Viewing Study NCT04880122



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Last Modification Date: 2024-10-26 @ 2:04 PM
Study NCT ID: NCT04880122
Status: COMPLETED
Last Update Posted: 2021-05-10
First Post: 2021-05-05

Brief Title: Dried Blood Spots for SARS-CoV-2 Serology COVID-19
Sponsor: University Ghent
Organization: University Ghent

Study Overview

Official 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
Status: COMPLETED
Status Verified Date: 2021-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 ie 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None