Turkeltaub P C
Food and Drug Administration, Bethesda, MD 20892.
Allergol Immunopathol (Madr). 1989 Mar-Apr;17(2):53-65.
Accurate and precise methods of skin testing are essential for "in vivo" standardization of extracts from the same and different sources, for diagnostic efficacy as well as an important prognostic factor for evaluating the risk and benefit of immunotherapy. Skin test methods such as parallel line bioassay and ID50EAL which are based on the intradermal erythema response and yield the most sensitive, accurate, and precise bioassays as well as requiring the fewest injections and replicates should be preferentially selected for clinical use. Differentiating characteristics of parallel line bioassay and the ID50EAL method are presented. Proficiency test methods for assessing puncture and intradermal skin test methodologies should be made part of the clinicians' training and be incorporated into clinical practice in conjunction with standardized allergenic extracts. Assignment of Allergy Units to reference extracts based on accurate and precise "in vivo" methods such as the ID50EAL and to test extracts based on "in vitro" assays predictive of their "in vivo" relative potency as determined by parallel-line bioassay should facilitate the safe and effective clinical use of allergenic extracts.
准确且精确的皮肤试验方法对于同一来源和不同来源提取物的“体内”标准化、诊断效力以及评估免疫疗法风险和益处的重要预后因素而言至关重要。诸如平行线生物测定法和ID50EAL等基于皮内红斑反应的皮肤试验方法，能产生最灵敏、准确且精确的生物测定结果，同时所需注射次数和重复次数最少，应优先选择用于临床。本文介绍了平行线生物测定法和ID50EAL方法的区别特征。评估点刺和皮内皮肤试验方法的能力验证方法应成为临床医生培训的一部分，并与标准化变应原提取物一同纳入临床实践。基于准确且精确的“体内”方法（如ID50EAL）为参考提取物分配变应原单位，并基于预测其“体内”相对效价的“体外”试验（由平行线生物测定法确定）为试验提取物分配变应原单位，应有助于变应原提取物安全有效地用于临床。
