CLSI I/LA23

Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays, 1st Edition

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.

This document is available in electronic format only.

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Chairholder: Dorothy J. Ball, PhD

Date of Publication: April 20, 2004

Order Code PDF: CLSI ILA23AE
ISBN Number: 1-56238-533-X

Order Code Print: print not available

Edition: First

Pages: 52

CLSI I/LA23 Additional Details

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of September 2016. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI I/LA23 Abstract

CLSI document I/LA23-A—Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved 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 Area Committee on Immunology and Ligand Assays merged NCCLS documents LA1-A2—Assessing the Quality of Radioimmunoassay Systems; Approved Guideline—Second Edition and DI4-T—Enzyme and Fluorescence Immunoassays; Tentative Guideline into one document assimilating the residual segments of LA1-A2, and updating information in DI4-T into a more generic model, along with the addition of new information for each topic. I/LA23-A has broader utility and applicability while providing resource information previously available in the other two documents. This new guideline describes the iterations in the development, performance characterization, and certification from sample collection to method transferability. Specific nuances of each of the different dose-response systems for immunoassays are addressed while placing emphasis on mechanisms to assess the quality of the different immunoassay systems—factors that contribute to reliable and reproducible results. This guideline is particularly useful for specific details on optimization and harmonization of immunoassays, especially for those measurands (analytes) that are measured only by quantitation of antigen-antibody reactions (e.g., protein hormones, IgG, serum specific proteins).