STANDARDIZATION AND SURVEILLANCE OF ALLERGENIC EXTRACTS

A.标有“无美国标准”的过敏原提取物的标准化 药效“：标准化工作的重点是八种草 (蒂莫西，肯塔基蓝(6月)，Perennance Rye，百慕大，Redtop，Orchard， )，三只蟑螂(德国、美国和 东方)，和巨大的豚草。斑点杂交法鉴定过敏血清 等电聚光灯(BIEF-Light)，并购买以建立 血清池。候选参考文献通过扫描可用来选择 等电聚焦(IEF)和等电聚焦(BIEF)的提取及比较 模式。每一个参考摘录都是从商业广告公司购买的 制造商，以便将其提交IND进行临床测试 测定其生物等效过敏单位(BAU)。到那时，公司必须 提交对其等电聚焦模式进行分析的摘录，总计 蛋白质含量测定：与RAST或ELISA法的相对效价比较 CBER参考提取物，或特定过敏原含量为 RID.B.草种标准化的体外试验 花粉提取物：所有经批准的草花粉提取物。 一种聚乳酸补充剂在体外通过酶联免疫吸附试验检测相对效力， 与IEF和BIEF-Light的CBER参考值相似，且总计 用NINHINDINE C测定蛋白质含量。标准化过敏原的监测 摘录：为方便摘录的标准化， 致敏产品检测实验室(APTL)目前提供所有 检测试剂和公司的参考资料。正在进行的测试是 需要为这些物品补充实验室用品。

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 giant ragweed. Allergic serum 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 NinhydrinC. Surveillance of Standardized Allergenic 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.