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Establishing a reference interval for serum anti-dsDNA antibody: A large Chinese Han population-based multi-center
Chuiwen Deng1,2, Shulan Zhang1,2, Chaojun Hu1,2
1Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Insights
This study established gender-specific reference intervals for anti-double-stranded DNA (dsDNA) antibody concentrations in the Chinese Han population. These findings are crucial for accurate clinical interpretation and decision-making.
Area of Science:
- Clinical immunology
- Laboratory medicine
- Population health studies
Background:
- Accurate reference intervals (RIs) for anti-dsDNA antibody are vital for clinical decision-making.
- Establishing population-specific RIs ensures reliable laboratory result interpretation.
- The Chinese Han population lacked established RIs for anti-dsDNA antibody.
Purpose of the Study:
- To establish reference intervals (RIs) for serum anti-double-stranded DNA (dsDNA) antibody.
- To define gender-specific RIs for the Chinese Han population.
- To provide essential data for clinical laboratories in China.
Main Methods:
- Study conducted following CLSI guideline C28-A3.
- 2,880 healthy individuals recruited from four Chinese regions.
- Serum anti-dsDNA antibody measured using AESKU, EUROIMMUNE, and INOVA systems.
- Nonparametric methods used to determine RIs after stratification by gender, age, and region.
Main Results:
- Gender-specific reference intervals (RIs) for serum anti-dsDNA antibody were successfully established.
- RIs were determined for the Chinese Han population across different regions.
- Data generated for commonly used analytical systems in China.
Conclusions:
- This study presents the first reference intervals for anti-dsDNA antibody in the Chinese Han population.
- Established gender-specific RIs are available for major assay methods used in China.
- These RIs will aid in the accurate diagnosis and management of autoimmune diseases.
Background:
A reference interval (RI) for the circulating concentration of anti-dsDNA antibody is essential for clinicians to interpret laboratory results and make clinical decisions. Therefore, we aimed to establish the RI for anti-dsDNA antibody in the Chinese Han population.
Methods:
This study was designed and carried out in accordance with guideline C28-A3, which is proposed by the International Federation of Clinical Chemistry and the Clinical and Laboratory Standards Institute. A total of 2,880 apparently healthy individuals were enrolled using a posteriori sampling. These individuals were recruited from four hospitals, representing the Han populations of north, south, east, and west China. Serum anti-dsDNA antibody levels were measured using the three analytical systems AESKU, EUROIMMUNE, and INOVA, which are the most commonly used systems in China. Individuals were stratified by gender, age, and region, and the RIs were obtained by nonparametric methods.
Results:
Gender-specific RIs for serum anti-dsDNA antibody in the Chinese Han population were established.
Conclusion:
This is the first exploration of the RI for anti-dsDNA antibody in the Chinese Han population. We have established gender-specific RIs for each assay method commonly used in China.
