The first COVID-19 diagnostic test with an at-home self-collection option has been authorized for emergency use by the U.S. Food and Drug Administration, the agency announced on Tuesday. But as governors raise alarms about the prospect of reopening their states in the coming weeks—and the lack of testing they need to do so—it remained to be seen if this was the the game-changer some were looking for.
The emergency use authorization applies to LabCorp’s $119 Pixel home collection kit—one of 50 authorized diagnostics tests in the country—which the company said will “initially be made available to healthcare workers and first responders who may have been exposed to COVID-19 or may be symptomatic.” A healthcare provider must recommend the kit for a patient to obtain it, and the process includes the completion of a COVID-19 questionnaire and a “Q-tip-style” cotton nasal swab, which is then mailed in an insulated package to LabCorp.
“We worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site,” said FDA Commissioner Stephen Hahn. “There is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”
Much has been made of the national shortage of diagnostic tests for the novel coronavirus in the United States—and the subsequent probable undercount of the nation’s pandemic death toll. New York Gov. Andrew Cuomo has specifically said his state, the global epicenter of the crisis, must obtain “millions and millions” more diagnostic and antibody tests before it can consider loosening social-distancing guidelines. A new plan released by the Rockefeller Foundation on Tuesday called for 30 million people to be screened for the virus each week and would cost up to $100 billion to implement. On the other hand, such an ambitious plan might stem the economic loss of $300 billion to $400 billion each month from the havoc the pandemic has wreaked, CNBC reported.
Dr. Jeffrey Klausner, an adjunct professor of epidemiology at the University of California Los Angeles who previously worked for the CDC, called the development a “breakthrough in the COVID-19 testing crisis” that demonstrates “home-based testing collection can be done accurately and effectively.”
“Now it’s time for politicians to invest in the marketing and distribution of these to make them widely available to people,” Klausner told The Daily Beast on Tuesday.
North Carolina-based LabCorp said it intends to make the home collection kits available to consumers in most states within weeks.
“Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time,” said Adam Schechter, president and CEO of LabCorp.
“This is progress, but there’s still more to be done,” cautioned Dr. Irwin Redlener, director of the National Center for Disaster Preparedness at Columbia University and an expert on U.S. readiness for pandemics. “What we really need is a point-of-contact test that would allow results in a few minutes.” Point-of-contact or point-of-care tests refer to those finished (almost) instantly—with results at the time or place they’re taken, and the FDA issued emergency authorization for such tests in lab settings in March.
The test used at the White House provides results within 15 minutes, and Redlener said that speed is necessary for most Americans in order to send most people back to work.
“One-off tests that you took last week will not be sufficient if we’re actually talking about limiting social-distancing and sheltering in place,” said Redlener, noting that the U.S. is far behind South Korea and Germany in terms of testing a proportion of citizens.
“We need millions more,” said Redlener. “We need accurate, fast tests that are able to be done in huge numbers, and that’s going to be the case for many months to come.”