STANDARDIZATION AND SURVEILLANCE OF ALLERGENIC EXTRACTS

点击翻译按钮获取中文摘要

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), four trees ( White Oak, Box Elder, American Elm, and White Birch), peanut, and giant ragweed. Allergic serum is identified by Blotted RadioImmunoElectroFocusing (BRIEF) and purchased to establish a serum pool. Candidate references are selected by scanning available extracts and comparing their IsoElectric focusing (IEF) and BRIEF patterns. Each reference extract is purchased from commercial manufacturers so that it will be submitted for clinical testing under IND to determine its Bioequivalents 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. 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. B. In vitro testing for the Standardization of Grass Pollen Extracts C. Surveillance of Standardized Allergenic Extracts