Showing posts with label covid-19 testing. Show all posts
Showing posts with label covid-19 testing. Show all posts

Thursday, April 1, 2021

More home covid tests available

On Wednesday, the Food and Drug Administration approved two rapid antigen home tests for use in the U.S.

Americans will soon be able to purchase Abbott's BinaxNOW and Quidel Quickvue tests at drug stores. The two options join a test made by Ellume, which received FDA approval in December, in the market. The two, newly-approved swab tests will be sold at a lower price point.

The BinaxNOW and Quickvue tests are expected to be sold in two-packs for around $15-20; Ellume costs $30.

  NPR

Wednesday, October 28, 2020

Thursday, August 27, 2020

Fingers crossed

The Food and Drug Administration has authorized emergency use of a coronavirus test that costs $5 and can produce results in 15 minutes without the use of any lab equipment.

[...]

Test-maker Abbott says it could soon manufacture 50 million of the rapid antigen tests per month, which could ease the country's testing bottleneck .

[...]

Health care providers still must administer the test but it can be done in point-of-care settings like offices.

[...]

Abbott CEO Robert Ford hinted that the test was on its way to market during the company’s July 16 earnings call, but declined to give specifics on when the company expected FDA to authorize the test.

  Politico
Perhaps because he knew it would be during the GOP convention?

Serious caveat:
The FDA said Monday that health providers can use antigen tests, which are less accurate than lab tests, to screen people without coronavirus symptoms on an “off-label” basis if lab turnaround times are too long.

The agency cautioned that negative results from such tests should be considered as presumptive negatives, and that different approaches, like repeated testing of the same person, should be considered.

[...]

Data that Abbott submitted to the FDA show that the test accurately detects 97.1 percent of positive samples and 98.5 percent of negative samples.
That seems pretty darned good.
The company says it plans to ship “tens of millions” of the tests to customers beginning in September, and is on track to manufacture 50 million tests a month from October on.

Abbott is also releasing a smartphone app that could allow people to display test results from their health care provider via a QR code when entering a public space.
So who's going to hack the app to allow people with positive results show they tested negative?

...but hey, do what you want...you will anyway.

Sideline the CDC

The CDC now says that close contacts of people diagnosed with COVID-19 might not need to be tested if they do not have symptoms. Previously, the agency had recommended testing for all close contacts of people diagnosed with COVID-19.

  alJazeera
Might not?
Admiral Brett Giroir, assistant secretary for health at the Department of Health and Human Services (HHS), said the goal was "appropriate testing" and not more testing, and that there was no political pressure from the administration behind the decision.
Bullshit. So are we just supposed to believe he woke up one day and realized he was wrong?
"This was a product produced by the scientific and medical people that was discussed extensively at the task force," said Giroir. The task force is led by Vice President Mike Pence.
That doesn't explain the reversal, unless he's saying that he made the original recommendation before getting the " scientific and medical people" and the task force involved.
CNN and The New York Times reported on Wednesday that US public health officials were ordered by high-level members of the Trump administration to go ahead with the changes.

[...]

"Suggesting that people without symptoms, who have known exposure to COVID-positive individuals, do not need testing is a recipe for community spread and more spikes in coronavirus," AMA President Susan Bailey said in a statement.

[...]

Giroir had said that tests of asymptomatic people conducted too early to accurately detect the virus can lead to a false sense of security and potentially help spread the virus.
That may be true. So don't test them too early, but test them, ffs.
Health experts also warned that the move could hurt contact tracing efforts to prevent virus spread.
Oh. Who would have thought? Jesus.
Anthony Fauci, the top US government infectious disease expert and member of the coronavirus task force, told CNN he had been undergoing surgery when the change was discussed, and was concerned about the move.

"I am concerned about the interpretation of these recommendations and worried it will give people the incorrect assumption that asymptomatic spread is not of great concern. In fact, it is," he said.

[...]

The latest US count showed that the country has diagnosed 5.8 million cases of COVID-19 and nearly 180,000 people have died. Almost 2.1 million have recovered.
How many of those 2.1 million have long-term serious side effects?
On Wednesday, California announced a deal with diagnostics firm PerkinElmer to nearly double the state's testing capacity.

New York Governor Andrew Cuomo also quickly challenged the assertion that politics played no role in the change.

"We need public health people who do public health and not politics, and we’re going to disregard the CDC guidance totally," he told MSNBC.
Good for them. Hopefully, you live in a "blue" state during this pandemic.

...but hey, do what you want...you will anyway.

