COVID Card Pilot Study to Detect Antibodies to SARS-CoV-2
A Pilot Study Investigating the Clinical Performance of a Novel, Point-of-care, Semi-quantitative Test for SARS-CoV-2 Antibodies in Patients Vaccinated Against COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A prospective, non-blinded, non-randomized trial will be conducted at the Adult Emergency Department at the University of Maryland Medical Center and Adult Urgent Care Center, which is managed by the Department of Emergency Medicine, located in Baltimore, Maryland.
Patients meeting eligibility criteria and who have signed the research informed consent will be enrolled in this study. Subject data collected will include demographic information and past medical history. Upon enrollment into the study, a study team member will obtain a fingerstick blood sample and a sample of blood obtained during usual care venipuncture. Both fingerstick blood and blood from venipuncture will be run on the point-of-care, semi-quantitative test. The test should be expected to result within minutes after the blood sample is added to the agglutinin. An additional tube of blood will be obtained and sent to the local central laboratory for quantitative serum SARS-CoV-2 antibody testing.
Additional data will be collected on the reported or documented COVID-19 immunization status and reported or documented history of prior COVID-19 infection.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Systems
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult (age > 18 years) emergency department patients
- ED workup includes blood testing
- Confirmed history of vaccination against SARS-CoV-2
Exclusion Criteria:
- Known to be pregnant at the time of evaluation
- Incarcerated at the time of evaluation
- Requires the use of an interpreter
- Patient is considered immunocompromised or has any other condition that the investigator feels makes the patient unsuitable for study inclusion.
- Has any other condition that the investigator feels makes the patient unsuitable for study inclusion
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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COVID Card
Enrolled patients will receive antibody testing using both: 1) point-of-care, semi-quantitative SARS-CoV-2 antibodies test, 2) SARS-CoV-2 central laboratory antibodies test
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A drop of blood obtained by both finger-prick and venipuncture will be placed on the test card, which has been activated by the addition of diluent. Visual clumping of red blood cells (RBCs) will be seen within minutes if SARS-CoV-2 antibodies are present. Additionally, the COVID card is semi-quantitative, meaning that the yielded hemagglutination pattern will correlate with the concentration of antibodies in the serum. A research team member will be present at bedside to provide their interpretation based on an established visual agglutination scoring system.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Clinical Performance
Time Frame: 6 months
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To measure the diagnostic sensitivity, specificity, and accuracy compared to the gold standard central laboratory SARS-CoV-2 antibody test.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Past Medical Conditions
Time Frame: 6 months
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To measure the diagnostic sensitivity, specificity, and accuracy compared to the gold standard central laboratory SARS-CoV-2 antibody test relative to patient past medical conditions
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6 months
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Time Since Vaccination
Time Frame: 6 months
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To measure the diagnostic sensitivity, specificity, and accuracy compared to the gold standard central laboratory SARS-CoV-2 antibody test relative to the time since vaccination
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6 months
|
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Inter-Rater Reliability
Time Frame: 6 months
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To measure differences in interpretation (scoring) of hemagglutination patterns between study team members.
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6 months
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Type of Blood
Time Frame: 6 months
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The test characteristics of blood obtained by fingerstick will be compared to that of blood obtained by venipuncture.
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6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Richard G Wilkerson, MD, University of Maryland School of Medicine
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00099032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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