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Saturday, January 29, 2022

Uptick in COVID cases in Olympic athletes, officials reported days before games to begin

 Days ahead of the start of the 2022 Beijing Winter Olympics, officials have reported an uptick in COVID-19 cases among team officials and athletes.

The 2022 Beijing Winter Olympics’ organizing committee said on Saturday that 36 COVID-19 infections had been detected in athletes and team staff, including seven who were in a “bubble” that is separate from the public, Reuters reported. Twenty-nine tested positive after arriving at the airport.

"Everyone is concerned that the test result will suddenly turn out to be positive. But the reality is such that we are living with COVID. We accept all the risks and fears," Anton Slepyshev, a Russian hockey player, told RIA Novosti news agency, according to Reuters.

During a news conference, Olympics medical chief Brian McCloskey said that officials were expecting the peak of infections to happen now given the number of people entering the country for the games, the news outlet noted.

McCloskey underscored it was unlikely that the public would be affected by the recent infections.

The 2022 Beijing Winter Olympics are set to begin in a matter of days, on Feb. 4

https://thehill.com/policy/international/591951-uptick-in-covid-cases-among-olympic-athletes-team-officials-reported

As Omicron Spreads, New PCR-Like At-Home Covid Tests Provide Fast, Accurate Results

 It’s Friday and you’ve got a scratchy throat and a mild headache. Time to play “Cold? Covid? Or Just Crazy?”—the only game more popular than Wordle.

Or you could open up your medicine cabinet and power-on a small white box. Swab your nose with a Lego-like stick, then slide that into the illuminated gadget. About 20 minutes later, your iPhone buzzes: “COVID-19 Positive.”

The future? Nope, it’s already here. For the past few weeks, I’ve been testing the Cue Health Monitoring system and the Detect Covid-19 Test, two systems from health-tech startups that put lab-like molecular testing right on your bathroom counter. No driving to the testing center. No waiting in line. No anticipating the results for days.

I recently had Covid-19. I didn’t catch it to test these systems, but I happened to have them on hand when I started feeling symptoms. (I’m out of isolation now and feeling much better. Thanks for asking.)

As Omicron has surged, at-home testing has become key to stopping the spread of the highly contagious variant. But while at-home rapid antigen tests are convenient and affordable (and sometimes free from the U.S. government), pricier molecular tests—such as PCR tests—are more sensitive and able to spot the virus earlier. The Detect system, which isn’t PCR but works similarly, reported I was positive on Friday, while an antigen test taken at the same time said negative. I confirmed the result with a laboratory PCR test.

Joanna’s positive Covid tests: The Cue system, which sends results to the paired app, left; the Detect system, middle; and Abbott's BinaxNow rapid antigen test, right.

This accuracy comes with a price. The Detect and Cue work like a Keurig—you own the machine, but you have to stock up on single-use test pods. The Detect Hub is $39; each test is $49. The Cue Reader is $249; a pack of three tests is $225. Meanwhile, at-home antigen tests cost $20-something per two-pack.

Are the pricier, more-accurate options worth it? If so, which one do you get? To answer those questions, I had to ask a bunch of other questions.

First, how do molecular and antigen tests differ? Molecular tests (specifically, for you science nerds, nucleic-acid amplification tests) use chemicals and equipment to amplify a sample’s genetic material billions of times to spot traces of the virus. I like to picture a mini Sherlock Holmes holding a magnifying glass to my snot.

An antigen test, on the other hand, pushes your nose-swab sample onto a paper laced with antibodies to detect viral protein. Those tests might not detect an early-stage Covid-19 infection, but they can tell if you’re carrying a lot of the virus. Some medical professionals call them “contagiousness tests.”

OK, so are molecular tests better than antigen tests? No one said that! “We have to really be thinking, ‘What is the tool that’s going to do the job we care about?’ ” Michael Mina told me. He’s an epidemiologist and chief science officer at eMed, a company that authenticates and verifies at-home testing.

