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Predictive Value of Laboratory Assays Toward Autoimmune Diseases
Kellen J Begeman1,2, Mark J White2, Elizabeth S Moore1
1University of Indianapolis, Indianapolis, Indiana, USA.
Journal of Clinical Laboratory Analysis
|October 24, 2025
Summary
Diagnosing autoimmune diseases (AD) can be improved by understanding key laboratory markers. Antinuclear antibody (ANA), complement C3, globulin, MLR, and BUN predict anti-ENA, while C3, C4, pH, urine protein, and NLR predict anti-dsDNA.
Area of Science:
- Immunology and Rheumatology
- Clinical Laboratory Science
Background:
- Autoimmune diseases (AD) present significant unmet medical needs in the United States.
- Accurate and efficient diagnosis of AD is crucial for effective patient management.
- Understanding the diagnostic value of laboratory assays is essential for healthcare providers.
Purpose of the Study:
- To investigate whether demographic factors and general laboratory test results can predict the presence of anti-ENA and anti-dsDNA antibodies in individuals with autoimmune disorders.
- To assess the utility of specific laboratory markers in the diagnostic pathways for autoimmune conditions.
Main Methods:
- A retrospective, nonexperimental study design was employed, analyzing data from 2018 to 2021.
- The study included 1495 individuals with positive anti-ENA antibodies and 1261 with positive anti-dsDNA antibodies.
- Multiple logistic regression analyses were used to identify predictive factors for antibody positivity.
Main Results:
- For anti-ENA prediction, antinuclear antibody (ANA), complement C3, globulin, monocyte-to-lymphocyte ratio (MLR), and blood urea nitrogen (BUN) were statistically significant (p < 0.001).
- The regression model for anti-ENA achieved 98.6% sensitivity and 16.1% specificity.
- For anti-dsDNA prediction, complement C3, complement C4, pH, urine protein, and neutrophil-to-lymphocyte ratio (NLR) were statistically significant (p < 0.001), with 77.7% sensitivity and 64.5% specificity.
Conclusions:
- ANA, complement C3, globulin, MLR, and BUN are important predictors for positive anti-ENA results in AD diagnosis.
- Complement C3, complement C4, pH, urine protein, and NLR are key factors in diagnosing Systemic Lupus Erythematosus (SLE) when anti-dsDNA is positive.
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