This document addresses the criteria for ANA testing by immunofluorescence and by enzyme immunoassay, including test components, quantification of results, and classification criteria.
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CLSI I/LA02-A2
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Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline, I/LA02A2E
Clinical and Laboratory Standards Institute , 03/22/2006
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