Molecular tests’ biggest benefit: They can spot Covid earlier—anywhere from 6 hours to two days, depending on the variant and other factors. Dr. Mina, who previously served as an adviser to Detect, said they’re good “if you’re really symptomatic and you definitely want to know, ‘Is this Covid?’ ”

However, if you’re using a test to determine whether you can safely go out into the world—back to work, back to school—the cheaper rapid antigen test would be best. “The problem with a molecular test is that it’s so sensitive that it may detect dead fragments and not live virus,” said Peter Chin-Hong, an infectious-disease specialist at the University of California, San Francisco.

This was the case for me. Even 12 days after I showed my first symptoms, when I was feeling all better, Cue and Detect said I was positive. The antigen tests showed me as negative by day nine.

How do home molecular tests work anyway? The Detect test has so many steps you start to feel like a lab tech.

The Detect Covid-19 molecular test requires a fair amount of gear and user involvement; thankfully, an app guides you through how to use it all.

After you swirl the included swab around your nostril, you stir it in a test tube with a special liquid for 15 seconds. Then you place an enzyme-filled cap on the tube and shake it like a bottle of salad dressing. You place that tube in the Detect Hub for about 55 minutes, where the machine heats the sample for optimal results.

The Detect app—which mercifully includes a step-by-step guide—will alert you when the tube is ready to be taken out.

Almost there! Now you squeeze more liquid from a dropper into a reader. You place your test tube in the chimney of the reader. The sample pours into the reader and…you wait 10 more minutes for your result. One line means you’re negative, two means you’re positive.

Well, that’s a lot. How about the Cue? If Apple made a home-testing kit, it’d be more like the Cue. This is perhaps why Google, the National Basketball Association, Major League Baseball and other organizations are distributing Cue systems to various personnel. Put the test cartridge into the Cue Reader, swab your nose with the fancy stick, then stick the stick into the cartridge. Your part is done.

To use the Cue Reader test, swab your nose with the stick, then put it into the cartridge sitting in the Reader device; the result pops up on an app on your smartphone. PHOTO: CUE HEALTH Inside the box, your sample combines with an enzyme. The Cue Health HLTH -3.44% app, connected to the Reader via Bluetooth, tells you how much time is left of the 20-minute process. When time is up, the result pops up in the app.

(Another at-home molecular test, the $75 Lucira CheckIt, is also simple to use, but I didn’t have it at the start of my Covid symptoms.)

Can I really trust the results of these systems? In the wake of the Theranos trial, it’s fair to be concerned about lofty-sounding claims made by tech startups about miniaturizing lab diagnostics, but medical experts I spoke with said these systems aren’t revolutionary new approaches, just streamlined versions of proven ones.

And the companies cited external validation and review by the Food and Drug Administration. In clinical studies, the Detect demonstrated 97.3% accuracy compared with a PCR test. An independent study by the Mayo Clinic showed the Cue test matched lab results with 97.8% accuracy.

Can these detect variants such as Omicron? The Cue and Detect tests can detect Omicron, Delta and all other known Covid-19 variants, the companies said.

Chief executive of Detect, Hugo Barra, explained if a future variant wasn’t detected by the current test, the company would just need to update that enzyme-filled cap.

Should I trust these companies with my data? Detect doesn’t collect any data about you. You don’t even need to open an account to take the test, nor do you have to report your results through the app (although you can if you want).

Cue requires an account and shows your results via the app. Ayub Khattak, Cue Health’s CEO and co-founder, told me the company doesn’t share or sell your data to third parties, and that any collected data is de-identified and used only to spot Covid-19 transmission trends.

Cue's $90-a-month subscription includes unlimited certified travel test results.

Can I use these results for travel? Both companies offer to proctor tests via video chat for an additional fee, after which they provide valid certification via email to share with your airline or airport security. Detect charges $20 extra for each test. Cue has a $90-a-month subscription, which includes unlimited, certified travel test results and in-app access to doctors, plus 20 test packs each year. Other companies, including eMed, verify antigen tests for travel.

Oof, those prices! So what should I do? Cue and Detect may soon tell you if you’re sick with something else. The companies are also working on ways to test at home for flu. That’s really the promise of both—our very own personal-health diagnostic computers. Hopefully, like PCs, the price will come down.

For now, those price tags currently hold them back from being as useful as rapid antigen tests. Dr. Mina said the most effective test is the test you can take more often. If cost is an issue, the answer is the $20-something kits sold at CVS and Walgreens.