Friday, July 31, 2020

Team Trump's disastrous failure


On Friday, July 31, the U.S. House Select Subcommittee on the Coronavirus, which is investigating the federal response, will hold a hearing to examine the “urgent need” for a comprehensive national plan, at which Dr. Fauci, CDC director Robert Redfield, and Admiral Brett Giroir will testify. Among other things, the subcommittee is probing whether the Trump administration sought to suppress testing, in part due to Trump’s claim at his Tulsa, Oklahoma, rally in June that he ordered staff to “slow the testing down.”

[...]

On March 31, three weeks after the World Health Organization designated the coronavirus outbreak a global pandemic, a DHL truck rattled up to the gray stone embassy of the United Arab Emirates in Washington, D.C., delivering precious cargo: 1 million Chinese-made diagnostic tests for COVID-19, ordered at the behest of the Trump administration.

[...]

This purchase did not appear in any government database. Nor was there any contract officer involved. Instead, it was documented in an invoice obtained by Vanity Fair, from a company, Cogna Technology Solutions (its own name misspelled as “Tecnology” on the bill), which noted a total order of 3.5 million tests for an amount owed of $52 million. The “client name” simply noted “WH.”

[...]

An Abu Dhabi–based artificial intelligence company, Group 42, with close ties to the UAE’s ruling family, identified itself as the seller of 3.5 million tests and demanded payment. Its requests were routed through various divisions within Health and Human Services, whose lawyers sought in vain for a bona fide contracting officer.

According to documents obtained by Vanity Fair, [the tests] were examined in two separate government laboratories and found to be “contaminated and unusable.”

[...]

During that period, more than 2.4 million Americans contracted COVID-19 and 123,331 of them died of the illness.

[...]

The secret, and legally dubious, acquisition of those test kits was the work of a task force at the White House, where Jared Kushner, President Donald Trump’s son-in-law and special adviser, has assumed a sprawling role in the pandemic response. That explains the “WH” on the invoice. While it’s unclear whether Kushner himself played a role in the acquisition, improper procurement of supplies “is a serious deal,” said a former White House staffer. “That is appropriations 101. That would be not good.”

[...]

[There was] an even more extraordinary effort that Kushner oversaw: a secret project to devise a comprehensive plan that would have massively ramped up and coordinated testing for COVID-19 at the federal level.

[...]

The irony is that, after assembling the team that came up with an aggressive and ambitious national testing plan, Kushner then appears to have decided, for reasons that remain murky, to scrap its proposal.

  Vanty Fair
Perhaps it's because Jared is part of the team determined to destroy this country.
Inside the White House, over much of March and early April, Kushner’s handpicked group of young business associates, which included a former college roommate, teamed up with several top experts from the diagnostic-testing industry. Together, they hammered out the outline of a national testing strategy. The group—working night and day, using the encrypted platform WhatsApp—emerged with a detailed plan obtained by Vanity Fair.

Rather than have states fight each other for scarce diagnostic tests and limited lab capacity, the plan would have set up a system of national oversight and coordination to surge supplies, allocate test kits, lift regulatory and contractual roadblocks, and establish a widespread virus surveillance system by the fall, to help pinpoint subsequent outbreaks.

The solutions it proposed weren’t rocket science—or even comparable to the dauntingly complex undertaking of developing a new vaccine. Any national plan to address testing deficits would likely be more on the level of “replicating UPS for an industry,” said Dr. Mike Pellini, the managing partner of Section 32, a technology and health care venture capital fund. “Imagine if UPS or FedEx didn’t have infrastructure to connect all the dots. It would be complete chaos.”

[...]

Some of those who worked on the plan were told that it would be presented to President Trump and likely announced in the Rose Garden in early April.

[...]

But no nationally coordinated testing strategy was ever announced. The plan, according to the participant, “just went poof into thin air.”

[...]

Countries that have successfully contained their outbreaks have empowered scientists to lead the response. But when Jared Kushner set out in March to solve the diagnostic-testing crisis, his efforts began not with public health experts but with bankers and billionaires. They saw themselves as the “A-team of people who get shit done,” as one participant proclaimed in a March Politico article.

Kushner’s brain trust included Adam Boehler, his summer college roommate who now serves as chief executive officer of the newly created U.S. International Development Finance Corporation, a government development bank that makes loans overseas. Other group members included Nat Turner, the cofounder and CEO of Flatiron Health, which works to improve cancer treatment and research.

