Validation of the abioSCOPE Device With an IgE Test Panel: Clinical Sensitivity and Specificity Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Abionic SA
- 试验地点
- 5
- 主要终点
- Sensitivity and Specificity of the abioSCOPE
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Atopic and non-atopic individuals are needed for this study. For enrollment in the atopic arm, patients must meet all of the inclusion criteria listed below to be eligible for participation:
- •Provide signed and dated written informed consent by patient or legally designated representative prior to any mandatory study-specific procedures, sample collection, or analysis. Assent will be obtained from pediatric patients who are ≥ 6 years of age and less than 18 years of age.
- •Male or female, ≥ 6 years of age.
- •Consulting for signs and/or symptoms of IgE-mediated allergies to perennial allergens.
- •For enrollment in the non-atopic arm, patients must meet all of the inclusion criteria list below to be eligible for participation:
- •Provide signed and dated written informed consent by patient or legally designated representative prior to any mandatory study-specific procedures, sample collection, or analysis. Assent will be obtained from pediatric patients who are ≥ 6 years of age and less than 18 years of age.
- •Male or female, ≥ 6 years of age.
- •Apparently healthy individuals who exhibit no signs/symptoms of IgE-mediated allergies including rhinitis, conjunctivitis, asthma, eczema, urticaria or food allergy symptoms upon exposure to animal danders, dust mites, cockroaches, pollens or food allergens (non-atopic).
排除标准
- •Patients must not meet any exclusion criteria below to be eligible for participation:
- •Patient participating in another study that may influence test results.
- •Subjects taking any of the following medications: antihistamines in the week preceding the consultation, systemic steroids (inhaled or nasal steroids are allowed), anti-cytokines or cytokines, systemic interferon (injection local interferon α for the treatment of HPV is allowed), anti-IgE therapy (approved or investigational) or treated with systemic chemotherapy.
- •On-going allergen immunotherapy or prior allergen immunotherapy within the prior 3 years.
- •Patient with a history of cancer, autoimmune, or immune deficiency disease.
- •Patient suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood test.
- •Known severe allergic reaction to any of the IVD CAPSULE Allergic Asthma panel allergen components
结局指标
主要结局
Sensitivity and Specificity of the abioSCOPE
时间窗: 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.
次要结局
未报告次要终点