If your company isn’t paying for your kits, your initial investment—or subscription commitment—for molecular home testing is steep. (Since at-home testing can be covered by insurance, check with your insurer, or try to submit claims for reimbursement.)

The Detect Hub isn’t as high-tech, but it’s a solid middle ground. It’s only $39, and Mr. Barra told me the price of the $49 tests will eventually go down—even though they often sell out at that price. So I bought one. I like the idea of having a highly accurate test in my home, whenever I feel the urge to play “Cold? Covid? Or Just Crazy?”

 https://www.wsj.com/video/series/joanna-stern-personal-technology/the-best-covid-19-home-test-pcr-like-gadgets-vs-rapid-antigen-kits/5A9B4DEF-DFA8-4B21-A76E-D43568F4678F 

 

Former CDC Director: Fauci-Shaped Paper On Origins Of COVID-19 'Antithetical To Science'

 by Zachary Stieber via The Epoch Times (emphasis ours),

The claim that the virus that causes COVID-19 definitely was not from a laboratory, put forth in a paper quietly shaped by Dr. Anthony Fauci that was cited by other scientists who called the lab idea a “conspiracy theory,” was “antithetical to science,” a former Centers for Disease Control and Prevention director says.

“The purpose of science is to have rigorous debate about different hypotheses. I’ve never really experienced in my life where there was private telephone calls among scientists that had a decision on what position they would take collectively, and to see that position then published in a scientific journal like Lancet, to say that individuals that thought like myself, had a different scientific hypothesis, somehow had to be put down and viewed as conspirators, this is really antithetical to science,” Dr. Robert Redfield, the agency’s head until Jan. 20, 2021, said during a Jan. 26 appearance on Fox News.

Emails recently made public show that Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), played a key role in shaping a paper published by Nature in early 2020.

The authors, most of whom messaged repeatedly with Fauci, joined him on a teleconference shortly before the paper was published, and have since received millions from Fauci’s agency, claimed that their analyses “clearly show that SARS-CoV-2 is not a laboratory construct or a purposefully manipulated virus.”

The Nature article was one of those cited by EcoHealth Alliance founder Peter Daszak and a separate group of scientists in an article later published in The Lancet. “We stand together to strongly condemn conspiracy theories suggesting that COVID-19 does not have a natural origin,” wrote Daszak, whose group funneled money from Fauci’s agency to scientists in Wuhan, China, and the other authors.

Many experts later acknowledged there’s no clear evidence that the CCP virus has a natural origin, and some have said the bulk of the evidence points to it coming from the set of laboratories in Wuhan.

Redfield is one of them.

I don’t think it’s biologically plausible that this virus emerged from a bat to some intermediate species into humans and became one of the most transmissible viruses that we know in human disease. This virus clearly had a detour and that detour was being educated how to infect human tissue in the laboratory. I think that’s the most plausible explanation,” he told Fox.

Dr. Francis Collins, Fauci’s boss when he was the head of the National Institutes of Health, and Fauci were trying to “protect science” by suppressing debate over the virus origins, Redfield posited. The problem is, “there’s very limited data” to support their position, he told Fox.

Asked if Fauci, who has been in his position since 1985, should be fired, Redfield demurred but said he did think Fauci should “reflect on this and then provide the science leadership that we need to move forward.”

“I have a lot of respect for him over the years. I think he needs to step back and not try to second guess and make things a way that he thinks the world can hear. We should just tell the truth,” Redfield said.

NIAID didn’t respond to requests for comment.

Redfield also said that he believes scientists will eventually solve the mystery of the origin of the virus.

https://www.zerohedge.com/covid-19/former-cdc-director-fauci-shaped-paper-origins-covid-19-antithetical-science

FDA Says Empowered Diagnostics Recalling COVID-19 Tests

 Empowered Diagnostics LLC is recalling its COVID-19 tests as they have not been cleared for use in the United States and could potentially lead to false results, the U.S. Food and Drug Administration (FDA) said on Friday.

The regulator has labeled the recall of the CovClear COVID-19 rapid antigen test and the ImmunoPass COVID-19 neutralizing antibody rapid test as Class 1, or the most serious type of recall.

