what's special about the bad proteins that are causing these diseases and then we can make antibodies highly selective against them. Our technology allows us to identify a region, an epitopes target, which is a series of four to six amino acids where the protein has misfolded. Not only do we know where this target site is located, importantly we also determine the shape (conformation) of this site. Proteins like amyloid and alpha synuclein and TDP 43 misfold and when these proteins misfold they become toxic, they kill neurons, resulting in disease," Dr. Goldstein explained.

ProMIS has transferred that thinking to the virus causing Covid-19. "The corona is composed of the spiky protein. Remember, we want to be able to distinguish between the coronavirus causing the common cold and the coronavirus causing Covid-19," Dr. Goldstein said. "If we can distinguish between the two, we can have an antibody test that's specific for Covid-19. We are looking at a region of the virus called the receptor binding domain, the RBD, that is part of the spike protein and how it attaches to cells. We have a core competency that allows us to identify sites, and not just the location of the sites, but the shape of the sites on complex protein molecules. That allows us then to use that knowledge to create either antibodies or to create serum tests, or even quite frankly, we can use those targets to create vaccines."

Using ProMIS' proprietary technology, the company has been able to "identify a site that we believe is only present on the Covid-19 virus and not on other coronaviruses. We are now initiating the synthesis of several different forms of that site; it's a small area," Dr. Goldstein stated. "That would then transfer to Dr. Hans Frykman's lab at University of British Columbia, a world-class serology lab. Then we will see if the targets we've identified are specific and selective antibodies against Covid-19."

When you test the serum of an individual, if they've been exposed to the virus and have the antibodies, "those antibodies should bind selectively and specifically to the target. So if the antibodies from the patient's serum are binding to the target site, we know it's a Covid-19 virus because that site is only visible in that shape on the Covid-19 virus and not the others. For the validation of our test, only in patients known to have had Covid-19 should we see binding of antibodies against Covid-19 to our target. The second validation is based on testing in serum from subjects known to have never been exposed to Covid-19 virus—such subjects have antibodies only from cold or other coronaviruses, and therefore the antibody test should be negative; there should be no binding. So we should only see binding in serum from a patient known to have recovered from COVID-19, and we should not see binding in serum from an individual known not to have been exposed to COVID-19," Dr. Goldstein explained.

"Our technology basically allows us to zero in with sniper-like precision on the structure of a protein and understand it, not only the structure overall but the shape of the regions on that protein and then that allows us to identify what is specific to that protein, in this case the spiky protein on the virus causing COVID-19," said Dr. Goldstein.

ProMIS expects to have initial results in June.

Disclosure:
1) Patrice Fusillo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: ProMIS Neurosciences. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of ProMIS, a company mentioned in this article.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: PMN:TSX; ARFXF:OTCQB, )

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