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testing Archives - Virus Reports http://virusreports.net/tag/testing/ Fri, 18 Sep 2020 23:21:21 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.7 https://s3.us-west-1.wasabisys.com/virusreports/2020/05/cropped-virus-favicon-32x32.png testing Archives - Virus Reports http://virusreports.net/tag/testing/ 32 32 C.D.C. Reverses Testing Guidelines for People Without Covid-19 Symptoms https://virusreports.net/c-d-c-reverses-testing-guidelines-for-people-without-covid-19-symptoms/ https://virusreports.net/c-d-c-reverses-testing-guidelines-for-people-without-covid-19-symptoms/#respond Fri, 18 Sep 2020 23:21:21 +0000 https://virusreports.net/c-d-c-reverses-testing-guidelines-for-people-without-covid-19-symptoms/ The agency now says anyone exposed to an infected person for more than 15 minutes needs a test. An earlier guideline saying it might not be necessary had shocked public health experts.Credit...David J. Phillip/Associated PressSept. 18, 2020, 5:10 p.m. ETThe Centers for Disease Control and Prevention on Friday reversed a controversial recommendation suggesting people who…

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The agency now says anyone exposed to an infected person for more than 15 minutes needs a test. An earlier guideline saying it might not be necessary had shocked public health experts.

Credit…David J. Phillip/Associated Press

The Centers for Disease Control and Prevention on Friday reversed a controversial recommendation suggesting people who have had close contact with a person infected with the coronavirus do not need to get tested if they have no symptoms.

The change comes after widespread criticism of the earlier guideline, as well as reporting from The New York Times that the recommendation came from political appointees in the Trump administration and skipped the agency’s usual rigorous scientific review.

The previous phrasing, which suggested asymptomatic people who have had close contact with an infected individual “do not necessarily need a test,” now clearly instructs them: “You need a test.”

Public health experts welcomed the change as consistent with research showing that people without symptoms can spread the virus to others.

“It’s good to see science and evidence taking a front seat for a change,” said Scott Becker, chief executive of the Association of Public Health Laboratories. “It has been a wild few weeks.”

Dr. Ashish Jha, dean of the School of Public Health at Brown University, said, “I’m thrilled to see it, it clearly needed to be done.” But he worried the damage to the agency’s credibility would be long-lasting.

The original guidance, posted on Aug. 24, drew sharp criticism even from the C.D.C.’s partners, including the Infectious Diseases Society of America, which urged its members to continue testing people without symptoms.

In a statement on Friday, Dr. Thomas File, the organization’s president, said, “The return to a science-based based approach to testing guidance from the Centers for Disease Control and Prevention is good news for public health.”

Several studies have shown that people can efficiently spread the virus even if they don’t have symptoms. Some research has suggested that they are actually most likely to transmit to others starting around a day before the onset of symptoms, when the viral load can be the highest.

“We know that asymptomatic transmission is what’s driving this pandemic, and we know that we cannot rein in Covid-19 unless we have widespread accessible testing,” said Dr. Leana Wen, a former assistant health commissioner for Baltimore.

“We should be encouraging far more people to get tested and not less,” she said. “Their previous guidance on this made no sense.”

After the initial pushback from the scientific community, the director of the C.D.C., Dr. Robert Redfield, sought last month to clarify the agency’s position, saying testing “may be considered” for people without symptoms.

The new recommendation was a “detailed follow-up to Dr. Redfield’s testing guidance clarification statement on August 27,” the agency said in a statement on Friday. “Current science shows that testing people who have been in close contact with someone with Covid-19 is an important part of preventing disease transmission.”

Previous directors of the agency said that it was normal for important documents to be cleared by administration officials at the White House and the Department of Health and Human Services, but that the degree of interference in the C.D.C.’s scientific work during the pandemic was unprecedented. The agency’s scientific recommendations and reports are normally vetted by dozens of scientists but the drafting and revising of these testing guidelines has largely been controlled by the Department of Health and Human Services and the White House task force on the coronavirus.

Dr. Thomas Frieden, who served as the agency’s director under President Obama, said the new testing recommendation was “an encouraging step in the right direction and confirms the importance of testing close contacts of people with Covid.”

“Now,” he added, “the administration needs to show that political interference with C.D.C. science will never happen again.”

In the case of this controversial guidance in August, the agency’s scientists saw early versions and made their disagreements known, but said their concerns went unheeded.

Adm. Brett P. Giroir, the administration’s testing coordinator and an assistant secretary at the Department of Health and Human Services, the agency’s parent organization, said in an interview on Thursday that the document had come from the C.D.C., but that he had edited and revised it, with input from scientific and medical members of the White House Coronavirus Task Force, and Dr. Scott Atlas, the president’s scientific adviser.

Admiral Giroir did not respond to a request for comment Friday on the new guidance.

Public health organizations said they were relieved to see science prevail again. “It is critical that science, evidence and data continue to serve as the foundation of every C.D.C. recommendation,” Dr. Mary Pittman, president and chief executive of the nonprofit Public Health Institute, said in a statement.

Dr. Susan Bailey, who heads the American Medical Association, a close partner of the C.D.C., said: “This decision acknowledges that our nation’s best interest is served when health care institutions are free to keep science at the fore of their decision-making and guidance.”

The new guidance also corrects some elementary errors C.D.C. scientists said they would never have made. It accurately refers to infection with the virus, for example, as opposed to the Covid-19 disease as the previous version did. And it does not refer to at-risk individuals as “vulnerable,” a term C.D.C. scientists generally avoid.

