COVID-19 Tests | Wish List

Howzitgoing
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Joined: Mon Jul 13, 2020 8:37 am

COVID-19 Tests | Wish List

Post by Howzitgoing »

Current swab/PCR tests evaluate if someone is currently positive with COVID-19.

An antibody test determines if someone already had the disease.


Is it possible for one test to determine with 90-100% accuracy both conditions, that is, CURRENTLY positive and/or PAST positive (antibodies)?

Reinfection is a major question, in addition to how long does immunity last, accuracy of tests are and, of course, scaling/manufacturing a test for (preferably) immediate home results.

There's hope.

https://www.biospace.com/article/monash ... d-19-test/
Australian Researchers Develop 20-Minute COVID-19 Antibody Test
Jul 17, 2020

The test can use 25 microliters of plasma from blood samples and is a simple agglutination assay. It is used to detect antibodies in response to SARS-CoV-2 infection. This is, as mentioned, an antibody test, which evaluates whether the individual had already had COVID-19. The more current swab/PCR tests evaluate if someone is currently positive with the disease, whereas an antibody test determines if someone already had the disease.
trader32176
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Re: COVID-19 Tests | Wish List

Post by trader32176 »

it looks good at first ,but after reading this - not so good .
while population screening to determine the extent of viral infection across communities is a longer-term need.
this brings more Karens to your front door .-imo
letting the clinical trial volunteer data always prove it out first , and not the general public later for screening , or tracking
would be another option
trader32176
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Re: COVID-19 Tests | Wish List

Post by trader32176 »

Connecticut says it found testing flaw, 90 false positives

https://www.thewesterlysun.com/news/cov ... 9e0d5.html

Scientists at Connecticut's public health laboratory say they've discovered a flaw in a manufacturer's testing system for the coronavirus that's used by labs around the country. So far, it's resulted in 90 people - mostly residents of Connecticut nursing homes and assisted living facilities - recently receiving false positive tests.

State public health officials are now reviewing whether nursing home residents who received false positive tests were grouped with other residents with accurate positive tests, given the state's recommendation to cohort nursing home residents who test positive for COVID-19.

“We don't know that yet,” said Josh Geballe, Gov. Ned Lamont's chief operating officer, noting that a team from the state's Department of Public Health has been reaching out to every clinician responsible for those individuals, as well as the facilities where they live, and compiling data on the situation.

Meanwhile, Dr. Deidre S. Gifford, the state's acting public health commissioner, said her agency is also reaching out to labs throughout the state to see how many of them use the testing platform manufactured by Thermo Fisher Scientific.

Yale epidemiologist and researcher Dr. Albert Ko, who co-chaired Lamont's reopening advisory committee, said the particular test is being used in many commercial labs around the U.S. He said the employees at Connecticut's state laboratory deserve “a shout-out” for discovering the flaw because it not only highlighted a potential problem in nursing home testing but “helped people all over the country who are using that test.”

But Ko noted that no test is perfect.

“In a state like ours, which is using large-scale, intense testing to keep down transmission, we are going to have false positives,” he said. "And that’s going to happen even in the best of tests because none of them are 100% positive."

DPH said the affected patients were originally tested between June 15 and July 17. A total of 144 tested positive and 90 were discovered to be false positives. The state has reported the flaw to the manufacturer and to the federal Food and Drug Administration. In a written statement, the agency said the exact cause of the false positive results is still being investigated.

Any nursing home resident that had a false positive COVID-19 test result will be retested as soon as possible, DPH said.

DPH said the false positive test results were discovered by DPH laboratory scientists while examining previously positive samples to determine the feasibility of testing “pooled” specimens at the state lab. Dr. Jafar Razeq, director of the state lab, said staff were looking at the “background information” of the specimens and “we realized that these specimens shouldn’t have not been reported as positive.”

