Tag Archives: Testing

U.S. FDA approves first rapid coronavirus test with 45 minutes detection time

By Kanishka Singh

(Reuters) – The U.S. Food and Drug Administration has approved the first rapid coronavirus diagnostic test, with a detection time of about 45 minutes, as the United States struggles to meet the demand for coronavirus testing.

The test’s developer, California-based molecular diagnostics company Cepheid, said on Saturday it had received an emergency use authorization from the FDA for the test, which will be used primarily in hospitals and emergency rooms. The company plans to begin shipping it to hospitals next week, it said.

The FDA confirmed its approval in a separate statement. It said the company intends to roll out the availability of its testing by March 30.

Under the current testing regime, samples must be sent to a centralized lab, where results can take days.

“With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them,” U.S. Secretary of Health and Human Services Alex Azar said on Saturday.

The United States is not even close to meeting domestic demand for coronavirus testing. Many medical experts have predicted that delayed and chaotic testing will cost lives, potentially including those of doctors and nurses.

On Friday, Anthony Fauci, director of National Institute of Allergy and Infectious Diseases, was asked whether the United States can currently meet demand for tests.

“We are not there yet,” Fauci said.

The diagnostic test for the virus that causes COVID-19 has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems globally, the company said.

The systems do not require users to have special training to perform testing, and are capable of running around the clock, Cepheid President Warren Kocmond said in the statement.

The company did not give further details or say how much the test will cost.

The U.S. FDA has been pushing to expand screening capacity for the virus while the World Health Organization has called for “order and discipline” in the market for health equipment needed to fight the outbreak.

(Reporting by Kanishka Singh in Bengaluru; Editing by Sonya Hepinstall and Daniel Wallis)

Google launches coronavirus website in the United States

Google launches coronavirus website in the United States
(Reuters) – Alphabet Inc’s Google said on Saturday it launched a United States-focused website with information about coronavirus guidance and testing, as the country works on slowing the spread of the highly contagious virus.

The site (google.com/covid19), which consists of resources and links focused on the potentially deadly respiratory illness COVID-19, will be available in more languages and countries in coming days, Google said in a blog post. https://bit.ly/2wq4f27

Google Chief Executive Sundar Pichai said in a blog post last Sunday that the search giant was partnering with the U.S. government to create a website by March 16.

However, the launch was delayed as local and national guidance changed significantly from Sunday to Monday and the company had said it would roll out the website later in the week.

(Reporting by Subrat Patnaik in Bengaluru; Editing by Raju Gopalakrishnan)

‘Fear of the unknown’: U.S. pregnant women worried by lack of virus research

By Gabriella Borter

(Reuters) – After the first two cases of the novel coronavirus in the state of Georgia were confirmed this week, Leigh Creel, who is 20 weeks pregnant and lives outside Atlanta, made a nervous phone call to her doctor to ask about the risk to her and her fetus.

The response she got was not comforting. Health experts do not know if pregnant women are more susceptible to the virus or if contracting it will increase the likelihood of adverse pregnancy outcomes, such as pre-term labor or transmission of the virus in utero.

They are racing to learn more about the sometimes fatal respiratory disease that has rapidly spread worldwide from China, including how it might uniquely affect pregnant women.

For expectant mothers, the mystery surrounding the virus is worrying.

“It’s concerning to me when I feel like I know as much as the healthcare professionals,” said Creel, who works in sales and lives with her husband and toddler.

The U.S. death toll from COVID-19 now stands at 14, most of them in Washington state, where 12 people have died in a cluster of at least 50 infections in the Seattle area. More than 3,400 people have died worldwide.

Public health officials in Washington’s Seattle and King Counties have advised that people at “higher risk of severe illness,” including pregnant women, should avoid physical contact and going out in public.

Dr. Laura Sienas, an obstetrician-gynecologist at the University of Washington Medical Center, said most of her pregnant patients have asked what they can do to protect themselves.

Sienas said her hospital has stopped short of urging pregnant women to quarantine themselves, contrary to local public health official guidelines.

Instead, she has emphasized diligent hygiene and avoiding close contact with others, the same guidance the U.S. Centers for Disease Control has offered on its website.

