STANDARDIZATION AND SURVEILLANCE OF ALLERGENIC EXTRACTS

a.标记为"无美国标准"的过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）、四棵树（白色橡树、黄檀木、美国榆树和白色 桦树），花生，和大豚草。 过敏性血清的鉴别方法是 印迹放射免疫电聚焦（BRIEF），并购买以建立 血清池。 通过扫描选择候选参考文献 提取并比较其等电聚焦（IEF）和BRIEF 模式. 每种参比浸提液均购自 制造商，以便根据IND提交临床试验 生物等效物过敏单位（BAU）。 企业必须 提交提取物，分析其等电聚焦模式，总计 茚三酮法测定蛋白质含量，并与RAST或ELISA相对效价进行比较 与CBER参考提取物的比对 为方便 标准化提取物，过敏性产品测试实验室 （APTL）目前向 企业 需要进行持续检测，以补充实验室用品 对于每一个项目。 B。草花粉提取物标准化的体外试验 C.标准化致敏提取物的监测

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), four trees ( White Oak, Box Elder, American Elm, and White Birch), peanut, and giant ragweed. Allergic serum is identified by Blotted RadioImmunoElectroFocusing (BRIEF) and purchased to establish a serum pool. Candidate references are selected by scanning available extracts and comparing their IsoElectric focusing (IEF) and BRIEF patterns. Each reference extract is purchased from commercial manufacturers so that it will be submitted for clinical testing under IND to determine its Bioequivalents 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. In order to facilitate the standardization of extracts, the Allergenic Products Testing Laboratory (APTL) currently supplies all testing reagents and references to the companies. Ongoing testing is needed to replenish laboratory supplies for each of these items. B. In vitro testing for the Standardization of Grass Pollen Extracts C. Surveillance of Standardized Allergenic Extracts