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NCT04880122 Clinical Trial

Dried Blood Spots for SARS-CoV-2 Serology (COVID-19).

SARS-CoV-2 Acute Respiratory Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04880122
Other study ID # BC-07665
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date September 30, 2020

Study information
Verified date May 2021
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to validate dried blood spots (DBS) for SARS-CoV-2 (Severe Acute Respiratory Syndrome 2) antibody detection in elderly individuals.

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.

Recruitment information / eligibility
Status Completed
Enrollment 440
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - nursing home staff and residents Exclusion Criteria: - Not applicable

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Dried blood spot and venous blood collection
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).

Locations
Country Name City State
Belgium Ghent University Ghent Oost-Vlaanderen

Sponsors (1)
Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity of DBS for SARS-CoV-2 antibody detection Sensitivity and specificity analysis baseline (single timepoint)
Primary Optimization of the cut-off for seropositivity. Optimization of the manufacturer recommended cut-off for seropositivity in DBS. baseline (single timepoint)
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