To that end, Sienas has tried to arrange check-ups via telephone, aiming to limit the number of in-person visits pregnant patients make to the hospital.

“There’s definitely that fear of the unknown, and pregnancy is a time when there are a lot of things that you don’t know and can’t control,” Sienas told Reuters. “Trying to give people small steps that they are able to control, like handwashing, has been a bit reassuring to patients.”

‘WE DON’T REALLY KNOW’

Scientists have not yet developed a vaccine against the virus, and research on its transmission and effects on pregnant women has been limited.

A narrow study of nine coronavirus-positive pregnant women in the Wuhan region of China, all in their third trimester, found no evidence that COVID-19 was transferred in utero. The women showed symptoms similar to non-pregnant adult patients.

The World Health Organization published an analysis of 147 pregnant women (64 of whom were confirmed to have COVID-19, 82 who were suspected and 1 who was asymptomatic) and found that 8% had a severe condition and 1% were critically ill.

“There’s some suggestion from other coronaviruses such as SARS that pregnant women may have a more severe disease, but we really don’t know,” said Dr. Denise Jamieson, chief of gynecology and obstetrics at Emory Healthcare in Atlanta and a former epidemic intelligence officer at the CDC.

Normal immunologic and physiologic changes in pregnant women might make them more susceptible to viral infections, including COVID-19, according to the CDC.

“There doesn’t seem to be any great answers out there for anyone, so your mind can really run wild with the possibilities,” said Rachel Storniolo, 36, who lives in Philadelphia and is due to give birth in May.

The study of the Chinese women, published in the scientific magazine The Lancet, found no traces of the virus in breast milk. Still, Jamieson said she would warn coronavirus-positive mothers that they risk transmitting the virus to their infants through respiratory droplets if they choose to breastfeed.

“If a woman has confirmed coronavirus, the safest thing in terms of ensuring that the infant does not get infected from the mother is to separate the mom and baby,” she said, adding that separation might be necessary for several days until the mother is asymptomatic.

Officials have not reported any cases of pregnant women with coronavirus in the United States, and they believe pregnant women – and the rest of the general public – who live outside the outbreak areas are at low risk.

But some women, like Brandi Cornelius, 36, of Portland, Oregon, who is 23 weeks pregnant, are not taking any chances.

“I went to the bank and I used hand sanitizer three times while I was there,” she said. “It helps my body to go to prenatal yoga, for example, but do I want to be in a room full of people?”

(Reporting by Gabriella Borter in New York; Editing by Frank McGurty and Dan Grebler)

UK conducts random coronavirus testing as part of early warning plan

LONDON (Reuters) – Britain has started random tests for coronavirus on flu patients to have an early warning system in place in case the outbreak becomes more widespread, a senior health official said.

Britain has so far had 13 cases of coronavirus. An outbreak in northern Italy worsened on Wednesday, and the illness has spread to Spain, Austria, Switzerland, Croatia and France via visitors who were recently in northern Italy.

“We’re heightening our vigilance because of the apparent spread of the virus in countries outside mainland China,” Public Health England’s medical director, Paul Cosford, told BBC radio on Wednesday.

The disease is believed to have originated in a market selling wildlife in the Chinese city of Wuhan late last year and has infected about 80,000 people and killed more than 2,700, the vast majority in China.

British health minister Matt Hancock said the government had plans in place in case the virus becomes a pandemic.

In Britain, random tests for the virus will be carried out at 11 hospitals and 100 general medical offices on people who have flu symptoms including a cough, plus shortness of breath and a fever.

“This testing will tell us whether there’s evidence of infection more widespread than we think there is. We don’t think there is at the moment,” PHE’s Cosford said.

“The other thing it will do is, if we do get to the position of more widespread infection across the country, then it will give us early warning that that’s happening,” he added.

Hancock told parliament the government expected more cases in Britain and was planning to introduce home testing.

“We are taking all necessary measures to minimise the risk to the public,” he said. “The public can be assured that we have a clear plan to contain, delay, research and mitigate this virus.”

