At-home antibody testing for COVID-19 is the subject of ample debate among the scientific and medical community, with some seeing it as a necessary step in the process of selectively re-opening parts of the economy through verification of individuals with immunity within the community, and others debating the accuracy and efficacy of currently available testing methods. Regardless of which side you’re on, it remains true that further testing is needed, and startup Scanwell has begun a sizeable study for its at-home antibody test, while it continues to work with the FDA on emergency use authorization for the diagnostic.
Scanwell is working with the state of North Carolina and Raleigh-based Wake Forest Baptist Health to distribute 1,000 of its at-home antibody test kits to a random sampling of citizens, funded in part by $100,000 from the state legislature. The sample population, chosen from the patient pool of Wake Forest Baptist Health’s system, and meant to be a statistically representative snapshot of the larger population, will get a finger-prick blood sample collection kit by mail, every month for a full year, in order to hopefully track the virus and immunity over time.
The Scanwell test can only be used for research purposes at this time, since it hasn’t yet received an emergency use authorization by the FDA. The FDA has so far specifically not authorized any at-home tests for COVID-19, including those supported by telemedicine, but it has recently updated its guidance to note that it “sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection,” and it says it is in the process of actively pursuing the development of tests that fit that profile in partnership with diagnostic companies.
LA-based Scanwell Health, which already provides at-home diagnostics for detecting UTIs, announced its work on securing FDA authorization for use of its at-home serological antibody test last month. The test kits can provide results in as little as 15 minutes once they’re received by diagnostic labs, but questions have been raised about the general accuracy of antibody testing overall regarding COVID-19, and there’s still some debate about the nature and duration of post-infection immunity for people who have contracted and recovered from the virus.
Better understanding immunity and who has recovered are key ingredients in any attempt to gradually relax isolation restrictions, so immunity testing is a core component that. It’s something that will be needed at scale, along with infection testing through existing molecular testing methods, and contact tracing, like the system being put in place through Apple and Google.