CLSI I/LA20-A2

Clinical and Laboratory Standards Institute document I/LA20-A2–Analytical Performance Characteristics and Clinical Utilityof Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; ApprovedGuideline–Second Edition is written for laboratorians/clinicians (users), manufacturers (producers), and governmental regulators(inspectors, legislators, reviewers). The guideline summarizes the current state of technology, biological specimens that areroutinely tested, practical methods for the evaluation of reagents, and clinical interpretation of results. Emphasis is placed onallergen nomenclature and methods for evaluating allergen-containing assay reagents and human IgE-specific, immunologicreagents. Procedures are included for evaluating assay precision, analytical accuracy, sensitivity, parallelism, interference, anddocumenting the quantitative status of an assay. Guidelines for supplier validation and quality assurance, intralaboratory qualitycontrol practices, and interlaboratory proficiency testing are discussed. Finally, performance targets are outlined withrecommendations for manufacturers, laboratorians, and users.

Published:

03/01/2009

ISBN(s):

1562386956

Number of Pages:

160