An interventional study of Dried blood spot and venous blood collection in SARS-CoV-2 Acute Respiratory Disease, sponsored by University Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-10.
Sponsored by University Ghent · Not applicable, Interventional, and Diagnostic
This study aims to validate dried blood spots (DBS) for SARS-CoV-2 (Severe Acute Respiratory Syndrome 2) antibody detection in elderly individuals.
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.
617 studies on the registry are indexed under Respiratory Tract Diseases; 111 are open to participants now.
This study's enrollment of 440 is above the median of 80 across 381 interventional studies indexed under Respiratory Tract Diseases.
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Exclusion Criteria:
Matched venous blood/dried blood spots collection in a single arm.
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).
Sensitivity and specificity of DBS for SARS-CoV-2 antibody detection
Sensitivity and specificity analysis
Time frame: baseline (single timepoint)
Optimization of the cut-off for seropositivity.
Optimization of the manufacturer recommended cut-off for seropositivity in DBS.
Time frame: baseline (single timepoint)
Plan to share: No
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University Ghent