梅毒非特异性类脂质反应素抗体试验操作的改进及应用评价  

Reformation and evaluation of an operating procedure for detecting syphilitic anticardiolipin reagin

作　　者：杨阳 吴磊 金月兰 蒋燕群[2] 刘瑛[3] 刘晓燕[4] 唐振华 张正银[6] 胡康容[7] 顾国宝[8] 徐龙[9] 莫小辉 王学民 顾伟鸣 

机构地区：[1]上海市皮肤病医院,200443 [2]上海交通大学附属第六人民医院 [3]上海交通大学附属新华医院 [4]复旦大学附属妇产科医院 [5]上海市国际妇幼和平保健医院 [6]上海市长宁区中心医院 [7]复旦大学附属华山医院静安分院 [8]上海长征医院闸北分院 [9]上海交通大学附属新华医院分院

出　　处：《中华皮肤科杂志》2011年第5期336-338,共3页Chinese Journal of Dermatology

基　　金：上海市自然科学基金（02ZB14084,09DZ1907104）

摘　　要：目的探讨标准化操作对梅毒非特异性类脂质反应素抗体试验的使用价值。方法上海市9个医院实验室按照统一的操作程序、使用相同试剂和水平反应装置，在检测系统受控情况下，对未知靶值（盲样）的梅毒血清质控品进行连续检测。在实施新操作方案前后，用一套靶值范围覆盖从阴性到1：128的7份新鲜血清样品各进行一次室间质量评价。统计反馈结果，分析误差产生的原因。结果9个实验室共计进行了388次盲样检测，结果分布在1：8、1：16和1：32分别是40．2％、49．2％和3．6％，总合格率为93．0％，没有高于合格标准的正向偏倚结果。两次室间质量评价的合格率经统计学分析，差异有统计学意义（X^2=4．17，P〈0．05）。结论改进的非梅毒螺旋体抗原试验程序有助于减少试验误差，为建立标准化操作和开展室内质控提供了基础。Objective To estimate the application value of a standard operating procedure （SOP） in the detection of syphilitic anticardiolipin reagin. Methods Clinical laboratories from 9 local hospitals in Shanghai participated the program. Quality control samples with unknown target value were qualitatively and quantitatively examined according to the uniform SOP in these laboratories with the same reagent and facility of horizontal reaction. External quality assessment （EQA） was carried out by using seven serum samples with no, or low （1 ： 128 dilution） to high （1 ： 1 dilution） concentrations of target before and after the implementation of SOP. The test results were statistically analyzed and the reasons for the detecting error were assessed. Results A total of 388 tests were performed in the 9 clinical laboratories. The total accuracy rate was 93.0%, including 40.2% in the detection of samples with 1 ： 8 dilution of target, 49.2% in the detection of samples with 1 ： 16 dilution of target, and 3.6% in the detection of samples with 1 ： 32 dilution of target. No forward bias was observed in these tests. There was a significant difference in the accuracy rate between the two times of EQA before and after the implementation of SOP （X^2 = 4.17, P 〈 0.05）. Conclusions The improved standard procedure for nontreponemal antigen test is beneficial to the decrease of testing error, and may provide a basis for the establishment of SOP and implementation of internal quality assessment.

关 键 词：梅毒血清诊断 参考标准 质量保证 

分 类 号：R759.1[医药卫生—皮肤病学与性病学]