STANDARDIZATION AND SURVEILLANCE OF ALLERGENIC EXTRACTS

A. 标为“无美国标准”的致敏性提取物的标准化 效力”： 标准化工作集中在八种草上（Timothy， 肯塔基州蓝（六月），多年生黑麦，百慕大，红顶，果园，甜 Vernal和Meadow Fescue）、三种蟑螂（德国、美国和 东方）和桦树花粉。 来自过敏个体的血清是 通过印迹等电聚焦-光（BIEF-光）鉴定， 购买来建立血清库。 已选择候选参考 通过扫描可用的提取物并比较它们的等电聚焦 (IEF)和BIEF光模式。 每种参比提取物均购自 商业制造商，以便提交临床 根据IND进行测试，以确定其生物等效过敏单位（BAU）。 然后，公司必须提交对其IsoElectric进行分析的提取物 聚焦模式、茚三酮法测定的总蛋白含量和RAST或ELISA 与CBER参比浸提液相比的相对效价，或 过敏原含量由RID确定。 B。 草花粉提取物标准化的体外试验： 所有草花粉提取物根据PLA补充申请批准 通过ELISA在体外测试相对效力， CBER参比品（IEF和BIEF-Light）和总蛋白含量（ 茚三 C. 标准化过敏性提取物的监测： 为了便于提取物的标准化和稳定性 标准化提取物测试，过敏性产品测试 实验室（APTL）目前提供所有参考的公司。 需要进行持续的检测，以补充以下各项的实验室用品： 这些东西 在更换 参比试剂，以最大限度地减少参比品间变异。

A. Standardization of Allergenic Extracts Labeled "No US Standard of Potency": Standardization efforts have focused on eight grasses (Timothy, Kentucky Blue (June), Perennial Rye, Bermuda, Redtop, Orchard, Sweet Vernal and Meadow Fescue), three cockroaches (German, American and Oriental), and birch tree pollen. Serum from allergic individuals is identified by Blotted IsoElectric Focusing-LIGHT (BIEF-Light) and purchased to establish a serum pool. Candidate references are selected by scanning available extracts and comparing their IsoElectric focusing (IEF) and BIEF-Light patterns. Each reference extract is purchased from commercial manufacturers so that it will be submitted for clinical testing under IND to determine its Bioequivalent Allergy Units (BAU). Companies must then submit extracts analyzed for their IsoElectric focusing pattern, total protein content by ninhydrin, and RAST or ELISA relative potency compared to the CBER reference extracts, or the specific allergen content is determined by RID. B. In Vitro Testing for the Standardization of Grass Pollen Extracts: All grass pollen extracts submitted for approval under a PLA supplement are tested in vitro for relative potency by ELISA, for similarity to the CBER reference by IEF and BIEF-Light and for total protein content by Ninhydrin C. Surveillance of Standardized Allergenic Extracts: In order to facilitate the standardization of extracts and stability testing of standardized extracts, the Allergenic Products Testing Laboratory (APTL) currently supplies all references to the companies. Ongoing testing is needed to replenish laboratory supplies for each of these items. Stringent test parameters are maintained when replacing a reference reagent to minimize reference-to-reference variation.