A COVID-19 test developed by a Korean company with a $10.3 million infusion from the U.S. government is so flawed at least one state stopped using it after just a few weeks and a third-world country flagged it as defective months ago. In late September, the rapid antigen tests received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) to test individuals suspected by healthcare providers of being infected and by the end of December the authorization was expanded to include asymptomatic individuals. The test is made by south Korean manufacturer GenBody and is being promoted by a “minority-owned, female-led” public relations agency based in southern California.
Utah began using GenBody in late December at state-run testing sites. This week the Utah Department of Health (UDOH) announced it will temporarily pause the use of the on-site rapid antigen tests at all state-operated facilities after data revealed more than half of the tests resulted in a false negative. “The UDOH analyzed test results from nearly 18,000 Utah residents who received both GenBody rapid antigen and PCR tests on the same day,” the UDOH statement says. “Among people who tested positive by PCR, more than half of them tested negative by GenBody rapid antigen test; this was true even for people who reported COVID-like symptoms.” State epidemiologists raised questions about the performance of the GenBody rapid tests, the agency further writes.
In a local newspaper article Utah state epidemiologist Leisha Nolen says concerns were raised last week when mobile testing partners “noticed that they were getting a lot more negatives that would come up later as positives.” The health official reveals that for every 100 people who tested positive on a PCR test, only 38% tested positive on the GenBody rapid antigen test. “Even for those who displayed clear symptoms of COVID-19, only 41% out of every 100 who tested positive on a PCR test also tested positive on a GenBody rapid test,” the news story says, adding that Nolan and her colleagues “were really concerned by those numbers.” The UDOH announcement acknowledges that rapid antigen tests are known to be less likely to identify a positive individual, but the difference identified in the state analysis was higher than expected.
Back in October, officials in the Philippines—an impoverished third-world country—issued a warning against 10 COVID-19 antigen and rapid tests that failed to meet its health department standards. GenBody appears on the top of the list. A director at the Philippine FDA explains in a local media report that all of the tests were manufactured abroad and failed to comply with the standard for sensitivity and specificity set by the southeast Asian country’s Research Institute for Tropical Medicine (RITM), the agency charged with protecting Filipinos against infectious disease. “Those test kits published with failed performance validation were not able to comply with the standard set for sensitivity, specificity or both,” according to the Filipino FDA director who is identified in the news article as Maria Cecilia Matienzo.
GenBody received $10.3 million from the U.S. Department of Health and Human Services (HHS) to develop the COVID-19 test kits. The money was doled out under a program called Rapid Acceleration of Diagnostics (RADx) launched by the National Institutes of Health (NIH), a division of HHS, to speed innovation in the development, commercialization and implantation of technologies for COVID-19 testing. “Accurate, fast, easy-to-use, and widely accessible testing is required before the nation can safely return to normal life,” the NIH writes in its overview of RADx. The initiative is described as a national call for scientists and organizations to bring their innovative ideas for new COVID-19 testing approaches and strategies. “Funded projects include new applications of existing technologies that make tests easier to use, easier to access, and more accurate,” according to the NIH.
“At the same time, NIH is seeking opportunities to move more advanced diagnostic technologies swiftly through the development pipeline toward commercialization and broad availability — with the goal of making millions of tests per week available to Americans, particularly those most vulnerable to and/or disproportionately impacted by COVID-19, and having even more tests available in time for the 2020–2021 flu season.”