用于检测结核分枝杆菌的赛沛Xpert MTB/RIF检测试剂的修订版设备标签。
Revised device labeling for the Cepheid Xpert MTB/RIF assay for detecting Mycobacterium tuberculosis.
出版信息
MMWR Morb Mortal Wkly Rep. 2015 Feb 27;64(7):193.
Abstract
The Food and Drug Administration (FDA) has cleared the Xpert MTB/RIF Assay (Cepheid; Sunnyvale, California) with an expanded intended use that includes testing of either one or two sputum specimens as an alternative to examination of serial acid-fast stained sputum smears to aid in the decision of whether continued airborne infection isolation (AII) is warranted for patients with suspected pulmonary tuberculosis. This change reflects the outcome of a recent multicenter international study demonstrating that negative Xpert MTB/RIF Assay results from either one or two sputum specimens are highly predictive of the results of two or three negative acid-fast sputum smears.
摘要
美国食品药品监督管理局（FDA）已批准Xpert MTB/RIF检测（塞菲德公司；加利福尼亚州桑尼维尔）扩大预期用途，包括检测一份或两份痰标本，作为连续抗酸染色痰涂片检查的替代方法，以帮助决定对疑似肺结核患者是否有必要继续进行空气传播感染隔离（AII）。这一变化反映了最近一项多中心国际研究的结果，该研究表明，一份或两份痰标本的Xpert MTB/RIF检测结果为阴性，高度预示着两份或三份抗酸痰涂片结果为阴性。
相似文献
1
Revised device labeling for the Cepheid Xpert MTB/RIF assay for detecting Mycobacterium tuberculosis.用于检测结核分枝杆菌的赛沛Xpert MTB/RIF检测试剂的修订版设备标签。
MMWR Morb Mortal Wkly Rep. 2015 Feb 27;64(7):193.
2
Added value of molecular assay Xpert MTB/RIF compared to sputum smear microscopy to assess the risk of tuberculosis transmission in a low-prevalence country.分子检测 Xpert MTB/RIF 比痰涂片显微镜检查在低流行国家评估结核病传播风险的附加价值。
Clin Microbiol Infect. 2016 Jul;22(7):613-9. doi: 10.1016/j.cmi.2016.04.010. Epub 2016 Apr 29.
3
Comparison of the Xpert MTB/RIF and Cobas TaqMan MTB assays for detection of Mycobacterium tuberculosis in respiratory specimens.比较 Xpert MTB/RIF 和 Cobas TaqMan MTB 检测呼吸道标本中结核分枝杆菌的应用。
J Clin Microbiol. 2013 Oct;51(10):3225-7. doi: 10.1128/JCM.01335-13. Epub 2013 Jul 17.
4
Xpert MTB/RIF assay shortens airborne isolation for hospitalized patients with presumptive tuberculosis in the United States.Xpert MTB/RIF检测缩短了美国疑似结核病住院患者的空气隔离时间。
Clin Infect Dis. 2014 Jul 15;59(2):186-92. doi: 10.1093/cid/ciu212. Epub 2014 Apr 11.
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
Xpert MTB/RIF assay can be used on archived gastric aspirate and induced sputum samples for sensitive diagnosis of paediatric tuberculosis.Xpert MTB/RIF检测可用于存档的胃抽吸物和诱导痰样本，以对儿童结核病进行敏感诊断。
BMC Microbiol. 2015 Sep 29;15:191. doi: 10.1186/s12866-015-0528-z.
7
Use of a Single Xpert MTB/RIF Assay to Determine the Duration of Airborne Isolation in Hospitalized Patients With Suspected Pulmonary Tuberculosis.采用单一 Xpert MTB/RIF 检测来确定疑似肺结核住院患者的空气传播隔离时间。
Infect Control Hosp Epidemiol. 2018 May;39(5):590-595. doi: 10.1017/ice.2018.25. Epub 2018 Mar 27.
8
Reassessment of the positive predictive value and specificity of Xpert MTB/RIF: a diagnostic accuracy study in the context of community-wide screening for tuberculosis.Xpert MTB/RIF 阳性预测值和特异性的再评估：在社区范围内进行结核病筛查背景下的诊断准确性研究。
Lancet Infect Dis. 2016 Sep;16(9):1045-1051. doi: 10.1016/S1473-3099(16)30067-6. Epub 2016 Jun 8.
9
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.
10
Combined tests with Xpert MTB/RIF assay with bronchoalveolar lavage fluid increasing the diagnostic performance of smear-negative pulmonary tuberculosis in Eastern China.联合 Xpert MTB/RIF 检测与支气管肺泡灌洗液检测提高中国东部地区菌阴肺结核的诊断性能。
Epidemiol Infect. 2020 Dec 28;149:e5. doi: 10.1017/S095026882000309X.
