NEW TESTING FOR ALLERGENIC EXTRACTS

A. 相对效价的ELISA：ELISA竞争试验已在 为过敏性提取物的标准化而开发。 电流 大多数过敏性产品的生产商都进行了效力测试 使用RAST抑制测定。 随着该测定的实施， 我们已经减少了由此产生的费用和人员时间， 实验室在过敏性产品发布前进行测试 供销售和作为新的参考。 目前，研究正在进行， 测试巨型豚草，乳胶，和美国，德国，和东方蟑螂 使用ELISA竞争测定。免疫印迹的化学发光： 一种进行免疫印迹的荧光方法已经发展起来 用于过敏性提取物的标准化。 之前的免疫印迹 过敏性产品的检测技术采用印迹法进行 放射性同位素等电聚焦（BRIEF）。 成功实施 荧光法（等电聚焦印迹-光或 BIEF-LIGHT），大大减少了费用和人员时间 本实验室在测试过敏性产品时， 解放军的和使用作为一个新的参考，并为每半年测试的所有 稳定性的参考。 对几种草花粉的初步研究， 短豚草花粉显示BIEF-LIGHT更敏感， 更安全（无放射性同位素），更快。 BIEF的验证研究- 进行了LIGHT方法，包括测试所有CBER 通过BIEF-LIGHT和BRIEF方法检测过敏性参考。 的 BIEF-LIGHT方法现在正在取代BRIEF. C。 化学发光法用于效价检测：ORIGEN免疫分析系统 作为等效或更好的方法进行效价评价 过敏性提取物的测试。 这个系统可以缩短 需要进行分析。 我们会做一个统计比较 与当前的ELISA竞争测定相比。

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.