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COVID-19: Why false positives matter, too

Americas|: In the high-stakes world of coronavirus testing, one mistake has taken center stage: the dreaded false negative, wherein a test mistakenly deems an infected person to be virus-free. These troublesome results, experts have said, can deprive a person of treatment and embolden them to mingle with others, hastening the spread of disease. But false negatives are not the only errors bedeviling coronavirus diagnostics. False positives, which incorrectly identify a healthy person as infected by the virus, can have serious consequences as well, especially in places where the virus is scarce. Although false positives may seem relatively harmless in comparison with their false-negative cousins, "people can absolutely get hurt," said Dr. Benjamin Mazer, a pathologist and diagnostics expert at Johns Hopkins University. False positives are generally very rare among tests that have been vetted by the Food and Drug Administration. But any test can be plagued by contamination, mishandling or technical glitches, leading a device to spot the coronavirus where it is not. Some rapid tests, which forgo sophisticated laboratory equipment and can deliver results in under an hour, have been criticized for returning high numbers of false positives, especially when used to screen people without symptoms. Even laboratory tests that rely on a very reliable technique called polymerase chain reaction, or PCR, have been known to return the occasional false positive. In places where the virus is relatively scarce, false positives may even outnumber actual positives - eroding trust in tests and, under some circumstances, prompting outbreaks of their own. A positive result on a coronavirus test sets off a cascade of consequences. According to guidelines published by the Centers for Disease Control and Prevention, people who test positive should immediately isolate for at least 10 days after their symptoms start (if they experience symptoms at all). That is 10 days spent away from friends and family, and 10 days of potential productivity in a school or workplace lost. The ever-increasing availability of virtual platforms might make that transition easy for some, Mazer said. But for people whose work can only be done in person or who lack a financial buffer, "this could be a huge deal," he said. "They could lose their paycheck. They could lose their job." Caregivers, too, may find themselves put in a precarious position by false positives, which could force them to separate from children, older family members or other vulnerable contacts. Should another person need to come in and take their place, the risks of exposure to the virus could increase for all involved. And for facilities with limited space, placing a person in unnecessary isolation could shift equipment, medical care and even follow-up tests away from someone who might need those resources more. Under certain circumstances, a false positive could seed new coronavirus cases. Crowded facilities, such as nursing homes, prisons or hospitals, might isolate coronavirus-positive people together. In a worst-case scenario, "if someone isn't actually positive, we could be sending them to their death," said Dr. Valerie Fitzhugh, a pathologist at Rutgers University. In early October, officials in Nevada ordered the state's nursing homes to halt the use of two rapid coronavirus tests until further notice, citing concerns about accuracy. (Nearly 40% of the country's known COVID-19 deaths have come from nursing homes, according to an analysis by The New York Times.) A rash of false positives had been uncovered, according to the directive, which had risked placing uninfected residents into units with infected people, giving the coronavirus more opportunity to spread. Such a scenario "could result in causing harm to a population that we have collectively worked so hard to protect," officials noted in a follow-up directive. Under pressure from the federal government, Nevada officials revoked the rapid testing prohibition Oct. 9. False positives can also be disastrous from a treatment standpoint, said Linoj Samuel, a clinical microbiologist at Henry Ford Health System in Detroit. People with the flu or COVID-19, for example, often show similar symptoms but may only be tested for one of them at a time. If a patient is given an incorrect diagnosis of COVID-19, that person could be deprived of treatment that could alleviate their illness or be given a costly therapy that does little to speed their recovery. "That's definitely a price you pay," Samuel said. Mounting evidence suggests that most people who have fought off the coronavirus once retain a degree of immunity that can thwart the virus a second time. Scientists do not know how long this immunity lasts or how it varies from person to person, but the CDC has issued guidelines that note that reinfection is unlikely within 90 days. People who don't have symptoms within this time window do not need to be tested again, the agency has said. That could be helpful advice for people who actually contracted the coronavirus. But people who unknowingly receive a false positive on a test might be misled into thinking that they are invincible, said Saskia Popescu, an infection prevention expert at George Mason University. However, if these people never actually encountered the virus, they would be just as vulnerable as before - if not more, should they choose to forgo masks or physical distancing after assuming their bodies are already bolstered against the virus. Dr. Catherine O'Neal, an infectious disease specialist at Louisiana State University, expressed similar concerns when discussing a false-positive result given to University of Alabama football coach Nick Saban this month. Should someone be dropped from routine testing, O'Neal said, they would not just imperil their own health. A false positive could put an entire group of close contacts at risk. With so many of the long-term consequences of coronavirus infections unknown, a positive result can understandably take an emotional toll on the person who receives it, Fitzhugh said. "You hear that news, and the first thing you think is, 'I could die,'" she said. On a recent call with Adm. Brett Giroir, who has led the nation's coronavirus testing efforts, Ruth Katz, senior vice president of policy at LeadingAge, an association of nonprofit providers of aging services, noted that the repercussions of false positives had been a source of extra heartache among residents and staff members. Mazer noted that false positives on coronavirus tests were likely to evoke some of the same stressful reactions as when other types of clinical screens like mammograms, which search for signs of breast cancer, return incorrect results. "We see the anxiety, the frustration," he said. As testing in the United States continues to increase, experts have expressed concerns that frequent and high-profile diagnostic errors could seed disillusionment among the general public. Tests with a reputation for spitting out incorrect results of any kind might struggle to gain widespread traction. People who are wary of coronavirus tests might even become more hesitant to take other types of tests, for fear that they will not be given the answers they require. More frequent and accessible testing is needed - but putting it in effect could be more challenging if the public is less willing to engage, Mazer said. "That could have long-term consequences," he said. These concerns and more have prompted several experts to call for more data evaluating how different types of tests perform outside of laboratories and clinics, in places where most sick people go to get a diagnosis. Some tests may be able to effectively screen the healthy and quash outbreaks before they spin out control, while others are ill-suited to for this purpose. Depending on the circumstances, certain tests might need their results to be confirmed with a second, more accurate test. As testing efforts ramp up nationwide, experts said, people taking tests will need to be well versed not only in the benefits of tests but in their limitations as well. No test is perfect, Fitzhugh said. But tests, and the ways in which they are deployed, must still be vetted thoroughly before they are rolled out in large numbers, she said. "People need to know that the tests they receive are the best we have to offer," Fitzhugh said.

