中国10个省级疾病预防控制中心无形体检测实验室质量控制分析  

Evaluation on external quality control assessment for laboratory diagnosis of Anaplasmosis in China

作　　者：张丽娟[1] 汪鹏[2] 姜霞[3] 钱振宇[3] 刘桂艳[4] 雷露[5] 刘学升[5] 雷霞[6] 南晓伟[6] 吴建英[7] 岳永杰 张铮 李文涓 邓红[9] 夏依旦[9] 禹惠兰[1] 王誓闻[1] 

机构地区：[1]中国疾病预防控制中心传染病预防控制所,北京102206 [2]甘肃省疾病预防控制中心 [3]河北省疾病预防控制中心 [4]吉林省疾病预防控制中心 [5]辽宁省疾病预防控制中心 [6]内蒙古自治区疾病预防控制中心 [7]青海省疾病预防控制中心 [8]陕西省病预防控制中心 [9]新疆维吾尔自治区疾病预防控制中心

出　　处：《疾病监测》2011年第5期344-347,共4页Disease Surveillance

基　　金：国家传染病防治科技重大专项"病原体实验室网络化监测技术研究"(No.2008ZX10004-008)及"传染病监测技术平台"(No.2009ZX10004-203)

摘　　要：目的对10个省、市级疾病预防控制中心(CDC)无形体及立克次体实验室检测质量控制进行评估。方法现场培训血清学及分子生物学标准化操作。其中血清学技术采用WHO立克次体协作中心推荐的标准方法——微量间接免疫荧光试验(mIFA),分子生物学技术使用2套巢式PCR分别扩增立克次体科(groEL基因)及无形体科(16S rRNA)大部分成员。标准化质控血清S1及S2、PCR模板P1、P2、P3、P4、P5及部分关键试剂,采用双盲法由中国CDC传染病预防控制所无形体室向参加单位发放,按统一实验操作程序,参加单位在各自本土化仪器、设备条件下进行操作。结果参加培训的10个省(市)CDC实验室,7个单位反馈血清学结果,S1及S2标准血清质控合格率均为71.4%(5/7)。反馈PCR结果的8个参加单位,其灵敏性存在较大差异,P2和P3模板合格率为62.5%(5/8),P4、P5、P6模板合格率为50%(4/8)。各单位血清学及PCR操作重复性评估均在允许误差范围内。结论参加单位均存在不同程度实验操作系统误差,应分析各自原因,加以改进并进一步优化条件,提高该类疾病诊断及鉴别诊断能力。强调室内质控日常化管理并定期参加外部质量控制活动。Objective To evaluate the results of the external quality assessment（EQA） on the laboratory diagnosis of Anaplasmosis and differential diagnosis between Anaplasma and other rickettsiae in 10 provincial/municipal CDCs laboratories in China.Methods The micro-indirect immunofluoresce assay（mIFA） recommended by WHO Rickettsial Diseases Collaborating Center was adopted as a standard serological diagnosis technique.The performances of two nested PCR assays,one testing for most members of family Rickettsia to amplify groEL gene and other targeting members of family Anaplasma to amplify 16S rRNA gene were evaluated.The laboratories involved received a package containing primers and reference templates（P1,P2,P3,P4,P5）for PCR tests and S1 and S2 reference sera for serological assays.Each laboratory was required to perform these procedures based on its own laboratory condition including equipments and some reagents except the reference materials provided.Results Seven laboratories from the 10 CDCs reported the results for testing S1 and S2 references,and the results in 5 of them（71.4%） were qualified according to the assessment criteria.Eight laboratories reported PCR results,but the significant differences on specificity and sensitivity of PCR between them were found,62.5%（5/8） of laboratories provided acceptable results for P2 and P3 references and 50%（4/8） of laboratories provided acceptable results for P4,P5,P6 references.For repeatability evaluation,all the laboratories reported acceptable results according to the statistical procedures described.Conclusion This EQA demonstrated all the laboratory involved had systematic errors in their performances.It is necessary for these laboratories to improve their test condition,strengthen the internal quality control and take part in the external quality control activity regularly to improve the diseases diagnosis and differential diagnosis capacity.

关 键 词：无形体 诊断 实验室检测 质量评估 

分 类 号：R197.2[医药卫生—卫生事业管理]