11家血站实验室抗-TP酶联免疫吸附试验临界值的评价  

Evaluation of the cut off values of anti-TP enzyme-linked immunosorbent assay used in 11 blood agency screening laboratories

作　　者：高楠[1] 王瑞[1] 常乐[2] 黄力勤[1] 胡京辉[1] 甄伟[1] 葛红卫[1] 王露楠[2] 王鹏 潘彤 韩卫[5] 李维[6] 王芳[7] 臧亮[8] 朱海峰[9] 朱卫清[10] 朱绍汶 曾劲峰[12] 释艳华 

机构地区：[1]北京市红十字血液中心,北京100088 [2]北京医院国家老年医学中心,卫生部临床检验中心,北京市临床检验工程技术研究中心 [3]北京市通州区中心血站 [4]天津市血液中心 [5]河北省血液中心 [6]重庆市血液中心 [7]辽宁省血液中心 [8]大连市血液中心 [9]山东省血液中心 [10]山东省济宁市红十字会中心血站 [11]江苏省血液中心 [12]深圳市血液中心 [13]湖北襄阳市中心血站

出　　处：《中国输血杂志》2017年第10期1201-1205,共5页Chinese Journal of Blood Transfusion

摘　　要：目的评价11家血站实验室采用酶联免疫吸附试验(ELISA)检测无偿献血者梅毒螺旋体抗体(抗-TP)过程中,血站实验室采用的工作临界值(CO)的适宜性及合理性。方法 11家血站实验室采用8种ELISA试剂中的1/2种均对1 372例标本进行抗-TP检测。对结果有差异的标本进行梅毒螺旋体颗粒凝集试验(TPPA)确证试验,利用确证试验结果明确标本真实血清学状态。对数据进行如下分析:1)分析11家血站实验室采用8种ELISA试剂中的1/2种试剂真阳性检出率、灰区标本确证阳性率;2)分析11家血站实验室抗-TP试验"灰区"设置的合理性,通过绘制ROC曲线确定11家血站实验室采用8种ELISA试剂中的1/2种试剂最佳CO值,比较不同CO值下(最佳CO值、厂商推荐CO值、血站实验室因采用灰区而设置的工作CO值)灵敏度与特异性的变化。结果 1)11家血站实验室采用8种ELISA试剂中的1/2种试剂对1 372例标本进行检测,真阳性检出率均为100%(489/489)、真阳性标本无1例漏检;9家设有灰区的血站实验室共检出136例灰区标本,经确证均为阴性,即灰区标本确证阳性率均为0。2)11家血站实验室采用8种ELISA试剂中的1/2种试剂ROC曲线确定的最佳CO值均大于厂商推荐CO值,设置灰区的9家血站实验室采用工作CO值灵敏度提高有限、特异性有所下降。结论 11家血站实验室使用厂商推荐CO值就可获得较高灵敏度、满足血液筛查的要求,实验结果支持血站实验室取消灰区设置。Objective To evaluate whether resonable and sensible cut off（ CO） values were set up and used for treponema pallidum antibody（ anti-TP） detection tests for donated blood samples in 11 blood agencies by enzyme-linked immunosorbent assay（ ELISA）.Methods 1 372 samples were processed for anti-TP using 1 or 2 of the 8 ELISA reagents in the11 blood laboratories. The samples with inconsistent results were re-confirmed by treponema pallidum pellet agglutination test（ TPPA） to determine the true serological status of the samples. The data were analyzed as follows： 1） The true positive detection rate and gray area confirmed positive rate were analyzed with 1 or 2 of the 8 ELISA reagents in the 11 blood laboratories; 2） The ＂ gray area＂ establishment in the anti-TP tests of the 11 blood laboratories was analyzed and compared. The ROC curve analysis was used to determine the optimal CO values regarding 1 or 2 of the 8 ELISA reagents in the 11 blood laboratories with different CO values（ the optimal CO values,the manufacturer＇s recommended CO values,the blood laboratory setting CO values due to the use of gray areas） compared based on sensitivity and specificity changes. Results 1） 1 372 samples were processed for anti-TP using 1 or 2 of the 8 ELISA reagents,the true positive detection rate was 100%（ 489/489）true positive samples without a missing case; 136 samples fell into the gray area setup by the 9 blood laboratories,which were all confirmed negtive. The positive rate within the gray area was0. 2） 11 blood laboratories,using 1 or 2 of the 8 ELISA reagents ROC curve presented optimal CO values higher than the manufacturer recommended CO values. The 9 blood laboratories within grey area establishment demonstrated limited improvement over sensitivity and specificity. Conclusion The 11 blood laboratories can achieve adequate test sensitivey and specificity with the manufacture recommended CO value. Based on these test results,we suggest the blood agencies abandon the gray area setup si

关 键 词：酶联免疫吸附试验 梅毒螺旋体抗体 临界值 灰区 

分 类 号：R446.11[医药卫生—诊断学] R514[医药卫生—临床医学]