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India: Man arrested for live streaming sexual acts with wife on app

India|: Vidisha: A man has been arrested in Vidisha for allegedly live-streaming sexual acts with his wife on an app in lieu of money from other users, Chief Superintendent of Police (CSP) Vikas Pandey said on Sunday. The senior police official said that the wife had lodged a complaint with police about the man, who had married her under false pretences, forcing her to perform sexual acts on the app. "On October 21 a woman came to us with the complaint that a man named Charanjeet had lured her through social media and brought her with him to Vidisha and married her. He hid the fact from her that he was previously married. A few days after the wedding he filmed some obscene videos of the woman and used it to blackmail her and force her to do live videos," the CSP said. Explaining the modus operandi of the app, the police official said customers 'like' profiles on the app and in exchange for money deposited into a bank account number sent to them via WhatsApp, get access to obscene acts by the people profiled. The police team has recovered gold worth Rs 15.5 lakh and Rs 45,500 in cash and four mobiles among other things from the accused. Three bank accounts of the accused have also been seized in which it is being estimated that close to six lakh rupees would be recovered. "A complaint has been filed under several sections of the IPC and the IT Act," Pandey said and added that the accused had been engaged in such acts ever since he got married to the woman. Further investigation is underway.

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Spain declares second state of emergency over coronavirus

Europe|: Madrid: Spain declared a national state of emergency Sunday and a curfew for the entire country except the Canary Islands to curb a second wave of coronavirus cases. The new state of emergency will last until early May, Prime Minister Pedro Sanchez said in a televised speech. "The situation we are going through is extreme," he stressed. The measures were agreed earlier Sunday at a two-and-a-half-hour cabinet meeting convened following calls from Spanish regions for the power to impose curfews themselves. A government statement said the overnight curfew would run from 11:00 pm until 6:00 am, currently 2200 GMT to 0500 GMT. While the state of emergency would initially last for just 15 days, the government planned to ask parliament to extend it for six months, the statement added. Sanchez nonetheless said that if conditions allowed, the measures could be lifted earlier than anticipated. "The state of emergency is the most effective tool to lower the rate of infection," he argued. On Wednesday, Spain became the first European country to record more than a million cases of the virus, and almost 35,000 people have died from it. Authorities were responding to calls for help from 10 Spanish regions and the city of Melilla, the government statement said. Under the state of emergency, the regions would have the power to limit movement in and out of their territories, and could also extend the curfew by an hour on either end depending on local conditions. Spain was locked down during an initial state of emergency that lasted from March 15 to June 21, and the measures were among the strictest anywhere in Europe. Sanchez said that he sought "at any price" to avoid a second severe lockdown. "Let's stay home as much as possible," he urged in the television address. "The more we stay home the more protected we and others will be."

