CLSI M34

Western Blot Assay for Antibodies to Borrelia burgdorferi, 1st Edition

This document addresses technical and interpretive considerations for use of Western blot assays that detect antibodies to Borrelia burgdorferi and other Borrelia species that cause Lyme disease.

This document is available in electronic format only.

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Chairholder: Alan G. Barbour, M.D.

Date of Publication: October 1, 2000

Order Code PDF: CLSI M34AE
ISBN Number: 1-56238-415-5

Order Code Print: print not available

Edition: First

Pages: 24

CLSI M34 Additional Details

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline 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 January 2017. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI M34 Abstract

Clinical and Laboratory Standards Institute document M34-A—Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline is intended for use as a critical tool in the diagnosis of Lyme disease for laboratorians who perform Western blot assays within clinical and reference laboratories. The document addresses the advantages and disadvantages of Western blot assays; antigen preparation; electrophoresis of antigens; transfer of antigens to the matrix; calibration of blots; quality control and proficiency testing; scoring the blot; reporting the results; and interpretation of the report. While the document specifically deals with Western blot assays for antibodies to Borrelia burgdorferi in the diagnosis of Lyme disease, the document’s generic recommendations are applicable to other situations in which Western blot assays are applied in the clinical or reference laboratory.