A Morgan Stanley banker with no notable health care experience, Jason Yeung took a leave of absence to join the task force. Along the way, the group reached out for advice to billionaires, such as Silicon Valley investor Marc Andreessen.

[...]

According to one participant, the group did not coordinate its work with a diagnostic-testing team at Health and Human Services, working under Admiral Brett Giroir, who was appointed as the nation’s “testing czar” on March 12. Kushner’s group was “in their own bubble,” said the participant. “Other agencies were in their own bubbles. The circles never overlapped.”

As it evolved, Kushner’s group called on the help of several top diagnostic-testing experts. Together, they worked around the clock, and through a forest of WhatsApp messages. The effort of the White House team was “apolitical,” said the participant, and undertaken “with the nation’s best interests in mind.”

[...]

The plan called for the federal government to coordinate distribution of test kits, so they could be surged to heavily affected areas, and oversee a national contact-tracing infrastructure. It also proposed lifting contract restrictions on where doctors and hospitals send tests, allowing any laboratory with capacity to test any sample. It proposed a massive scale-up of antibody testing to facilitate a return to work. It called for mandating that all COVID-19 test results from any kind of testing, taken anywhere, be reported to a national repository as well as to state and local health departments.

And it proposed establishing “a national Sentinel Surveillance System” with “real-time intelligence capabilities to understand leading indicators where hot spots are arising and where the risks are high vs. where people can get back to work.”

[...]

But the effort ran headlong into shifting sentiment at the White House. Trusting his vaunted political instincts, President Trump had been downplaying concerns about the virus and spreading misinformation about it—efforts that were soon amplified by Republican elected officials and right-wing media figures. Worried about the stock market and his reelection prospects, Trump also feared that more testing would only lead to higher case counts and more bad publicity. Meanwhile, Dr. Deborah Birx, the White House’s coronavirus response coordinator, was reportedly sharing models with senior staff that optimistically—and erroneously, it would turn out—predicted the virus would soon fade away.

[...]

Most troubling of all, perhaps, was a sentiment the expert said a member of Kushner’s team expressed: that because the virus had hit blue states hardest, a national plan was unnecessary and would not make sense politically. “The political folks believed that because it was going to be relegated to Democratic states, that they could blame those governors, and that would be an effective political strategy,” said the expert.

[...]

“It was very clear that Jared was ultimately the decision maker as to what [plan] was going to come out,” the expert said.
You want to read that again?
[B]ecause the virus had hit blue states hardest, a national plan was unnecessary and would not make sense politically. “The political folks believed that because it was going to be relegated to Democratic states, that they could blame those governors, and that would be an effective political strategy."

[...]

On April 27, Trump stepped to a podium in the Rose Garden, flanked by members of his coronavirus task force and leaders of America’s big commercial testing laboratories, Quest Diagnostics and LabCorp, and finally announced a testing plan: It bore almost no resemblance to the one that had been forged in late March, and shifted the problem of diagnostic testing almost entirely to individual states.

[...]

It soon became clear that ceding testing responsibility to the states was a recipe for disaster, not just in Democratic-governed areas but across the country.

In April, Phoenix, Arizona, was struggling just to provide tests to its health care workers and patients with severe symptoms of COVID-19. When Mayor Kate Gallego reached out to the federal government for help, she got an unmistakable message back: America’s fifth-largest city was on its own. “We didn’t have a sufficient number of cases to warrant” the help, Gallego told Vanity Fair.

Phoenix found itself in a catch-22 [...] “On a call with the county last week the Mayor was told that the region has [not] received FEMA funds related to testing because we don’t have bad numbers. The problem with that logic is that the Mayor believes we don’t have bad numbers because [of] a lack of testing.”

In June, Phoenix’s case counts began to rise dramatically. At a drive-through testing site near her house, Gallego saw miles-long lines of cars waiting in temperatures above 100 degrees. “We had people waiting 13 hours to get a test,” said Gallego. “These are people who are struggling to breathe, whose bodies ache, who have to sit in a car for hours.”

[...]

Gallego’s own staff members were waiting two weeks to get back test results, a period in which they could have been unwittingly transmitting the virus. “The turnaround times are way beyond what’s clinically relevant,” said Dr. James Lawler, executive director of international programs and innovation at the Global Center for Health Security at the University of Nebraska Medical Center.

[...]

Gallego ultimately prevailed in her public demand for help: Health and Human Services agreed to set up a surge testing site in Phoenix. “The effect was, we had to be in a massive crisis before they would help,” said Gallego.

