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Immunology
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ILA02A2
Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition
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This document addresses the criteria for ANA testing by immunofluorescence and by enzyme immunoassay, including test components, quantification of results, and classification criteria.The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement. ANA reference preparations, antinuclear antibodies, autoantibodies, enzyme immunoassay, indirect
immunofluorescence, nuclear antigen, quality assurance
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Member price: $
50.00
Non-member price: $
100.00
Your price: $ 100.00
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ILA20A2
Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline-Second Edition
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This document provides guidance for the design, analytical performance, standardization, quality assurance, and clinical application of laboratory assays used in the measurement of human IgE antibodies of defined allergen specificity.Allergen, allergy, assay methods, analyte-specific reagents, clinical utility, human, IgE, IgE-antibody of defined specificity, performance, quality assurance, sensitivity, specificity, total IgE, type-1 hypersensitivity
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Member price: $
50.00
Non-member price: $
100.00
Your price: $ 100.00
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ILA21A2
Clinical Evaluation of Immunoassays; Approved Guideline-Second Edition
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This document addresses the need for clinical evaluation of new immunoassays and new applications of existing assays, as well as multiple assay formats and their uses. As a guide to designing and executing a clinical evaluation, this document will aid developers of "in-house" assays for institutional use, developers of assays used for monitoring pharmacologic effects of new drugs or biologics, and clinical and regulatory personnel responsible for commercializing products.The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement. clinical evaluation, clinical evaluation investigator, clinical performance characteristics, database management, diagnostic evaluation, diagnostic performance characteristics, evaluation population, informed consent, institutional review board, pilot evaluation, sponsor, statistical tests
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Member price: $
60.00
Non-member price: $
120.00
Your price: $ 120.00
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ILA23A
Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline
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This guideline addresses components for harmonizing and assessing the quality of
immunoassay systems for several commonly used dose-response indicator categories,
e.g., radioisotopes, enzymes, fluorescence, luminescence, reagents, and experimental
components criteria essential to characterizing an immunoassay.The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement. Antibody, assessment, enzyme immunoassay, fluorescence immunoassay, fluorescence system, heterogeneous immunoassay, homogeneous immunoassay, labeling, performance evaluation, quality control, radioimmunoassays, reference materials, separation systems
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Member price: $
50.00
Non-member price: $
100.00
Your price: $ 100.00
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ILA24A
Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved Guideline
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This document describes the basic principles, the reference mateials, and the laboratory procedures upon which quantitative fluorescence calibration is based.The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement. Antibody binding capacity (ABC), calibration, effective F/P ratio, flow cytometry, fluorescence, fluorescence yield, fluorochrome, fluorochrome-ligand conjugate, fluorometer, immunophenotyping, ligand binding assays, molecules of equivalent soluble fluorochrome (MESF), reference materials, spectrophotofluorometer, standardization
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Member price: $
50.00
Non-member price: $
100.00
Your price: $ 100.00
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