引用本文的文献
1
Limitations of the MTB/RIF Assay: An Xpert Review of 4 Clinical Cases.MTB/RIF检测的局限性：4例临床病例的Xpert回顾
Open Forum Infect Dis. 2025 Mar 5;12(4):ofaf132. doi: 10.1093/ofid/ofaf132. eCollection 2025 Apr.
2
Second Time's the Charm? Assessing the Sensitivity and Yield of Inpatient Diagnostic Algorithms for Pulmonary Tuberculosis in a Low-Prevalence Setting.第二次会有好结果吗？在低发病率环境中评估住院患者肺结核诊断算法的敏感性和检出率。
Open Forum Infect Dis. 2024 May 3;11(6):ofae253. doi: 10.1093/ofid/ofae253. eCollection 2024 Jun.
3
Use of Nucleic Acid Amplification Testing for Rapid Detection of Complex Among US Tuberculosis Patients, 2011‒2017.2011 - 2017年美国肺结核患者中使用核酸扩增检测技术快速检测混合感染情况
Open Forum Infect Dis. 2021 Oct 20;8(11):ofab528. doi: 10.1093/ofid/ofab528. eCollection 2021 Nov.
4
Age and sex distribution of Mycobacterium tuberculosis infection and rifampicin resistance in Myanmar as detected by Xpert MTB/RIF.Xpert MTB/RIF 检测到的缅甸结核分枝杆菌感染和利福平耐药的年龄和性别分布。
BMC Infect Dis. 2021 Aug 9;21(1):781. doi: 10.1186/s12879-021-06296-0.
5
The diagnostic impact of implementing a molecular-based algorithm to standard mycobacterial screening at a reference laboratory with an intermediate prevalence for non-respiratory samples.在一个非呼吸道样本患病率处于中等水平的参考实验室，实施基于分子技术的算法用于标准分枝杆菌筛查的诊断影响。
Saudi J Biol Sci. 2021 Aug;28(8):4103-4108. doi: 10.1016/j.sjbs.2021.05.080. Epub 2021 Jun 11.
6
COVID-19 and Tuberculosis Coinfection in a 51-Year-Old Taxi Driver in Mexico City.墨西哥城一名51岁出租车司机的新冠病毒与结核病合并感染情况
Am J Case Rep. 2020 Nov 5;21:e927628. doi: 10.12659/AJCR.927628.
7
Association of Rapid Molecular Testing With Duration of Respiratory Isolation for Patients With Possible Tuberculosis in a US Hospital.快速分子检测与美国医院疑似结核病患者呼吸道隔离时间的关联。
JAMA Intern Med. 2018 Oct 1;178(10):1380-1388. doi: 10.1001/jamainternmed.2018.3638.
8
Practical Guidance for Clinical Microbiology Laboratories: Mycobacteria.临床微生物学实验室实用指南：分枝杆菌。
Clin Microbiol Rev. 2018 Jan 31;31(2). doi: 10.1128/CMR.00038-17. Print 2018 Apr.
9
Clinical Impact and Cost-effectiveness of Xpert MTB/RIF Testing in Hospitalized Patients With Presumptive Pulmonary Tuberculosis in the United States.美国住院疑似肺结核患者中Xpert MTB/RIF检测的临床影响和成本效益
Clin Infect Dis. 2017 Feb 15;64(4):482-489. doi: 10.1093/cid/ciw803.
10
Use of Nucleic Acid Amplification Tests in Tuberculosis Patients in California, 2010-2013.2010 - 2013年加利福尼亚州结核病患者中核酸扩增检测的应用
Open Forum Infect Dis. 2016 Dec 5;3(4):ofw230. doi: 10.1093/ofid/ofw230. eCollection 2016 Oct.
本文引用的文献
1
Impact of GeneXpert MTB/RIF assay on triage of respiratory isolation rooms for inpatients with presumed tuberculosis: a hypothetical trial.GeneXpert MTB/RIF检测对疑似结核病住院患者呼吸道隔离病房分诊的影响：一项假设性试验。
Clin Infect Dis. 2014 Nov 15;59(10):1353-60. doi: 10.1093/cid/ciu620. Epub 2014 Aug 4.
2
Xpert MTB/RIF assay shortens airborne isolation for hospitalized patients with presumptive tuberculosis in the United States.Xpert MTB/RIF检测缩短了美国疑似结核病住院患者的空气隔离时间。
Clin Infect Dis. 2014 Jul 15;59(2):186-92. doi: 10.1093/cid/ciu212. Epub 2014 Apr 11.
3
Availability of an assay for detecting Mycobacterium tuberculosis, including rifampin-resistant strains, and considerations for its use - United States, 2013.检测结核分枝杆菌（包括利福平耐药菌株）的检测方法的可及性及其使用注意事项-美国，2013 年。
MMWR Morb Mortal Wkly Rep. 2013 Oct 18;62(41):821-7.
Zotero 插件