河南地区电化学发光法CEA、CYFRA21-1、NSE参考值的建立

Establishment of reference values of CEA,CYFRA21-1 and NSE by electrochemiluminescence in Henan area

目的 建立河南地区电化学发光法癌胚抗原(CEA)、细胞角蛋白19片段(CYFRA21-1)、神经元特异性烯醇化酶(NSE)的参考值,为临床诊断提供有价值的参考依据。方法 采用罗氏电化学发光分析系统检测并进行性能验证,按照WS/T 402-2012临床实验室检验项目参考区间的制定要求筛选符合标准的参考个体组成参考人群。进行CEA检测男1 517例,女923例;进行CYFRA21-1检测男1 456例,女1 049例;进行NSE检测男1 494例,女1 295例。以40岁为界分别统计≤40岁和>40岁的参考值。性别间差异比较采用Mann-Whitney U检验,差异无统计学意义时,合并统计参考值,差异有统计学意义时,则分别统计参考值。以单侧95%百分位数法确定参考值。结果 参考值如下。CEA:男(≤40岁)0.60~5.09μg/L,男(>40岁)0.60~7.86μg/L,女(≤40岁)0.60~2.95μg/L,女(>40岁)0.60~9.24μg/L。CYFRA21-1:(≤40岁)0.30~3.93μg/L,(>40岁)0.30~5.02μg/L。NSE:男(≤40岁)0.15~19.83μg/L,男(>40岁)0.15~23.06μg/L,女(≤40岁)0.15~19.73μg/L,女(>40岁)0.15~21.95μg/L。经小样本验证,全部通过。除≤40岁女性CEA低于罗氏说明书提供的参考值上限外,其他均高于罗氏说明书提供的参考值上限(P<0.001)。结论 国内使用罗氏电化学发光法检测CEA、CYFRA21-1、NSE的实验室不宜直接使用罗氏说明书提供的参考值,而应该先验证罗氏参考值是否适用于该实验室服务的人群,必要时建立自己实验室的参考值。

Objective To establish the reference values of carcinoembryonic antigen(CEA),cytokeratin19(CYFRA21-1)and neuronspecific enolase(NSE)by electrochemiluminescence in Henan area to provide valuable reference basis for clinical diagnosis.Methods The Roche electrochemiluminescence analysis system was used to conduct the detection and performance validation,the reference population meeting the standard was selected according to the formulation requirement of clinical laboratory test items reference interval in WST 402-2012.The CEA detection was performed in 1517 males and 923 females;the CYFRA21-1 was performed in 1456 males and 1049 females;the NSE detection was performed in 1494 males and 1295 females.The reference values in≤40 years old and>40 years old conducted the statistics with 40 years old as the boundary.The Mann-Whitney U test was used to compare the differences between genders.If there were no statistically significant differences between gender,the statistical reference values were combined;if the differences were statistically significant,the reference values were counted separately.The reference value was determined by the unilateral 95%percentile method.Results CEA:male(≤40 years old)0.60-5.09μg/L,male(>40 years old)0.60-7.86μg/L,female(≤40 years old)0.60-2.95μg/L,female(>40 years old)0.60-9.24μg/L.CYFRA21-1:(≤40 years old)0.30-3.93μg/L,(>40 years old)0.30-5.02μg/L.NSE:male(≤40 years old)0.15-19.83μg/L,male(>40 years old)0.15-23.06μg/L,female(≤40 years old)0.15-19.73μg/L,male(>40 years old)0.15-21.95μg/L.After the small sample verification,all passed.Except that the CEA in female≤40 years old was lower than the upper limit of the reference value provided by the Roche manual,all the others were higher than the upper limit of the reference value provided by the Roche manual.Conclusion The domestic laboratories that using the Roche electrochemical luminescence method to detect CEA,CYFRA21-1 and NSE should not directly use the reference values provided by Roche′s instructions,but should first verify whether the Roche reference values are applicable to the people served by the laboratory.The reference values for your own laboratory should be established if necessary.