Results investigation and influencing factors analysis of cytokeratin 19 fragment detection in different adult populations

Sun Guowei; Zhang Mingfang; Zhao Nannan; Wang Yifan; Tang Jianhua; Wang Qinglin; Qi Jiguang

doi:10.3969/j.issn.1674-7151.2024.01.001

Abstract：Objective To investigate the distribution range of cytokeratin 19 fragment(CYFRA21-1)in different populations,discuss whether the reference interval is suitable for each population,and analyze the influencing factors.Methods The CYFRA21-1 data of samples determined in the laboratory of Heilongjiang Dean Medical Laboratory Co.,Ltd.from January 2021 to April 2023 were collected.According to the sample source population,the patients were divided into three groups such as routine department group(11699 samples),oncology department group(47529 samples)and physical examination group(183 samples).The data missing and inconsistent information were eliminated.The differences in the distribution of results among the three groups were discussed.The relationship between the CYFRA21-1 results and age or gender was studied using statistical nonparametric test Mann-Whitney U test analysis method.At the same time,the suitability of the reference interval for one-side 95th percentile(P95)was analyzed.Results The CYFRA21-1 results of the three groups showed a skewed distribution.The CYFRA21-1 test results of the population aged above 50 years old in physical examination group and routine department group were significantly higher than those under 50 years old[physical examination group(μg/L):2.43(2.04,2.66)vs.1.71(1.61,1.92);routine department group(μg/L):2.46(2.42,2.48)vs.1.70(1.66,1.74);both P＜0.05].The CYFRA21-1 test results of male in physical examination group and routine department group were significantly higher than those of female[physical examination group(μg/L):2.32(1.97,2.61)vs.1.88(1.67,2.27);routine department group(μg/L):2.41(2.37,2.45)vs.2.06(2.02,2.10);both P＜0.05].The CYFRA21-1 test result of patients in oncology department group was significantly higher than those in routine department group and physical examination group[μg/L:2.46(2.45,2.48)vs.2.25(2.22,2.28),2.00(1.95,2.32),both P＜0.05],and the CYFRA21-1 test result in routine department group was significantly higher than that in physical examination group(P＜0.05).Conclusions Different laboratories should establish corresponding CYFRA21-1 reference intervals for different age and gender groups.When the CYFRA21-1 results of the subjects are higher than the normal reference range,analysis should be conducted based on individual dynamic changes of the patients,and influencing factors should be excluded.