Still, the rapidly changing guidance has created “mass confusion,” Dr. Wen warned. Testing sites may still be turning away people, and insurance companies may be denying coverage to those without symptoms, she said.

She and others also lamented the blows to the agency’s credibility.

“One of the most important tools the C.D.C. has and the government has in times of crises is trust,” said Dr. Richard Besser, who served as acting director of the agency in 2009. “When you lose trust, it’s really hard to regain it.”

Others were less restrained in their outrage at the administration’s meddling in science.

“To see the way these people have politicized the science,” said Dr. Jha, “I have not felt rage that often.”

Dr. Jha said he was also baffled by the administration’s choice to doctor this particular testing recommendation.

“How much political benefit did they get for undermining the C.D.C. on this? Not that much, because nobody believed it,” he said. “It’s really like killing the golden goose for the egg. You only do it once.”

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Testing slowdown: Fewer coronavirus tests casts doubt on falling case counts https://virusreports.net/testing-slowdown-fewer-coronavirus-tests-casts-doubt-on-falling-case-counts/ https://virusreports.net/testing-slowdown-fewer-coronavirus-tests-casts-doubt-on-falling-case-counts/#respond Sun, 16 Aug 2020 15:21:22 +0000 https://virusreports.net/testing-slowdown-fewer-coronavirus-tests-casts-doubt-on-falling-case-counts/ CLOSE At-home testing could transform the fight against the novel coronavirus. USA TODAYTesting for the coronavirus that causes COVID-19 has dropped nationwide the past two weeks even as the evidence builds disease spread is picking up in many states.Nowhere is the danger of the testing slowdown more evident than the South. In Mississippi, more than one…

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CLOSE

At-home testing could transform the fight against the novel coronavirus.

USA TODAY

Testing for the coronavirus that causes COVID-19 has dropped nationwide the past two weeks even as the evidence builds disease spread is picking up in many states.

Nowhere is the danger of the testing slowdown more evident than the South. In Mississippi, more than one in five tested for the virus in the past week were positive, the highest rate in the nation as of Friday. The average number of daily tests in Texas and Florida dropped but the ratio of positive tests in each state is more than double what the World Health Organization recommends. 

Official case counts have dropped nationally but reporting problems and generally reduced testing in some states makes it hard to place any confidence that infection rates are improving. And in some states with more reliable data, testing slowdowns coincide with increasing or stable positive rates. 

“The enhanced positivity rate is the thing that bothers people more than anything else,” said Dr. William Schaffner, a professor of preventive medicine and infectious disease specialist at Vanderbilt University School of Medicine. “Because it suggests this virus is circulating still very briskly, especially in certain parts of the country. In fact, much of the country.”

The WHO recommends 5% or fewer tests should be positive two consecutive weeks before a community loosens restrictions on businesses opening. If a positive test rate is above that benchmark, it’s a sign an area is only testing the sickest patients and not adequately tracking the virus.

The average number of coronavirus tests reached 793,000 per day in the last two weeks of July. But testing dropped to fewer than 650,000 per day during the first 12 days of August, according to figures from the COVID Tracking Project

More than half of states nationwide have positive rates above 5%, and a dozen states are above 10%.  

As testing has slowed, positive rates increased over the last week in 35 states as of Friday,  according to Johns Hopkins University’s Coronavirus Resource Center

“If testing is going down and positivity is going up, that is what you would expect in an uncontrolled outbreak,” said Amesh Adalja, a senior scholar at Johns Hopkins Center for Health Security.

Although positive rates are still too high,  Adalja sees positive signs such as fewer hospitalizations and declining case counts.

Experts believe several factors are leading to a testing decline in parts of the nation. 

A surge in testing demand in July showed more Americans sought tests than the nation’s labs could process in a timely manner. Even when people got tested last month at a doctor’s office, testing site or clinic, wait times ballooned – making it too late to trace contacts of an infected person. 

More: ‘States duking it out for supply’: Lack of federal plan leads to coronavirus testing delays

More: ‘Totally unacceptable’: Testing delays force labs to prioritize COVID-19 tests for some, not others

More: ‘We’re in for a bad and rocky ride:’ Ex-WHO doctor who helped eradicate smallpox predicts COVID-19 turmoil for years

Storms temporarily closed testing centers in states such as Florida, New York and New Jersey.  And people might be more relaxed after an early summer surge in the South and West relented and case counts drop. 

But experts say dropping case counts can be a deceiving sign when the share of positive tests holds steady or increases.

Texas probes higher positive rate

Texas Gov. Greg Abbott acknowledged this week testing had dropped and positive rates increased, but he announced more surge testing would help get the state’s positive rate back down to 10%.

In Texas, the one-week average for positive rates reached 24.5% before dropping to 16% on Wednesday. The rate dropped even more, down to 12%, as of Friday, according to the Texas Department of State Health Services.

The state health department is investigating the high rate of positive tests as the number of hospitalized COVID-19 patients decreases. The lab reporting system was upgraded Aug. 1 and a hospital lab and commercial lab resolved coding errors. Fewer people also visited community testing sites, a spokeswoman said. 

The state also is working to clear a backlog of 1.1 million “pending” tests that had incomplete paperwork or were not assigned to the patient’s home county. Those cases already have been counted in the totals and would not affect positive rates, the spokeswoman said. 

