While all research labs were shut down for a few months, late March to mid-June 2020, for all but COVID19 related research, I turned my biochemical skills to a project to help evaluate one version of a serum COVID-19 antibody test that can use a single droplet (10 microliters) of blood from a finger-poke and which gives a reliable result in 15 minutes. Also without using any powered equipment. Cheap, mobile reliable tests like this can be used in almost any location. The problem in January to March 2020 was that many unreliable kits for such tests were rolled out mostly by firms looking to cash in, even selling online to the public. The main problem with those test kits was that they either 1) fail to detect antibodies to COVID19 when people have them, or 2) they say you are positive for antibodies to COVID19 BUT you are not.
Using finger-tip blood for tests of this type is very possible, and in fact, there are FDA and European Union approved tests that use this format "lateral flow test" for AIDS and Legionnaires Disease. However, those tests have been around for some time and were of course tested to confirm their reliability. So I approached a particular manufacturer of antibody-based research reagents when I heard they were turning their expertise to making a reliable family of tests for COVID19 antibodies in blood.
This company, I already knew, has made reliable reagents I have used in my own research lab, and their reagents had worked where others had failed to deliver. Working with one and now a second of our medical school students, we have successfully started a research study to evaluate this particular test system and have had the study approved by our Biosafety Committee and our IRB (Institutional Review Board). After testing about the first 50 volunteers, we already see that the test does NOT suffer from false positives, and it does detect antibodies to COVID19 in persons who have also had positive antibody tests from the standard clinical arm-drawn blood test that is FDA approved.
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| Lateral Flow Assays showing actual test example results from a volunteer who had antibodies to COVID19 (IgG positive) and a volunteer who did not. Mitton Lab, Oakland University, Rochester Michigan. |
We continue the study, underway now, and continue to recruit volunteers for a finger-poke based testing. Our test subjects are persons who have had a standard clinical serum antibody test (positive or negative) or persons who have had COVID19 and are now recovered from the illness. If you live around Oakland University in Auburn Hills / Rochester Michigan area, Oakland County or surrounding counties, then consider volunteering your finger for 15 minutes.
Two months into this study we are interested in more volunteers who have recovered now from COVID19 to complete evaluation of this new useful tool.
The official recruitment information and how to contact us is in our recent blog post here:
COVID19 Serum Antibody Test Research Project – at Oakland University.
The official IRB approved advertisement for this study is posted below, and thank you to all our kind volunteers.
Ken MItton
Oakland University Research Study: Evaluation of Finger-Tip Blood Testing for COVID19 Antibody (IgG & IgM).
Research Volunteers Needed
Evaluation of Finger-Tip Blood Testing for COVID19 Antibody (IgG & IgM).
I am Meron Tarekegn, a medical student at Oakland University William Beaumont School of Medicine, under the direction of Dr. Kenneth Mitton PhD, Associate Professor of Biomedical Sciences, 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.
OR
2) 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).
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 09/24/20
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