Virus World

Abbott Laboratories won Food and Drug Administration emergency clearance for its portable test for Covid-19 that will sell for just $5 and allow for “frequent mass testing” in schools and workplaces, the company said. The FDA’s “emergency use authorization” awarded to Abbott’s “BinaxNOW Covid-19 Ag Card” rapid test could be a game-changer given it turns around results within 15 minutes and could be administered in schools, workplaces and other sites. Such a test, which still requires a nasal swab by a health professional, is akin to a pregnancy test in its use of “lateral flow technology” and is about the size of a credit card. “With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others,” Abbott said in announcing the FDA’s emergency use authorization. It’s the latest diagnostic test for Covid-19 that Abbott has developed. The company in March received an FDA emergency use authorization for the Abbott ID NOW Covid-19 rapid molecular “point-of-care” diagnostic test that can be used in temporary screening locations, doctor’s office labs and nursing homes to detect the Coronavirus strain COVID-19 within a half hour. But BinaxNOW is different than IDNow in that it requires “no instrumentation,” Abbott said. And the new BinaxNow includes a companion mobile app Abbott will launch for iPhone and Android devices and make available at no charge called NAVICATM” that quickly displays test results.

"The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing," Joseph Petrosino, professor and chairman or molecular virology and microbiology at the Baylor College of Medicine in Houston said in a statement provided by Abbott. "With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don't spread the virus."  Abbott said the new BinaxNOW tests will begin to be shipped by the end of the month with the company expecting to produce 50 million such tests a month by October. "We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives," Abbott president and chief executive Robert Ford said. "BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a digital health tool to help us have a bit more normalcy in our daily lives."

The Food and Drug Administration has approved the first antigen test that can rapidly detect whether a person has been infected by the coronavirus, a significant advancement that promises to greatly expand the nation’s testing capacity. The test, by the Quidel Corporation of San Diego, was given emergency use authorization late Friday by the F.D.A., according to a notice on the agency’s website.

Even as the United States ramped up coronavirus testing from about 100,000 per week in mid-March to more than 5 million per week in late July, the country fell further behind in stemming the spread of the virus. Now, diagnostics experts, public health officials, and epidemiologists are calling for a radical shift in testing strategy: away from diagnosing people who have symptoms or were exposed and toward screening whole populations using faster, cheaper, sometimes less accurate tests. By making it possible to identify and isolate infected individuals more quickly, proponents say, the shift would slow the virus' spread, key to safely reopening schools, factories, and offices. “America faces an impending disaster,” says Rajiv Shah, president of the Rockefeller Foundation. Testing, he says, needs to focus on “massively increasing availability of fast, inexpensive screening tests to identify asymptomatic Americans who carry the virus. Today, we are conducting too few of these types of tests.” Rebecca Smith, an epidemiologist at the University of Illinois, Urbana-Champaign (UIUC), agrees. To stop outbreaks from overwhelming communities, she says, “we need fast, frequent testing,” which could mean faster versions of existing RNA tests or new kinds of tests aimed at detecting viral proteins. But researchers say the federal government will need to provide major financial backing for the push.

Today, COVID-19 testing relies primarily on the polymerase chain reaction (PCR), a technique to amplify the virus' genetic material, making it easy to detect. If administered properly, such tests are highly accurate, spotting positive cases nearly 100% of the time. That accuracy is vital for decisions about treating individual patients. But PCR tests cost about $100 each, require specialized machinery and reagents, and typically take at least 1 to 2 days to return results. The recent increase in coronavirus cases across the United States has added to the delay, pushing wait times to 2 weeks in some places. While they wait, people who are infected but don't yet know it may continue to interact with others and spread the virus. And if their infective period ends before they get their results, isolating them won't help. “It's like calling the fire department after your house burns to the ground,” says A. David Paltiel, an operations research expert at the Yale School of Public Health. “You can't play catch up with this virus.” A 24 July preprint on medRxiv underscored the downsides of slow tests. Shixiong Hu, a researcher with the Hunan Provincial Center for Disease Control and Prevention, and his colleagues followed 1178 people who tested positive for SARS-CoV-2 from January to April and tested their 15,648 contacts, defined as people who had been within 1 meter of a positive person between 2 days before and 14 days after the person's symptoms began. Based on which contacts were infected and when, the researchers estimated that people were most likely to spread the virus 1.8 days before the onset of symptoms. The finding suggests testing people only when they show symptoms and giving them test results days to weeks later does little to slow viral spread, says Daniel Larremore, an applied mathematician at the University of Colorado, Boulder...