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Completed

NCT Number: NCT04880122

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

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

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Key information

Conditions

SARS-CoV-2 Acute Respiratory Disease COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • nursing home staff and residents

Exclusion criteria

  • Not applicable

Treatment and study plan

Dried blood spot and venous blood collection

Diagnostic Test

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 outcomes

  1. Sensitivity and specificity of DBS for SARS-CoV-2 antibody detection

    Time frame: baseline (single timepoint)

    Sensitivity and specificity analysis

  2. Optimization of the cut-off for seropositivity.

    Time frame: baseline (single timepoint)

    Optimization of the manufacturer recommended cut-off for seropositivity in DBS.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 10, 2021
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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