NEW TESTING FOR ALLERGENIC EXTRACTS

答：相对效价的酶联免疫吸附试验：一种酶联免疫吸附试验竞争试验已经 为过敏性提取物的标准化而开发。当前 大多数过敏性产品的制造商都会进行效力测试 使用RAST抑制试验。随着这项化验的实施， 我们已经减少了由此产生的费用和人员时间 在过敏原产品发布前对其进行测试的实验室 出售，并作为新的参考资料。目前，研究正在进行中，以 测试巨型豚草、乳胶和美国、德国和东方蟑螂 使用ELISA竞争分析。B.免疫印迹化学发光： 一种进行免疫印迹的化学发光方法已经被开发出来。 用于过敏原提取物的标准化。之前的免疫印迹 使用印迹技术进行过敏性产品的技术 放射性同位素等电聚焦(简写)成功实施 化学发光法(斑点等电聚焦-光或 BIEF-LIGHT)，大大减少了所发生的费用和人员时间 由本实验室在检测过敏原产品中支持 作为新的参考，并用于每半年测试一次 关于稳定性的参考。几种禾本科植物花粉的初步研究 短豚草花粉显示BIEF-LIGH更敏感， 更安全(不含放射性同位素)，更快。BIEF-2的效度研究 执行轻型方法，包括测试所有CBER BIEF-LIGHT和Brief方法中的致敏参考文献。这个 BIEF-LIGHT方法现在被用来代替BRIEF.C。 用于效力测试的化学发光：Origen免疫分析系统是 被评估为同等或更好的执行效力的方法 过敏提取物的测试。这个系统可以缩短时间。 进行化验所需的。我们会做一个统计比较 将该系统应用于目前的酶联免疫吸附试验。

A. ELISA for Relative Potency: An ELISA competition Assay has been developed for the standardization of allergenic extracts. Current potency testing by manufacturers of most allergenic products is performed using the RAST Inhibition Assay. With the implementation of this assay, we have reduced the expense and the personnel time incurred by this laboratory in the testing of allergenic products prior to their release for sale and as new references. Currently, studies are proceeding to test giant ragweed, latex, and American, German, and Oriental cockroaches using the ELISA Competition Assay.B. Chemiluminescence for Immunoblots: A chemiluminescent method of performing immunoblots has been developed for the standardization of allergenic extracts. The previous immunoblot technique for allergenic products was performed using Blotted Radioisotopic IsoElectric Focusing (BRIEF). Successful implementation of the chemiluminescent method (Blotted IsoElectric Focusing - Light or BIEF-LIGHT), has greatly reduced the expense and personnel time incurred by this laboratory in the testing of allergenic products in support of PLA's and for use as a new reference, and for semi-annual testing of all references for stability. Initial studies with several grass pollens and short ragweed pollen have shown the BIEF-LIGHT to be more sensitive, safer (no radioisotope), and faster. A validation study of the BIEF- LIGHT method was performed that included testing all of the CBER allergenic references by both the BIEF-LIGHT and the BRIEF methods. The BIEF-LIGHT method is now being used in place of the BRIEF.C. Chemiluminescence for potency testing: The ORIGEN Immunoassay System is being evaluated as an equivalent or better method for performing potency testing of allergenic extracts. This system could shorten the time required to perform the assays. We will make a statistical comparison of this system to the current ELISA Competition Assay.