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CLSI I/LA30

Immunoassay Interference by Endogenous Antibodies, 1st Edition

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 is available in electronic format only.

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Details

Chairholder: Joan H. Howanitz, MD

Date of Publication: February 25, 2008

Order Code PDF: CLSI ILA30AE
ISBN Number: 1-56238-658-1

Order Code Print: print not available

Edition: First

Pages: 44

CLSI I/LA30 Additional Details

If interested in ordering larger quantities of this document in print, please contact us here.

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/LA30 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.