Optimal Concentration of Allergen Extract of Dermatophagoides Pteronyssinus to be Used in Diagnostic Allergy Skin Prick Test Among Thai Population
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- appropriate concentration of diagnostic reagent of house dust mite (Dp)
研究概览
简要总结
The purpose of this study is to determine the appropriate concentration of diagnostic reagent of house dust mite (Dp) to be used in diagnostic allergy skin prick test among Thai population with allergic rhinitis.
详细描述
The current allergy diagnostic reagent of house dust mites marketed in the USA is at 10,000 AU/ml. This is based on the IDEAL50 concept put forth by Turkeltaub et al, almost 3 decades ago. Such concentration has been shown to give large degree of false positives even in the US population.
In Thailand, it was anecdotally observed that at such concentration, sizes of positive tests among atopic subjects were quite large and could lead to discomfort and a possible anaphylaxis in certain allergic individuals. Moreover, up to 40% of normal individuals could give positive reaction to this concentration.
It is therefore desirable to reexamine the appropriate concentration of diagnostic reagent of house dust mites among the Thai population and will be the main objective of this research.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •allergic rhinitis
- •clinical diagnosis of allergic rhinitis
- •has skin prick test positive to standard Dp extract (wheal diameter 3 mm. or greater)
- •not take any medications that interfere the tests (skin prick test and nasal allergen provocation test)
- •Inclusion Criteria:healthy subject
- •no underlying disease
- •not take any medications that interfere the tests (skin prick test and nasal allergen provocation test)
排除标准
- •has skin prick test positive to standard Dp extract with wheal diameter more than 10 mm.
- •has chronic disease eg. HIV infection, neurological diseases, hypertension, cardiac diseases, pulmonary diseases, hepatobiliary diseases, renal diseases, endocrinological diseases, congenital malformation, malignancy
- •if has asthma, uncontrolled asthma symptom or PEF < 70%
- •during pregnancy or lactation
- •has chronic skin disease
- •participate other project within 30 days
- •has abnormal anatomy of the nose
结局指标
主要结局
appropriate concentration of diagnostic reagent of house dust mite (Dp)
时间窗: 15 minutes
to determine appropriate dilutional concentration of diagnostic reagent of house dust mite (Dp) that has high sensitivity and positive predictive value and wheal size not more than 10 mm. to be used in diagnosis allergic rhinitis in Thai population by skin prick test.
次要结局
- false positive rates of various dilutions of diagnostic reagent (house dust mite: Dp) that be used in skin prick test in Thai healthy population(15 minutes)
- false negative rates of various dilutions of diagnostic reagent (house dust mite: Dp) that be used for diagnosis allergic rhinitis in Thai population by skin prick test(15 minutes)