Extract Allergen From Betula Verrucosa. Test Sensitivity and Specificity of Diagnostic in Prick Test Preparation.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Specificity for 50 HEP/mL
研究概览
简要总结
The main objective is to evaluate the concentration of allergen extract of Betula verrucosa that elicit a papule equivalent to that produced by a solution of histamine dihydrochloride 10 mg / ml in size.
详细描述
Open, prospective, unblinded and non-randomized biological assay. Each patient was tested with four concentrations of allergen and with a histamine and saline solution as positive and negative controls, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General inclusion criteria for both groups:
- •Positive skin prick test with the positive control (Histamine HCl at 10 mg/mL). The length of the largest diameter of the wheal induced by this control should be ≥ 3 mm.
- •Negative skin prick test with the negative control. The length of the largest diameter of the wheal induced by this control should be < 3 mm.
- •All ages and both genders.
- •For the group of patients CH+ (true positive to Betula verrucosa): All these patients had a previous diagnosis of allergy to the birch pollen:
- •A positive case history with inhalant allergy related to exposure to birch pollen.
- •A positive skin prick test (mean wheal diameter ≥ 3 mm) when tested with a biologically standardized extract prepared from birch pollen. This preparation, from another manufacturer, was the one used in the routine in the Hospital.
- •Positive test for specific IgE (CAP value > 0.35 IU/mL). For the group of patients CH- (true negative to Betula verrucosa): All these patients had a previous diagnosis of allergy to agents unrelated to birch pollen.
- •A negative case history with inhalant allergy related to exposure to birch pollen or to pollen with known cross-reactivity with the birch pollen. These patients could be allergic to other pollen or other allergens, such mites.
- •A negative prick test (largest diameter of the wheal ≥ 3 mm) when tested with a standardized extract prepared from the allergen source in question.
- •A negative test for specific IgE (CAP value < 0.35 IU/mL) to birch pollen or to pollen with known cross-reactivity with birch pollen: Corylus avellana, Quercus verrucosa, Fagus sylvatica, Castanea satavia, Carpinus betelus and Alnus glutinosa.
排除标准
- •for both groups:
- •Patients that were using drugs that may interfere with the skin prick tests.
- •Patients using the following drugs 24 hours before the test: theophylline, systemic corticosteroids.
- •Patients in which the largest diameter of the wheal induced by the positive control was < 3 mm.
- •Patients in which the largest diameter of the wheal induced by the negative control was ≥ 3 mm.
- •Pregnancy, dermographism, atopic dermatitis (locally at the test site), urticaria.
- •Patients who suffer disease in which the use of adrenaline is not allowed.
- •Patients with any severe psychiatric disease.
- •For the patients CH+:
- •Patients that received or are treated with immunotherapy with an allergenic extract of birch pollen and/or with allergen extracts with known cross-reactivity to birch pollen (Corylus avellana, Quercus verrucosa, Fagus sylvatica, Castanea satavia, Carpinus betelus and Alnus glutinosa).
- •For the patients CH-:
- •Patients sensitized to pollen with demonstrated cross-reactivity with the pollen of Betula verrucosa. These pollen included Corylus avellana, Quercus verrucosa, Fagus sylvatica, Castanea satavia, Carpinus betelus and Alnus glutinosa.
结局指标
主要结局
Specificity for 50 HEP/mL
时间窗: 1 hour
Specificity for 50 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of negatives that are correctly identified by the test. Specificity: True negatives/Total no disease.
Sensitivity for 100 HEP/mL
时间窗: 1 hour
Sensitivity for 100 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of positives that are correctly identified by the test. Sensitivity: True positives/Total disease
Sensitivity for 25 HEP/mL
时间窗: 1 hour
Sensitivity for 25 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of positives that are correctly identified by the test. Sensitivity: True positives/Total disease
Sensitivity for 10 HEP/mL
时间窗: 1 hour
Sensitivity for 10 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of positives that are correctly identified by the test. Sensitivity: True positives/Total disease
Sensitivity for 50 HEP/mL
时间窗: 1 hour
Sensitivity for 50 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of positives that are correctly identified by the test. Sensitivity: True positives/Total disease
Specificity for 100 HEP/mL
时间窗: 1 hour
Specificity for 100 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of negatives that are correctly identified by the test. Specificity: True negatives/Total no disease.
Specificity for 25 HEP/mL
时间窗: 1 hour
Specificity for 25 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of negatives that are correctly identified by the test. Specificity: True negatives/Total no disease.
Specificity for 10 HEP/mL
时间窗: 1 hour
Specificity for 10 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test. It is the proportion of negatives that are correctly identified by the test. Specificity: True negatives/Total no disease.
次要结局
未报告次要终点