And that is where the U.S. finds itself today—in a massive testing crisis.

[...]

It is obvious to experts that 50 individual states cannot effectively deploy testing resources amid vast regulatory, financial, and supply-chain obstacles.

[...]

Experts are now warning that the U.S. testing system is on the brink of collapse. “We are at a very bad moment here,” said Margaret Bourdeaux. “We are about to lose visibility on this monster and it’s going to rampage through our whole country. This is a massive emergency.”In late January, Rajiv Shah, president of the Rockefeller Foundation, went to Davos, Switzerland. [...] There, he had coffee with WHO Director-General Dr. Tedros Adhanom Ghebreyesus, whom he’d known from his years working in global public health, first at the Gates Foundation and then as director of USAID, an international development agency within the U.S. government.

Shah returned to New York, and to the Rockefeller Foundation headquarters, with a clear understanding: SARS-CoV-2 was going to be the big one.

[...]

On April 21, the Rockefeller Foundation released a detailed plan for what it described as the “largest public health testing program in American history,” a massive scale-up from roughly 1 million tests a week at the time to 3 million a week by June and 30 million by the fall.

Estimating the cost at $100 billion, it proposed an all-hands-on-deck approach that would unite federal, state, and local governments; academic institutions; and the private and nonprofit sectors. Together, they would rapidly optimize laboratory capacity, create an emergency supply chain, build a 300,000-strong contact-tracing health corps, and create a real-time public data platform to guide the response and prevent reemergence.

The Rockefeller plan sought to do exactly what the federal government had chosen not to: create a national infrastructure in a record-short period of time.

[...]

Reaching out to state and local governments, the foundation and its advisers soon became flooded with calls for help from school districts, hospital systems, and workplaces, all desperate for guidance. In regular video calls, a core advisory team that includes Shah, former FDA commissioner Mark McClellan, former National Cancer Institute director Rick Klausner, and Section 32’s Mike Pellini worked through how best to support members of its growing coalition.

[...]

In the absence of trustworthy federal guidance, the Rockefeller team hashed out an array of issues: How should schools handle symptomatic and asymptomatic students? What about legal liability? What about public schools that were too poor to even afford a nurse?

(Last week, the CDC issued new guidelines that enthusiastically endorsed reopening schools and downplayed the risks, after coming under heavy pressure from President Trump to revise guidelines that he said were “very tough and expensive.”)

[...]

It may seem impossible for anyone but the federal government to scale up diagnostic testing one hundred-fold through a painstaking and piecemeal approach. But in private conversations, dispirited members of the White House task force urged members of the Rockefeller coalition to persist in their efforts. “Despite what we might be hearing, there is nothing being done in the administration on testing,” one of them was told on a phone call.

[...]

Despite the Rockefeller Foundation’s round-the-clock work to guide the U.S. to a nationwide testing system essential to reopening, the foundation has not yet been able to bend the most important curve of all: the Trump administration’s determined disinterest in big federal action.

On July 15, in a video call with journalists, Dr. Shah looked visibly frustrated. The next day, the Rockefeller Foundation would be releasing a follow-up report: It called on the federal government to commit $75 billion more to testing and contact tracing, work to break through the testing bottlenecks that had led to days-long delays in the delivery of test results, and vastly increase more rapid point-of-care tests.

Though speaking in a typically mild-mannered tone, Shah delivered a stark warning: “We fear the fall will be worse than the spring.” He added, putting it bluntly: “America is not near the top of countries who have handled COVID-19 effectively.”

Just three days later, news reports revealed that the Trump administration was trying to block any new funding for testing and contact tracing in the new coronavirus relief package being hammered out in Congress.

[...]

The gamble that son-in-law real estate developers, or Morgan Stanley bankers liaising with billionaires, could effectively stand in for a well-coordinated federal response has proven to be dead wrong.
And those test kits that were sent to the UAE embassy?
Finally, on June 26, lawyers for the Department of Health and Human Services sent a cable to the embassy, directed to the company which had misspelled its own name on the original invoice: Cogna Technology Solutions LLC.

The cable stated, “HHS is unable to remit payment for the test kits in question, as the Department has not identified any warranted United States contracting officer” or any contract documents involved in the procurement. The cable cited relevant federal contract laws that would make it “unlawful for the Government to pay for the test kits in question.”
Who ordered them?
But perhaps most relevant for Americans counting on the federal government to mount an effective response to the pandemic and safeguard their health, the test kits didn’t work. As the Health and Human Services cable to the UAE embassy noted: “When the kits were delivered they were tested in accordance with standard procedures and were found to be contaminated and unusable.”

