目的探讨Xpert MTB/RIF联合宏基因组高通量测序对菌阴肺结核的诊断价值。方法回顾性分析2019年12月至2022年5月诊断为菌阴肺结核的70例患者,分别进行XpertMTB/RIF检测、宏基因组高通量测序及二者联合检测。采用固体培养法和比例法对生...目的探讨Xpert MTB/RIF联合宏基因组高通量测序对菌阴肺结核的诊断价值。方法回顾性分析2019年12月至2022年5月诊断为菌阴肺结核的70例患者,分别进行XpertMTB/RIF检测、宏基因组高通量测序及二者联合检测。采用固体培养法和比例法对生化病原菌进行诊断并分析诊断效能。采用预测值绘制受试者操作特征曲线。结果Xpert MTB/RIF诊断阳性率75.57%,阴性率21.43%;宏基因组高通量测序诊断阳性率78.57%,阴性率21.43%;联合诊断阳性率88.57%,阴性率11.43%。Xpert MTB/RIF检测敏感度为77.55%、特异性为59.86%,曲线下面积(area under the curve,AUC)为0.827;宏基因组高通量测序检测敏感度为77.47%、特异性为61.02%,AUC为0.808;联合检测敏感度为89.75%、特异性为89.57%,AUC为0.925。结果显示Xpert MTB/RIF联合宏基因组高通量测序在菌阴肺结核中诊断的敏感度、特异性均高于单一检测(P<0.05)。结论XpertMTB/RIF联合宏基因组高通量测序在菌阴肺结核诊断中具有较好的应用价值,值得临床推广使用。展开更多
Introduction: The Central African Republic is one of the 30 high Tuberculosis burden countries in the world, with an incidence of 540 cases per 100,000 population and a mortality of 91 deaths per 100,000 population. S...Introduction: The Central African Republic is one of the 30 high Tuberculosis burden countries in the world, with an incidence of 540 cases per 100,000 population and a mortality of 91 deaths per 100,000 population. Since 2020, following WHO recommendations, the National Reference Laboratory for Tuberculosis has been using the Xpert<sup>®</sup> MTB/RIF assay as a first-line diagnostic test for the early detection of Drug Resistance Tuberculosis. The goal of this study was to evaluate the contribution of the Xpert<sup>®</sup> MTB/RIF assay to the surveillance of rifampicin resistance in new and previously treated tuberculosis cases. Materials and Methods: The data relative to the Xpert<sup>®</sup> MTB/RIF assay carried out on various categories of tuberculosis patients registered at the National Reference Laboratory for Tuberculosis in 2020 were analyzed retrospectively. The categories of tuberculosis patients were new cases, failed treatment cases, relapse cases, lost-to-follow-up cases and multidrug-resistant tuberculosis contact cases. Results: A total of 1404 tuberculosis patients were registered at the NRL-TB in 2020;the mean age was 39.2 years (2 - 90 years) and the male-to-female sex ratio was 1.16:1. Overall, 32.7% (454/1404) proved infected with tuberculosis, of which 22.5% (102/454) cases showed resistance to rifampicin. The primary resistance rate was 9.1% (27/298) and the secondary resistance rate was 46.6% (75/161). Treatment failures and relapsed cases were significantly associated with rifampicin resistance (p 0.005). Conclusion: Large-scale use of Xpert<sup>®</sup> MTB/RIF, especially in the provinces of the Central African Republic, will help the Ministry of Health to better control Drug Resistance Tuberculosis in the country.展开更多
Background: Tuberculosis (TB) diagnostics, such as Xpert MTB/RIF, is still limited by cost. Testing of pooled samples from presumptive TB patients has been thought as a cost-saving strategy to diagnose TB. We assessed...Background: Tuberculosis (TB) diagnostics, such as Xpert MTB/RIF, is still limited by cost. Testing of pooled samples from presumptive TB patients has been thought as a cost-saving strategy to diagnose TB. We assessed the utility and cost-saving of pooled Xpert MTB/RIF testing strategy for the diagnosis of TB in Mwanza, Tanzania. Methods: Sputum samples from Presumptive TB patients were submitted to TB laboratory for routine diagnosis of TB using Xpert MTB/RIF. The TB results from the individual sputum samples were used as the reference standard and were concealed to the investigating laboratory technicians. The remainder of samples were collected serially and were pooled (5 samples per pool) for testing. The agreement of the results between individual sample testing against pooled sample testing and cost-savings was assessed. Results: A total of 250 sputum samples from