2012—2017年江苏省抗结核药物敏感性试验熟练度测试结果
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摘要
目的评价江苏省各地结核病实验室药敏试验能力建设水平。方法 2012-2017年对全省13个设区市开展抗结核药物敏感性试验(Drug susceptibility proficiency testing,DST,简称"药敏试验")实验室进行第五~九轮药敏试验熟练度测试,每次下发30株结核分枝杆菌菌株(含10株重复菌株),分别进行异烟肼(H)、利福平(R)、卡那霉素(Km)、氧氟沙星(Ofx)药敏试验熟练度测试。采用WHO推荐的基于固体罗氏培养基的比例法进行药敏试验。国家结核病参比实验室统一进行结果比对。计算各个实验室结果的敏感度、特异度、重复性和一致性等指标。结果 5轮DST熟练度测试合格率为94.4%~100.0%,一致性为(97.18%±2.22%)~(98.84%±1.09%),4种药物总敏感度93.51%~100.00%,总特异度84.00%~100.0%,总重复性88.57%~100.00%,总一致性94.06%~100.00%。结论江苏省近年各结核病实验室药敏试验熟练度水平较高,一致性较好,耐多药菌株检出能力较强。部分实验室应固定专业技术人员,加强培训,以保证检测准确性和稳定性。
Objective To evaluate the capacity of drug sensitivity tests for tuberculosis laboratories in Jiangsu province.Methods From 2012 to 2017,the anti tuberculosis drug sensitivity test(DST)was carried out in the 13 cities of Jiangsu province for the 5 th to 9 th round of DST proficiency test.30 strains of Mycobacterium tuberculosis(including 10 repeated strains)were distributed,DST proficiency tests for rifampicin(R),kanamycin(Km),ofloxacin(Ofx)and isoniazid(H)were carried out respectively.The DST was carried out by the ratio method based on solid Roche medium recommended by WHO.The results were evaluated by national tuberculosis reference laboratory.The sensitivity,specificity,repeatability and consistency of the results of each laboratory were calculated.Results For 5 round tests,the qualified rates were from 94.4%to 100.0%,the consistency rates were from(97.18%±2.22%)to(98.84%±1.09%),the sensitivity of 4 drugs tested were from 93.51%to100.00%,the overall specificity were from 84.00%to100.00%,the overall repeatability were from 88.57%to 100.00%,the overall consistency were from 94.06%to 100.00%.Conclusion In recent years,the proficiency of drug susceptibility tests of tuberculosis laboratories in Jiangsu province showed relatively high level,the consistency was good.Some laboratories should have certain professionals and technical personals for DST and enhance training in order to ensure the accuracy and stability of testing.
Objective To evaluate the capacity of drug sensitivity tests for tuberculosis laboratories in Jiangsu province.Methods From 2012 to 2017,the anti tuberculosis drug sensitivity test(DST)was carried out in the 13 cities of Jiangsu province for the 5 th to 9 th round of DST proficiency test.30 strains of Mycobacterium tuberculosis(including 10 repeated strains)were distributed,DST proficiency tests for rifampicin(R),kanamycin(Km),ofloxacin(Ofx)and isoniazid(H)were carried out respectively.The DST was carried out by the ratio method based on solid Roche medium recommended by WHO.The results were evaluated by national tuberculosis reference laboratory.The sensitivity,specificity,repeatability and consistency of the results of each laboratory were calculated.Results For 5 round tests,the qualified rates were from 94.4%to 100.0%,the consistency rates were from(97.18%±2.22%)to(98.84%±1.09%),the sensitivity of 4 drugs tested were from 93.51%to100.00%,the overall specificity were from 84.00%to100.00%,the overall repeatability were from 88.57%to 100.00%,the overall consistency were from 94.06%to 100.00%.Conclusion In recent years,the proficiency of drug susceptibility tests of tuberculosis laboratories in Jiangsu province showed relatively high level,the consistency was good.Some laboratories should have certain professionals and technical personals for DST and enhance training in order to ensure the accuracy and stability of testing.
引文
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[7]竺丽梅,刘巧,虞浩,等.江苏省结核病定点医院模式的患者管理质量分析[J].江苏预防医学,2013,24(6):33-35.
[8]柳正卫,何海波.浙江省第1轮结核分枝杆菌药敏试验室间质量保证结果分析[J].中国防痨杂志,2008,30(1):30-32
[9]周丽平,侯双翼,王鸣秋,等.湖北省4市结核病检测实验室药敏菌株复检结果分析[J].应用预防医学,2014,20(1),20:40-42.
[10]魏淑贞,梁庆福,赵永,等.2008~2013年福建省一线和二线抗结核药物敏感试验熟练度测试结果分析[J].预防医学论坛,2015(2):81-84.
[2]THOMPSON AP,STERNICKI LM,WEGENER KL,等.生物素——抗结核药物新研究方向[J].江苏预防医学,2016,27(3):257-261.
[3]宋红焕,邵燕,李国莉,等.肺结核诊断3种检测方法及联用的临床价值研究[J].江苏预防医学,2017,28(4):389-391.
[4]姜广路,尚美,宋媛媛,等.中国疾病控制体系实验室第1轮结核杆菌药物敏感试验室间质量评估分析[J].中国防痨杂志,2010,32(12):806-810.
[5]Wu MH,Chiang CY,Deng YM,et al.Proficiency of drug susceptibility testing for Mycobacterium tuberculosis in Taiwan,2007-2011[J].Int J Tuberc Lung D,2009,17(1):113.
[6]Laszlo A,Rahman M,Espinal M,et al.Quality assurance programme fordrug susceptibility testing of Myeobaeteriurn tuberculosis in the WHO/IUATLD Supranational Reference Laboratory Network:five rounds of proficiency testing,1994—1998[J].Int J TubercLung D,2002,6(9):748-756.
[7]竺丽梅,刘巧,虞浩,等.江苏省结核病定点医院模式的患者管理质量分析[J].江苏预防医学,2013,24(6):33-35.
[8]柳正卫,何海波.浙江省第1轮结核分枝杆菌药敏试验室间质量保证结果分析[J].中国防痨杂志,2008,30(1):30-32
[9]周丽平,侯双翼,王鸣秋,等.湖北省4市结核病检测实验室药敏菌株复检结果分析[J].应用预防医学,2014,20(1),20:40-42.
[10]魏淑贞,梁庆福,赵永,等.2008~2013年福建省一线和二线抗结核药物敏感试验熟练度测试结果分析[J].预防医学论坛,2015(2):81-84.