2016年浙江省艾滋病检测确证实验室质量管理结果分析  

Status of quality control of AIDS confirmatory laboratories in 2016 in Zhejiang

作　　者：郭志宏[1] 张佳峰[1] 夏燕[1] 张文君[1] 丁晓贝[1] 

机构地区：[1]浙江省疾病预防控制中心,杭州310052

出　　处：《中国艾滋病性病》2017年第12期1141-1144,共4页Chinese Journal of Aids & STD

摘　　要：目的促进艾滋病确证实验室提高质量管理水平,确保检测工作质量。方法组织并指导全省确证实验室参加上级实验室组织的艾滋病能力验证和室间质评活动,促进检测技术能力提高;开展现场技术督导,及时发现问题,提供针对性建议进行整改;定期对确证实验室确证阳性样本抽检,监督确证检测质量;开展确证实验室职能考核,促进管理水平提高。结果 2016年11家确证实验室参加全省艾滋病实验室室间质评和国家疾病预防控制中心艾滋病参比实验室组织的艾滋病病毒(HIV)血清学能力验证,8家实验室参加了CD4+T淋巴细胞检测能力验证,3家实验室参加了HIV-1病毒载量检测能力验证,均获得较好成绩;对11家确证实验室现场技术督导,在人员、设施,实验室质量控制,原始记录检验报告和设备、样品、资料等管理方面均符合国家相关要求;对11家确证实验室确证阳性留样样本进行抽检,全年4次抽检293例,定性符合率100.0%,条带符合率95.9%,不符合条带主要为p17、p55;9家确证实验室职能考核获得优秀,2家获得良好。结论浙江省艾滋病检测确证实验室具备较强的艾滋病检测技术能力,实验室质量体系运转良好,能够提供有效的艾滋病检测服务。Objective To improve quality control of AIDS confirmatory laboratories in Zhejiang province,to ensure the quality of HIV detection.Methods Proficiency testing（PT）and external quality assessment（EQA）were conducted for 11 AIDS confirmatory laboratories in company with on-site technical supervision and regular sampling inspection of positive samples for confirmation.Results 11 labs participated in the national PT and provincial EQA,among which 8 labs received the national PT of CD4 cell counts,and 3 labs got the national PT of HIV viral load.All labs obtained excellent results.On-site technical supervision showed that the 11 labs performed well in line with the requirements in the aspects of their personnel,facilities,laboratory quality control,the original records,inspection reports and equipment,samples,and data management etc.Sampling inspection were done for 4 times in the year of 2016 to collect 289 confirmed samples,with 100% of qualitative coincidence rate and 95.9% of WB strips coincidence rate.The strips not up to the standards mainly lay in p17,and p55.9 labs received the＂excellent＂and3 labs got＂good＂results in the laboratory quality assessment.Conclusion The AIDS confirmatory laboratories in Zhejiang province have strong ability of HIV testing technology.The laboratory quality control system is running well,and can provide effective HIV testing services.

关 键 词：艾滋病确证实验室质量管理 能力验证和室间质评 实验室现场督导 

分 类 号：R512.91[医药卫生—内科学]