As of Monday, there have been more than 48,000 positive cases statewide in Connecticut, a figure that grew by 162 since Friday. Lamont said Connecticut's positive rate is 0.6%, still among the lowest in the country. Meanwhile, the number of COVID-associated deaths increased by 10 since Friday, for a total of 4,406. Hospitalizations dropped by 12 to 54.

———

CONNECTICUT QUARANTINE RULES

Lamont said Connecticut is planning to require out-of-state travelers from states with high COVID-19 infection rates to fill out online travel health forms, the latest effort to beef up Connecticut's 14-day quarantine requirement. Lamont also warned there could be a $1,000 fine for violators.

Lamont said Connecticut is working with New York, New Jersey and Massachusetts on the concept where people will be required to fill out the form before they land at Bradley International Airport or drive into the state, possibly from other regional airports. He said Connecticut Department of Public Health staff will be Bradley, making sure people have filled out the form, which will include information about which state the person came from, where they're staying in Connecticut and how they can be reached.

Lamont said enforcement of the quarantine requirement will evolve over time.

“But we want to send the message loud and clear, as you look at the incredible infection rates in other parts of the country,” he said. “We know that COVID came to this part of the country by airplane and we don’t want it to come by airplane again. So we’re being particularly strict about how we do that going forward.”

The state is still exempting travelers from those states with high infection rates from the 14-day quarantine if they can prove they've tested negative in the past 72 hours.

———

Follow AP coverage of the pandemic at https://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak.
trader32176
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Re: COVID-19 Tests | Wish List

Post by trader32176 »

FDA authorizes first test for asymptomatic Covid-19 cases

https://www.cnn.com/world/live-news/cor ... index.html

7/24/20

The US Food and Drug Administration has authorized the first coronavirus test for asymptomatic Covid-19 cases and for those who don’t think they’re infected with the virus at all.

The agency reissued an emergency use authorization for a LabCorp Covid-19 RT-PCR test after the company provided scientific proof that the test was able to detect the virus in asymptomatic people. RT-PCR tests amplify genetic matter from the virus so it’s detectable.

The emergency use authorization also allows the test to be used on pooled samples.

“Today's authorization eliminates the need for a provider to consider risk factors such as exposure or community spread when prescribing this test,” the FDA said in a statement.

The test could be a game changer for hospitals, businesses, schools and others, the FDA said.

"FDA's authorization of the first diagnostic test to be used for anyone, regardless of whether they are showing symptoms of Covid-19 or have other exposure risk factors, is a step toward the type of broad screening that may help enable the reopening of schools and workplaces," FDA Commissioner Dr. Stephen Hahn said in a statement Friday.

The FDA’s emergency use authorization for the LabCorp test also allows the company to test pooled samples of up to five individual swabs at a time to help test more samples using fewer testing supplies, which are in high demand and short supply in some areas.

"By authorizing another test for use with pooled samples, we also further help increase the possibility that patients may be able to receive results sooner, while also conserving vital testing supplies, which are under increased demand during the pandemic,” Hahn said.

The test is only available through a prescription, the FDA said, and is only authorized for sample collection with LabCorp’s test kits or by a health provider.

The test first received an emergency use authorization in mid-March for testing only on people suspected of having Covid-19 and was not authorized for pool testing.
trader32176
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Re: COVID-19 Tests | Wish List

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The road to COVID-19 testing: The role of a Canadian biotech pioneer

7/29/20

https://theconversation.com/the-road-to ... eer-143176


Canadians are updated daily on the multi-faceted devastation caused by SARS-CoV-2 and on the results of COVID-19 testing from across the country. Few people may be aware that these tests are based on a method innovated by the first-ever biotech company, Cetus, co-founded in California by Canadian-born and educated Ron Cape. He was Cetus’s first president in 1971, and then chairman and CEO.

Biotech was nonexistent before this. Cape obtained his PhD at McGill in 1967 with John Spencer as his supervisor, who was one of the pioneers in DNA biochemistry. At the same time, Cape was president of the Professional Pharmaceutical Corporation in Montréal.

