Wednesday, May 13, 2020

First at-home saliva test for COVID-19 earns FDA approval

The U.S. Food and Drug Administration (FDA) has approved the first at-home saliva collection test for COVID-19, which people could use to sample their own saliva and send it into a lab for results.

Developed by RUCDR Infinite Biologics, a biorepository based at Rutgers University in New Jersey, the test received "amended emergency use authorization" from the FDA late on May 7, according to a statement from the university. In April, the lab received emergency use authorization for their saliva collection method, which allowed health care workers to begin testing New Jersey residents at select sites throughout the state, The New York Times reported April 29.

Now, the amended authorization will allow people to collect their own saliva at home and avoid potentially risky contact with people at testing sites. The only other at-home coronavirus test on the market requires users to collect samples using a nose swab, The New York Times reported May 7.

"Collecting a saliva sample at home mitigates the risk of exposure needed to travel to a facility or drive-through and is less invasive and more comfortable and reliable than sticking a swab up your nose or down your throat," Andrew Brooks, chief operating officer and director of technology development at RUCDR, said in the statement.

When compared with swab tests for the coronavirus, which rely on samples collected from the nose and throat, the saliva-based test generated fewer false-negative results in severely infected people, meaning it was more reliable at confirming an active infection, according to the Times report published April 29. The rate at which COVID-19 swab tests deliver false-negative results has raised concerns among health care professionals, Live Science previously reported; saliva-based tests could provide consistency where these other tests have faltered.

In the same comparison, the saliva tests garnered no false-positive results, either.

During collection, a person would spit into a container holding a preservative liquid developed by the medical equipment manufacturer Spectrum Solutions, according to the Rutgers statement. The exact recipe for the solution remains a secret, but the ingredients are readily available, the Times reported. Like swab tests, however, the saliva-based test relies on PCR machines to process sampled genetic material; specific chemical reagents are needed to run the machines and could present supply chain problems, Angela Rasmussen, a virologist at Columbia University, told the Times.

That said, the at-home saliva test could address "many critical issues associated with large-scale screening that is required to get people back to their normal daily lives," Brooks said. During the month of April, the Rutgers lab processed nearly 90,000 tests conducted at their in-person testing sites and planned to increase their testing capacity to 30,000 tests a day, Brooks told the Times. At the time, test results could be delivered back to patients within 72 hours, but the turnaround time could be cut down to only a few hours with all the right infrastructure in place, according to the Times report.

Now that people can collect their own samples remotely, the Rutgers lab could feasibly process "tens of thousands of samples daily," according to the statement.



Coronavirus pandemic takes staggering toll on mental health

By Jean Twenge

When the novel coronavirus roared into the U.S., mental health took a back seat to physical health. The number one priority was making sure hospitals wouldn’t be overwhelmed and that as many lives as possible could be saved.

Schools closed, remote work became the norm, restaurants shuttered and getting together with friends was no longer possible. The news cycle spun with story after story highlighting the ever-increasing number of cases and deaths, while unemployment soared to levels not seen since the Great Depression.

Any one of these shifts could be expected to cause an increase in mental health issues. Put together, they created a a perfect storm for a crisis.

Experts speculated as much, and polls showed that many people seemed to intuitively grasp the mental toll of the pandemic. However, data on mental health metrics was scant; we didn’t know the magnitude of any changes in mental health issues, nor did we understand which groups of people were suffering more than others.

So I decided to collect data on mental health during the pandemic and compare it to data from before all of this happened. The differences were even worse than I anticipated.

A generational divide

On April 27, I surveyed 2,032 U.S. adults using a standard measure of mental distress that asks, for example, how often a respondent felt sad or nervous in the last month. I compared the responses with a sample of 19,330 demographically similar people in a 2018 government-sponsored survey of U.S. adults that asked the same questions.

The results were staggering: The 2020 participants were eight times as likely to screen positive for serious mental illness – 28%, compared to 3.4% in the 2018 survey. The vast majority of the 2020 participants, 70%, met criteria for moderate to serious mental illness, compared with 22% in 2018.

Clearly, the pandemic has had a devastating effect on mental health.

Yet some people are suffering more than others. Younger adults ages 18 to 44 – mostly iGen and millennials – have borne the brunt of the mental health effects. They’ve experienced a tenfold increase in serious mental distress compared with 2018. Meanwhile, adults 60 and older had the smallest increases in serious mental health issues.

Why might this be the case? After all, the virus has far more dire health implications for older people.

It could be because older people are more protected from the economic disruptions of the pandemic. Younger adults were more likely to lose their jobs as restaurants and stores closed and were more likely to be in a precarious financial position to begin with. The youngest adults were also already struggling with mental health issues: Depression among 18- to 25-year-olds surged from 2012 to 2017, possibly because young adults spent less time interacting with others in person than they used to, a situation only exacerbated by the pandemic.

Parents under pressure

The other group in distress won’t be a surprise to parents: those with children under 18 at home. With schools and daycares closed during the pandemic, many parents are trying to do the near-impossible by working and supervising their children at the same time. Sports, scouting, music classes, camps and virtually every other activity parents rely on to keep their kids occupied have been canceled. Even parks were closed for weeks.

This trend didn’t occur just because people with children at home are younger. Even among 18- to 44-year-olds, those with children at home showed larger increases in mental distress than those without kids.

In 2018, parents were actually less likely to be experiencing mental distress than those without children. But by the end of April 2020, parents were more likely to be in distress than their childless peers.

Where do we go from here?

The findings of this study are preliminary. The 2020 and 2018 samples, though very similar in age, gender, race and region, came from different sources and thus might differ in other ways.

