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

Study Overview
=================
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.

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.

Conditions
-----------------
SARS-CoV-2 Acute Respiratory Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Dried blood spot and venous blood collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nursing home staff and residents Exclusion Criteria: Not applicable

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nursing home residents/staff members<br>Matched venous blood/dried blood spots collection in a single arm. | Diagnostic Test: Dried blood spot and venous blood collection<br>* 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).<br>|

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 | Sensitivity and specificity analysis | baseline (single timepoint) | 
| Optimization of the cut-off for seropositivity. | Optimization of the manufacturer recommended cut-off for seropositivity in DBS. | baseline (single timepoint) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serology, dried blood spot, elderly, nursing home residents, COVID-19, antibodies, immunoglobins, serosurveillance, vaccination, enzyme-linked immunosorbent assay (ELISA)