The method used globally to test for the presence of the SARS-CoV-2 virus that causes COVID-19 is known as the polymerase chain reaction or PCR. This revolutionary innovation was developed at Cetus by in-house scientist Kary Mullis. Awarded the Nobel Prize in chemistry in 1993, Mullis received the only Nobel Prize for a discovery made by a biotech company.

DNA technology was the key strategy for Cetus’s business plan when the company was founded by Cape and his partners. In 1983, Kary Mullis discovered a method to exponentially amplify specific sequences of DNA in the test tube. He called it the polymerase chain reaction.

His key insight was to use an enzyme that was active at high temperature to copy DNA. This DNA-copying enzyme, known as Taq DNA polymerase, had itself been discovered by David Gelfand and Susanne Stoffel at Cetus.

Amplifying DNA

Biologist James Watson and physicist Francis Crick described the structure of DNA in 1953: two strands that are stable in a double helix structure. Each strand of DNA is aligned anti-parallel (parallel but running in opposite directions) with another complementary strand, held together by what are known as hydrogen bonds. These bonds are broken by heat.

Mullis wanted to find a way to make multiple copies of DNA that itself could be used to make the proteins that Cetus wished to commercialize as therapeutics for cancer. His insight was to design a method to do this using Taq DNA polymerase.

Mullis designed a protocol using varying temperatures and repeated cycles to amplify DNA. He first used a high temperature to separate the double strands of DNA. Lowering the temperature allowed the Taq DNA polymerase to copy and extend sequences along the DNA strands. Once a cycle of copying was done, the temperature was raised again to re-separate the strands allowing for continuation of another amplification cycle.

With Cetus, Mullis designed a machine, the thermocycler, to enable the repeating of such cycles to make exponential amounts of DNA, much like a nuclear chain reaction — hence the term polymerase chain reaction.

PCR and SARS-CoV-2 testing

The genes in the SARS-CoV-2 virus are stored as RNA, not DNA. The standard testing protocol is to take a deep nasal swab from a patient. To detect the virus by PCR-based tests, the RNA of the virus is copied into DNA using another enzyme called reverse transcriptase. It is this copied DNA which is used for PCR amplification.

The urgency for a cure for COVID-19 has made science discoveries move at an accelerated pace. On Jan. 11, the gene sequence of the SARS-CoV-2 virus was made openly available from scientists in China. By Jan. 24, the World Health Organization made available PCR-based protocols to test for SARS-CoV-2.

The legacy of Montréaler Ron Cape and the first biotech company is the PCR test we use to detect COVID-19 disease.

Canada’s National Microbiology Laboratory in Winnipeg set up the SARS-CoV-2 test for COVID-19 based on the data distributed by WHO in January 2020 for PCR testing.

The Public Health Agency of Canada regulates the National Microbiology Laboratory. The PHAC was created in 2004 after the SARS outbreak of 2003, as a consequence of a devastating report written by David Naylor, who was then dean of medicine at the University of Toronto, regarding Canada’s lack of preparedness for the lethal SARS outbreak.

Advancing Canada’s testing expertise

Testing is our only way to know who has been infected, where and when. The lack of coherence and standardization of tests and the communication of the results should be unacceptable today given the recommendations of the 2003 Naylor report on SARS.

Genome Canada harbours exceptionally talented scientists whose expertise is the mapping of genomes. The agency is undertaking heroic efforts to help Canada’s COVID-19 response.

Using Genome Canada’s testing expertise through its six genome centres could help address the gap in complete, accurate and permanent testing and reporting for the expected next SARS-CoV-2 surge, or the next pandemic.

If not now, after COVID-19, when?
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TimGDixon
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Post by TimGDixon »

Very interesting Trader.
trader32176
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Tim,
sometimes Trader exists in genetoland , not gellatoland on other platfroms. :lol: :lol: :lol:
trader32176
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Test sites quickly attract thousands for COVID-19 vaccine study

8/7/20

https://www.news-medical.net/news/20200 ... study.aspx


Dr. Eric Coe jumped at the chance to help test a COVID-19 vaccine.