An FDA spokesperson told Vanity Fair the tests may have been rendered ineffective because of how they were stored when they were shipped from the Middle East. “The reagents should be kept cold,” the spokesperson said.

Although officials with FEMA and Health and Human Services would not acknowledge that the tests even exist, stating only that there was no official government contract for them, the UAE’s records are clear enough. As a spokesperson for the UAE embassy confirmed, “the US Government made an urgent request for additional COVID-19 test kits from the UAE government. One million test kits were delivered to the US government by April 1. An additional 2.5 million test kits were delivered to the US government by April 20.”



...but hey, do what you want...you will anyway.

Monday, July 13, 2020

This is not good

For the richest, most technologically advanced (so we say) country in the world, this is really pathetic.
The long testing turnaround times are making it impossible for the United States to replicate the central strategy used by other countries to effectively contain the virus — test, trace and isolate. Like catching any killer, speed is of the essence when it comes to the coronavirus.

[...]

“It makes contact tracing almost useless. By the time a person is getting results, they already have symptoms, their contacts may already have symptoms and have gone on to infect others.”

[...]

More efficient testing — such as in South Korea, where results are often given the next day — might [prevent people] from getting the virus. But such turnarounds seem out of reach in the United States because of a lack of federal coordination, supply shortages and surging demand as outbreaks in some states spiral out of control.

Since the beginning of the pandemic, the United States has been plagued by testing problems. In the past four months, testing capacity expanded dramatically; roughly 40 million tests have now been conducted. But the federal government never fixed fundamental infrastructure problems, experts say.

  WaPo
Well, Trump told us all that he demanded "his people" to slow down the testing.
"[O]ur federal response was to do the very least possible. So each time the system is stretched now, it breaks down all over again,” said Ashish K. Jha, who directs the Harvard Global Health Institute. “It’s frustrating because . . . it’s not like, ‘Oh my god, we just figured out we need to do testing.’ We’ve literally been talking about this for months.”

[...]

Coronavirus tests must be covered by insurance under the Cares Act, and free tests are available at the federal, state and local level. As demand has surged, it has created backlogs and choke points at almost every step of the testing chain.

“It’s not shortages of any one thing. It’s now spot shortages of all of them,” said Scott Becker, chief executive of the Association of Public Health Laboratories.

[...]

“Arizona is a hot spot, and it cannot stop testing,” she said. Right now, about a quarter of tests in Arizona are coming back positive, an indication that many other infections are going undetected.

Aguirre said she believes long wait times for results — up to 14 days — have discouraged many from getting tested.
Understandable.
Trump administration officials Friday said testing has improved dramatically and blamed state and local officials for some missteps.

In a statement, the testing czar appointed by President Trump, Assistant Secretary for Health Brett Giroir, blamed some problems “on mismanagement and miscommunication at the state level, and a lack of flexibility to use resources.” He noted that compared with mid-March — when daily tests numbered in the tens of thousands — “we are currently completing over 600,000 tests per day, and last week reached over 700,000 in one day, clearly demonstrating our efforts toward a million tests per day by the fall will be achieved.”

Giroir was appointed in March to focus exclusively on testing but resumed his responsibilities this month at his regular job at the Department of Health and Human Services.
Did he displease Trump?
HHS spokeswoman Mia Heck said turnaround times at large commercial laboratories are “generally increasing.” In about half of states, she said, it takes two to three days on average to get results, and in 24 states, it takes three to four days.

[...]

But because testing is being conducted by a mix of commercial, public and hospital labs, the average waiting time is not known with precision state by state.

[...]

“Some labs have indicated that their turnaround time could be as long as 10 days,” said Jason Mahon, a spokesman for the Florida Division of Emergency Management.

[...]

Only two states have [reported] average turnaround times as long as four to five days [...] . But that does not include further delays in getting the results to patients.
Which is the point, if you want to get a handle on the outbreak.
What’s still missing and urgently needed is a federally coordinated plan “assessing our testing capacity and identifying bottlenecks, forecasting what our future testing needs would be,” said Jennifer Nuzzo, a senior scholar at Johns Hopkins University’s Center for Health Security. Without that, Nuzzo said, the U.S. response remains “a kind of janky flotilla, that, you know, is put together with gum and duct tape.”
As long as Trump is in office, we're not going to get a federally coordinated plan.
This week, eight organizations representing those working in U.S. labs sent a letter to Vice President Pence pleading for help with test supplies.