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Arabs favour Biden over Trump in US election: poll

Americas|Mena|: Riyadh: Democratic nominee Joe Biden substantially leads his Republican opponent Donald Trump as the Arab world's preferred candidate in next month's US presidential candidate, an opinion poll indicated Sunday. Out of 3,097 people polled across 18 Middle East and North African countries, around 39 percent favoured Biden while only 12 percent opted for Trump, according to the survey carried out by British pollster YouGov and commissioned by Saudi daily Arab News. "When asked which candidate would be better for the Arab World if elected president, most believe that neither candidate (49 percent) would fulfil such a description, yet Biden is still considered a better option to Trump," the survey said. The November 3 election, in which incumbent Trump is fighting to secure a second term in office, is being closely watched across the Arab world, where the United States plays a key role. "If the Arab world were choosing the next president, Biden would win by a landslide," YouGov's chief Stephan Shakespeare told AFP. "But that's partly because they don't know much about Biden - only half say they have heard of them, while nearly everyone has heard of Trump." Should Biden win, some 58 percent of Arabs said he "must distance himself from the Obama administration policies." Biden served as vice president in the Obama administration. Trump won some support in the poll for scrapping an Obama-era nuclear agreement with Tehran and imposing strict sanctions against the Iranian regime, but only 17 percent Arabs felt his stance would made the region safer. The poll listed youth empowerment, the Arab-Israeli conflict and the global coronavirus pandemic among the top three concerns Arabs would like the next US president to focus on.

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COVID-19 vaccine storage issues could leave 3b people without access

