Xpert MTB/RIF 外部质量评估干培养物斑：南非第一阶段试点研究结果。
Dried culture spots for Xpert MTB/RIF external quality assessment: results of a phase 1 pilot study in South Africa.
机构信息
Department of Molecular Medicine and Haematology, University of the Witwatersrand, 7 York Road, Parktown, Johannesburg, South Africa.
出版信息
J Clin Microbiol. 2011 Dec;49(12):4356-60. doi: 10.1128/JCM.05167-11. Epub 2011 Oct 5.
Abstract
Implementation of Xpert MTB/RIF requires quality assessment. A pilot program using dried culture spots (DCSs) of inactivated Mycobacterium tuberculosis is described. Of 274 DCS results received, 2.19% generated errors; the remainder yielded 100% correct Mycobacterium tuberculosis detection. The probe A cycle threshold (C(T)) variability of three DCS batches was ≤ 3.47. The study of longer-term DCS stability is ongoing.
摘要
Xpert MTB/RIF 的实施需要质量评估。本文描述了一个使用已灭活结核分枝杆菌干燥培养物斑点（DCS）的试点项目。在收到的 274 份 DCS 结果中，有 2.19%出现错误；其余的结果均为 100%正确的结核分枝杆菌检测。三个 DCS 批次的探针 A 循环阈值（C(T)）变异性≤3.47。目前正在对 DCS 的长期稳定性进行研究。
相似文献
1
Dried culture spots for Xpert MTB/RIF external quality assessment: results of a phase 1 pilot study in South Africa.Xpert MTB/RIF 外部质量评估干培养物斑：南非第一阶段试点研究结果。
J Clin Microbiol. 2011 Dec;49(12):4356-60. doi: 10.1128/JCM.05167-11. Epub 2011 Oct 5.
2
Evaluation of GeneXpert /Rifampin for the detection of complex and rifampicin resistance in nonrespiratory clinical specimens.使用GeneXpert/利福平检测非呼吸道临床标本中的复合耐药和利福平耐药情况评估
Int J Mycobacteriol. 2019 Apr-Jun;8(2):132-137. doi: 10.4103/ijmy.ijmy_83_19.
3
Performance monitoring of mycobacterium tuberculosis dried culture spots for use with the GeneXpert system within a national program in South Africa.在南非的一项国家计划中，对用于GeneXpert系统的结核分枝杆菌干培养斑点进行性能监测。
J Clin Microbiol. 2013 Dec;51(12):4018-21. doi: 10.1128/JCM.01715-13. Epub 2013 Sep 25.
4
Detection of Mycobacterium tuberculosis in paucibacillary sputum: performances of the Xpert MTB/RIF ultra compared to the Xpert MTB/RIF, and IS6110 PCR.检测少菌痰液中的结核分枝杆菌：Xpert MTB/RIF ultra 与 Xpert MTB/RIF 及 IS6110 PCR 的性能比较。
Diagn Microbiol Infect Dis. 2019 Aug;94(4):365-370. doi: 10.1016/j.diagmicrobio.2019.02.008. Epub 2019 Feb 21.
5
The New Xpert MTB/RIF Ultra: Improving Detection of and Resistance to Rifampin in an Assay Suitable for Point-of-Care Testing.新型Xpert MTB/RIF Ultra：在适用于即时检测的检测方法中提高对结核分枝杆菌的检测及利福平耐药性检测
mBio. 2017 Aug 29;8(4):e00812-17. doi: 10.1128/mBio.00812-17.
6
The performance of an in-house loop-mediated isothermal amplification for the rapid detection of Mycobacterium tuberculosis in sputum samples in comparison with Xpert MTB/RIF, microscopy and culture.与Xpert MTB/RIF、显微镜检查和培养相比，一种用于痰液样本中结核分枝杆菌快速检测的内部环介导等温扩增技术的性能。
Rev Inst Med Trop Sao Paulo. 2020 Jun 5;62:e36. doi: 10.1590/S1678-9946202062036. eCollection 2020.
7
Rapid diagnosis of extrapulmonary tuberculosis with Xpert Mycobacterium tuberculosis/rifampicin assay.使用Xpert结核分枝杆菌/利福平检测法快速诊断肺外结核病
J Med Microbiol. 2017 Jul;66(7):910-914. doi: 10.1099/jmm.0.000522. Epub 2017 Jul 15.