One of those groups, the American Association for Clinical Chemistry, said it raised those same concerns last month in a call with Giroir, who said he had designated an official in each state to oversee the test supply chain and promised to give the organizations a list of those officials so they could direct pleas for help to them.

But the group never received that list and has not heard back from the administration.

“Instead, we’re all still competing against each other like the Hunger Games for critical supplies,” said David Grenache, president-elect of the association and chief scientific officer of a lab in New Mexico.

[...]

Some hospitals have begun producing their own chemical reagents — substances used to conduct laboratory tests — because they can’t find any on the market, experts say. States and cities have resorted to negotiating directly with foreign governments for supplies.
Scandalous.
Seattle, for instance, partnered with the University of Washington and has been able to maintain free, unrestricted testing with one- to two-day turnaround times.

[...]

“As a region, you could pool your dollars, sit down with national and international suppliers and tackle the problem,” Jha said. “That said, there’s probably a limit to what states can do. We as a country are just not designed to have absentee federal government.”

[...]

HHS spokeswoman Heck said, “At this time, HHS and FEMA are meeting all state testing needs.” HHS noted that the federal government has sent many testing supplies to states, and that states are responsible for distributing them to labs.
Not our fault; not our problem.
“You’re going to see so many more symptomatic people, who won’t know if they have the flu or coronavirus and are going to need testing for both,” said Kelly Wroblewski, infectious-disease director at the Association of Public Health Laboratories. “We’re expecting a coming crush of tests, even more than we’re seeing now.”

Wednesday, June 24, 2020

Genius

“Let me make it clear. We have got the greatest testing program anywhere in the world. We test better than anybody in the world. Our tests are the best in the world and we have the most of them,” Trump said, adding that more tests allow the United States to detect more cases. “By having more cases it sounds bad, but actually what it is is finding more people.”

  The Hill
Let me guess...he just found that out.

And he doesn't want to find more people.

Thursday, May 28, 2020

The real hoax is minimizing the count

In at least a dozen states, health departments have inflated testing numbers or deflated death tallies by changing criteria for who counts as a coronavirus victim and what counts as a coronavirus test, according to reporting from POLITICO, other news outlets and the states' own admissions. Some states have shifted the metrics for a “safe” reopening; Arizona sought to clamp down on bad news at one point by simply shuttering its pandemic modeling. About a third of the states aren’t even reporting hospital admission data — a big red flag for the resurgence of the virus.

[...]

The lack of accurate and consistent Covid-19 data, coupled with the fact that the White House no longer has regular briefings where officials reinforce the need for ongoing social distancing, makes [the task of public health officials trying to help Americans make safe decisions] even harder.

[...]

The problems are widespread and have infiltrated federal health agencies as well. The Centers for Disease Control and Prevention blended diagnostic and antibody tests, boosting the nation's overall testing numbers.

The Department of Health and Human Services took out of context data on the danger of “deaths of despair” from overdoses and suicides amid an economic debacle, according to the authors of the report in question. On Tuesday, an ethics center at Harvard rebuked the White House for misleadingly citing numbers from one of its studies to buttress the administration's national testing report.

[...]

The District of Columbia this week became the latest jurisdiction to endure scrutiny, with the city using a “community spread” metric — excluding nursing homes, correctional facilities and others — as a justification for reopening the area.

Iowa Gov. Kim Reynolds told reporters that the state will share information about outbreaks at meatpacking plants only upon request. And Georgia has only just begun to differentiate between the two types of coronavirus tests it's been adding into its testing totals for weeks.

[...]

The country, [Irwin Redlener, a public health expert at Columbia University] said, is confronting an “unheard of level of chaos in the data, the protocols, the information.”

[...]

In Georgia, where Gov. Brian Kemp has been among the strongest proponents of reopening, the inclusion of antibody tests inflated the state’s overall testing count by nearly 78,000 — a disclosure that came a few weeks after officials posted a chart of new confirmed cases in Georgia with the dates jumbled out of order, showing a downward trajectory.

Like several other states, Georgia's health department began listing separate totals for its antibody and diagnostic test counts only after reporters discovered it had been quietly combining the two.

Georgia's count of hospitalized coronavirus patients also includes only those who were already in the hospital when their diagnosis was reported to the state, a limitation that the state has openly admitted likely creates “an underestimation of actual hospitalizations.”

[...]