It cautioned people to stop using the two tests, which have been distributed with labeling that incorrectly indicates that they are authorized by the FDA.

The company could not be immediately reached for comment.

Empowered Diagnostics initiated the recall in December and has pulled back at least 284,575 antigen tests and 2,100 antibody tests in the United States, according to the regulator.

The CovClear test is currently authorized in Canada and the European Union, according to the company's website.

https://www.usnews.com/news/top-news/articles/2022-01-28/u-s-fda-says-empowered-diagnostics-recalling-covid-19-tests

U.S. Orders 100 Million Additional COVID-19 Tests to Give Out

 The United States government has procured more than 100 million additional COVID-19 tests from testmaker iHealth Lab Inc. as part of the White House's plan to distribute 500 million free at-home tests across the country, the Department of Defense said Friday.

Starting in January, the U.S. government has been allowing households to order four free at-home COVID-19 tests from the website COVIDTests.gov with shipping expected within seven to 12 days of ordering. [L1N2TU2S0]

The batch of free tests are aimed at easing a shortage of tests across the country amid increased demand during the rapid spread of the Omicron variant.

Reuters reported earlier this month that the White House plans to purchase an additional 500 million tests on top of its initial purchase to increase test availability.

The president has come under criticism for not focusing more on testing earlier as part of his strategy for fighting the pandemic. A nationwide shortage of tests has plagued the pandemic response in recent weeks during the rampant spread of the highly contagious Omicron variant.

https://www.usnews.com/news/top-news/articles/2022-01-28/u-s-orders-100-million-additional-covid-19-tests-to-give-out

Goldman Sachs Expecting Five Rate Hikes This Year

 Goldman Sachs is forecasting that the U.S. Federal Reserve will raise interest rates five times in 2022, versus four previously, with a hike expected in March, according to a note from its economists late on Friday.

Economists have scrambled to update rate hike expectations since the Fed on Wednesday said it was likely to hike interest rates in March and reaffirmed plans to end its bond purchases that month in what Fed Chairman Jerome Powell pledged will be a sustained battle to tame inflation.

At the conclusion of Wednesday’s meeting, Powell said a decision would be made in coming months on when to start shrinking the central bank's government bonds and mortgage-backed securities.

Goldman economists David Mericle and Jan Hatzius said in the note they expect the Fed to hike rates in March and May and announce the start of its balance sheet reduction in June, then follow with hikes in July and September. They subsequently expect the Fed to return to a quarterly pace in the fourth quarter with one hike in December to end the year at 1.25-1.5%.

The economists said they had revised up their inflation path expectation following data this week while in addition, "Chair Powell’s comments earlier this week made it clear that the Fed leadership is open to a more aggressive pace of tightening."

Goldman said it continues to expect three hikes in 2023 and for the Fed to reach the same terminal rate of 2.5-2.75% in 2024.

Earlier in January, Goldman said it expected four hikes this year and for the process of balance sheet reduction to start as soon as July.

https://money.usnews.com/investing/news/articles/2022-01-29/goldman-sachs-expecting-five-rate-hikes-this-year

Doc Group Calling for Kids' Prompt Return to Normal Met With Swift Criticism

 A group of physicians and scientists has called for all schools and children's activities to return to pre-pandemic norms by the middle of next month, but their recommendations, published earlier this week, are drawing the ire of others in the field.

As the U.S. grapples with yet another surge in COVID-19 cases and hospitalizations, the group -- including viral immunologist Scott Balsitis, PhD, as well as physicians Lucy McBride, MD; Monica Gandhi, MD; Tracy Beth Høeg, MD; Jeanne Noble, MD; and Kwadwo Kyeremanteng, MD, as well as a number of pediatricians -- is steadfast in their belief that children are being harmed by mitigation measures.

The primary goal of the group -- known as "Urgency of Normal" -- is to empower administrators, teachers, parents, and students to have a full understanding of the current situation and to make the best decisions they can for themselves, Balsitis told MedPage Today.

The group's recommendations include maintaining in-person learning regardless of COVID case counts; de-escalating fear around getting COVID; applying focused protection measures for individuals who remain at high risk; changing the focus to supporting kids' mental, emotional, and social health; and making masks optional in schools.