8
Xpert MTB/RIF assay for the diagnosis of extrapulmonary tuberculosis: a diagnostic evaluation study.Xpert MTB/RIF assay 检测在肺外结核诊断中的应用：一项诊断评估研究。
Clin Microbiol Infect. 2019 Aug;25(8):1000-1005. doi: 10.1016/j.cmi.2018.12.018. Epub 2018 Dec 22.
9
Burden of tuberculosis in intensive care units in Cape Town, South Africa, and assessment of the accuracy and effect on patient outcomes of the Xpert MTB/RIF test on tracheal aspirate samples for diagnosis of pulmonary tuberculosis: a prospective burden of disease study with a nested randomised controlled trial.南非开普敦重症监护病房的结核病负担，以及对 Xpert MTB/RIF 检测在诊断肺结核方面的准确性及其对患者结局影响的评估：一项采用嵌套随机对照试验的疾病负担前瞻性研究。
Lancet Respir Med. 2015 Aug;3(8):621-30. doi: 10.1016/S2213-2600(15)00198-8. Epub 2015 Jul 22.
10
Comparison of two nucleic acid amplification assays, the Xpert MTB/RIF assay and the amplified Mycobacterium Tuberculosis Direct assay, for detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens.比较两种核酸扩增检测方法，Xpert MTB/RIF 检测法和扩增分枝杆菌直接检测法，用于检测呼吸道和非呼吸道标本中的结核分枝杆菌。
J Clin Microbiol. 2011 Oct;49(10):3659-62. doi: 10.1128/JCM.00211-11. Epub 2011 Aug 24.
引用本文的文献
1
Construction and application of a heterogeneous quality control library for the Xpert MTB/RIF assay in tuberculosis diagnosis.构建并应用 Xpert MTB/RIF 检测用于结核病诊断的异质质量控制文库。
Front Cell Infect Microbiol. 2023 Mar 17;13:1128337. doi: 10.3389/fcimb.2023.1128337. eCollection 2023.
2
Advancing proficiency testing for ultra in resource-limited settings using dried tube specimen: A study by SRL-Uganda.利用干血斑标本提高资源有限环境下的能力验证水平：乌干达 SRL 的研究。
PLoS One. 2023 Mar 10;18(3):e0282650. doi: 10.1371/journal.pone.0282650. eCollection 2023.
3
National Proficiency Testing of Molecular Diagnostics for Tuberculosis and Drug Resistance Detection - China, 2014-2019.2014 - 2019年中国结核病及耐药性检测分子诊断国家能力验证
China CDC Wkly. 2021 Mar 19;3(12):247-251. doi: 10.46234/ccdcw2021.072.
4
Flow cytometry method for absolute counting and single-cell phenotyping of mycobacteria.流式细胞术绝对计数和分枝杆菌单细胞表型分析方法。
Sci Rep. 2021 Sep 20;11(1):18661. doi: 10.1038/s41598-021-98176-5.
5
The Development of a Standardized Quality Assessment Material to Support Xpert HIV-1 Viral Load Testing for ART Monitoring in South Africa.用于支持南非抗逆转录病毒治疗监测的Xpert HIV-1病毒载量检测的标准化质量评估材料的开发
Diagnostics (Basel). 2021 Jan 22;11(2):160. doi: 10.3390/diagnostics11020160.
6
A global proficiency testing programme for Xpert® MTB/RIF using dried tube specimens, 2013-2015.2013 - 2015年使用干管标本进行的Xpert® MTB/RIF全球能力验证计划。
Afr J Lab Med. 2020 Nov 27;9(1):1167. doi: 10.4102/ajlm.v9i1.1167. eCollection 2020.
7
Development of dried tube specimens for Xpert MTB/RIF proficiency testing.用于Xpert MTB/RIF能力验证的干燥管标本的研制
Afr J Lab Med. 2020 Sep 29;9(1):1166. doi: 10.4102/ajlm.v9i1.1166. eCollection 2020.
8
Performance of the Roche cobas MTB Assay for the Molecular Diagnosis of Pulmonary Tuberculosis in a High HIV Burden Setting.罗氏 cobas MTB 检测在高 HIV 负担环境下对肺结核分子诊断的性能。
J Mol Diagn. 2020 Oct;22(10):1225-1237. doi: 10.1016/j.jmoldx.2020.06.018. Epub 2020 Aug 1.