Africa|: Gampela, Burkina Faso: The chain breaks here, in a tiny medical clinic in Burkina Faso that went nearly a year without a working refrigerator. From factory to syringe, the world's most promising coronavirus vaccine candidates need non-stop sterile refrigeration to stay potent and safe. But despite enormous strides in equipping developing countries to maintain the vaccine ``cold chain,'' nearly 3 billion of the world's 7.8 billion people live where temperature-controlled storage is insufficient for an immunization campaign to bring COVID-19 under control. The result: Poor people around the world who were among the hardest hit by the virus pandemic are also likely to be the last to recover from it. The vaccine cold chain hurdle is just the latest disparity of the pandemic weighted against the poor, who more often live and work in crowded conditions that allow the virus to spread, have little access to medical oxygen that is vital to COVID-19 treatment, and whose health systems lack labs, supplies or technicians to carry out large-scale testing. Maintaining the cold chain for coronavirus vaccines won't be easy even in the richest of countries, especially when it comes to those that require ultracold temperatures of around minus 70 degrees Celsius (minus 94 F). Investment in infrastructure and cooling technology lags behind the high-speed leap that vaccine development has taken this year due to the virus. With the pandemic now in its eighth month, logistics experts warn that vast parts of the world lack the refrigeration to administer an effective vaccination program. This includes most of Central Asia, much of India and southeast Asia, Latin America except for the largest countries, and all but a tiny corner of Africa. The medical clinic outside Burkina Faso's capital, a dirt-streaked building that serves a population of 11,000, is a microcosm of the obstacles. After its refrigerator broke last fall, the clinic could no longer keep vaccines against tetanus, yellow fever, tuberculosis and other common diseases on site, nurse Julienne Zoungrana said. Staff instead used motorbikes to fetch vials in insulated carriers from a hospital in Ouagadougou, making a 40-minute round-trip drive on a narrow road that varies between dirt, gravel and pavement. A mother of two who visits the Gampela clinic says she thinks a coronavirus inoculation program will be challenging in her part of the world. Adama Tapsoba, 24, walks four hours under scorching sun to get her baby his routine immunizations and often waits hours more to see a doctor. A week earlier, her 5-month-old son had missed a scheduled shot because Tapsoba's daughter was sick and she could only bring one child on foot. "`It will be hard to get a (COVID-19) vaccine,'' Tapsoba said, bouncing her 5-month-old son on her lap outside the clinic. "People will have to wait at the hospital, and they might leave without getting it.'' To uphold the cold chain in developing nations, international organizations have overseen the installation of tens of thousands of solar-powered vaccine refrigerators. Keeping vaccines at stable temperatures from the time they are made until they are given to patients also requires mobile refrigeration, reliable electricity, sound roads and, above all, advance planning. For poor countries like Burkina Faso, the best chance of receiving a coronavirus vaccine is through the Covax initiative, led by the World Health Organization and the Gavi vaccine alliance. The goal of Covax is to place orders for multiple promising vaccine candidates and to allocate the successful ones equitably. The United Nations' children's agency, UNICEF, began laying the global distribution groundwork months ago, in Copenhagen. At the world's largest humanitarian aid warehouse, logistics staff are trying to foresee shortages by learning from the past, especially the spring chaos surrounding global shortages of masks and other protective gear that were commandeered off airport tarmacs or stolen and traded on the black market. Currently, 42 coronavirus vaccine candidates are in clinical trials and another 151 are in pre-clinical evaluation, according to WHO. The ones most likely to end up in the Covax mix must be stored at 2 to 8 degrees Celsius (25-46 F). A Pfizer candidate is among the ones in advanced testing requiring storage at ultracold temperatures. The company, which has designed a special carrying case for its vaccine, has expressed interest in Covax and signed contracts with the United States, Europe and Japan. Medical freezers that go down to minus 70 degrees Celsius are rare even in US and European hospitals. Many experts believe the West African countries that suffered through a 2014-16 Ebola outbreak may be the best positioned, because a vaccine against that virus also requires ultracold storage. For more than two-thirds of the world, however, the advanced technology is nowhere on the horizon, according to a study by German logistics company DHL. Meanwhile, billions of people are in countries that don't have the necessary infrastructure to maintain the cold chain for either existing vaccines or more conventional coronavirus candidates, the study said. Opportunities for vaccines to be lost expand the farther a vaccine travels. DHL estimated that 15,000 cargo flights would be required to vaccinate the entire planet against COVID-19, stretching global capacity for aircraft and potentially supplies of materials such as dry ice. "We need to find a bridge'' for every gap in the cold chain, DHL chief commercial officer Katja Busch said. "We're talking about investments ... as a society, this is something we have to do.'' Gavi and UNICEF worked before the pandemic to supply much of Africa and Asia with refrigeration for vaccines, fitting out 40,000 facilities since 2017. UNICEF is now offering governments a checklist of what they will need to maintain a vaccine supply chain and asking them to develop a plan. "The governments are in charge of what needs to happen in the end,'' said Benjamin Schreiber, who is among the directors of UNICEF's vaccination program. Cracks in the global cold chain start once vaccines leave the factory. Container ships are not equipped to refrigerate pharmaceutical products with a limited shelf life. Shipping vaccines by air costs a lot more, and air cargo traffic is only now rebounding from pandemic-related border closures. Even when flights are cold