This document examines the impact of endogenous antibodies on immunoassay results, providing insights into their origin, prevalence, and interference mechanisms. It offers practical strategies for identifying, characterizing, and minimizing interference, helping laboratories, manufacturers, and regulatory bodies ensure accurate and reliable testing.
Clinical and Laboratory Standards Institute document I/LA30-A—Immunoassay Interference by Endogenous Antibodies; Approved Guideline presents information on the origin, nature, and prevalence of circulating endogenous antibodies, which cause interference with immunoassay results. The mechanisms of the interference along with some specific examples are included. To address the problem, recommendations for regulatory bodies, reagent manufacturers, and laboratorians are provided.
Scope
This guideline discusses the nature and causes of interfering antibodies as well as their effects on immunoassays and mechanisms by which interference occurs. Methods to identify and characterize the interferences are addressed along with assessment of methods used to eliminate interference. This document suggests guidelines for regulatory bodies, manufacturers, and laboratorians in their roles identifying and eliminating endogenous interfering antibodies in patient specimens. Although examples of specific assay interferences are included, the document does not intend to describe all methods or analytes where antibody interference has been reported. The guideline does not address other types of immunoassay interferences, such as hemolysis, cross-reacting substances, and drug interference, except when the drug is an antibody. The intended users of the guideline are organizations responsible for regulatory oversight of immunoassay reagent production, manufacturers of immunoassay reagents, and laboratorians performing immunoassays.
Product Details
ILA30AE
1-56238-658-1
44
Additional Details
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 document is available in electronic format only.
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.
A CLSI-IFCC joint project.
Authors
Joan H. Howanitz, MD
Johan Bjerner, MD, PhD
Nina M. Chace, MS
Bernard C. Cook, PhD, DABCC, FACB
Pradip Datta, PhD, DABCC
Robert C. Doss, PhD
Steven C. Kazmierczak, PhD, DABCC, FACB
Stanley S. Levinson, PhD
Vadiraja V. Murthy, PhD
Robert M. Nakamura, MD
Wadid Sadek, PhD
Jennifer A. Snyder, PhD
Abstract
Clinical and Laboratory Standards Institute document I/LA30-A—Immunoassay Interference by Endogenous Antibodies; Approved Guideline presents information on the origin, nature, and prevalence of circulating endogenous antibodies, which cause interference with immunoassay results. The mechanisms of the interference along with some specific examples are included. To address the problem, recommendations for regulatory bodies, reagent manufacturers, and laboratorians are provided.
Scope
This guideline discusses the nature and causes of interfering antibodies as well as their effects on immunoassays and mechanisms by which interference occurs. Methods to identify and characterize the interferences are addressed along with assessment of methods used to eliminate interference. This document suggests guidelines for regulatory bodies, manufacturers, and laboratorians in their roles identifying and eliminating endogenous interfering antibodies in patient specimens. Although examples of specific assay interferences are included, the document does not intend to describe all methods or analytes where antibody interference has been reported. The guideline does not address other types of immunoassay interferences, such as hemolysis, cross-reacting substances, and drug interference, except when the drug is an antibody. The intended users of the guideline are organizations responsible for regulatory oversight of immunoassay reagent production, manufacturers of immunoassay reagents, and laboratorians performing immunoassays.
Additional Details
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 document is available in electronic format only.
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.
Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities
