我国结核病定点医疗机构实验室检测能力调查分析

Investigation and analysis of laboratory diagnostic capabilities in tuberculosis-designated hospitals in China

目的:了解我国结核病定点医疗机构实验室检测技术的开展能力和质量。方法:本研究基于中国疾病预防控制中心结核病防治临床中心2023年开展的“全国结核病医疗机构防治体系和运行机制研究”收集的结核病医疗机构相关数据,通过与2015年结核病定点医疗机构调查数据进行比较,以分析结核病实验室检测技术开展的情况和趋势。两次调查同时覆盖单位共46家,包括综合性医院、传染病院、院所合一的结核病防治机构、公共卫生中心和结核病专科医院。结果:纳入的46家结核病定点医疗机构中包括省级机构19家(41.3%)和地市级机构27家(58.7%)。调查机构2022年平均门诊人次为16424例次,其中耐多药/利福平耐药结核病门诊185例次;平均收治结核病患者1460例,其中收治耐多药/利福平耐药结核病患者131例。在实验室检测开展方面,调查机构2022年实验室检测主要以涂片、培养和药物敏感性试验三大常规检测技术为主。从不同机构类型来看,三级甲等医疗机构在PCR检测(70.8%,17/24)、基因芯片检测(37.5%,9/24)、分子菌种鉴定(58.3%,14/24)的开展率方面明显高于其他等级医疗机构[分别为27.3%(6/22)、4.5%(1/22)和22.7%(5/22);χ^(2)=8.712、5.518和6.002,P=0.003、0.019和0.014],且在传统结核病实验室检测技术(痰涂片、痰培养、传统药物敏感性试验)开展的总体工作量[分别为19825(11253,38363)、13266(4164,24213)和1264(534,2523)例次]均明显高于其他等级医疗机构[分别为8072(2132,17239)、2292(1076,10075)和323(101,1572)例次;Z=-2.452、-2.702和-2.225,P=0.014、0.007和0.026]。从地区分布来看,仅高分辨率熔解曲线开展率检测东部地区(35.3%,6/17)略低于中部地区(76.5%,13/17),差异有统计学意义(χ^(2)=6.494,P=0.039)。从历年变化来看,2022年GeneXpert MTB/RIF检测(93.5%,43/46)、基因芯片检测(21.7%,10/46)等简便、快速的诊断技术较2014年[开展比例分别为41.3%(19/46)和8.7%(4/46)]应用更为广泛,且GeneXpert MTB/RIF检测[2014年诊断38(11,150)例次;2022年诊断2485(856,8349)例次;Z=-3.724,P<0.001]、抗体检测[2014年诊断500(200,1010)例次;2022年诊断3401(1066,7275)例次;Z=-4.235,P<0.001]等技术的诊断工作量呈上升趋势。在实验室质控方面,培养技术的质量控制仍然是需要重点关注的领域,2022年仅有76.1%(35/46)的医疗机构被室间质控,且参与最多的为第三方机构质控[74.3%(26/35)]。结论:2014年以来,我国结核病定点医疗机构的实验室检测能力有了不同程度的提升,特别是分子生物学检测能力有了显著的发展,在关注结核病实验室检测能力建设的基础上,实验室工作质量是未来重点关注领域。

Objective:To evaluate the diagnostic capabilities and quality control measures in tuberculosis-designated hospitals across China.Methods:This study utilized data from the 2023‘Research on the Prevention and Control System and Operation Mechanism of National Tuberculosis Medical Institutions’conducted by the Clinical Center for Tuberculosis Prevention and Control of China CDC.These data were compared with survey data from 2015 to analyze the status and trends of tuberculosis laboratory testing technologies.Both surveys encompassed 46 units,including general hospitals,infectious disease hospitals,tuberculosis prevention and control institutions,public health centers,and specialized tuberculosis hospitals.Results:Among the 46 designated medical institutions for tuberculosis,19(41.3%)were provincial institutions and 27(58.7%)were municipal institutions.In 2022,the average number of outpatient visits per institution was 16424,including 185 visits for multidrug/rifampicin-resistant tuberculosis.On average,1460 tuberculosis patients were admitted per institution,including 131 patients with multidrug/rifampicin-resistant tuberculosis.In terms of laboratory testing,these institutions primarily utilized three routine techniques in 2022:smear microscopy,culture,and drug susceptibility testing.From the perspective of different types of institutions,the implementation rates of PCR detection(70.8%,17/24),gene chip detection(37.5%,9/24),and molecular strain identification(58.3%,14/24)in third-grade class-A medical institutions were significantly higher than those in other grade medical institutions(27.3%(6/22),4.5%(1/22),and 22.7%(5/22),respectively;χ^(2)=8.712,5.518,and 6.002,P=0.003,0.019,and 0.014).Additionally,the overall workload of traditional tuberculosis laboratory detection techniques(sputum smear,sputum culture,and traditional drug susceptibility testing;19825(11253,38363),13266(4164,24213),and 1264(534,2523)cases)was significantly higher than that in other medical institutions(8072(2132,17239),2292(1076,10075),and 323(101,1572)cases,respectively;Z=-2.452,-2.702,and-2.225,P=0.014,0.007 and 0.026).From a regional distribution perspective,the high-resolution melting curve detection rate in the eastern region(35.3%,6/17)was slightly lower than that in the central region(76.5%,13/17),with the difference being statistically significant(χ^(2)=6.494,P=0.039).Historically,in 2022,simple and rapid diagnostic techniques such as GeneXpert MTB/RIF detection(93.5%,43/46)and gene chip detection(21.7%,10/46)were more widely used compared to 2014(41.3%(19/46)and 8.7%(4/46),respectively).Furthermore,the diagnostic workload of GeneXpert MTB/RIF increased from 38(11,150)cases diagnosed in 2014 to 2485(856,8349)cases in 2022(Z=-3.724,P<0.001),and antibody detection increased from 500(200,1010)cases in 2014 to 3401(1066,7275)cases in 2022(Z=-4.235,P<0.001),indicating an upward trend.In terms of laboratory quality control,the oversight of cultivation techniques remained a critical focus area.In 2022,only 76.1%(35/46)of medical institutions participated in inter-laboratory quality control,with the majority being monitored by third-party institutions(74.3%,26/35).Conclusion:Since 2014,the laboratory detection capabilities of tuberculosis-designated medical institutions in China have improved to varying degrees,particularly in molecular biology detection.Moving forward,while continuing to enhance tuberculosis laboratory detection capabilities,ensuring the quality of laboratory work will be a critical area of focus.