At his urging, so did his girlfriend, his son and his daughter-in-law. All received shots last week at a clinical research site in central Florida.

"My main purpose in doing this was so I could spend more time with my family and grandchildren," Coe said, noting that he's seen them only outside and from a distance since March.

"There's a lot less risk to getting the vaccine than contracting the virus," said Coe, 74, a retired cardiologist. "The worst thing that can happen is if I get the placebo."

The Coes' eagerness to offer up their bodies to science reflects the widespread public interest in participating in the pivotal, late-stage clinical trials of the first two COVID vaccine candidates in the United States.

Those trials began rolling out July 27. During the next two months, vaccine makers hope to recruit 60,000 Americans to roll up their sleeves to test the two vaccines, one made by Pfizer and BioNTech, a German company, and the other by biotech startup Moderna. While small tests earlier this year showed the preventives were safe and led to participants developing antibodies against the virus, the final phase 3 testing is designed to prove whether the vaccine reduces the risk of infection.

Amid a pandemic that in the U.S. has caused roughly 5 million infections and nearly 160,000 deaths while decimating the economy, the vaccine trials have drawn far more interest than is typical for a clinical trial, organizers said.

Also, the test sites pay volunteers as much as $2,000 for completing the two-year study.

"We have no shortage of volunteers and we have thousands of people interested in participating," said Dr. Ella Grach, CEO of M3-Wake Research of Raleigh, North Carolina, which is conducting vaccine trials at six sites.

Eric and Lisa Coe volunteered for a COVID-19 vaccine trial at a clinical research site in central Florida last week, after Eric's father, also named Eric, recommended it. During the next two months, vaccine makers hope to recruit 60,000 volunteers to test two vaccines - one made by Pfizer and BioNTech, a German company, and the other by Moderna, a biotech startup. (Mary Shambora)

Paul Evans, president of Velocity Clinical Research in Durham, North Carolina, said his company plans to recruit more than 10,000 volunteers in seven states to test COVID vaccines. At least four of Velocity's sites - in Ohio, California and Oregon - have already started injecting volunteers with the Moderna vaccine.

"It's been phenomenal," he said. Patient recruitment is one of the biggest challenges to running trials, but this time patients have been eager to sign up.

"I've been working in this business for 30 years," said Evans. "Outside of a COVID study, you might have to reach out to four or five, up to 10 people to find [one person] who is suitable."

Other vaccine candidates are being tested abroad and more tests will be launched in the U.S. later this year.

People 18 and older are eligible to participate in the trials, and Moderna and Pfizer are pushing to include high-risk individuals such as health workers, the elderly and people with chronic conditions such as diabetes and asthma. Organizers are also seeking to enroll Blacks and Hispanics, groups hit hard by the virus.

The vaccine makers have contracted with dozens of clinical research sites across the country. About 15 have started inoculating, and it will likely take until September for all volunteers to get their first shot. The participants will get a booster shot about a month later. They are asked to keep an electronic diary to record any symptoms. Because the virus is widespread across the country, the studies are expected to be able to note differences between infection rates in those who got the vaccine and those who received a placebo.

Government health experts say they hope to know if the vaccines are working by this fall. If the trials are successful, it would likely take until early next year before a vaccine could gain federal approval to start widespread distribution.

To determine effectiveness, half of the trial participants will receive the vaccine and half a placebo.

Dr. Eric Coe jumped at the chance to help test a COVID-19 vaccine at a clinical research site in central Florida. "There's a lot less risk to getting the vaccine than contracting the virus," says Coe, a retired cardiologist in Leesburg, Florida. "The worst thing that can happen is if I get the placebo." (Eric Coe)

Coe, of Leesburg, Florida, said that several hours after getting his shot on Saturday he developed chills and was tired, symptoms that lasted until Sunday afternoon. "I'm virtually certain that I did not get a placebo because normal saline would not do that," he said. His daughter-in-law, Lisa Coe, 46, said she did not have any reaction other than soreness at the injection site.

