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

U

University Ghent

Status

Completed

Conditions

SARS-CoV-2 Acute Respiratory Disease

Treatments

Diagnostic Test: Dried blood spot and venous blood collection

Study type

Interventional

Funder types

Other

Identifiers

NCT04880122
BC-07665

Details and patient eligibility

About

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

Full 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.

Enrollment

440 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • nursing home staff and residents

Exclusion criteria

  • Not applicable

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

440 participants in 1 patient group

Nursing home residents/staff members
Experimental group
Description:
Matched venous blood/dried blood spots collection in a single arm.
Treatment:
Diagnostic Test: Dried blood spot and venous blood collection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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