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 Details — Status: Completed

Administrative data

• NCT number: NCT05196932
• Other study ID #: HP-00099032
• Status: Completed
• Start date: August 31, 2022
• Est. completion date: April 21, 2023

Study information

• Verified date: May 2023
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 21, 2023
• Est. primary completion date: April 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV2 Infection

Intervention

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.

Locations

Country	Name	City	State
United States	University of Maryland Medical Systems	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Past Medical Conditions	To measure the diagnostic sensitivity, specificity, and accuracy compared to the gold standard central laboratory SARS-CoV-2 antibody test relative to patient past medical conditions	6 months
Secondary	Time Since Vaccination	To measure the diagnostic sensitivity, specificity, and accuracy compared to the gold standard central laboratory SARS-CoV-2 antibody test relative to the time since vaccination	6 months
Secondary	Inter-Rater Reliability	To measure differences in interpretation (scoring) of hemagglutination patterns between study team members.	6 months
Secondary	Type of Blood	The test characteristics of blood obtained by fingerstick will be compared to that of blood obtained by venipuncture.	6 months