Crucial Research Objective: How Many Asymptomatic Adults Have Covid-19 Antibodies?
A new study has started to recruit volunteers at the National Institutes of Health (NIH) in Bethesda, Maryland, to help determine how many adults in the United States have antibodies to the COVID-19 virus yet do not have a confirmed history of infection. Detection of antibodies in the blood indicates prior infection with the virus.
Known as a “serosurvey,” NIH researchers will collect blood samples from as many as 10,000 volunteers and will analyze these samples to obtain much-needed data for epidemiological models. These results will be crucial in helping to answer critical questions that remain open through the following:
- obtaining evidence concerning the extent that the virus has spread undetected throughout the United States
- shedding further light on which patient populations, communities, and regions are most affected
Per Anthony S. Fauci, M.D., a world-renowned infectious disease expert and Director of the NIH’s National Institute for Allergy and Infectious Diseases (NIAID):
“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…These crucial data will help us measure the impact of our public health efforts now and guide our COVID-19 response moving forward.”
The study’s investigators will test the study volunteers’ blood samples for SARS-CoV-2 antibodies, which are proteins produced by the immune system to attack specific infectious agents. If a person’s test result is positive, he or she has previously been infected with COVID-19 and may have had no or extremely mild symptoms. In contrast, most diagnoses of the virus have been based on molecular tests that use a cotton swab to confirm the presence of the virus in a person’s airways. Although such molecular testing provides results relatively rapidly and effectively confirm active infection, they are unable to detect whether a person had previously been infected with the coronavirus and recovered.
The study researchers will analyze blood samples for two different types of antibodies using an enzyme-linked immunosorbent assay (ELISA) developed at the NIAID and the National Institute of Biomedical Imaging and Bioengineering (NIBIB). The two enzyme types are anti-SARS-CoV-2 S protein IgG and IgM. ELISA is a rapid immunochemical test that involves an enzyme to detect a small molecule (called a ligand) in a liquid sample using antibodies directed against the protein in question. For those samples that confirm the presence of antibodies against COVID-19, the NIH investigators may also conduct further testing to analyze immune response to the virus to help determine why such study participants’ cases were asymptomatic or extremely mild compared to those with severe responses that have resulted in hospitalization.
How Can You Enroll in This Study?
People who can be considered for this study must:
- Be over the age of 18 years who are healthy
- Live anywhere in the United States
- Not have current symptoms associated with Covid-19 infection
- Not have a confirmed history of COVID-19.
Potential participants will be asked to provide their consent to enrollment by phone.
Once participants are enrolled in the study, they will attend a “virtual clinic visit,” during which they will be asked to complete a health assessment questionnaire and to provide the study team with basic demographic information, including sex, age, race, ethnicity, and occupation. They will then be asked to submit blood samples.
For those study participants who work at the NIH Bethesda Campus in Maryland, they will have their blood samples drawn at the NIH Clinical Center.
Other participants will conduct at-home blood sampling. A medical device firm based in California, Neoteryx, will supply the study with at-home blood collection kits. The study investigators will ship a Mitra®Home Blood Collection Kit to each participant, which will include detailed instructions on the necessary steps to collect a microsample of blood and mail it back for analysis. The Neoteryx website linked above also has instructional videos on how to accurately obtain a blood sample using the Mitra®Home Blood Collection Kit
Kaitlyn Sadtler, Ph.D., study lead for laboratory testing and chief of the NIBIB’s Section for Immunoengineering, stressed that using at-home blood collections is safe, effective, and easy-to-use. ” She emphasized that “With a small finger-pick, volunteers can help scientists fight COVID-19 from their homes.”
What are the Next Steps for Joining This Coronavirus (COVID-19) Pandemic Serum Sampling Study?
People who are interested in participating in this study should contact clinicalstudiesunit@nih.gov. You can locate additional information on the study by visiting the NIAID’s website at Questions and Answers and by visiting ClinicalTrials.gov using the identifier NCT04334954.
Social Distancing:
How are You and Your Family Coping?
Many of us throughout our country are “sheltering in place,” working remotely (some for the very first time) and rarely leaving our homes or apartments except to walk our dogs and purchase groceries, medications, pet food, and additional necessary home supplies.
Please leave a comment below, discussing any suggestions or tips that you’ve found helpful in coping with our world as it is today.
Have you found any creative ways to prevent feelings of social isolation?
For example, click here to see one bored couple’s amazing “mini art gallery” that they made specifically for their pet gerbils. Absolutely incredible, creative, and adorable!
Have you found fun ways to keep your children engaged with their remote schoolwork? Have you come up with great ideas to help reduce your kids’ screen times on their smart phones, tablets, and other devices?
Have you finally taken an online course on a subject you love, taken up a new hobby such as baking, or started to tackle a project you’ve never had time for before?
Do you have any helpful tips and resources for those who are working from home for the first time?
Please consider sharing your ideas here, so that we can provide one another with helpful, positive, creative, and educational ways to get through this scary time together. I pray that you, your families, and all your loved ones are safe and well.
The Musings of a Cancer Research Advocate 