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

May 6, 2021 updated by: University Ghent

Comparison of Dried Blood Spots and Venous Blood for the Detection of SARS-CoV-2 2 Antibodies in a Population of Nursing Home Residents.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Ghent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • nursing home staff and residents

Exclusion Criteria:

  • Not applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nursing home residents/staff members
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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Piet Cools, University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

September 30, 2020

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (ACTUAL)

May 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-07665

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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