Clinical and Laboratory Standards Institute document I/LA20-A2--Analytical Performance Characteristics and Clinical Utility
of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved
Guideline--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 are
routinely tested, practical methods for the evaluation of reagents, and clinical interpretation of results. Emphasis is placed on
allergen nomenclature and methods for evaluating allergen-containing assay reagents and human IgE-specific, immunologic
reagents. Procedures are included for evaluating assay precision, analytical accuracy, sensitivity, parallelism, interference, and
documenting the quantitative status of an assay. Guidelines for supplier validation and quality assurance, intralaboratory quality
control practices, and interlaboratory proficiency testing are discussed. Finally, performance targets are outlined with
recommendations for manufacturers, laboratorians, and users.
| ISBN(s) : | 1562386956 |
| Number of Pages : | 160 |
| Published : | 03/01/2009 |
