T/CITS 179-2024 Anti-nuclear antibody indirect immunofluorescence assay and clinical application guideline

Scope

Scope: This document provides guidance on the principles and methods of indirect immunofluorescence (IIF) for detecting antinuclear antibodies (ANA), pre-operational preparations, IIF-ANA testing procedures, quality control, and clinical applications of ANA testing. This document is applicable to medical institutions and third-party laboratories conducting ANA testing, as well as clinicians interpreting and applying ANA test results. Main technical content: Foreword Introduction 1 Scope 2 Normative reference documents 3 Terms and definitions 4 Abbreviations 5 Testing principles and methods 5.1 Testing principles 5.2 Testing methods 6 Pre-operational preparations 6.1 Performance verification 6.2 Personnel training 6.3 Instrument calibration 6.4 Development of standard operating procedures (SOPs) 7 IIF-ANA testing procedures 7.1 Pre-test 7.2 Testing process 7.3 Result interpretation 7.4 Result reporting 8 Quality control 8.1 Internal quality control 8.2 Inter-laboratory evaluation 8.3 Data summary 9 Clinical applications of ANA testing 9.1 Diagnosis of autoimmune diseases 9.2 Disease monitoring and therapeutic evaluation References

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