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

Not Applicable

Completed

• Conditions: SARS-CoV-2 Acute Respiratory Disease
• Interventions: Diagnostic Test: Dried blood spot and venous blood collection

• Registration Number: NCT04880122
• Lead Sponsor: University Ghent

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.

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2021-05
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-06
• Last Update Submitted: 2021-05-06
• Study First Posted: 2021-05-10
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

• nursing home staff and residents

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nursing home residents/staff members	Dried blood spot and venous blood collection	Matched venous blood/dried blood spots collection in a single arm.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of DBS for SARS-CoV-2 antibody detection	baseline (single timepoint)	Sensitivity and specificity analysis
Optimization of the cut-off for seropositivity.	baseline (single timepoint)	Optimization of the manufacturer recommended cut-off for seropositivity in DBS.

Trial Locations

Locations (1)

Ghent University; 🇧🇪 Ghent, Oost-Vlaanderen, Belgium