Quality assurance in the HIV/AIDS laboratory network of China.

Quality assurance in the HIV/AIDS laboratory network of China.
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DOI:
10.1093/ije/dyq224
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发表时间:
2010-12
影响因子:
7.7
通讯作者:
Su X
Su X
中科院分区:
医学1区
文献类型:
--
作者:
Jiang Y;Qiu M;Zhang G;Xing W;Xiao Y;Pan P;Yao J;Ou CY;Su X

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2009年,全国共有8273个地方筛查实验室、254个确诊实验室、35个省级确诊中心实验室和1个国家艾滋病参考实验室。这些实验室位于疾病控制和预防中心设施、医院、献血诊所、妇幼保健医院和边境卫生检疫卫生保健设施。方法国家实验室和省级实验室通过技术、生物安全和管理培训提供质量保证;定期能力测试;现场监督检查;商业血清学试剂盒评估。结果2002年至2009年,筛查实验室进行了2.2亿多次艾滋病毒抗体检测,所有反应性和不确定样本均在确认实验室得到确认。近年来,包括CD4细胞计数、病毒载量、基于干血斑(DBS)的婴儿早期诊断(EID)、耐药性(DR)基因分型、HIV-1亚型分型和发病率测定在内的技术高度复杂的检测方法的使用有所增加,并密切监测其性能质量。结论中国在建立协调良好的艾滋病毒实验室网络和质量保证体系方面取得了重大进展。但是,需要加强艾滋病毒检测和质量保证方案的覆盖面和强度,以确保更多的感染者得到诊断,并得到及时的预防和治疗服务。
Background In 2009, there were 8273 local screening laboratories, 254 confirmatory laboratories, 35 provincial confirmatory central laboratories and 1 National AIDS Reference Laboratory (NARL) in China. These laboratories were located in Center for Disease Control and Prevention (CDC) facilities, hospitals, blood donation clinics, maternal and child health (MCH) hospitals and border health quarantine health-care facilities. Methods The NARL and provincial laboratories provide quality assurance through technical, bio-safety and managerial training; periodic proficiency testing; on-site supervisory inspections; and commercial serologic kit evaluations. Results From 2002 to 2009, more than 220 million HIV antibody tests were performed at screening laboratories, and all reactive and indeterminate samples were confirmed at confirmatory laboratories. The use of highly technically complex tests, including CD4 cell enumeration, viral load, dried blood spot (DBS)-based early infant diagnosis (EID), drug resistance (DR) genotyping, HIV-1 subtyping and incidence assays, have increased in recent years and their performance quality is closely monitored. Conclusion China has made significant progress in establishing a well-coordinated HIV laboratory network and QA systems. However, the coverage and intensity of HIV testing and quality assurance programmes need to be strengthened so as to ensure that more infected persons are diagnosed and that they receive timely prevention and treatment services.
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