"We believe the data point to restoring full normalcy for children," said Balsitis, who confirmed the group feels this should happen by February 15. "We really mean the full normal."

Nearly 400 medical professionals have already co-signed in support of what the group calls its advocacy toolkit via its website, but their recommendations have also been met with swift criticism from peers.

"Proselytizing for a predetermined conclusion under the guise of objective, evidence-based analysis is not junk science, it's just junk," tweeted Mark Kline, MD, of Children's Hospital New Orleans, in response to the group. "With the health, well-being and lives of children at stake, we have every right to expect much more of our physicians."

In an interview with MedPage Today, Kline, who is also a professor of pediatrics at Tulane University and LSU New Orleans, said that he believes the toolkit was put forth as something people can use to argue against school closures, the general use of masks in schools, and other mitigation measures. He added that he was especially disappointed to see that a number of pediatricians had signed on to the document.

"It's not an evidence-based discussion of the pros and cons," he said. "It's just simply, here is the conclusion we've come to, and here is the argument we would use in favor of this conclusion. And I think it's flawed ... start to finish."

"I think if we were to do as they are proposing, which is to basically do away with mitigation measures where the schools are concerned, and basically throw in the towel and just focus our efforts on a subset of children that are high risk ... that it's bound to lead to more cases of COVID ... more hospitalizations among children, and probably more deaths," Kline noted.

He pointed out that even with mitigation measures, more than 1,000 children have died as a result of COVID-19 over the past 2 years.

Kline disputes the idea that there is no risk to children and that mitigation measures are all risk and no benefit, as suggested in the toolkit, in part because he's seen many children who have been hospitalized with COVID-19 in his own hospital.

Vaccination uptake in children ages 5 to 11 has been "abysmal," and younger kids don't yet have the option, he added.

The toolkit also doesn't take into account the disparities that exist when it comes to access to safe schools and healthcare, among other areas, he noted.

"We are not a homogeneous population, and some children and some families and some communities are at greater risk of this disease than others," Kline said. "That is not accounted for in the document, at all."

Lakshmi Ganapathi, MBBS, a pediatric infectious disease physician at Boston Children's Hospital and Harvard Medical School, concurred, pointing out that many policy proposals are being shaped by opinions of the privileged.

"They really silence the realities of communities of color," she said.

Ganapathi further took issue with the group's recommendations placing the burden of protection on the vulnerable. "We do need to act collectively," she said. "That's a core public health principle."

The Urgency of Normal is also receiving pushback on the data it cited in its toolkit.

Twitter thread by Tyler Black, MD, a child and adolescent psychiatrist and suicidologist in Vancouver, noted that a line in the toolkit "about 'deaths from child suicide vastly outnumbering deaths from COVID and are increasing' is about as awful as it gets. I consider it ghoulish to wield child suicide statistics inaccurately to make advocacy points." (The line has since been removed from the toolkit.)

However, Balsitis maintained that the idea behind the recommendations in the toolkit are simple.

COVID-19 has never been extremely high risk for children, even for unvaccinated children, he said. Vaccines are available to make the risk even lower, and current data on children's mental health are "increasingly alarming."

"We think it makes sense to shift our focus away from taking action that may or may not have any efficacy against mild COVID infection [and instead focus on] whole person health," Balsitis explained.

He said that the group originated from his desire to empower his family's and community's schools, especially when so much of the strategy had focused on preventing transmission altogether. It became clear that Omicron was going to change that strategy, he noted, and communities have continued to live with a high level of fear, school closures, and "highly disruptive measures" imposed on kids.

"Everywhere else in medicine, it is necessary to carefully quantify the benefit of an intervention and thoroughly screen for any unintentional downsides," he said.

The burden of proof shouldn't be on parents who feel that mitigation measures are hurting their child, but instead should lie with those who want to apply the intervention, he added. "If someone is more comfortable making one choice than the other, they should have the option to make that choice."

However, Kline disagreed. "They're basically saying the mitigation measures that we've been using are unnecessary, so let's get rid of them. But imagine where we'd be if we hadn't used the mitigation measures that we have," he said.

https://www.medpagetoday.com/special-reports/exclusives/96926