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. Most manufacturers of allergenic extracts have adopted the ELISA Competition Assay in place of the RAST Inhibition for potency testing. 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 birch tree pollen, latex, and American, German, and Oriental cockroaches using the ELISA Competition Assay. B. Modified Ninhydrin Assay for Total Protein: A modified ninhydrin assay was developed and validated for testing protein in allergenic extracts. This method reduces personnel time for performing ninhydrin proteins by more than half. Validation studies by the Allergenic Product Testing Lab have shown good correlation between the Ninhydrin Assay and the Modified Ninhydrin Assay. The method was sent to manufacturing and other testing laboratories for their input into correlation of the two methods. Data from the laboratories will be analyzed. C. Chemiluminescence for Potency Testing: The ORIGEN Immunoassay System was evaluated as an equivalent or better method for performing potency testing of allergenic extracts. It was determined that the restricted number of tubes that could be tested at one time would cause a slower turn-around time for lot release testing. D. SDS-Page and Western Blotting of Allergenic Extracts: Studies are being conducted to determine if SDS-Page and Western blotting techniques can be used in conjunction with or to replace IsoElectric Focusing and BIEF-Light methods for characterization of allergenic extracts and serum from allergic individuals.