Florida has weathered a string of controversies over its evidence to support GOP Gov. Ron DeSantis’ boasts that the state is faring better than most, including an attempt to block access to information on nursing home deaths and the firing of a health department official who now alleges she was pushed out for refusing to manipulate the state’s data.

[...]

New Jersey revised down its nursing home coronavirus death count by about 1,400 after concluding it would only count those with a lab-confirmed diagnosis of the disease, a move a GOP state legislator called a “whitewash.”

[...]

At least a half-dozen states have admitted to inflating their testing figures by mixing two different types of tests into its totals, a practice widely derided as scientifically unsound.

[...]

Nearly half the U.S., meanwhile, has registered rising caseloads as states press ahead with reopening the economy. While some of that reflects increased testing, an accompanying uptick in hospitalizations is worrying experts.

[...]

HHS Secretary Alex Azar warned during a recent Cabinet meeting that the U.S. could see 65,000 additional “deaths of despair” if the country does not get back on track to normalcy soon.

In reality, the study he cited explicitly warned against lifting lockdowns before health data showed it was safe to do so.

“Some might use this report to argue that this is why our economy needs to open up fast. But that’s NOT what we are saying,” wrote the authors of the report, which was published by the American Academy of Family Physicians and Well Being Trust. “Even as of today parts of the country are opening, data suggest that this is premature due to a lack of consistent testing, which allows public health authorities to trace, treat and isolate to prevent further spread.”

Harvard University’s Safra Center for Ethics similarly publicly chastised the administration. HHS used one of the center’s testing models to suggest the U.S. was already testing enough people to contain the virus — when the center was arguing that testing is woefully inadequate to ensure a safe reemergence from “stay at home.”

“The Department’s Report does not provide an accurate summary of the modeling supporting our recommendations,” said the center’s director, adding that HHS had cited a “nonprimary” model in the study’s appendix and then adjusted the assumptions underpinning it.

[...]

[T]he Centers for Disease Control and Prevention has established few firm standards for how states should monitor Covid-19 and made little overt effort to coordinate its messaging with state and local health departments.

That’s created a patchwork system where key health information is collected and communicated with little uniformity, and amid rising concern over whether Americans are receiving reliable reports about the pandemic fight.

[...]

It’s an environment that threatens to erode public trust, experts warn. “You want people to trust what authorities are telling them,” said Jennifer Kates of the Kaiser Family Foundation, and that trust is going to be difficult to earn.

  Politico
Too late.

UPDATE:


Friday, May 22, 2020

Par for the Trump admin course

The Centers for Disease Control and Prevention (CDC) acknowledged Thursday that it is combining the results from viral and antibody COVID-19 tests when reporting the country's testing totals, despite marked differences between the tests.

[...]

“You’ve got to be kidding me,” Ashish Jha, director of the Harvard Global Health Institute, told The Atlantic. “How could the CDC make that mistake? This is a mess.”

Viral tests — commonly referred to as PCR tests as most of them use a process known as polymerase chain reaction — are used by health professionals to determine whether or not a person is currently infected with the disease. During the pandemic, viral tests have been the most effective way of being able to diagnose a positive case of COVID-19. They are what state governments have been counting to track the number of confirmed cases of the virus they have.

Antibody, or serology, tests serve a different purpose. Unlike viral tests that are taken by nose swab or saliva sample, antibody tests examine a person's blood to see if their immune system has created antibodies to combat COVID-19. These tests allow doctors to see if someone has previously been exposed to the virus. As the push for widespread testing in the U.S. has strengthened, antibody tests have been widely produced, many experts have balked at saying that antibodies equate to immunity from COVID-19. Serology tests are also less accurate than PCR tests, increasing the chances for a false negative.

Moreover, a negative test means different things for either test. A negative PCR test indicates to physicians that the patient isn't currently ill with the disease. But, a negative serology test means that the patient has most likely not been exposed to or infected with COVID-19.

  The Hill
Dollars to doughnuts that was not a mistake. It was a Trump admin attempt to make it appear we're doing more testing for infection than we are. Also...
The combining of the tests could lead to the skewing of the overall positivity rate of the test, a measurement that is one of the benchmarks used in the reopening guidelines released by the White House and CDC.

"I suspect it will artificially lower the percent positive," Caitlin Rivers, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, told NPR.

The White House's guidelines say that for a state to reopen it must observe a downward trajectory in its number of daily cases or its percentage of positive cases.
It wasn't a mistake. It was intentional.

...but hey, do what you want...you will anyway.