Media have reported several schools have closed or sent pupils home after returning from trips to northern Italy during last week’s school holiday. Hancock said there was no need for schools to close or other students or staff to be sent home.

(Reporting by Sarah Young and Kylie MacLellan; Editing by William Schomberg and Stephen Addison)

Trump signs order to test vulnerabilities of U.S. infrastructure to GPS outage

WASHINGTON (Reuters) – U.S. President Donald Trump on Wednesday signed an executive order directing U.S. agencies to test the vulnerabilities of critical infrastructure systems in the event of a disruption or manipulation of global positioning system services (GPS).

GPS is critical to a variety of purposes ranging from electrical power grids, weather forecasting, traffic signals, smartphone applications and vehicle navigation systems. The order said “disruption or manipulation of these services has the potential to adversely affect the national and economic security of the United States.” Trump’s order directed federal agencies to within one year develop a plan to test infrastructure systems.

(Reporting by David Shepardson; Editing by Chizu Nomiyama)

Exclusive: U.S. Army forms plan to test 40,000 homes for lead following Reuters report

FILE PHOTO: Professor Alexander Van Geen, Research Professor of Geochemistry at Columbia University, tests lead samples from Fort Benning, Georgia at the Lamont-Doherty Earth Observatory in Palisades, New York, U.S. March 29, 2018. REUTERS/Mike Wood/File Photo

By Joshua Schneyer and Andrea Januta

NEW YORK (Reuters) – The U.S. Army has drafted a plan to test for toxic lead hazards in 40,000 homes on its bases, military documents show, in a sweeping response to a Reuters report that found children at risk of lead poisoning in military housing.

The inspection program, if implemented, would begin quickly and prioritize thousands of Army post homes occupied by small children, who are most vulnerable to lead exposure. Ingesting the heavy metal can stunt brain development and cause lifelong health impacts.

The lead inspections would cost up to $386 million and target pre-1978 homes to identify deteriorating lead-based paint and leaded dust, water or soil, according to the military documents.

A draft Army Execution Order says the program’s mission is to mitigate all identified lead hazards in Army post homes in the United States. In homes where dangers are detected, the Army would offer soldiers’ families “temporary or permanent relocation” to housing safe from lead hazards, it says.

The Army’s mobilization comes after Reuters published an investigation on August 16 describing lead paint poisoning hazards in privatized military base homes. It documented at least 1,050 small children who tested high for lead at base clinics in recent years. Their results often weren’t being reported to state health authorities as required, Reuters found.

Behind the numbers were injured families, including that of a decorated Army colonel, J. Cale Brown, whose son JC was poisoned by lead while living at Fort Benning, in Georgia.

The article drew a quick response from lawmakers, with eight U.S. senators demanding action to protect military families living in base housing.

The Army’s planned response is laid out in military documents, including the draft Execution Order, minutes from a private meeting attended by top Army brass, and other materials.

One priority, detailed by Under Secretary of the Army Ryan McCarthy in an August 22 meeting, is for the military’s response to counter any sense “that we … are not taking care of children of Soldiers and are not taking appropriate action quickly enough,” meeting minutes say. “The Army will remain focused on the actions to assess, inspect, and mitigate risks to Soldiers and Families,” the minutes say, citing McCarthy and Vice Chief of Staff General James C. McConville.

Army spokeswoman Colonel Kathleen Turner acknowledged plans are being formulated but said no decisions have been made. “Out of an abundance of caution, we are going above and beyond current requirements to ensure the safety of our soldiers and their families who work and live on all of our installations,” Turner said in a statement. “We are currently evaluating all options to address these concerns.”

Old lead-based paint becomes a poisoning hazard when it deteriorates, and poor maintenance of military base homes can leave legions at risk. About 30 percent of service families – including some 100,000 small children – live in U.S. military housing owned and operated by private companies in business with the military.

There are nearly 100,000 homes on U.S. Army bases, and the lead inspections are expected to focus on the approximately 40,000 built before a 1978 U.S. ban on the sale of lead paint.

The plans depart from guidance that appeared on the Army Public Health Center’s website as recently as last week, which “discouraged” lead-based paint inspections in Army homes. The website has since been updated and omits that language.