and frequent enough, air freight carries other potential hazards. WHO estimates that as much as half of vaccines globally are lost to wastage, sometimes due to heat exposure or vials breaking while in transit. With coronavirus vaccines, which will be one of the world's most sought-after products, theft is also a danger. "They can't be left on a tarmac and fought over because they would actually be spoiled and they would have no value _?or worse still, people would still be trying to distribute them,'' said Glyn Hughes, the global head of cargo for the International Air Transport Association. Tinglong Dai, a Johns Hopkins University researcher who specializes in health care logistics, said creativity will be needed to keep the cold chain intact while coronavirus vaccines are distributed on a global scale. Gavi and UNICEF have experimented with delivering vaccines by drone. Indian officials have floated the idea of setting aside part of the country's vast food storage network for the coronavirus vaccines. "If people can figure out how to transport ice cream, they can transport vaccines,'' Dai said. Temperature-sensitive labels that change color when a vaccine is exposed to heat too long and no longer safe to use, and live delivery tracking to ensure vaccines reach their destinations as intended also have allowed for progress in delivering safe shots. Yet chances for something to go wrong multiply on the ground as vaccines are prepped to leave national depots. Since the cold chain is so fragile, logistics planning is crucial" syringes and disposal boxes must be available as soon as vaccine shipments arrive. By the end of the year, UNICEF expects to have 520 million syringes pre-positioned for coronavirus vaccines in the developing world and maps of where the refrigeration needs are greatest "to ensure that these supplies arrive in countries by the time the vaccines do,'' Executive Director Henrietta Fore said. The last vaccine requiring cold storage that India's national program adopted was for rotavirus, a stomach bug that typically affects babies and young children. Dr. Gagandeep Kang, who led the research for that vaccine, estimated that India has about 30% less storage capacity than it would need for a coronavirus vaccine. In countries such as India and Burkina Faso, a lack of public transportation presents another obstacle to getting citizens inoculated before vaccines go bad. Dr. Aquinas Edassery, who runs two clinics in one of India's poorest and least developed regions, said patients must walk for hours to receive health care. The trip on a single road that winds 86 kilometers (53 miles) over steep hills and washes out for months at a time will pose an insurmountable barrier for many residents of the eastern district of Rayagada, Edassery said. As with most logistics, the last kilometer (mile) is the hardest part of delivering a coronavirus vaccine to the people who need it. In Latin America, perhaps nowhere more than Venezuela provides a glimpse into how the vaccine cold chain could go dramatically off course. When a blackout last year left much of the nation in the dark for a week, doctors in several parts of Venezuela reported losing stocks of vaccines. The country's largest children's hospital had to discard thousands of doses of vaccines for illnesses like diphtheria, according to Dr. Huniades Urbina, head of the Venezuelan Society of Childcare and Pediatrics. "We won't be able to halt either the coronavirus or measles,'' Urbina said. Preserving the cold chain has only grown more difficult since then. Gas shortages limit the ability to move vaccines quickly from one part of Venezuela to another. Dry ice to keep vaccines cool during transport is harder to find. And after years of economic decline, there also are fewer doctors and other professionals trained to keep the chain intact. "I'm not optimistic on how the vaccine would be distributed in the inner states because there is no infrastructure of any kind to guarantee delivery _ or if it gets delivered, guarantees the adequate preservation under cold conditions,'' Dr. Alberto Paniz-Mondolfi, a Venezuelan pathologist, said. Venezuela presents an extreme example, but a coronavirus vaccine also is likely to test parts of Latin America with more robust health care systems. In Peru, private businesses that typically transport fish and beef have offered their trucks, though it remains unclear whether the Health Ministry will accept. Back in Burkina Faso, vaccination days became an ordeal at the Gampela clinic when the refrigerator went out, said Zoungrana, the nurse. Staff members on hospital courier runs must buy fuel they often can't afford and make a second trip to and from the capital to return any unused doses. "We're suffering,'' said Zoungrana, who was run off the road on her motorbike just a few weeks ago. Days after journalists from The Associated Press visited the clinic this month, a long-awaited solar refrigerator arrived. With technicians in short supply, the clinic was waiting to be sure the appliance would function properly before stocking it with vaccines. Nationwide, Burkina Faso is about 1,000 clinical refrigerators short, and less than 40% of the health facilities that conduct vaccinations have reliable fridges, national vaccination director Issa Ouedraogo said. Multi-dose vials _ the equivalent of bulk storage for vaccines _ can drastically reduce global transportation costs. But once a vial is opened, its shelf life counts down even faster" if too few people show up for their jabs in time, whatever remains in the larger vials must be discarded. "It's really upsetting to have wastage like that. It'll result in loss of lives and pain and suffering. It's a waste of resources, '' said University of Massachusetts at Amherst professor Anna Nagurney, who studies supply chain logistics. For now, UNICEF is betting on 20-dose vials of coronavirus vaccine and hoping that the amount wasted will stay below 3% for closed vials and 15% for open multi-dose vials that do not get used up, according to Michelle Siedel, one of the U.N. agency's cold chain experts. If Burkina Faso were given 1 million doses of a coronavirus vaccine today, the country wouldn't be able to handle it, Jean-Claude Mubalama, UNICEF's head of health and nutrition for the African nation. "If we had to vaccinate against the coronavirus now, at this moment, it would be impossible,'' he said.