Dear Friends,
As you can read below, NIH is seeking volunteers to try to better
understand the infection rate of COVID-19. You do NOT have to leave home to
volunteer.
There is a link towards the bottom of the NIH press release that gives you
the email address to use if you're willing to help.
Please also share this info with others you believe would be willing to
help.
Thank you!
Laurie
---------- Forwarded
-----Original Message-----
From: NIH OLIB (NIH/OD) <olib@xxxxxxxxxx>
Sent: Friday, April 10, 2020 4:20 PM
To: List NIHPRESS <NIHPRESS@xxxxxxxxxxxx>
Subject: NIH BEGINS STUDY TO QUANTIFY UNDETECTED CASES OF CORONAVIRUS
INFECTION
NIH BEGINS STUDY TO QUANTIFY UNDETECTED CASES OF CORONAVIRUS INFECTION
Blood samples from healthy volunteers needed to inform public health
decision making
A new study has begun recruiting at the National Institutes of Health in
Bethesda, Maryland, to determine how many adults in the United States
without a confirmed history of infection with SARS-CoV-2, the virus that
causes coronavirus disease 2019 (COVID-19), have antibodies to the virus.
The presence of antibodies in the blood indicates a prior infection. In
this "serosurvey," researchers will collect and analyze blood samples from
as many as 10,000 volunteers to provide critical data for epidemiological
models. The results will help illuminate the extent to which the novel
coronavirus has spread undetected in the United States and provide insights
into which communities and populations are most affected.
The study will be conducted by researchers at the National Institute of
Allergy and Infectious Diseases (NIAID) and the 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), all parts of NIH.
"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 <https://www.flickr.com/photos/niaid/35450606566>,
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 <
https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html>
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."
Investigators will analyze blood samples for two types of antibodies,
anti-SARS-CoV-2 S protein IgG and IgM, using an ELISA (enzyme-linked
immunosorbent 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. 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. Neoteryx, a medical
device firm based in Torrance, California, will supply at-home blood
collection kits. Researchers will ship each study participant a Mitra(r)
Home Blood Collection Kit and provide detailed instructions on collecting a
microsample of blood and mailing it back for future analysis in the
laboratory.
"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 <
https://www.nibib.nih.gov/labs-at-nibib/section-immunoengineering>. "With a
small finger-pick, volunteers can help scientists fight COVID-19 from their
homes."
People interested in joining this study should contact
clinicalstudiesunit@xxxxxxx . For more information on this study, please
visit ClinicalTrials.gov using identifier NCT04334954 <
https://clinicaltrials.gov/ct2/show/NCT04334954?term=serosurvey&cond=covid-19&draw=2&rank=1>.
For more information on the U.S. government response to the COVID-19
pandemic, visit <www.coronavirus.gov>.
NIAID conducts and supports research -- at NIH, throughout the United
States, and worldwide -- to study the causes of infectious and
immune-mediated diseases, and to develop better means of preventing,
diagnosing and treating these illnesses. News releases, fact sheets and
other NIAID-related materials are available on the NIAID website <
http://www.niaid.nih.gov/>.
About the National Institutes of Health (NIH): NIH, the nation's medical
research agency, includes 27 Institutes and Centers and is a component of
the U.S. Department of Health and Human Services. NIH is the primary
federal agency conducting and supporting basic, clinical, and translational
medical research, and is investigating the causes, treatments, and cures
for both common and rare diseases. For more information about NIH and its
programs, visit <www.nih.gov>.
NIH...Turning Discovery into Health -- Registered, U.S. Patent and
Trademark Office ### This NIH News Release is available online at: <
https://www.nih.gov/news-events/news-releases/nih-begins-study-quantify-undetected-cases-coronavirus-infection
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