NCT05196932

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• COVID-19
• SARS-CoV2 Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-31
• Primary completion: 2023-04-21
• Completion: 2023-04-21
• First posted: 2022-01-19
• Last updated: 2023-05-10

Locations

1 site across 1 country: United States