高通量ELISA测定血清糖类抗原125的方法学评价  

Methodological evaluation of high-throughput ELISA for detecting serum CA125

作　　者：陈娟 张蓉 于水 曲松本 

机构地区：[1]山东省青岛市中心医院检验科,266042 [2]山东省青岛市妇女儿童医院检验科,266034

出　　处：《检验医学与临床》2017年第22期3292-3294,共3页Laboratory Medicine and Clinic

基　　金：国家卫生计生委医药卫生科技发展研究中心专项课题资助项目(28-2-8);山东省医药卫生科技发展计划项目(2013WS0016)

摘　　要：目的对高通量酶联免疫吸附试验(ELISA)检测血清糖类抗原(CA)125进行方法学评价,实现高通量ELISA定量检测CA125的标准化。方法收集住院患者血清标本共4 180例,健康查体者血清标本200例。对高通量ELISA测定CA125的线性范围、精密度、正确度、参考区间、敏感度、特异度及抗干扰能力进行评价,将其与电化学发光法(ECLIA)结果进行比对,评价其临床应用价值。结果高通量ELISA测定CA125的线性范围为0.0~500.0U/mL;低、中、高水平的批内变异系数(CV)分别为4.18%、3.80%、4.75%,天间CV分别为3.33%、3.11%、2.17%%,总CV分别为6.74%、6.76%、6.34%;中位数回收率为97.40%;参考区间为0.00~35.89U/mL,敏感度为3.0U/mL。癌胚抗原(CEA)≤2 500mIU/mL、甲胎蛋白(AFP)≤500IU/mL、CA50≤500IU/mL、CA724≤500IU/mL,对该方法无明显交叉反应。三酰甘油小于或等于4 mmol/L,胆红素小于或等于150μmol/L、血红蛋白小于或等于2.0g/L,对检测结果无明显影响。检测结果与ECLIA结果呈直线相关(R2=0.948),阳性率比较差异无统计学意义(P>0.05)。结论该研究建立的高通量ELISA检测CA125的标准操作规程,测定血清CA125结果可靠、稳定,与ECLIA结果具有可比性,可降低检验成本,提高检测效率。ObjectiveTo conduct the methodological evaluation on high throughput enzyme linked immunosorbent assay（ELISA）for detecting serum carbohydrate antigen 125（CA125）to realize the standardization of high throughput ELISA for quantitatively detecting serum CA125.MethodsA total of 4 180 serum samples of inpatients and 200 serum samples of healthy people were collected.The linear range,precision,accuracy,reference interval,sensitivity,specificity and anti interference ability of high throughput ELISA for detecting CA125 were evaluated.The results were compared with those detected by the electrochemiluminescence immunoassay（ECLIA）and its clinical application value was assessed.ResultsThe linear range of high throughput ELISA for detecting CA125 was 0.0-500.0 U/mL. The intra batch coefficienct of variation（CV）of low, medium and high levels were 4.18%, 3.80% and 4.75% respectively, the inter batch CV were 3.33%, 3.11% and 2.17% respectively, the total CV were 6.74%, 6.76% and 6.34% respectively. The median recovery rate was 97.40%.The reference interval was 0.00-35.89 U/mL. The sensitivity was 3.0 U/mL. Under the conditions of CEA≤2 500 mIU/mL, AFP≤500 IU/mL, CA50≤500 IU/mL and CA724≤500 IU/mL, the method had no obvious cross reactivity. Under the conditions of triglycerides≤4 mmol/L, bilirubin≤150 μmol/L and hemoglobin≤2.0 g/L, which had no obvious influence on detection results. The detection results by high throughput ELISA had linear correlation with those by electrochemiluminescence assay（R2=0.948）. The positive rate had no statistically significant difference between the two methods（P〉0.05）.ConclusionThe standard operating procedure for detecting serum CA125 established by high throughput ELISA is reliable and stable in the results for detecting CA125,has comparability with the results of ECLIA,which can reduce the detection cost and increases the detection efficiency.

关 键 词：高通量酶联免疫吸附试验 糖类抗原125 方法学评价 

分 类 号：R512.62[医药卫生—内科学]