However, there are also other indications that mental health is suffering during the pandemic. For example, calls to mental health hotlines appear to have surged.



Isolation Is Also Deadly

Isolation is the key to social or physical distancing aimed at curbing the transmission of COVID-19. But isolation of both the ill and symptomatic along with the well also intensifies problems with mental health, like depression. It’s impacting one key aspect of those in recovery from addictions, not to mention the deaths and diseases of despair.

Healthy social interactions range from the mundane of encountering smiling faces in our daily comings and goings to individuals who partner with a group or a counselor to overcome addictions through accountabilities. These human touches and encounters are needed in our lives for our own purpose, self-worth, camaraderie, and identity.

With the prolonged isolation of both sick and well, positive COVID cases with hospitalizations are not the only numbers that have to be considered. Deaths of despair will soon be part of the death count, though there won’t be extra COVID funding coming for those lives.

Forced unemployment in double digits has placed Americans who would never in their lives expect to receive a government unemployment check out of work. Wait, they’re told, on the population centers to stabilize their case counts and hospitalization rates. Wait on some authority to allow “nonessential businesses” — the estimated 30.2 million sole proprietors or authentic small businesses that make up more than 98% of all businesses in the U.S. — to resume operations.

Remember the opioid epidemic? Deaths of despair were characteristic of the opioid crisis, because there is a a correlation between economic instability or collapse and the increase in illicit drug use and addiction. Hence, the opioid epidemic had part of its roots in economic distress. According to the National Institutes of Health, in 2017, there were 70,000 deaths due to opioid overdoses. America didn’t close its economy but there was a mounted response to intervene and reverse course, which happened to include improved economic opportunities for millions.

Yet today, some push a straw argument in efforts to marginalize the opposition in order to keep everything locked down. It goes like this: If you want to reopen the economy, you’re greedy and want people to die. Rhetorically, the question is posed, “How many deaths are too many before it’s time to close businesses again?”

It’s not just the out-of-work adults facing despair. The Wall Street Journal’s James Freeman records several reports of increased volume at the teen suicide hotline as a result of social and physical isolation combined with family pressures within the home.

Social determinants and adverse childhood events are buzzwords in the academic community, with massive efforts to reconstruct environments to end destructive behaviors into more favorable and thriving situations. Yet the harsh polarizing defenses employed to keep strict closures and the quarantine of all — well, vulnerable, sick, and healthy — runs counter to the very foundations of these priorities when addressing children and youth in physical and mental health by addressing a variety of factors, including family income and socialization.

There was a need to understand this virus — its transmission and presentation — and to have a temporary intervention to contain and mitigate its spread. This virus from Wuhan is here to stay. But keeping businesses closed, workers unemployed, and government printing and borrowing money is neither sustainable nor healthy for adults, teens, or families. Yes, isolation kills. But it kills more than the viral transmission of a pathogen. It also kills an individual’s well-being through work, self-reliance, community, and ability to support a family.

The poison of political hatred, however, will cause a significant truth to be missed or dismissed: There’s a mountain of data and research demonstrating a wealth-health connection tying economic growth and work directly to better health and well-being.



FDA Grants Emergency Use Authorization to First Coronavirus Antigen Test

The Food and Drug Administration (FDA) has issued the first emergency use authorization to a coronavirus antigen test. The Trump administration has been working to quickly expand testing abilities, and the antigen test represents a new category of testing that can rapidly detect infections of the Wuhan coronavirus.

Public health experts have said widespread testing is paramount to safely reopening the country, and the FDA's emergency use authorization to diagnostic health care manufacturer Quidel's new coronavirus antigen test is part of that effort.

Antigen tests have the potential to test millions of Americans per day and are cheaper to produce than polymerase chain reaction (PCR) tests. Expanded testing will allow infected individuals to be quickly identified and quarantined to help stop the virus from spreading.

According to CNBC, the new tests can quickly detect protein fragments belonging on or within the virus by testing samples collected through naval cavity swabs. The test results are returned in minutes, and while the new tests can't detect all active infections, the positive test results are highly accurate. Negative test results may require additional PCR tests to confirm the subject is negative for the virus. PCR tests are more accurate but take longer to analyze.




Attorney General William Barr's office shreds NBC's Chuck Todd for "deceptive editing" of Barr's comments (The Daily Wire)

House Speaker Nancy Pelosi is reportedly drafting a $750 billion bill to aid state and local governments; Republicans aren't happy (Fox News)

Office of Special Counsel blocks removal of HHS whistleblower Dr. Rick Bright to investigate claim of "political retaliation" (National Review)

Encouraging illegal aliens to remain in the U.S. is a crime, the Supreme Court rules unanimously (The Daily Caller)

Rhode Island becomes first in Northeast bloc to lift stay-at-home order (Fox News)

Field hospitals stand down, most without treating any coronavirus patients (NPR)

Joe Biden's virtual rally in Tampa goes hilariously wrong (The Daily Wire)

Policy: The left is at war with the Little Sisters of the Poor (American Enterprise Institute)


For more blog postings from me, see  TONGUE-TIED, EDUCATION WATCH INTERNATIONAL, GREENIE WATCHPOLITICAL CORRECTNESS WATCH, AUSTRALIAN POLITICS, and Paralipomena (Occasionally updated), A Coral reef compendium and an IQ compendium. (Both updated as news items come in).  GUN WATCH is now mainly put together by Dean Weingarten. I also put up occasional updates on my Personal blog and each day I gather together my most substantial current writings on THE PSYCHOLOGIST.

Email me  here (Hotmail address). My Home Pages are here (Academic) or  here  (Personal).  My annual picture page is hereHome page supplement


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