NEW TESTING FOR ALLERGENIC EXTRACTS

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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.