The NIH has begun recruiting patients for a “serosurvey” study designed to quantify how many U.S. adults without a confirmed history of infection with SARS-CoV-2 have antibodies to the virus indicating prior infection.
Researchers from four NIH institutes and centers plan to collect and analyze blood samples from up to 10,000 volunteers, with the aim of providing critical data for epidemiological models. The results will help illuminate the extent to which the novel coronavirus has spread undetected in the U.S. and provide insights into which communities and populations are most affected, according to the agency.
The serostudy is being conducted by researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Biomedical Imaging and Bioengineering (NIBIB), with additional support from the National Center for Advancing Translational Sciences (NCATS) and the National Cancer Institute (NCI).
The investigators will test participants’ blood samples for the presence of SARS-CoV-2 antibodies. A positive test result indicates previous infection. To date, reporting of U.S. cases of COVID-19 has mostly relied on molecular tests that determine the presence of the virus in a person’s airways using a noninvasive cotton swab. The cotton swab-based tests rapidly and effectively identify active infection, but do not determine whether a person was previously infected with SARS-CoV-2 and recovered.
Researchers will analyze blood samples for two types of antibodies, anti-SARS-CoV-2 S protein IgG and IgM, using an ELISA assay developed by researchers at NIAID and NIBIB. In blood samples found to contain antibodies against SARS-CoV-2, researchers may perform additional tests to evaluate the volunteers’ immune responses to the virus—data which may provide insight as to why these cases were less severe than those that lead to hospitalization, the NIH said.
Healthy volunteers over the age of 18 from anywhere in the U.S. can participate and will be asked to consent to enrollment over the telephone. Individuals with a confirmed history of COVID-19 or current symptoms consistent with COVID-19 are not eligible to participate.
After enrollment, study participants will attend a virtual clinic visit, complete a health assessment questionnaire and provide basic demographic information—including race, ethnicity, sex, age and occupation—before submitting samples in one of two ways: participants working at the NIH Bethesda campus will have blood drawn at the NIH Clinical Center; other volunteers will participate in at-home blood sampling, the NIH added.
Neoteryx, a medical device firm based in Torrance, CA, will supply at-home blood collection kits. Researchers will ship each study participant a Mitra Home Blood Collection Kit and provide detailed instructions on collecting a microsample of blood and mailing it back for laboratory analysis.
“This study will give us a clearer picture of the true magnitude of the COVID-19 pandemic in the United States by telling us how many people in different communities have been infected without knowing it, because they had a very mild, undocumented illness or did not access testing while they were sick,” NIAID Director Anthony S. Fauci, M.D., said in a statement. “These crucial data will help us measure the impact of our public health efforts now and guide our COVID-19 response moving forward.”