FDA Steps Up Scrutiny of Coronavirus Antibody Tests to Ensure Accuracy
The Food and Drug Administration (FDA) on Monday announced commercial coronavirus antibody tests will have to pass agency muster, including meeting standards for quality and accuracy. Officials said "unscrupulous actors" have been "marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans' anxiety." The new requirements will make it more difficult to buy questionable tests, but agency officials say there should still be enough reliable options for hospitals, doctors, and consumers. FDA already has authorized 12 antibody tests for emergency use, and is working with companies on authorizations for an additional 200 serology tests. Under the new rules, companies already marketing tests will be required to file applications for FDA emergency-use authorizations, including data on their tests, within 10 business days. Makers of new tests will have to file such applications within 10 days of notifying the agency of their plans to go to market. Under such authorizations, FDA allows unapproved medical products to be used in a public health emergency without being subjected to a full-fledged review. If commercial test makers do not submit applications for authorizations within the 10-day time limit, the agency plans to make that information public and consider enforcement action to take the products off the market.
Labs Across U.S. Join Federal Initiative to Study Coronavirus Genome
New York Times
A national effort unveiled Thursday by the Centers for Disease Control and Prevention (CDC) to examine the nationwide spread of COVID-19 includes at least 75 public health, academic, and commercial institutions studying its genome. As the novel coronavirus replicates, mutations increase in its genetic code, which can help researchers identify patterns of transmission and probe outbreaks. The mutations also help researchers understand how the virus is evolving, which can affect the performance of diagnostic tests, treatments, and vaccines. Participating labs have agreed to publicly release their information in a standard way via an initiative called SPHERES (Sequencing for Public Health Emergency Response, Epidemiology and Surveillance). Their findings will be used for surveillance, emergency response, and applied research, according to CDC. Pavitra Roychoudhury, PhD, a scientist with the University of Washington's virology department and the Fred Hutchinson Cancer Research Center, is helping to coordinate her institutions' work with SPHERES. She says the project, which launched in early April prior to being announced, already "made a tangible impact in the number of sequences we're able to deposit and make publicly available on a daily basis." The consortium seeks to standardize what information should accompany each sequence, such as where and when a sample was taken.
Drive-Through Coronavirus Testing Spreads Across 30 States, Lowering Risk of Exposure to Phlebotomists and Clinical Laboratory Professionals
As of April 22, consumers who meet certain criteria for exposure to the novel coronavirus can have their specimens collected at drive-through testing centers across 30 states. New Rochelle, N.Y., launched the state's first drive-through testing facility on March 13. During the center's first four days, 1,882 people were tested. Qualifying symptoms for patients included fever and cough and being a member of a high-risk population, such as the elderly or those with preexisting conditions. Patients must make an appointment either via a doctor's referral addressed to the New York State Health Department, or by calling the New York State Coronavirus hotline. Vivian Velasquez-Caldera, a phlebotomist who volunteered to work at the New Rochelle drive-through testing center, says the site collects more than 1,000 specimens per day on average and that every three hours, couriers pick up the samples for testing. Healthcare workers wear full hazmat suits when they approach a patient's car to obtain a series of nasal swabs. Velasquez-Caldera says, "It's a delicate process and just one mistake could lead to test result errors." Another drive-through testing center is being operated by Katherine Shaw Bethea (KSB) Hospital in Dixon, Ill. The team at KSB used role-playing scenarios prior to opening the center, and local health departments process the tests and follow up with patients.