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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID Card | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel point-of-care, semi-quantitative test for SARS-CoV-2 antibodies | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Performance | To measure the diagnostic sensitivity, specificity, and accuracy compared to the gold standard central laboratory SARS-CoV-2 antibody test. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time Since Vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Richard G Wilkerson, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Systems | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34469185 | Background | 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. |
| Label | URL |
|---|---|
| Journal of Clinical Microbiology | View source |
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IDP will not be made available to other researchers.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
|
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 |
| Inter-Rater Reliability | To measure differences in interpretation (scoring) of hemagglutination patterns between study team members. | 6 months |
| Type of Blood | The test characteristics of blood obtained by fingerstick will be compared to that of blood obtained by venipuncture. | 6 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |