We are Meron Tarekegn and Nahrain Putris, medical students at Oakland University William Beaumont School of Medicine, and Kaylee Gwyn, senior bioscience student, under the direction of Dr. Kenneth Mitton PhD, Associate Professor of Biomedical Sciences, Eye Research institute, Oakland University. While COVID-19 antibody status can be measured using clinical lab testing services, the current tests require drawing blood from veins in the arm and shipping of blood collection tubes to central labs.
We are conducting a research study to test the feasibility for using a fingertip blood sample to detect if a person has developed antibodies to the COVID-19 coronavirus. This test format will use an indicator system that gives a result in 15 minutes and could potentially be used for on-site testing and by mobile testing teams. To use such an on-site finger-tip blood test, we must first confirm that the test method can detect persons with antibodies to COVID-19, and that the test is reliable. This is a research study to evaluate the testing method itself and will not provide volunteers with any medical diagnosis.
We are recruiting individuals who are over the age of 18 to state whether they have received any COVID-19 coronavirus related testing and whether they have experienced symptoms and their onset. We especially desire to have subjects who:
1) have already been subjected to a COVID-19 antibody test by a clinical lab testing service and have either a positive or negative result
2) OR have had a confirmed diagnosis of COVID-19 and have since recovered from the illness and tested negative for the COVID-19 virus OR have been clinically cleared by medical staff (i.e. department of health and/or your primary care physician).
3) OR have received one or two doses of an FDA-approved COVID-19 vaccine.
For the testing, volunteers would provide a small finger-tip blood sample. The finger stick procedure is very similar to the way a diabetic checks his or her own blood sugar. Your finger will be stuck once, using a sterile single-use finger-tip lancet (very small with a sharp point). The interviewer will collect drops of your blood from a finger stick, mix the blood sample in a solution to carry out the test, and then load the mixed sample on to the indicator test. The research will take approximately 5-15 minutes of your time.
Your participation in this study is voluntary. The fingertip testing will take place in the Eye Research Institute on the campus of Oakland University.
If you have any questions concerning the research study or wish to consider volunteering, please email our research team members, and mention “Serum Antibody Research” in your subject line or text, to:
igenomes@gmail.com
We will reply with an email to confirm your preferred method of communication (i.e. phone or email) so that we can confirm your eligibility for the research study, review how the test will be done, and how we can schedule your participation should you decide to volunteer.
Oakland University IRB #: 2020-92, Recruitment Script Approved Version 02/22/21