Sunday, May 17, 2020

Home testing

The Food and Drug Administration (FDA) has granted emergency clearance for a coronavirus testing kit that allows people to take a nasal sample in their own homes and send it to a laboratory for diagnostic testing.

The FDA granted the clearance to the company Everlywell, Inc.

  The Hill
When it depends on the user doing it properly, there are going to be problems. And those problems will not likely be false positives.

Also...we're gonna need the post office.

...but hey, do what you want...you will anyway.

Saturday, May 16, 2020

We MUST get rid of this administration

The Food and Drug Administration (FDA) halted a coronavirus testing program promoted by billionaire Bill Gates and Seattle health officials pending reviews.

The program sought to send test kits to the homes of people both healthy and sick to try to bring the country to the level of testing officials say is necessary before states can begin safely reopening. The program, which had already gone through thousands of tests, found dozens of cases that had been previously undiagnosed.

[...]

The FDA "recently clarified its guidance for home-based, self-collected samples to test for COVID-19. We have been notified that a separate federal emergency use authorization (EUA) is required to return results for self-collected tests," SCAN said. "The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test, but we have been asked to pause testing until we receive that additional authorization."

  The Hill
When hell freezes over.
The pause is emblematic of the fractured national response to the coronavirus, with federal officials proposing guidelines but leaving much of the implementation and administration of tests to states and localities.

[...]

Gates, the billionaire founder of Microsoft who has dedicated much of his personal fortune to global health issues, said the program could be an effective tool in guiding public health responses.

“Not only will it help improve our understanding of the outbreak in Seattle, it will also provide valuable information about the virus for other communities around the world,” Gates wrote in a blog post this week.

An FDA spokesperson told The New York Times, which was the first to report on the pause, that the home testing kits raised concerns about the safety and accuracy of the results.
Like the CDC tests, you mean?

...but hey, do what you want...you will anyway.

Thursday, May 14, 2020

What the everloving fuck!




Honestly, I'm not sure our country can make it to November.

...but hey, do what you want...you will anyway.

Friday, April 10, 2020

Friday, April 3, 2020

Stop using mice, use Dan Patrick instead

Straight to human testing will speed things up, and Texas Lt. Gov. Dan Patrick should be happy to volunteer.


Story here.

Saturday, March 28, 2020

Better late than never?

The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization for a new coronavirus test that takes just 15 minutes to complete.

The test's maker, Abbott, announced the news Friday evening in a press release, saying it plans to start delivering 50,000 tests per day starting next week.

  The Hill
This could have been done by the middle of February had Trump not led the way to his administration's complacency approach. And by now, everyone could have been tested and those infected (including asymptomatic people who tested positive) could have been quarantined, controlling the spread of the virus and the overwhelming of our health system (which is in dire need of an overhaul anyway).
Abbott will run the tests on its point-of-care ID NOW platform, a portable platform that weighs less than 7 pounds and can be deployed to coronavirus hotspots. The company said it expects to produce about 5 million tests per month.
At this point, that's not nearly enough.
It marks one of the fastest tests for COVID-19 available and comes just a week after the FDA approved another 45-minute rapid point-of-care test.
Will this supercede the 45-minute test or will they be able to increase the amount of tests they can do by using both? This article doesn't answer that question.
The United States on Thursday became the country with the largest number of cases, surpassing China and Italy, and on Friday, the U.S. hit more than 100,000 diagnosed cases of COVID-19.

[...]

The U.S. is now adding more than 14,000 new cases per day.
While Trump will not be able to "open up" the country by Easter as he's claimed he wants to do, getting everyone tested to isolate the virus will be key to get it going again.

Saturday, March 21, 2020

FDA approves rapid test

The Food and Drug Administration (FDA) has approved the first coronavirus diagnostic test that can be conducted entirely at the point of care.

The test from California-based Cepheid will deliver results in about 45 minutes — much faster than current tests that require a sample to be sent to a centralized lab, where results can take days.

The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide, of which 5,000 are in the U.S., the company said. The systems are already being used to test for conditions such as HIV and tuberculosis. The systems do not require users to have specialty training to perform testing and are capable of running around the clock.

[...]

The test initially will be used primarily by hospitals, the company said, but the FDA's "emergency use authorization" covers all “patient care settings,” including doctors’ offices.

The test will begin shipping next week.

  The Hill
That's of course good news, but if the Criminal in Chief had allowed the experts to guide him instead of his desire to hide news that might adversely affect his reelection, this could have been done two months ago. And how many people would have been spared if it had?

UPDATE:  Also...