Angela Clendenin, an epidemiologist at Texas A&M University School of Public Health, said too many Texans don’t pursue testing because there’s still confusion over who’s eligible for testing. Other factors include a belief that things are safer after the governor ordered people wear masks, closed bars and limited restaurant seating.

“It’s a false sense of security,” she said.

Testing reluctance persists

Fatigue and skepticism also are factors, Clendenin said, especially among people whose social circles or communities have had few infections.

“If you don’t know anybody who’s been infected by COVID-19, why are you going to worry about it?” Clendenin  said. “There’s been a lot of skepticism about the evidence and science behind the guidance we are providing.”

Although Texas case counts have dropped the last week, she said the drop in testing is concerning. “The high positivity rate is indicative of the fact all we’re doing is testing symptomatic people.”

Others cite an urban-rural divide on testing. Metro regions have abundant testing options, easy access and people more willing to get tested. But some rural resident are far more skeptical, especially if they live in a community where there are few known cases. 

“There are still many parts of the country, and as you get more rural, the notion becomes stronger, they’re really questioning the validity of all of this information,” Schaffner said. They think, “‘Is this all really all just a hoax of some sort?'”  

Schaffner sees the skepticism in Tennessee’s rural counties where “compliance just plummets” on proven strategies of social distancing, mask wearing and testing. The state’s testing has remained stable but the positive rate ticked up slightly in the past week to a still manageable 8%.

“If we had more testing, I think we’d find more cases, find more people who are genuinely sick and many who have only minimal symptoms, documenting that this is a virus that truly is circulating in rural communities, as all of us think it is,” he said.

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With major delays in Covid-19 testing, AMA and other medical groups push for testing priority guidelines https://virusreports.net/with-major-delays-in-covid-19-testing-ama-and-other-medical-groups-push-for-testing-priority-guidelines/ https://virusreports.net/with-major-delays-in-covid-19-testing-ama-and-other-medical-groups-push-for-testing-priority-guidelines/#respond Fri, 14 Aug 2020 13:21:04 +0000 https://virusreports.net/with-major-delays-in-covid-19-testing-ama-and-other-medical-groups-push-for-testing-priority-guidelines/ (CNN)While some Americans wait several days or longer for Covid-19 test results, the American Medical Association and other groups want new federal guidelines to help fast-track those who need testin…

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(CNN)While some Americans wait several days or longer for Covid-19 test results, the American Medical Association and other groups want new federal guidelines to help fast-track those who need testin…
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With Testing Delays And Cases Surges, Contact Tracing Is Stymied In Some States : Shots https://virusreports.net/with-testing-delays-and-cases-surges-contact-tracing-is-stymied-in-some-states-shots/ https://virusreports.net/with-testing-delays-and-cases-surges-contact-tracing-is-stymied-in-some-states-shots/#respond Tue, 28 Jul 2020 13:21:03 +0000 https://virusreports.net/with-testing-delays-and-cases-surges-contact-tracing-is-stymied-in-some-states-shots/ People wait in line outside a testing site in Florida. The state has seen unprecedented surges in coronavirus cases in recent weeks. Lynne Sladky/AP hide caption toggle caption Lynne Sladky/AP People wait in line outside a testing site in Florida. The state has seen unprecedented surges in coronavirus cases in recent weeks. Lynne Sladky/AP When…

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People wait in line outside a testing site in Florida. The state has seen unprecedented surges in coronavirus cases in recent weeks.

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People wait in line outside a testing site in Florida. The state has seen unprecedented surges in coronavirus cases in recent weeks.

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When the coronavirus pandemic began, public health experts had high hopes for the United States. After all, the U.S. literally invented the tactics that have been used for decades to quash outbreaks around the world: Quickly identify everyone who gets infected. Track down everyone exposed to the virus. Test everyone. Isolate the sick and quarantine the exposed to stop the virus from spreading.

The hope was that a wealthy country like the United States would deploy those tried-and-true measures to rapidly contain the virus — like quickly dousing every ember from a campfire to keep it from erupting into a forest fire.

Today, that hope has been extinguished — not the fire. A return to more restrictive shutdowns of businesses and public gatherings is likely necessary in many places, public health leaders say, to bring the number of cases low enough that “test, trace and isolate” can be used to douse epidemic embers.

“Right now we are experiencing a national forest fire of COVID that is readily consuming any human wood that’s available to burn,” says

Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Testing, contact tracing and isolation are the tactics being used successfully to crush outbreaks in countries such as South Korea and Germany. But those places never had the level of case surges that many U.S. states are now experiencing.

“When you have something like this happening, there’s no way that traditional testing and tracing is going to have any meaningful impact,” Osterholm says. “I liken it to trying to plant your petunias in the middle of a Category 5 hurricane.”

Others agree. At this point, there are just too many new infections occurring too quickly for underfunded, understaffed public health departments to effectively use testing and contract tracing, according to Dr. Jeffrey Engel, the senior adviser for the COVID-19 response for the Council of State and Territorial Epidemiologists.

As Coronavirus Surges, How Much Testing Does Your State Need To Subdue The Virus?

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“It’s just this massive effort,” he says. “It’s just not feasible.”

That has become especially true because of the long delays in getting the results of coronavirus tests, which can now take days or even weeks because of the surge in demand for testing. By that time, anyone who’s infected could have already spread the virus to other people.

“I think it’s the right response when you have a nearly controlled epidemic and you’re trying to mop up the spills. But we’re not there in most places,” says Marc Lipsitch, a professor of epidemiology at the Harvard School of Public Health. “In many places, I think, we’re engaging in collective wishful thinking.”