9
Performance and workflow assessment of six nucleic acid extraction technologies for use in resource limited settings.在资源有限的环境下，对六种核酸提取技术的性能和工作流程评估。
PLoS One. 2019 Apr 18;14(4):e0215753. doi: 10.1371/journal.pone.0215753. eCollection 2019.
10
Genetic Mimetics of Mycobacterium tuberculosis and Methicillin-Resistant Staphylococcus aureus as Verification Standards for Molecular Diagnostics.结核分枝杆菌和耐甲氧西林金黄色葡萄球菌的遗传模拟物作为分子诊断的验证标准。
J Clin Microbiol. 2017 Dec;55(12):3384-3394. doi: 10.1128/JCM.01111-17. Epub 2017 Sep 20.
本文引用的文献
1
Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study.基层应用 Xpert MTB/RIF 检测诊断结核分枝杆菌感染和耐药的可行性、诊断准确性和效果：一项多中心实施研究。
Lancet. 2011 Apr 30;377(9776):1495-505. doi: 10.1016/S0140-6736(11)60438-8. Epub 2011 Apr 18.
2
Laboratory diagnosis of tuberculosis in resource-poor countries: challenges and opportunities.资源匮乏国家的结核病实验室诊断：挑战与机遇。
Clin Microbiol Rev. 2011 Apr;24(2):314-50. doi: 10.1128/CMR.00059-10.
3
Comparison of the Xpert MTB/RIF test with an IS6110-TaqMan real-time PCR assay for direct detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens.比较 Xpert MTB/RIF 检测与 IS6110-TaqMan 实时 PCR 检测在呼吸道和非呼吸道标本中直接检测结核分枝杆菌的效果。
J Clin Microbiol. 2011 May;49(5):1772-6. doi: 10.1128/JCM.02157-10. Epub 2011 Mar 16.
4
Rapid and efficient detection of Mycobacterium tuberculosis in respiratory and non-respiratory samples.快速、高效检测呼吸道和非呼吸道样本中的结核分枝杆菌。
Int J Tuberc Lung Dis. 2011 Apr;15(4):553-5. doi: 10.5588/ijtld.10.0497.
5
Evaluation of the Cepheid Xpert MTB/RIF assay for direct detection of Mycobacterium tuberculosis complex in respiratory specimens.评价 Cepheid Xpert MTB/RIF assay 直接检测呼吸道标本中的结核分枝杆菌复合群。
J Clin Microbiol. 2011 Apr;49(4):1621-3. doi: 10.1128/JCM.02214-10. Epub 2011 Feb 2.
6
Rapid molecular detection of extrapulmonary tuberculosis by the automated GeneXpert MTB/RIF system.应用自动化 GeneXpert MTB/RIF 系统快速检测肺外结核。
J Clin Microbiol. 2011 Apr;49(4):1202-5. doi: 10.1128/JCM.02268-10. Epub 2011 Jan 26.
7
Rapid detection of Mycobacterium tuberculosis complex and rifampin resistance in smear-negative clinical samples by use of an integrated real-time PCR method.采用整合实时 PCR 方法快速检测涂阴临床标本中的结核分枝杆菌复合群和利福平耐药性。
J Clin Microbiol. 2011 Mar;49(3):1137-9. doi: 10.1128/JCM.01831-10. Epub 2010 Dec 29.
8
Xpert(®) MTB/RIF for point-of-care diagnosis of TB in high-HIV burden, resource-limited countries: hype or hope?Xpert(®) MTB/RIF 即时检测系统在高 HIV 负担、资源有限国家的结核病点检测诊断：炒作还是希望？
Expert Rev Mol Diagn. 2010 Oct;10(7):937-46. doi: 10.1586/erm.10.67.
9
Rapid molecular detection of tuberculosis and rifampin resistance.快速分子检测结核分枝杆菌及利福平耐药性。
N Engl J Med. 2010 Sep 9;363(11):1005-15. doi: 10.1056/NEJMoa0907847. Epub 2010 Sep 1.
10
Evaluation of the analytical performance of the Xpert MTB/RIF assay.评估 Xpert MTB/RIF assay 的分析性能。
J Clin Microbiol. 2010 Jul;48(7):2495-501. doi: 10.1128/JCM.00128-10. Epub 2010 May 26.
Zotero 插件