Establishment of biological reference interval of renal function test items based on indirect method
ZHANG Chunjiao1, HUANG Rong2, CAI Tingting3, GU Jin1
1. Lianyungang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Lianyungang 222000, China; 2. Panyu Maternal and Child Care Service Centre of Guangzhou, Guangzhou 511400, China; 3. The Affiliated Hospital of Hebei University, Baoding 071000, China
Abstract：Objective To establish the reference interval of creatinine, urea and uric acid based on dry chemical system in Jiangsu、Guangzhou and Hebei by indirect method. Methods Collect laboratory information system (LIS) data from Lianyungang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Panyu Maternal and Child Care Service Centre of Guangzhou, and The Affiliated Hospital of Hebei University from January 1, 2023 to June 3, 2023. The K-S test was used to test the normality of the data, the interquartile range method was used to eliminate outliers, the Mann Whitney U test was used to classify the sex and age groups, and the percentage method (P2.5-P97.5) was used to establish the reference interval of each group, and compared with the reference interval of the manual. Results plasma creatinine, urea and uric acid were significantly different between sexes. There is no statistical significance in creatinine between the male under 30 years old group and the 31-60 years old group, and the reference interval can be established in combination. There is statistical significance between the other age groups, and the reference interval needs to be established separately. The biological reference interval of creatinine is 41.59-159.00 umol/L for men over 60 years old, 41.00-138.80 umol/L for men under 60 years old, 35.20-114.27 umol/L for women over 60 years old and 34.20-99.64 umol/L for women over 30 years old under 60 years old. The reference interval of urea is 3.50-11.20 mmol/L for men over 60 years old, 3.10-9.90 mmol/L for men over 30 years old, 2.39-8.95 mmol/L for men under 30 years old, 3.20-10.20 mmol/L for women over 60 years old, and 3.20-10.20mmol/L for women over 30 years old under 60 years old. The reference interval of uric acid is 165.35-570.93 umol/L for men over 60 years old, and 189.13-586.38 umol/L for men over 30 years old under 60 years old. The relative deviation of creatinine in men at all ages, creatinine in women over 60 years old, urea in men over 60 years old and urea in women over 60 years old are greater than RCV, indicating that there is a statistical difference between the self built reference range and the current reference range, and the self built reference range is required. The relative deviation between the self built reference range and the current reference range of other projects is less than RCV, indicating that the difference is not statistically significant. Conclusion There are sex and age differences in creatinine, urea and uric acid . Some items are different from the current reference interval, so it is necessary to establish a reference interval. Indirect method is a feasible method to establish the biological reference range of test items.
2024, Vol. 21 