Another problem is that test results in the U.S. often don’t include basic information needed to find people who test positive, such as phone numbers and addresses. And even if public health workers can find infected people in time, it’s often difficult to persuade their contacts to quarantine, Engel says.

“It’s voluntary. And they have other things to do,” Engel says. “They may be essential workers. They may need to get to work. Life takes over.”

So if testing, contact tracing, isolation and quarantine won’t work , what will?

“Given our basic failure to fix the gaps in testing and the bottlenecks, that really puts us on a path where there is no viable alternative beyond shutdowns,” says Jennifer Nuzzo, a senior scholar at the Johns Hopkins Center for Health Security.

Now, Nuzzo doesn’t think all hope is lost. If enough people finally start wearing masks, and get vigilant about staying at least 6 feet away from other people, especially indoors, there may still be hope in at least some places of avoiding new shutdowns, she says.

“I do really worry about forcing an entire state or country to retreat to our homes for extended periods. These are harmful measures in themselves,” Nuzzo says.

And there may still be some places where the virus may not have yet spread widely, or has been suppressed low enough, for testing and contact tracing to be effective, some say.

“Hawaii!” wrote Caitlin Rivers of the Johns Hopkins Bloomberg School of Public Health, in an email to NPR. “They have the advantage of being an island, though.”

Massachusetts has also built an effective public health workforce, she notes.

And in places that can’t avoid new shutdowns, some hope they won’t have to be as draconian as the first time. Outdoor spaces — such as parks, playgrounds and beaches — could remain open, for example, as long as people wear masks and maintain 6 feet of physical distance from anyone outside their household.

“We know more about the virus and how it spreads now then we did in the spring,” says Rivers. “So, I think, for jurisdictions that take steps backward toward closing — I don’t think it will have to look like it did in the spring.”

Other scientists have proposed that lockdowns could be avoided if 95% of the U.S. population would start to wear masks consistently in public. But currently mask usage is much lower than that. And some public health experts doubt masks alone could be enough.

Can Masks Save Us From More Lockdowns? Here's What The Science Says

“The degree to which masking will drop transmission has been unfortunately overstated substantially by a number of people,” Osterholm argues. He points to Hong Kong, which has a big surge despite widespread masking.

“Use masks. They’re a complementary part of our response. But they’re not going to get us to the level where we can control this virus,” Osterholm says.

Now, none of this means testing and contact tracing is useless, experts say. Far from it. Indeed, experts say they want to see it continued and expanded. It can be used strategically to determine how to target shutdowns more selectively in situations and locations where the virus is spreading the most. For example, specific bars where people frequently infect each other can be identified and closed.

Bars Are Reopening In Some Places And Closing In Others. If You Go, Know The Risks

Osterholm hopes more measured lockdowns may work in some places too. But he’s skeptical, especially about the hottest of the hot spots.

“If we want to be like other countries in the world that have successfully contained the virus, then we have got to take the medicine now,” Osterholm says.

“We will not get there unless we bring this virus level down again. And there’s just no other way to do it literally but a kind of second lockdown,” he says. “And this time let’s get it right.”

That could knock the virus back enough to let schools safely reopen, get some people back to work, and give the nation time to hopefully, finally get enough tests and hire enough contact tracers. It could help the U.S. get off the current roller-coaster of case surges and regain as least some version of normalcy.

“Those countries that were on fire last spring and then did a lockdown are now the ones that have been successfully reopening,” Osterholm says. “Their economies are back, they’re enjoying life — and they’re still maintaining control over the virus.”

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COVID-19 testing at universities threatens to strain nationwide capacity | TheHill https://virusreports.net/covid-19-testing-at-universities-threatens-to-strain-nationwide-capacity-thehill/ https://virusreports.net/covid-19-testing-at-universities-threatens-to-strain-nationwide-capacity-thehill/#respond Mon, 27 Jul 2020 03:22:09 +0000 https://virusreports.net/covid-19-testing-at-universities-threatens-to-strain-nationwide-capacity-thehill/ Demand for COVID-19 testing could soar in the fall with the reopening of some universities and schools, threatening to overburden an already strained system. Many schools and universities are planning to regularly test students and staff in an effort to stop the spread of COVID-19 on their campuses.But public health officials and experts worry there is…

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Demand for COVID-19 testing could soar in the fall with the reopening of some universities and schools, threatening to overburden an already strained system. 

Many schools and universities are planning to regularly test students and staff in an effort to stop the spread of COVID-19 on their campuses.

But public health officials and experts worry there is not enough capacity and supplies to test thousands of people who aren’t showing any symptoms of the disease.

“I think what we’re starting to recognize is that it really is not going to be feasible in probably most areas of the U.S. to try to put together some type of testing strategy where you’re testing multiple times, especially if the results don’t come back for a while,” said Dr. Tina Tan,  a member of the board of directors for the Infectious Diseases Society of America.

“I don’t think it really gives you a lot of information, and you’re using critical resources that could be better spent in other places.”

While capacity for COVID-19 testing has improved significantly since the early days of the pandemic, there is still not enough to handle the increased demand caused by surging outbreaks in the South and West. 

About half of COVID-19 testing in the U.S. is performed by commercial labs like Quest and Labcorp, which are reporting turnaround times of several days, or even weeks. 

Labs are still experiencing shortages of supplies needed to process tests, including chemicals, pipettes and personal protective equipment, due to the global demand caused by the pandemic. 