Under the plans, the documents show, the Army would:

– Inspect all pre-1978 Army family housing units nationwide, including visual lead-based paint assessments by certified personnel, swipe-testing for toxic lead paint dust, and testing of tap water. Some homes will also receive soil testing. This phase alone, described as “near-term actions,” will cost between $328 million to $386 million, the Army’s Installation Services director estimated.

– Temporarily or permanently relocate families when hazards are found. “If a Family or Soldier are concerned with potential negative impacts from lead; the U.S. Army will offer them a chance to relocate to a new residence,” the documents say. “We must do everything we can to maintain that trust.”

– Conduct town hall meetings on Army posts to address residents’ lead concerns. The Army intends to do so with “empathy,” the meeting minutes say. “Tone is key and can be just as important as the actions we take.”

The documents leave some questions unanswered. They don’t say how long it would take to inspect all 40,000 homes. Also unclear is whether the Army has funds immediately available for the program, or would need Congressional authorization to set them aside.

The Army would ensure that the private contractors who operate base housing “are meeting their obligations” to maintain base homes, the documents say and would require them to show compliance with lead safety standards through independent audits.

The documents do not discuss whether private housing contractors would bear any of the costs of the lead inspections, or how any repairs would be funded.

In most cases, Army post homes are now majority-owned by private real estate companies. Under their 50-year agreements with the Army, corporate landlords operating military housing agreed to control lead, asbestos, mold, and other toxic risks present in some homes, particularly historic ones.

FAMILIES, SENATORS PRESS FOR ANSWERS

The Army plans come as base commanders and housing contractors face a wave of complaints about potential home lead hazards, and a rush of military families seeking lead tests for their children.

Last week, the hospital at Fort Benning, where Reuters reported that at least 31 small children had tested high for lead exposure in recent years, began offering “walk-in” lead testing. Some concerned families are already being relocated; in other homes, maintenance workers are using painter’s tape to mark peeling paint spots that residents found contained lead by using store-bought testing kits.

Lead poisoning is preventable, and its prevalence in the United States has declined sharply in recent decades. Still, a 2016 Reuters investigation documented thousands of remaining exposure hotspots, mostly in civilian neighborhoods.

Last week, eight senators, including Republican Johnny Isakson of Georgia and Democrat Claire McCaskill of Missouri, pushed amendments to legislation to examine and address the military’s handling of lead exposure risks.

In coming weeks, Army officials plan to meet with lawmakers to address their concerns, the military documents show.

(Edited by Ronnie Greene and Michael Williams)

Chemical weapons inspectors to collect new samples in UK nerve agent poisoning

A forensic investigator, wearing a protective suit, emerges from the rear of John Baker House, after it was confirmed that two people had been poisoned with the nerve-agent Novichok, in Amesbury, Britain, July 6, 2018. REUTERS/Henry Nicholls

AMSTERDAM (Reuters) – Inspectors of the world’s chemical weapons watchdog will return to Britain on request of the government to take new samples of the nerve agent which killed one person and injured another in Amesbury, England, in June.

The Organization for the Prohibition of Chemical Weapons (OPCW) on Tuesday said it would deploy a team to collect additional samples, to be analyzed in two laboratories designated by the agency.

In July the British government asked the OPCW to independently identify a substance which the authorities had found to be Novichok — the same nerve agent used to poison former Russian spy Sergei Skripal and his daughter Yulia in March.

Britain blamed Russia for the Skripal poisoning but the Kremlin denied involvement.

In June, two Britons fell ill in Amesbury after being exposed to the poison in southwest England, close to where the Skripals were attacked. One of them died.

Britain is ready to ask Russia to extradite two men it suspects of carrying out a nerve agent attack on Skripal, the Guardian newspaper reported on Monday, citing government and security sources.

