Study seeks to determine the real number of coronavirus cases in the US

A new study has begun to determine how many adults in the US without a confirmed history of infection with the virus that causes COVID-19 have antibodies to the virus.

The National Institute of Allergies and Infectious Diseases has begun recruiting volunteers whose blood will be screened for antibodies to the virus, which would indicate a prior infection. Researchers will collect and analyze blood samples from as many as 10,000 volunteers to provide critical data for epidemiological models.

NIAD is pat of the National Institutes of Health.

The study's results will help illuminate the extent to which the novel coronavirus has spread undetected in the US. The "serosurvey, as it is called, also will provide  insights into which communities and populations are most affected.

“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,” said Anthony S. Fauci, M.D., NIAID director. “These crucial data will help us measure the impact of our public health efforts now and guide our COVID-19 response moving forward.”

Investigators will test participants’ blood samples for the presence of SARS-CoV-2 antibodies , proteins the immune system produces to fight a specific infectious agent. 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. While these cotton swab-based tests rapidly and effectively identify active infection, they do not determine whether a person was previously infected with SARS-CoV-2 and recovered.

“An antibody test is looking back into the immune system’s history with a rearview mirror,” said Matthew J. Memoli, M.D., M.S., principal investigator of the study and director of NIAID’s Laboratory of Infectious Diseases Clinical Studies Unit. “By analyzing an individual’s blood, we can determine if that person has encountered SARS-CoV-2 previously.

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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. These data may provide insight as to why these cases were less severe than those that lead to hospitalization.

Healthy volunteers over the age of 18 from anywhere in the United States 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 with blood collection kits they will receive and return by mail.

“Researchers have considerable experience using these at-home blood collection kits to track the spread of other infectious diseases like influenza, and this method is safe, effective and easy-to-use,” said Kaitlyn Sadtler, Ph.D., study lead for laboratory testing and chief of NIBIB’s Section for Immunoengineering. “With a small finger-pick, volunteers can help scientists fight COVID-19 from their homes.”

People interested in joining this study should contact . For more information about the study, visit ClinicalTrials.gov using identifier NCT04334954. For more information on the U.S. government response to the COVID-19 pandemic, visit www.coronavirus.gov.

NIAID, which is part of the National Institutes of Health, conducts and supports research throughout the US and worldwide, to study the causes of infectious and immune-mediated diseases and to improve means of preventing, diagnosing and treating these illnesses. For more, to the  NIAID website.