This is a multicenter, prospective, observational study designed to determine the clinical sensitivity and specificity of the Abionic IVD CAPSULE Allergic Asthma panel performed on Abionic's abioSCOPE device using K3-EDTA anticoagulated plasma samples from atopic and non-atopic pediatric and adult patients. Patients' sensitization determined with the abioSCOPE will be compared to the clinical assessment of allergy.
Study Type
OBSERVATIONAL
K3-EDTA venous whole blood 9 mL 1 venous draw
George Washington University, Washington DC
Washington D.C., District of Columbia, United States
Johns Hopkins University, Baltimore
Baltimore, Maryland, United States
Johns Hopkins
Baltimore, Maryland, United States
Creticos Research Group, LLC
Crownsville, Maryland, United States
Sensitivity and Specificity of the abioSCOPE
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.
Time frame: Day 1
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The Bernstein Clinical Research Center Cincinnati
Cincinnati, Ohio, United States