COVID Card Pilot Study to Detect Antibodies to SARS-CoV-2

NCT05196932 | Completed

• 1 other identifier: HP-00099032
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the clinical performance characteristics of the novel point-of-care, semi-quantitative test for SARS-CoV-2 in the Emergency Department compared to the gold standard (ELISA).

Conditions

COVID-19; SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (1)

• Clinical Performance

  To measure the diagnostic sensitivity, specificity, and accuracy compared to the gold standard central laboratory SARS-CoV-2 antibody test.

  6 months

Secondary Outcomes (4)

• Past Medical Conditions

  6 months

• Time Since Vaccination

  6 months

• Inter-Rater Reliability

  6 months

• Type of Blood

  6 months

Study Arms (1)

COVID Card

Enrolled patients will receive antibody testing using both: 1) point-of-care, semi-quantitative SARS-CoV-2 antibodies test, 2) SARS-CoV-2 central laboratory antibodies test

Device: Novel point-of-care, semi-quantitative test for SARS-CoV-2 antibodies

Interventions

Novel point-of-care, semi-quantitative test for SARS-CoV-2 antibodies DEVICE

A drop of blood obtained by both finger-prick and venipuncture will be placed on the test card, which has been activated by the addition of diluent. Visual clumping of red blood cells (RBCs) will be seen within minutes if SARS-CoV-2 antibodies are present. Additionally, the COVID card is semi-quantitative, meaning that the yielded hemagglutination pattern will correlate with the concentration of antibodies in the serum. A research team member will be present at bedside to provide their interpretation based on an established visual agglutination scoring system.

Also known as: Covid Card

COVID Card

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient's presenting to the ED for symptoms other than Covid and are fully vaccinated (at least 2 vaccines). Patients with no suspicion of Covid symptoms or have tested negative.

You may qualify if:

• Adult (age \> 18 years) emergency department patients
• ED workup includes blood testing
• Confirmed history of vaccination against SARS-CoV-2

You may not qualify if:

• Known to be pregnant at the time of evaluation
• Incarcerated at the time of evaluation
• Requires the use of an interpreter

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Systems

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Kruse RL, Huang Y, Lee A, Zhu X, Shrestha R, Laeyendecker O, Littlefield K, Pekosz A, Bloch EM, Tobian AAR, Wang ZZ. A Hemagglutination-Based Semiquantitative Test for Point-of-Care Determination of SARS-CoV-2 Antibody Levels. J Clin Microbiol. 2021 Nov 18;59(12):e0118621. doi: 10.1128/JCM.01186-21. Epub 2021 Sep 1.

  PMID: 34469185 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Richard G Wilkerson, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 19, 2022
• Study Start: August 31, 2022
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)