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

NCT05196932 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2023-05-10

No results posted yet for this study

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

Interventions

DEVICE

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

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.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Richard G Wilkerson, MD · University of Maryland, Baltimore

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-04-21
Completion
2023-04-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05196932 on ClinicalTrials.gov