Clinical trial NCT05196932: COVID Card Pilot Study to Detect Antibodies to SARS-CoV-2
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV2 Infection
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient's presenting to the ED for symptoms other than Covid and are fully vaccinated (at least 2 vaccines). Patients with no suspicion of Covid symptoms or have tested negative.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Performance
timeFrame: 6 months
Secondary outcomes:
measure: Past Medical Conditions
timeFrame: 6 months
measure: Time Since Vaccination
timeFrame: 6 months
measure: Inter-Rater Reliability
timeFrame: 6 months
measure: Type of Blood
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Systems
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Richard G Wilkerson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.