Back to resultsDried Blood Spots for SARS-CoV-2 Serology (COVID-19).
Primary Purpose
SARS-CoV-2 Acute Respiratory Disease
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Dried blood spot and venous blood collection
Sponsored by
About this trial
This is an interventional diagnostic trial for SARS-CoV-2 Acute Respiratory Disease focused on measuring serology, dried blood spot, elderly, nursing home residents, COVID-19, antibodies, immunoglobins, serosurveillance, vaccination, enzyme-linked immunosorbent assay (ELISA)
Eligibility Criteria
Inclusion Criteria:
- nursing home staff and residents
Exclusion Criteria:
- Not applicable
Sites / Locations
- Ghent University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nursing home residents/staff members
Arm Description
Matched venous blood/dried blood spots collection in a single arm.
Outcomes
Primary Outcome Measures
Sensitivity and specificity of DBS for SARS-CoV-2 antibody detection
Sensitivity and specificity analysis
Optimization of the cut-off for seropositivity.
Optimization of the manufacturer recommended cut-off for seropositivity in DBS.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04880122
Brief Title
Dried Blood Spots for SARS-CoV-2 Serology (COVID-19).
Official Title
Comparison of Dried Blood Spots and Venous Blood for the Detection of SARS-CoV-2 2 Antibodies in a Population of Nursing Home Residents.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to validate dried blood spots (DBS) for SARS-CoV-2 (Severe Acute Respiratory Syndrome 2) antibody detection in elderly individuals.
Detailed Description
In the current SARS-CoV-2 pandemic, testing for SARS-CoV-2 specific antibodies is paramount to monitor immune responses in post-authorization vaccination and sero-epidemiology studies. However, large scale and iterative serological testing by venipuncture in older persons can be challenging. Capillary blood sampled using a finger prick and collected on protein saver cards, i.e., dried blood spots (DBS), has already proven to be a promising alternative. However, elderly persons have a reduced cutaneous microvasculature, which may affect DBS-based antibody testing. Therefore, we aimed to evaluate the performance of DBS for the detection of SARS-CoV-2 antibodies in nursing homes residents. We collected venous blood and paired Whatman and EUROIMMUN DBS from nursing home residents, and from staff as a reference population. Venous blood samples were analyzed for the presence of SARS-CoV-2 IgG antibodies using the Abbot chemiluminescent microparticle immunoassay (CMIA). DBS were analyzed by the EUROIMMUN enzyme-linked immuno sorbent assay (ELISA) for SARS-CoV-2 IgG antibodies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Acute Respiratory Disease
Keywords
serology, dried blood spot, elderly, nursing home residents, COVID-19, antibodies, immunoglobins, serosurveillance, vaccination, enzyme-linked immunosorbent assay (ELISA)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
440 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nursing home residents/staff members
Arm Type
Experimental
Arm Description
Matched venous blood/dried blood spots collection in a single arm.
Intervention Type
Diagnostic Test
Intervention Name(s)
Dried blood spot and venous blood collection
Intervention Description
A paired venous blood and capillary blood sample (dried blood spot) were collected in every participant for validation purpose. Venous blood samples were analyzed using a chemiluminescent microparticle immunoassay ( the Architect i2000sr Plus system, Abbott), as a reference. Dried blood spots (EUROIMMUN, PerkinElmer Health Sciences Inc., Lübeck, Germany) or (Whatman™, GE Healthcare Sciences, Cardiff, UK) were analyzed by means of a SARS-CoV-2 IgG ELISA (EUROIMMUN, PerkinElmer Health Sciences Inc., Lübeck, Germany).
Primary Outcome Measure Information:
Title
Sensitivity and specificity of DBS for SARS-CoV-2 antibody detection
Description
Sensitivity and specificity analysis
Time Frame
baseline (single timepoint)
Title
Optimization of the cut-off for seropositivity.
Description
Optimization of the manufacturer recommended cut-off for seropositivity in DBS.
Time Frame
baseline (single timepoint)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
nursing home staff and residents
Exclusion Criteria:
Not applicable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piet Cools
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dried Blood Spots for SARS-CoV-2 Serology (COVID-19).
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