Widespread testing of students and staff without symptoms could further overwhelm the nation’s testing capacity and stretch resources, experts warn.

“There is a thirst to do non-medical, non-clinical testing so people can get back to work, back to school,” said Scott Becker, chief executive officer of America’s Public Health Labs.

But, he added, it would require an “enormous amount of supply” to test people for non-medical reasons, and those are supplies needed to test people who have COVID-19 symptoms or have had contact with a confirmed case.

“The answer is not going to be to test everyone all the time. That’s not possible.”

The concern about potentially infected students returning to school in the fall is heightened by worries that many potentially infected young adults will not show symptoms of COVID-19 but could transmit it to others who can experience serious illness. 

Some colleges like the University of Virginia and Purdue University in Indiana will require returning students show proof of a negative COVID-19 test before returning to campus. 

Others institutions, like Harvard, Yale and Princeton, plan to test students once they arrive, and several times thereafter throughout the semester, in an attempt to quickly squash any COVID-19 cases from becoming large outbreaks that force closures.

Colby College in Maine will test all students three times a week at the beginning of the semester, with results delivered by a local lab within 24 hours. 

Department of Health and Human Services (HHS) Secretary Alex Azar told governors on a call this week that he is hearing too many cases of universities striking deals with private labs. He wants to discourage this, he said, because there is just not enough supply. 

Admiral Brett Giroir, the administration’s testing czar, added that the U.S. needs to avoid putting 75 million students into the testing pool, and universities and schools should instead rely on surveillance as opposed to widespread testing. He gave the example of Louisiana State University, which plans to test 10 to 15 percent of their student population in the fall, rather than doing universal testing. 

“In general, testing people before going back to the university… is not a strategy that we recommend, nor does the [Centers for Disease Control and Prevention] recommend, because you’re only negative for that one moment, you could be positive the next day and it doesn’t relieve any responsibility about wearing a mask and doing all those kinds,” Giroir told reporters Thursday. 

The CDC recommends against so-called “entry testing” of all students, faculty and staff because its effectiveness in stopping its spread has not been “systematically studied,” according to its guidance. 

Giroir said schools should use surveillance testing instead of universal testing of all students. That could be done through pool testing, Giroir said, in which samples from several people are combined and then tested together instead of individually.

Pool tests that come back positive are followed by individual tests for everyone in the group, while negative pool tests are cleared.

Pool testing is thought to work best in areas where virus spread is low. 

“Nothing’s a perfect solution, but it does not burden the health care system. It lets colleges keep control of how they want to do it,” he said.

However, Dr. Thomas Tsai, an assistant professor in the Department of Health Policy and Management at the Harvard T.H. Chan School of Public Health, said he thinks it is important students be tested before they come onto campus followed by surveillance testing focused on certain populations afterward. 

“I think everybody agrees that it’s important to test before students come onto campus,” he said. “The hope is to really change the conversation and stop letting capacity dictate our guidance.” 

He argued the U.S. has become too reliant on commercial labs like Quest and LabCorp when there are other options available. 

“We need to think beyond just the traditional capacity for providing tests and there’s capacity available beyond the commercial laboratories,” he said, like at health care systems, academic research groups. 

Point of care tests are becoming more widely available, he noted. 

Labs have also said they can’t do it on their own, and new technologies are needed to ease the demand for their services.

“This is something we have said from the beginning: labs can’t do this alone,” an American Clinical Lab Association spokesperson told The Hill. “Labs, diagnostic manufacturers, providers, public health officials the federal government all have a role here.”

“I think when you look to the fall it continues to be the case that we need to put the full range of testing tools we have available to deploy where they’re most needed and that includes point of care testing, which is not something we currently perform,” the spokesperson also said. “The bottom line is it’s going to take all of us.” 

The Trump administration is hoping to expand access to point of care tests which can give results in 15 minutes at a doctor’s office or a patient’s bedside without lab processing. 

Giroir told NPR last week he expects the U.S. to have 15 million to 20 million point of care tests ready for use by September. 

“That’s going to dramatically reduce the burden [on labs],” he said.

The National Institutes of Health (NIH) is currently running a “Shark Tank”-like contest that seeks to accelerate the arrival of point of care tests to the market. 

Still, the ACLA and other groups are asking Congress for more funding to expand testing capacity into the fall. Some of the nation’s largest labs have already maxed out at their testing capacity due to shortages of machines and chemicals needed to process tests.

“We share the goal of safely reopening the economy and returning to normal business, but this will require a sustained federal investment in testing facilitated by the public health and existing health care delivery system,” reads a letter sent Tuesday to Congressional leaders.

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COVID-19 testing capacity and supplies are strained. Some labs are turning to pooling tests to meet the demand. https://virusreports.net/covid-19-testing-capacity-and-supplies-are-strained-some-labs-are-turning-to-pooling-tests-to-meet-the-demand/ https://virusreports.net/covid-19-testing-capacity-and-supplies-are-strained-some-labs-are-turning-to-pooling-tests-to-meet-the-demand/#respond Sat, 25 Jul 2020 19:21:01 +0000 https://virusreports.net/covid-19-testing-capacity-and-supplies-are-strained-some-labs-are-turning-to-pooling-tests-to-meet-the-demand/ CLOSE SportsPulse: There's one major reason why a fall without football is a real possibility: lack of robust COVID-19 testing. We dissect why. USA TODAYWith results from COVID-19 tests routinely taking one week or longer to complete, some labs are trying a new approach called sample pooling.The idea is labs can save coveted supplies if…

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SportsPulse: There’s one major reason why a fall without football is a real possibility: lack of robust COVID-19 testing. We dissect why.