"We are eager to get the vaccine and get on with the normal course of our lives," she said. "I'm not too worried about my own health, but I am worried about unknowingly transmitting it to anyone at risk."

Dr. Bruce Rankin, a physician investigator at Accel Research Sites in DeLand, Florida, where the Coes got their shots, said more than 1,000 adults have volunteered there already.

Accel recruits on social media sites such as Facebook and Instagram. It prescreens volunteers to make sure they understand what's expected, to learn their basic health history and get other demographic information such as race.

"I thought the opportunity to be part of something like this would be very cool," said Ginny Capiot, 45, of Fayetteville, North Carolina. "I believe it's pretty safe and there wasn't much to lose."

Capiot works in the marketing department at a hospital, where her diabetes puts her at increased risk of serious complications from the coronavirus.

Her visit to the test site last week lasted about three hours. After she filled out paperwork, health workers registered her temperature and other vital signs, gave her a COVID-19 test via a nasal swab and then took some blood. After Capiot was inoculated, she had to wait in a room in case she had any reaction. She did not.

"My arm is not even sore," she said a couple of days after the vaccination.

Volunteers in DeLand are paid as much as $1,200 over the course of the two-year trial. Participants in the Velocity-run trials will each receive $1,962 in compensation for time and travel. But Evans said many are motivated by altruism.

Ginny Capiot, of Fayetteville, North Carolina, is participating in one of the COVID vaccine trials. She works at a local hospital and also has diabetes, putting her at increased risk for COVID-19 complications. "I thought the opportunity to be part of something like this would be very cool," she says. "I believe it's pretty safe and there wasn't much to lose." (Rachael Santillan)

"They understand a couple of things," he said. "This has to happen for us to get a resolution or a solution to the pandemic. They also understand that there's a chance if they get the active vaccine and it works, they will benefit."

Not everyone is excited to test the unproven vaccine.

Dr. Atoya Adams, principal investigator for AB Clinical Trials, which is testing the Moderna vaccine in Las Vegas, said recruiting efforts there found that some people were confused or skeptical. They mistakenly worried they could contract COVID-19 from the vaccine.

The vaccines do not include any live virus. Earlier, smaller studies showed few major safety issues.

Adams has spent a lot of time on the phone, explaining that the vaccine appears safe and that volunteers are needed to see whether it's effective. "I've literally had to tell patients in prescreening, it's something I would feel safe giving to myself or my family," she said.

George Washington University in Washington, D.C., hopes to enroll 500 people at its testing site, and it received inquiries from at least that many in just the first week of recruitment.

"It's been overwhelming and really highlights that everyone understands the need for a vaccine," said Dr. David Diemert, professor of medicine at the GW School of Medicine and Health Sciences.

To gain an ethnically and racially diverse group, the university reached out to food banks, senior living communities and churches looking for volunteers. Participants can get paid nearly $1,100.

In Mississippi, the Hattiesburg Clinic has generated strong interest among potential volunteers, especially among health care personnel.

"People who care for these COVID patients have a very healthy fear of this illness," said Rambod Rouhbakhsh, chief investigator with MediSync Clinical Research, whose Moderna vaccine trial site is the only one in Mississippi.

He expects no trouble reaching people who would be at high risk of COVID complications, including those who are obese or have diabetes or heart disease. "In southern Mississippi, there are plenty of people who meet the high-risk categories," he said.
trader32176
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Ohio Gov. Mike DeWine tests negative for coronavirus for second time after false positive

8/8/20

https://www.cnn.com/2020/08/08/politics ... index.html
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TimGDixon
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Re: COVID-19 Tests | Wish List

Post by TimGDixon »

This issue of testing is pretty useless if you ask me unless you are sick or feel sick - people lining up in their cars to give the government their DNA - i'll remind everyone that early on fauci and birx both stated on TV that the genetic samples obtained in every state is also being sent to CDC. If you think the gov isn't building a DNA database you might want to rethink that position.
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