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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 quality control of invisible body and Rickettsia laboratory in 10 provincial and municipal CDC centers. Methods On-site training in serological and molecular biology standardized practices. Among them, the serological technique adopted the standard method recommended by the WHO Rickettsia Collaboration Collaborative Center (MIFA), and molecular biology techniques used 2 sets of nested PCR to amplify the groEL gene and Most members of the Anaplasma (16S rRNA). Standardization of quality control serum S1 and S2, PCR templates P1, P2, P3, P4, P5 and some of the key reagents, using double-blind method by CDC infectious disease prevention and control of the body room to the participating units, according to a unified experimental procedures, Participating units in their respective local equipment, equipment conditions for operation. Results The CDC laboratories in 10 provinces (municipalities) and 7 units of feedback training serological results, the S1 and S2 standard quality control pass rate was 71.4% (5/7). The sensitivity of 8 participating units of feedback PCR results were quite different. The pass rate of P2 and P3 templates was 62.5% (5/8), and the pass rate of P4, P5 and P6 templates was 50% (4/8). The serological and PCR procedures of all units were evaluated within the allowable error range. CONCLUSIONS All participating units have varying degrees of experimental operating system errors. Their causes should be analyzed, improved and further optimized, and the diagnostic and differential diagnosis ability of such diseases should be improved. Emphasize day-to-day management of quality control in the interior and regularly participate in external quality control activities.