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

COVID-19 Clinical Trial

Official title:
A Pilot Study Investigating the Clinical Performance of a Novel, Point-of-care, Semi-quantitative Test for SARS-CoV-2 Antibodies in Patients Vaccinated Against COVID-19

Clinical Trial 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).

Clinical Trial Description

A prospective, non-blinded, non-randomized trial will be conducted at the Adult Emergency Department at the University of Maryland Medical Center and Adult Urgent Care Center, which is managed by the Department of Emergency Medicine, located in Baltimore, Maryland. Patients meeting eligibility criteria and who have signed the research informed consent will be enrolled in this study. Subject data collected will include demographic information and past medical history. Upon enrollment into the study, a study team member will obtain a fingerstick blood sample and a sample of blood obtained during usual care venipuncture. Both fingerstick blood and blood from venipuncture will be run on the point-of-care, semi-quantitative test. The test should be expected to result within minutes after the blood sample is added to the agglutinin. An additional tube of blood will be obtained and sent to the local central laboratory for quantitative serum SARS-CoV-2 antibody testing. Additional data will be collected on the reported or documented COVID-19 immunization status and reported or documented history of prior COVID-19 infection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05196932
Study type Observational
Source University of Maryland, Baltimore
Contact
Status Completed
Phase
Start date August 31, 2022
Completion date April 21, 2023
View Details
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