CLSI ILA23
Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays
This document provides guidance on standardizing and assessing the quality of immunoassay systems using radioisotopes, enzymes, fluorescence, and luminescence. It helps laboratories and manufacturers ensure the accuracy, consistency, and reliability of immunoassay performance.
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{{FormatPrice(nonMemberPrice)}} List PriceCLSI 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).
This document presents guidelines for immunoassays of macromolecular analytes. The factors likely to be important in achieving reliable and reproducible results are emphasized. Use of this document should promote greater reliability and comparability in immunoassay results.
The definitions, information, and procedures necessary to properly assess the quality of immunoassay systems are described. Awareness of the evaluation process allows laboratory personnel to better assess systems that meet the specific needs of the patient population.
Immunoassays are widely used to quantitate specific measurands (analytes) in complex mixtures such as clinical samples. Immunoassays using enzymes or fluorescers as labels are recent developments. Enzyme immunoassays (EIA), fluorescence immunoassays (FIA), and luminescence immunoassays (LIA) were developed to provide a simple, sensitive immunoassay technique that does not use unstable and potentially dangerous radioisotopes. At present, enzyme, fluorescence, and luminescence immunoassays are typically less sensitive than radioimmunoassays (RIA). However, high sensitivity is not necessary in many applications, and there are reasons to expect that sensitivity comparable to radioimmunoassay can and will be achieved by EIA and FIA in the near future. There are no criteria on whether RIA, EIA, FIA, or LIA is the best method for a particular analyte measurement. When radioisotopes cannot be used or when radioisotope decay counters are not available, techniques such as EIA, FIA, or LIA are obligatory. In practice, EIA, FIA, and LIA systems have exhibited other advantages, including high specific activity, reagent stability, and applicability to simple instrumentation. Immunoassays using luminescent technologies are now among the most sensitive, with analytical detection limits as low as one zeptomole (10-21 moles).
This document is available in electronic format only.
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 and because of its value to the laboratory community, it is being retained in CLSI’s library.
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).
This document presents guidelines for immunoassays of macromolecular analytes. The factors likely to be important in achieving reliable and reproducible results are emphasized. Use of this document should promote greater reliability and comparability in immunoassay results.
The definitions, information, and procedures necessary to properly assess the quality of immunoassay systems are described. Awareness of the evaluation process allows laboratory personnel to better assess systems that meet the specific needs of the patient population.
Immunoassays are widely used to quantitate specific measurands (analytes) in complex mixtures such as clinical samples. Immunoassays using enzymes or fluorescers as labels are recent developments. Enzyme immunoassays (EIA), fluorescence immunoassays (FIA), and luminescence immunoassays (LIA) were developed to provide a simple, sensitive immunoassay technique that does not use unstable and potentially dangerous radioisotopes. At present, enzyme, fluorescence, and luminescence immunoassays are typically less sensitive than radioimmunoassays (RIA). However, high sensitivity is not necessary in many applications, and there are reasons to expect that sensitivity comparable to radioimmunoassay can and will be achieved by EIA and FIA in the near future. There are no criteria on whether RIA, EIA, FIA, or LIA is the best method for a particular analyte measurement. When radioisotopes cannot be used or when radioisotope decay counters are not available, techniques such as EIA, FIA, or LIA are obligatory. In practice, EIA, FIA, and LIA systems have exhibited other advantages, including high specific activity, reagent stability, and applicability to simple instrumentation. Immunoassays using luminescent technologies are now among the most sensitive, with analytical detection limits as low as one zeptomole (10-21 moles).
This document is available in electronic format only.
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 and because of its value to the laboratory community, it is being retained in CLSI’s library.