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ORIGINAL ARTICLEReference Intervals of Cytokeratin-19 Fragment (CYFRA 21-1) in Healthy Adults in China by Yunhai Dai, Wei Qu, Shibiao Sang, Shaoneng Tao, Yan Li, Yan Wang, Qingru Li, Tingting Wu, Anyou Zhu, Qing Chen, Jiaqi Song, Qing Li, Yongliang Ji, Yijie Zheng, Fengchao Wang

Background: The reference intervals for serum cytokeratin-19 fragment (CYFRA 21-1) have not been established in Chinese population. This study aimed to measure serum CYFRA 21-1 levels in healthy Chinese subjects.
Methods: This cross-sectional, four-center study in two Chinese provinces enrolled participants (aged 18 - 85 years) with normal liver/kidney function and normal results for routine blood tests/urinalysis. Serum CYFRA 211 level was measured by ARCHITECT immunoassay (Abbott Diagnostics).
Results: The study included 3,366 participants. The median (interquartile range) value for serum CYFRA 21-1 level was 1.38 (1.00 - 1.89) ng/mL and tended to increase with age. The upper limit of the 97.5th percentile was 3.55 ng/mL and tended to increase with age. Serum CYFRA 21-1 median level varied between the four centers from 1.22 (0.89, 1.71) to 1.55 (1.12, 2.18) ng/mL, while the 97.5th percentile varied from 3.24 to 4.09 ng/mL. CYFRA 21-1 level correlated weakly with age and creatinine level.
Conclusions: These new data can help to establish the ‘normal range’ of serum CYFRA 21-1 in people in China.

DOI: 10.7754/Clin.Lab.2017.170708