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

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: COVID-19; SARS-CoV2 Infection

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

Study type: Observational

Funder types: Other

Identifiers

NCT05196932

HP-00099032

Details and patient eligibility

About

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).

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Known to be pregnant at the time of evaluation
2. Incarcerated at the time of evaluation
3. Requires the use of an interpreter
4. Patient is considered immunocompromised or has any other condition that the investigator feels makes the patient unsuitable for study inclusion.
5. Has any other condition that the investigator feels makes the patient unsuitable for study inclusion

Trial design

56 participants in 1 patient group

COVID Card

Description:

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

Treatment:

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