US Works With Clinical Laboratories to Launch Several Large-Scale COVID-19 Serological Surveys to Track Undetected COVID-19 in the Nation's Population
Health officials in the United States are taking steps to conduct wide-scale serological surveys to detect and track previously undetected cases of COVID-19. The aim is to determine how many adults nationwide with no confirmed history of COVID-19 have antibodies to the novel coronavirus. Michael Busch, MD, PhD, senior vice president, research and scientific affairs at Vitalant, a nonprofit community blood service provider, says the first study is being funded by the National Institutes of Health (NIH), and will be conducted in the metropolitan areas of Seattle, New York City, San Francisco, Los Angeles, Boston, and Minneapolis. Researchers will test blood samples from people donating blood. In March, participating blood centers in each region started saving 1,000 donor samples per month, with 6,000 samples evaluated monthly for a six-month period. Researchers will use an antibody testing algorithm to gauge how people develop COVID-19 antibodies over time. Busch says the regional data will be used to create three "national, fully representative serosurveys of the U.S. population using blood donors." The first national serosurvey will study 50,000 donations in September and December of 2020 and in November 2021.
FDA Clears Another Coronavirus Testing Kit for Use at Home
New York Times
Everlywell is the second company to be granted the Food and Drug Administration's (FDA) emergency clearance for an at-home coronavirus testing kit. FDA says the company "leveraged" data from studies supported by the Bill and Melinda Gates Foundation and UnitedHealth Group to show that the specimens would stay stable during shipping. Jeffrey Shuren, MD, director of FDA's Center for Devices and Radiological Health, says the new test "not only provides increased patient access to tests, but also protects others from potential exposure." Health care workers can risk COVID-19 infection when they administer diagnostic tests. Everlywell's kit will contain a swab for taking a sample from inside a person's nostrils, and a tube filled with a saline solution to put the swab in for sending to one of two private lab companies, Fulgent Therapeutics or Assurance Scientific Laboratories. The company intends to work with additional laboratories. Some public health researchers say at-home nasal swab tests can be less accurate compared with those that require a long nasal swab to be inserted through the nose to the back of the throat. Everlywell spokeswoman Christina Song says consumers will be required to take an online screening survey to determine if they fulfill federal guidelines for the test. The survey will be assessed by health care providers affiliated with PWNHealth, a telemedicine firm, and if a consumer qualifies, a test will be shipped out immediately. Song says the entire "process is designed to take 3 to 5 days," at a cost of $135. The test kits are expected to be available later in May, she says.
As Coronavirus Testing Expands, a New Problem Arises: Not Enough People to Test
A survey of state health departments and governors' offices by The Washington Post reveals that COVID-19 testing capacity exceeds patient demand in at least a dozen states. Utah, for instance, is testing about 3,500 people per day, but its maximum test capacity is about 9,000 per day. Utah Health Department spokesman Tom Hudachko observes, "It could be that people are so mildly symptomatic that they're just not concerned that having a positive lab result would actually change their course in any meaningful way." Experts also say there may be a continuing sense of scarcity, lack of access in rural and underserved communities, concerns about cost, and concerns about testing operations. Ashish Jha, who directs the Harvard Global Health Institute, says: "We want to be at a point where everybody who has mild symptoms is tested." The federal government is investing $75.5 million through the Defense Production Act to increase swab production and has pledged to supply 12.9 million swabs directly to states in May. The Food and Drug Administration eased regulations to allow the use of swabs made from polyester in addition to nylon and foam. A national strategy could make that effort more effective, said Danielle Allen, director of Harvard's Edmond J. Safra Center for Ethics, which published a road map estimated to cost $74 billion that calls for 24-hour contact tracing and isolation facilities for people who test positive.