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With results from COVID-19 tests routinely taking one week or longer to complete, some labs are trying a new approach called sample pooling.

The idea is labs can save coveted supplies if they test samples from multiple patients at once. If the test finds no signs a pooled sample contains the coronavirus that causes COVID-19, the group of people tested are considered negative.  A positive result requires each sample to be tested individually.

It’s another example of how labs are adapting to unprecedented circumstances that have stressed supplies, workforces and capacity to deliver meaningful and timely test results. But the testing method won’t deliver results more quickly, which remains a hurdle for labs struggling to keep pace in hotspot communities. 

Public or academic health labs in California, Washington and Nebraska have used or gained approval for the testing method. And last weekend, Quest Diagnostics became the first commercial laboratory to get Food and Drug Administration authorization to conduct sample pooling. It’s part of the lab company’s effort to hike capacity to 150,000 tests each day by the end of July.

Dr. Anthony Fauci, the nation’s leading infectious-disease expert, described pooling as “a really good tool” during a Senate hearing last month. Dr. Deborah Birx, coordinator for the White House Coronavirus Task Force, told the health news site STAT last month pooling would hike capacity “from a half a million tests a day to potentially 5 million individuals tested per day.” 

Dr. Emily Volk, a pathologist and president-elect of the College of American Pathologists, said pooling makes efficient use of limited reagents labs need to run tests. Public health, hospital and commercial labs are contemplating pooling because these chemicals are in short supply globally, straining labs capacity to deliver timely tests to diagnose and limit the virus’s spread.

“Testing is the tool we use to make our enemy visible during this pandemic,” said Volk,  senior vice president of clinical services at University Health System in San Antonio.  “If we had unlimited supplies of reagents, I think it would be wonderful if everybody could be tested every day … We’re nowhere near that ideal right now.”

Peter Iwen, director of Nebraska Public Health Laboratory, began pooling in March because his lab faced a shortage of reagents. He received authorization from the governor after the state declared a state of emergency.

He said his lab pooled 6,000 to 7,000 samples for more than one month until outbreaks at meatpacking plants sent the state’s positive rate too high to make such group testing feasible. It has remained too high to return to pooling, but he would like to resume when the infection rate lowers.

“It got us over the hump,” Iwen said.  “We were able to save on reagents. We were able to keep the lab operating. And we felt like we were putting out good results.”

Pushing the frontiers’: Long lines for COVID tests, stressed labs delay results as demand spikes

‘Trade-offs with every diagnostic test’

Pooling is the latest tool in the nation’s improvisational testing strategy, which has shifted responsibility to state and private industry to test and slow the spread of coronavirus.  

Pooling is used to process molecular-based tests that require a nasal swab sample from an individual. The sample is placed in a liquid tube called transport media and sent to a lab. When the lab pools samples, it mixes the liquid samples from several tubes while separating a portion of the original sample. If the pooled sample tests positive, lab workers then test the individual samples to determine which patients have the virus.

Pooling is not for point-of-care tests that can deliver quick results at doctor’s office or other clinical settings. Nor is it used for rapid “antigen” tests, which some promote as a lower-cost answer to screen more people quickly, albeit with less sensitive, or accurate, results.

“There’s a lot of controversy in the field right now. What’s more important, get highly sensitive tests or get more tests out?” said Dr. Yvonne Maldonado, director of infection control at Stanford Children’s Hospital.

Maldonado said it’s important to adapt to circumstances. If a sick patient shows up to a clinic or hospital, doctors might collect a specimen for a molecular test and a lab would process the individual sample as a test. But pooling samples might be appropriate when screening larger populations – such as university student returning to campus.

“(There) are trade-offs you have with every diagnostic test, really,” Maldonado said. “If you’re screening large populations to go back to school, I think the broader, pool-based tests could work.”

‘States duking it out for supply’:Lack of federal plan leads to coronavirus testing delays

Time, manpower and supplies

Pooled testing only works in limited scenarios, Volk said. If the method is used incorrectly, or labs must adapt their workflows, it can slow testing and waste valuable supplies.

Experts says the method is best used to screen patients who show no symptoms, and is mainly reserved for communities where fewer people are infected and rates of positive tests are low.

Kelly Wroblewski, the Association of Public Health Laboratories’ director of infectious disease, said group testing works best when disease “prevalence” does not exceed 5% to 7% of a community. When that rate reaches double digits, labs will get too many positive tests.

“That’s where it stops being a resource save and it becomes a resource  drain,” Wroblewski said. “It takes more time. It takes more manpower and it takes more supplies.”

In Arizona, for example, the positive rates from molecular tests were 14.6% on Thursday, too high for the region’s dominant lab, Sonora Quest, to use pooling, said a spokeswoman. 

The lab at the University of Washington, however, began pooling samples several weeks ago under the state’s emergency use authorization because COVID-19 infection rates there are low. Dr. Geoffrey Baird, interim chair of the university’s Department of Laboratory Medicine, said the UW lab pools four samples at a time, but is careful when choosing which ones.

‘Grave concerns’: COVID-19’s surge in Sunbelt states shows the virus, not testing, to blame

Labs also must make sure they have the right instruments to run the pool tests. Large commercial labs have “sample-to-answer” platforms that allow workers to input samples in machines that yield computerize results within four hours. The instruments are in high demand and also are experiencing shortages of reagents needed to run tests, Baird said.

