检验医学与临床2024，Vol.21Issue(1)：79-82,4.DOI:10.3969/j.issn.1672-9455.2024.01.018
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
侯艳丽 1闫春宇 1陈秀 1付海雁 1齐振普1
作者信息
- 1. 郑州迪安医学检验所检验实验室,河南郑州 450000
- 折叠
摘要
Abstract
Objective To establish the reference values of carcinoembryonic antigen(CEA),cytokeratin19(CYFRA21-1)and neuronspecific enolase(NSE)by electrochemiluminescence in Henan area to provide valu-able 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 1 517 males and 923 females;the CYFRA21-1 was performed in 1 456 males and 1 049 females;the NSE detection was performed in 1 494 males and 1 295 females.The ref-erence 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)0.60-5.09 μg/L,male(＞40 years old)0.60-7.86 μg/L,female(≤40 years old)0.60-2.95 μg/L,female(＞40 years old)0.60-9.24μg/L.CYFRA21-1:(≤40 years old)0.30-3.93 μg/L,(＞40 years old)0.30-5.02 μg/L.NSE:male(≤40 years old)0.15-19.83 μg/L,male(＞40 years old)0.15-23.06 μg/L,female(≤40 years old)0.15-19.73μg/L,male(＞40 years old)0.15-21.95 μg/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.关键词
电化学发光/癌胚抗原/细胞角蛋白19片段/神经元特异性烯醇化酶/参考值Key words
electrochemiluminescence/carcinoembryonic antigen/cytokeratin19/neuronspecific eno-lase/reference value分类
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侯艳丽,闫春宇,陈秀,付海雁,齐振普..河南地区电化学发光法CEA、CYFRA21-1、NSE参考值的建立[J].检验医学与临床,2024,21(1):79-82,4.
