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CLSI I/LA02

Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods, 2nd Edition

This document addresses the criteria for ANA testing by immunofluorescence and by enzyme immunoassay, including test components, quantification of results, and classification criteria.

This document is available in electronic format only.

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Details

Chairholder: Marilyn M. Lightfoote, MD, PhD

Date of Publication: March 22, 2006

Order Code PDF: CLSI ILA02A2E
ISBN Number: 1-56238-601-8

Order Code Print: print not available

Edition: Second

Pages: 40

CLSI I/LA02 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 guideline for use in satisfying a regulatory requirement.

This document was formerly sold under the code DI10.

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/LA02 Abstract

Clinical and Laboratory Standards Institute document I/LA02-A2, Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline—Second Edition provides guidance for laboratory scientists and manufacturers who perform immunofluorescence tests for autoantibodies to nuclear antigen to detect diseases. Topics addressed include substrate and fixative variations, fluorochrome-labeled conjugates; microscope optics; assay requirements; assay validation; ELISA enzyme labeled conjugates; ELISA detection methods; coating and blocking concentrations; quantitation of antibodies; reference intervals and reporting test results; intralaboratory quality control; and reference preparations.