UW has developed its own test to match the lab’s supplies. The test requires a slower, more hands-on approach, with lab workers interacting with robots that help process liquid samples. Halfway through the process, workers must take tubes out of one instrument and into another to complete the test.

The UW lab has purchased more robotic power and is hiring more licensed technologists to work in the lab. 

“What we’ve done is we’re sort of shifted a problem of supply chain to a problem of workforce,” Baird said. “It’s still a problem it’s just somewhat more tractable.”  

Quest Diagnostics will begin pooling at labs in Chantilly, Virginia and Marlborough, Massachusetts, and plans to add more throughout the United States. But company spokeswoman Kimberly Gorode offered words of caution. 

“Pooling will help expand testing capacity but it is not a magic bullet, and testing times will continue to be strained as long as soaring COVID-19 test demand outpaces capacity,” she said.

Alltucker is on Twitter as @kalltucker or can be emailed at alltuck@usatoday.com.

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Testing delays once again hamper COVID-19 response | TheHill https://virusreports.net/testing-delays-once-again-hamper-covid-19-response-thehill/ https://virusreports.net/testing-delays-once-again-hamper-covid-19-response-thehill/#respond Wed, 22 Jul 2020 13:21:04 +0000 https://virusreports.net/testing-delays-once-again-hamper-covid-19-response-thehill/ Surging COVID-19 outbreaks in several states are straining testing capacity across the country as people wait several days or even weeks to get their results back, causing another setback to the U.S. response to the months-long pandemic.Lengthy turnaround times are undermining the fight against the coronavirus, experts say, making efforts to trace contacts of confirmed…

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Surging COVID-19 outbreaks in several states are straining testing capacity across the country as people wait several days or even weeks to get their results back, causing another setback to the U.S. response to the months-long pandemic.

Lengthy turnaround times are undermining the fight against the coronavirus, experts say, making efforts to trace contacts of confirmed cases almost pointless. That, in turn, potentially leads to more infections that threaten to strain testing capacity further.

“The concern is it’s just starting to spiral out of control,” said Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials.

While public health officials say people should be self-isolating while they wait for their test results, there’s little data to indicate how often that’s happening. Longer turnaround times run the risk of making it less likely someone will self-isolate, especially if they’re not experiencing any symptoms.

“It really undermines our infection control,” Plescia said. “Somebody who has COVID but has less typical symptoms or doesn’t feel that bad, they may feel like it’s probably not COVID, and they’ll be going out in public. And if it turns out they really do have COVID, they could have infected significant numbers of people.”

Large outbreaks in Florida, Texas, California, Arizona and Georgia, have overwhelmed private labs like Quest Diagnostics and LabCorp, leading to slower turnaround times. Some states with smaller case numbers are even seeing delays.

While commercial labs have significantly increased the capacity for testing since the early days of the pandemic, there is still not enough to handle the increased demand.

Congress has appropriated $25 billion to improve testing and contact tracing, but none of that has gone to commercial labs that are bearing the brunt of testing.

“It’s the demand that’s changed very, very significantly,” said a spokesperson for the American Clinical Lab Association, which represents clinical laboratories like Quest and LabCorp.

“Labs across the board are seeing significantly increased testing demand and constraints in the availability of supplies and equipment.”

Quest Diagnostics, the largest lab in the U.S., says the turnaround time for “priority patients” — symptomatic health care workers and hospitalized patients — is about two days. The turnaround time for everyone else is more than seven days or up to two weeks.

LabCorp on Monday said the average turnaround time is now between three and five days, though some people have waited longer for their results.

“The value of a test that comes back even five days later is very little,” said Tom Frieden, director of the Centers for Disease Control and Prevention during the Obama administration.

“People are most infectious both about the two days before they get sick, and maybe three or four days after they get sick. So if you’re telling someone they were infected five days after they felt sick, they’ve already infected most of the people they’re going to infect. And those people have already potentially become infected as well.”

The delays have had a negative impact on contact tracing, the process public health officials use to try to break the chains of transmission by contacting people who test positive and asking them to quarantine while tracers reach out to their close contacts to get them tested, also asking them to self-isolate while they await results.

“Some states and communities are sort of wondering if there’s a little bit of futility in trying to do any contact tracing,” Plescia said.

Contact tracing requires quick test results, especially for COVID-19, which spreads easily and exhibits no symptoms in a large percentage of carriers. People who are asymptomatic can still transmit the disease to others.

“Until you know the results of somebody’s test, you can’t really find out who their contacts are and contact those people and tell them that they may be infected as well,” Plescia said. “A lot of state and locals [governments] are very concerned that they’re missing the window of opportunity for where their contact tracing can make the difference.”

The surge in cases and increased demand for testing has renewed calls for a national testing strategy from the Trump administration.

Labs still don’t have enough supplies needed to run tests in high volumes, and as demand grows, some labs are finding they need more machines that are also in short supply.

President TrumpDonald John TrumpMore than a dozen people wounded in shooting near Chicago funeral home Cleveland Indians players meet with team leadership to discuss potential name change Pelosi calls coronavirus the ‘Trump virus’ MORE briefly addressed the issue on Tuesday.

“We’re also working to reduce turnaround time,” Trump said during a press briefing at the White House but did not elaborate.

“We’ve done more testing than anybody. Some of the tests, because it is a massive volume, it takes longer. Other tests, as you know, are very quick. They’re five minutes and 15 minutes tests and those are the ones I prefer.”

