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Antinuclear antibody determination in a routine laboratory
1Research Centre for Rheumatic Diseases Amsterdam, Arthron, Netherlands.
Annals of the Rheumatic Diseases
|October 1, 1996
Summary
This study details pitfalls in antinuclear antibody (ANA) testing using indirect immunofluorescence. Laboratories must establish and maintain their own validated methods for accurate ANA detection and interpretation.
Area of Science:
- Immunology
- Clinical Chemistry
- Laboratory Medicine
Background:
- Indirect immunofluorescence is a common method for detecting antinuclear antibodies (ANA).
- Standardization and quality control are crucial for reliable ANA testing.
- Variability in laboratory methods can lead to inconsistent results.
Purpose of the Study:
- To identify and address common pitfalls in the indirect immunofluorescence assay for ANA.
- To emphasize the importance of laboratory-specific method validation and standardization.
- To provide guidance on establishing reliable positive/negative cutoffs for ANA detection.
Main Methods:
- Description of potential pitfalls in indirect immunofluorescence ANA testing.
- Outline of the use of international standard preparations and control sera.
- Method for determining optimal border dilutions for positive/negative ANA results.
Main Results:
- Laboratory-specific methods for ANA detection should be established and rarely changed.
- Daily control of assay variables using standardized control sera is essential.
- ANA test results are best reported as titres or fluorescence intensity expressions.
Conclusions:
- The ANA indirect immunofluorescence test serves as a valuable screening tool for other diagnostic tests.
- Laboratories must define and maintain their own positive/negative cutoffs using local control populations.
- Regular participation in external quality assessment schemes is vital for continuous improvement in ANA testing.