两种方法检测血清糖类抗原125性能验证与临床应用评价  

Analysis on performance and value of two methods for detection of CA 125 in serum

作　　者：兰克涛[1] 陈娟[1] 赵自云[1] 周爱凤[1] 牟晓峰[1] 

机构地区：[1]青岛大学医学院第二附属医院检验科,山东青岛266000

出　　处：《中华医院感染学杂志》2015年第19期4365-4367,共3页Chinese Journal of Nosocomiology

基　　金：卫生部医药卫生科技发展研究中心基金资助项目(28-2-8)

摘　　要：目的：比较高通量ELISA法与电化学发光法定量测定血清糖类抗原125（CA125）的结果，验证两种方法的性能。方法2013年3－12月从门诊及住院患者中选择含有检测项目CA125的血清标本447份，用高通量ELISA法与电化学发光法分别测定血清CA125，比较两种方法测定结果的相关性和偏差，评价ELISA定量的线性范围，验证血清样本的稀释准确性；计算两种方法检测结果的批内不精密度（C V批内）、批间不精密度（C V批间）和总不精密度（CV 总）；高通量 ELISA 法检测200例查体者血清CA125的表达水平，确定健康人群血清CA125的参考值范围。结果 CA125低浓度（0．0～35．0 U／ml ）的测定值两组比较差异有统计学意义，中浓度（35．1～200．0 U／ml、200．1～500．0 U／ml）的测定值两组比较差异无统计学意义，ELISA法线性范围窄（0．0～500．0 U／ml ），高浓度（＞500．0 U／ml ）标本需用生理盐水稀释后测定并计算CA125的实际浓度，与电化学发光的结果比较差异无统计学意义；两种方法有高度相关性，线性范围内两种方法测定结果的相关系数 r＝0．98，高值标本（＞500．0 U／ml）两种方法测定结果的相关系数 r＝0．95；两种方法皆具有良好的重复性；3种浓度的混合血清用ELSIA定量法检测的批内变异系数分别为13．13％、3．78％和4．75％，批间变异系数分别为0．89％、6．52％和3．62％，总变异系数分别为11．79％、8．36％和6．34％；用电化学发光法检测的批内变异系数分别为5．50％、4．58％和4．00％，批间变异系数分别为0、2．30％和3．78％，总变异系数分别为4．81％、4．65％和4．95％；高通量ELISA定量法测定健康人群血清CA125的参考值上限为36．02 U／ml。结论高通量ELISA法与电化学发光法检测的血清CA125结果具有一致性，高通量ELISA定量检测血清CA125具有良好的临床应用前OBJECTIVE To evaluate the sensitivity and precision of high‐throughput ELISA assay for the determina‐tion of CA125 by comparison with electrochemiluminescence immunoassay （ECLIA） .METHODS Sera were ob‐tained from outpatients and inpatients from Mar .to Dec .2013 .Serum CA125 from 447 cases of outpatients and inpatients was quantified by high‐throughput ELISA assay and ECLIA ,respectively .The results of the two meth‐ods were evaluated by measuring the relevance and bias ,the linear range and the accuracy of dilution .The batch imprecision ,inter‐assay imprecision and total imprecision of the two methods were calculated .The reference range of serum CA125 from healthy people （200 cases） was determined by high‐throughput ELISA assay .RESULTS The difference was significant between the two groups in low CA125 concentration （0 .0035 .0 U/ml） .There were no significant differences between the two groups in middle CA125 concentration （35 .10200 .0 U/ml ,200 .10500 . 0 U/ml） .Samples of CA125 over 500 .0 U/ml were diluted first to calculate the actual concentration .There was no significant difference between the two groups in high CA125 concentration （＆gt;500 .0 U/ml） .The two methods were highly correlated .The correlation coefficient was 0 .98 within the linear range and was 0 .95 for high‐value specimens .Both methods had good reproducibility .Three kinds of mixed sera were determined .For the high‐throughput ELISA assay , intra‐assay coefficients of variation （CV ） were 13 .13% , 3 .78% and 4 .75% ;inter‐assay CVs were 0 .89% ,6 .52% and 3 .62% ;total CVs were 11 .79% ,8 .36% and 6 .34% .For the ECLIA , intra‐assay CVs were 5 .50% ,4 .58% and 4 .00% ;inter‐assay CVs were 0 ,2 .30 % ,and 3 .78% ;total CVs were 4 .81% ,4 .65% and 4 .95% .The upper reference limit of serum CA125 in healthy population was 36 .02 U/ml determined by high‐throughput ELISA assay .CONCLUSION High‐throughput ELISA assay is consistent with the results of ECLIA . Quantization of serum CA12

关 键 词：高通量ELISA法 电化学发光法 糖类抗原125 

分 类 号：R446[医药卫生—诊断学]