The administration has mostly let states set their own testing goals, even though some of the largest labs have operations across the country.

“Unquestionably, we need a national testing strategy that does not simply provide each state with the ability to define what’s best for them,” said Heather Pierce, senior director of science policy and regulatory counsel for the Association of American Medical Colleges.

“States are essential partners, but in terms of understanding reagent shortages and prioritizing where reagents and test supplies go, that should be done on a national comprehensive level,” she added.

Trump administration officials acknowledged the slower turnaround times in a call with governors this week, with Admiral Brett Giroir saying it would put a greater focus on point of care tests that can be done in 15 minutes at a patient’s bedside or doctor’s office.

The Department of Health and Human Services (HHS) plans to send point-of-care test instruments and kits to all 15,400 nursing homes in the U.S., potentially freeing up some capacity at commercial labs. However, HHS noted that it is a one-time shipment, and nursing homes will need to find their own test kits after that.

The Food and Drug Administration also recently approved a request from Quest to “pool” tests, in which samples from several patients are combined and then tested together instead of individually.

Patients in pools that test positive for COVID-19 are then individually tested, while negative pools are cleared. The goal of pool testing is saving time and limited resources.

However, experts say these efforts are unlikely to be useful in hotspots or settings like nursing homes or prisons, where the virus spreads at a furious pace. The pooling approach might be more useful as a surveillance tool, they said, to quickly identify where new cases are occurring.

Experts think some states might need to go back to prioritizing tests for certain populations, like hospitalized patients and close contacts of confirmed cases, in order to decrease turnaround times.

“I think there’s just no doubt about it that we don’t have as many tests as we need — let’s be frank about that. And, therefore, we’re going to have to prioritize and determine which patients should get them first and which patients to get which tests,” Frieden said.

“Prioritization can help a lot. Unless we have test times down, we’re not going to get ahead of the virus.”

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‘None of us lie’: Coronavirus testing czar rejects Trump’s attacks on health officials https://virusreports.net/none-of-us-lie-coronavirus-testing-czar-rejects-trumps-attacks-on-health-officials/ https://virusreports.net/none-of-us-lie-coronavirus-testing-czar-rejects-trumps-attacks-on-health-officials/#respond Tue, 14 Jul 2020 20:22:17 +0000 https://virusreports.net/none-of-us-lie-coronavirus-testing-czar-rejects-trumps-attacks-on-health-officials/ Adm. Brett Giroir, the Trump administration’s coronavirus testing czar. | Kevin Lamarque-Pool/Getty Images Adm. Brett Giroir, the Trump administration’s coronavirus testing czar, on Tuesday rejected President Donald Trump’s suggestion that his own public health officials are liars. “Look, we may occasionally make mistakes based on the information we have, but none of us lie. We…

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Adm. Brett Giroir, the Trump administration’s coronavirus testing czar. | Kevin Lamarque-Pool/Getty Images

Adm. Brett Giroir, the Trump administration’s coronavirus testing czar, on Tuesday rejected President Donald Trump’s suggestion that his own public health officials are liars.

“Look, we may occasionally make mistakes based on the information we have, but none of us lie. We are completely transparent with the American people,” Giroir told NBC’s “Today” show.

Giroir’s remarks came after Trump retweeted a message Monday from Chuck Woolery, the conservative former game show host, who wrote online: “Everyone is lying. The CDC, Media, Democrats, our Doctors, not all but most, that we are told to trust.”

Asked about that social media post Tuesday, Giroir was dismissive. “I’m a physician. I’m a scientist. I’m not a Twitter analyst. And to be quite honest, I don’t spend time looking at any of that on Twitter, because who knows what it means or how it’s interpreted,” he said.

Giroir also sought to defend the integrity of the White House coronavirus task force amid recent efforts by the president and the White House to discredit the very administration officials tasked with combating the pandemic.

Trump has expressed particular frustration with Dr. Anthony Fauci, the country’s top infectious disease expert. Over the weekend, the White House provided various news outlets with a list of statements the immunologist made in the early days of the outbreak in the U.S. that could appear damaging in retrospect.

On Tuesday, Giroir said Fauci and other task force members including White House coronavirus response coordinator Deborah Birx, FDA Commissioner Stephen Hahn and CDC Director Robert Redfield all “work together every single day” and enjoy a “great, collegial relationship.”

“None of us are 100 percent right. That’s why we have multiple diverse views there,” he said. On Sunday, however, Giroir was less embracing of Fauci as reports of the White House’s smear campaign against him began surfacing.

“I respect Dr. Fauci a lot, but Dr. Fauci is not 100 percent right, and he also doesn’t necessarily — and he admits that — have the whole national interest in mind,” Giroir told NBC’s “Meet the Press” then. “He looks at it from a very narrow public health point of view.”

Fauci has refrained from addressing the White House’s criticism in interviews this week, although he spoke Tuesday about the importance of not letting “anything that even smacks slightly of any ideology get in the way” of his job.

“You’ve got to just stick with the science,” Fauci told Crooked Media’s “America Dissected” podcast, adding: “And if that clashes with something that is political, then don’t get involved in any of that.”

Trump similarly targeted Redfield last Wednesday, disavowing the CDC’s guidelines for reopening schools as “very tough & expensive,” and threatening to slash federal funding to schools that do not physically reopen.

Vice President Mike Pence subsequently announced the CDC would produce “additional guidance” this week, but Redfield said he would not alter the agency’s recommendations based on Trump’s input.

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