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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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Publication Details

Chairholder: Marilyn M. Lightfoote, MD, PhD

Date of Publication: March 22, 2006

ISBN Number: 1-56238-601-8

Order Code PDF: ILA02A2E

Order Code Print: print not available

Edition: Second

Pages: 40

I/LA02 Additional Details

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 is no longer being reviewed as part of our consensus process. However, because of its usefulness to a limited segment of the healthcare community, we are continuing to make the document available for its informational content.