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Nationwide Multicenter Reference Interval Study for 28 Common Biochemical Analytes in China.
Liangyu Xia1, Ming Chen, Min Liu
1From the Department of Clinical Laboratory, Peking Union Medical College Hospital, Chinese Academic Medical Science and Peking Union Medical College (LX, XC, XQ, JH, PL, LH, SY, LQ), Beijing, China; and Department of Clinical Laboratory Medicine, Institute of Surgery Research, Daping Hospital, the Third Military Medical University (MC), Chongqing, China; Department of Clinical Laboratory, the first Affiliated Hospital, Sun Yat-sen University (ML), Guangzhou, China; Department of Clinical Laboratory, the Second Affiliated Hospital of Zhejiang University School of Medicine (ZT), Hangzhou, China; Department of Clinical Laboratory, the First Affiliated Hospital of Dalian Medical University (SL), Dalian, China; Department of Clinical Laboratory, Xinjiang Medical University (LW), Urumuqi, China; and Faculty of Health Sciences, Yamaguchi University Graduate School of Medicine (KI), Ube, Japan.
This study established new reference intervals for 28 common biochemical analytes in China. These updated values account for sex, age, and BMI variations, improving diagnostic accuracy for the Chinese Han population.
Area of Science:
- Clinical Biochemistry
- Laboratory Medicine
- Reference Value Determination
Background:
- Establishing accurate reference intervals is crucial for clinical diagnostics.
- Global studies aim to standardize reference values across diverse populations.
- China's large and diverse population requires specific reference interval data.
Purpose of the Study:
- To establish reference intervals for 28 common biochemical analytes in the Chinese Han population.
- To investigate sources of variation, including sex, age, and BMI.
- To contribute to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) global study.
Main Methods:
- Nationwide multicenter study involving 3148 healthy volunteers across 6 Chinese cities.
- Standardization using certified reference materials and value-assigned serum panels.
- Statistical analysis including multiple regression and 3-level nested ANOVA, with parametric methods for interval derivation.
Main Results:
- Established reference intervals for 28 analytes, partitioned by sex and/or age for 17 analytes.
- Identified significant sex-related (12 analytes) and age-related (12 analytes) differences.
- Detected BMI-related variations in 9 analytes for men and 6 for women; minor regional differences in albumin, glucose, and sodium.
Conclusions:
- Reference intervals for 28 common chemistry analytes applicable to the Chinese Han population were established using modern methodologies.
- Twenty analytes with traceable results can serve as common reference intervals.
- Other analytes provide assay system-specific intervals for use in China.
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