abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04442932|
Recruitment Status : Withdrawn (Sponsor financial has been stopped.)
First Posted : June 23, 2020
Last Update Posted : October 5, 2020
|Condition or disease||Intervention/treatment|
|Allergy Allergic Asthma Allergy to Cats Allergy to House Dust Allergy to Dog Dander Allergy Cockroach||Device: Blood Collection|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Validation of the abioSCOPE Device With an IgE Test Panel: Clinical Sensitivity and Specificity Study|
|Estimated Study Start Date :||November 15, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||March 15, 2021|
Per test, a minimum of 40 atopic subjects for a given allergy and a total of at least 100 non-atopic subjects. To ensure that sufficient subjects with valid results are enrolled, the atopic enrollment goal per allergy is approximately 50 subjects. For each allergen, approximately 20% of the samples must be in the range of 0.70 to 3.5 IUA/mL and the remainder must cover a measuring range that is representative of the target population. Results from a single positive subject can be used in the analyses of more than one allergen if the subject is sensitized for more than one allergen.
Device: Blood Collection
K3-EDTA venous whole blood 9 mL 1 venous draw
- Sensitivity and Specificity of the abioSCOPE [ Time Frame: Day 1 ]The primary objective will be evaluated by estimating the Sensitivity and Specificity of the abioSCOPE to detect sensitization to each of the five allergens or group of allergens. The estimates will be accompanied by 95% Clopper-Pearson Confidence Intervals. The acceptance criteria will be compared to the lower bound of the 95% confidence interval. The ability of the abioSCOPE to detect sensitization to each allergen will be considered acceptable if both the sensitivity and specificity of the allergen meet both performance goals.
- Determination of Positive Predictive Value (PPV), Negative Predictive Value (NPV), Concordance and study prevalence of allergen sensitization. [ Time Frame: Day 1 ]Presentation of Positive Predictive Value (PPV), Negative Predictive Value (NPV), Concordance and study prevalence of allergen sensitization based of the classification of 40 subjects for each allergen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04442932
|United States, District of Columbia|
|George Washington University, Washington DC|
|Washington, District of Columbia, United States, 20037|
|United States, Maryland|
|Johns Hopkins University, Baltimore|
|Baltimore, Maryland, United States, 21215|
|Baltimore, Maryland, United States, 21287|
|Creticos Research Group, LLC|
|Crownsville, Maryland, United States, 20132|
|United States, Ohio|
|The Bernstein Clinical Research Center Cincinnati|
|Cincinnati, Ohio, United States, 45231|