(Reporting by Bart Meijer; Editing by Raissa Kasolowsky)

Oklahoma parents fret over childcare, testing as teachers strike

FILE PHOTO: Teachers rally outside the state Capitol for the second day of a teacher walkout to demand higher pay and more funding for education in Oklahoma City, Oklahoma, U.S., April 3, 2018. REUTERS/Nick Oxford/File Photo

By Heide Brandes and Lenzy Krehbiel-Burton

OKLAHOMA CITY/TULSA, Okla. (Reuters) – Oklahoma parent Matt Reynolds backs a teachers’ strike that has shut schools statewide, but each day it drags on is another he has to pay for daycare for three of his children.

“I’m mad at the teachers for walking out, but I’m more mad at the government for forcing them to do this,” said Reynolds, a 51-year-old chef in Yukon.

Lawmakers and striking teachers remained at odds over the state’s financing of its public education on Thursday, the 11th day of a walkout that has affected about a half million students.

The standoff is testing the patience of parents, many of whom support the labor action after seeing firsthand the fallout from slashed education budgets. But they are weary of making special accommodations for their children, and worry about how the missed class time will affect upcoming state testing and national advanced placements exams.

Some parents said the strike that started on April 2 has made them consider private schools, home schooling or moving to a district with more secure funding. Many said the prospects of a prolonged strike would eventually lead them to lobby their local districts to return to class.

“I’m at the point where if education doesn’t get adequate funding, I’ll say screw it and home school my kids since we can’t afford to move,” said Lisa Snell, who has been forced to take her two children to work during the strike.

Snell’s empathy runs deep for the state’s teachers, who are among the worst paid educators in the United States.

She has been asked to provide pencils, crayons, paper and tissue for the struggling elementary school her children attend near Tahlequah in eastern Oklahoma. Her kids bring home school books in tatters and have to go shoeless in gym class to preserve the decaying floor, Snell said.

“I know what those teachers are going through,” Snell said. “It’s not just about raises.”

The main union in the strike is urging parents to make their voices heard by voting in this year’s midterm election for candidates who back increased spending, or have educators run for office.

Republicans, who dominate state politics, are appealing to conservative voters by saying they have done enough by raising education spending by more than 20 percent, and more spending would be wasteful.

PRESSURE EXPECTED TO MOUNT

The legislature passed its first major tax hikes in a quarter century to raise funds for schools and increase teacher pay by an average of $6,100. Educators are asking for a $10,000 raise for teachers over three years.

“We’ve accomplished a whole lot, and I just don’t know how much more we can get done this session,” state Representative John Pfeiffer, a top Republican lawmaker, told reporters this week on the education funding issue.

Pressure is likely to build on legislators and teachers to reach a deal that gets kids back to class.

For the most part, teachers have been given permission by their districts to participate in walkouts and have been paid, with the idea that they would make up for lost time as they do for closures due to inclement weather. But that could soon change as the cushion in school calendars runs out.

Two large districts, Bartlesville and Sand Springs, ordered schools to resume on Thursday. Tulsa Public Schools, the state’s second-largest district, has run out of inclement weather days and plans to lengthen school days when students return.

Legislators also are in a tough spot, said Gregg Garn, dean of the Jeannine Rainbolt College of Education at the University of Oklahoma.

“They have kids in public schools and they live in the communities,” he said. “They are getting the signal that the investments need to be there.”

Candice Stubblefield, 43, of Midwest City wants a quick resolution.

“They have missed so many days now,” said Stubblefield, whose daughter attends public school. “Both the legislature and teachers seem like they are being stubborn and unyielding.”

(Reporting by Lenzy Krehbiel-Burton in Tulsa, Heide Brandes in Oklahoma City and Jon Herskovitz in Austin, Texas; Writing by Jon Herskovitz; Editing by Colleen Jenkins and Richard Chang)

U.S. lawmakers seek compromise on Zika virus funding

U.S. Senate Majority Leader Mitch McConnell speaks at the Republican National Convention in Cleveland

By Richard Cowan

WASHINGTON (Reuters) – U.S. lawmakers sought on Wednesday to break a logjam over $1.1 billion in funding to combat the Zika virus, with the Senate possibly considering legislation as soon as next week, even as one congressman toted a jar full of mosquitoes to the House floor to condemn congressional inaction.

“Can you imagine the fears and anxieties if the mosquitoes were not in this jar?” Florida Republican David Jolly told his colleagues as he brandished the container holding about 100 of the insects in the House of Representatives chamber.

“Members of Congress would run down the hall to the physician’s office to be tested,” added Jolly, whose state is the first in the nation with local transmission of the mosquito-borne virus that has spread through the Americas.

The potential Senate Zika measure could advance as part of a broader legislative effort to temporarily keep federal agencies operating in the 2017 fiscal year that begins Oct. 1.

Republicans and Democrats huddled separately in closed meetings in both the Senate and House to see if they could reach a compromise during a 19-day work session this month, before lawmakers break for a recess in the weeks before the Nov. 8 U.S. election. Lawmakers returned to work this week after a seven-week summer recess.

Senate Majority Leader Mitch McConnell told reporters he was in talks with Senate Democratic leader Harry Reid.

“We’re looking for a way forward. And I’m hopeful and optimistic that we’ll be able to do that,” McConnell, a Republican, said of both a temporary agency funding bill and Zika money.

In February, President Barack Obama asked Congress to approve $1.9 billion in emergency funds to deal with the Zika virus, which can cause severe birth defects when pregnant women become infected.

Since then, both parties have backed $1.1 billion as the funding figure. But fights over side issues related to abortion and Obama’s signature healthcare law have bitterly divided the two parties.

One of the biggest controversies involves Democrats’ opposition to language, backed by Republicans, that they say would prevent Zika funds for abortion providers like Planned Parenthood, mainly in Puerto Rico.

The Miami Herald on Tuesday quoted Senators Marco Rubio of Florida and Senator Roy Blunt of Missouri, who chairs a Senate panel overseeing healthcare funding, suggesting the Planned Parenthood language might have to be dropped in order to reach a deal.

Aides to both senators declined to confirm or deny the accuracy of the quotes.

Republican Senator Susan Collins of Maine, asked by Reuters whether she thought Planned Parenthood funding restrictions should be eliminated from Zika legislation, said: “That would be my preference.”

Still, some Republicans were resisting a deal that would abandon the Planned Parenthood language in the Zika bill.

(Reporting by Richard Cowan and Susan Cornwell; Editing by Will Dunham)

Zika virus found in tears of mice – U.S. study

CHICAGO (Reuters) – A new study has found genetic fragments of Zika in the eyes and the tears of laboratory mice infected with the virus, a finding that offers a potential new route of human infection.

“Our study suggests that the eye could be a reservoir for Zika virus,” said Dr. Michael Diamond of Washington University St. Louis, whose paper was published in the journal Cell Reports.

“We need to consider whether people with Zika have infectious virus in their eyes and how long it actually persists.”

For the study, the team infected adult mice under the skin, resembling the way people get infected by mosquito bites, and found live virus in the eyes a week later. When tested 28 days later, the tears of infected mice contained genetic material from the virus, but not infectious virus.

The researchers said their findings raise the possibility that Zika could be spread through contact with the tears of infected people, but said that would have to be proven.

“We are planning studies in people to find out whether infectious virus persists in the cornea or other compartments of the eye, because that would have implications for corneal transplantation,” said Dr. Rajendra Apte, a senior author of the study. Other blood-borne viruses such as herpes simplex virus have been transmitted accidentally through corneal transplants.

Although principally spread by mosquitoes, Zika has been shown to persist in sites of the body where the immune system is less active, including semen, vaginal fluid, saliva and now, possibly, tears.

That could help account for why Zika has spread so quickly, outpacing what might be expected if the virus were only carried by mosquitoes, Diamond said. “Sexual transmission is probably not playing a major role, but it could be some other bodily fluid – saliva, or urine or tears,” he said.

Zika infections in pregnant women have been shown to cause microcephaly – a severe birth defect in which the head and brain are undersized – as well as other brain abnormalities. The connection between Zika and microcephaly first came to light last fall in Brazil, which has since confirmed more than 1,800 cases of microcephaly.

In adults, Zika infections have also been linked to a rare neurological syndrome known as Guillain-Barre, as well as other neurological disorders.

(Reporting by Julie Steenhuysen; Editing by Jonathan Oatis)