presumptive TB patients were analyzed and 50 pools were made with each pool containing 5 samples. Of the 50 sputum pools made, Mycobacterium tuberculosis (MTB) was detected in 17 (34.0%) pools. Results from the individual sputum samples MTB/RIF testing were retrieved for all 250 samples and there were 28 (11.2%) samples in which MTB was detected whereas 222 (88.8%) samples had no MTB detected. Following re-analysis of positive pools, all 28 (100%) individual positive MTB samples were detected within the 17 positive pools, with 1 to 3 individual MTB positive samples per pool. The individual sputum samples were correctly identified by pooled sputum on Xpert MTB/RIF testing, with the sensitivity of 100% and specificity of 100%. Using pooling of sputum samples strategy, we saved 46.0% (115/250) of the cartridges. Conclusion: The pooled sputum testing strategy reduced cartridge costs by 46.0% and has the potential to increase the affordability of Xpert MTB/RIF testing in countries with limited resources, such as Tanzania.展开更多
Background The Xpert MTB/RIF showed high sensitivity and specificity in previous studies carried out in different epidemiological and geographical settings and patient populations in high-burden tuberculosis （TB） co...Background The Xpert MTB/RIF showed high sensitivity and specificity in previous studies carried out in different epidemiological and geographical settings and patient populations in high-burden tuberculosis （TB） countries.However,there were little data obtained by validation or demonstration study of the assay in China.In this study,the performance of Xpert MTB/RIF was investigated in two county-level laboratories in Hunan Province,China.Methods Consecutive patients with suspected pulmonary tuberculosis （PTB） and suspicion for multidrug-resistant tuberculosis （MDR-TB） were enrolled.For each patient suspected to have PTB,three sputum specimens （one spot sputum,one night sputum,and one morning sputum） were collected and each sputum was tested with smear microscopy,L（o）wenstein-Jensen （LJ） culture,and Xpert MTB/RIF test.For comparison across subgroups and testing methods,95％ confidence intervals were calculated.All analyses were done with SPSS 16.0,and P ＜0.05 was regarded as significant.Results For case detection,the sensitivity of Xpert MTB/RIF was 100％ for smear-and culture-positive TB and 88.6％ for smear-negative and culture-positive TB; the overall sensitivity was 94.5％ for all culture-positive patients.The specificity was 99.8％.The sensitivity of Xpert MTB/RIF assay was 22.0％ in clinical TB patients and the specificity reached 100.0％ in the group of patients who are infected with nontuberculous mycobacteria.For the detection of rifampin resistance,the sensitivity of MTB/RIF RIF-resistance detection was 92.9％,and the specificity was 98.7％.Of the 26 Xpert MTB/RIF-positive and RIF-resistant patients confirmed by LJ proportion tests,20 （76.9％） patients were infected by MDR-TB.Conclusions The Xpert MTB/RIF assay is a highly sensitive and specific method for diagnosis of TB and RIF resistance,which will enable it to have the potential to be used in county-level laboratories and lead to the reduction of the infectious pool and improvements in TB control in China.Further evaluations in county-level laboratories for implementing the assay are still required.展开更多
文摘目的探讨Xpert MTB/RIF联合宏基因组高通量测序对菌阴肺结核的诊断价值。方法回顾性分析2019年12月至2022年5月诊断为菌阴肺结核的70例患者,分别进行XpertMTB/RIF检测、宏基因组高通量测序及二者联合检测。采用固体培养法和比例法对生化病原菌进行诊断并分析诊断效能。采用预测值绘制受试者操作特征曲线。结果Xpert MTB/RIF诊断阳性率75.57%,阴性率21.43%;宏基因组高通量测序诊断阳性率78.57%,阴性率21.43%;联合诊断阳性率88.57%,阴性率11.43%。Xpert MTB/RIF检测敏感度为77.55%、特异性为59.86%,曲线下面积(area under the curve,AUC)为0.827;宏基因组高通量测序检测敏感度为77.47%、特异性为61.02%,AUC为0.808;联合检测敏感度为89.75%、特异性为89.57%,AUC为0.925。结果显示Xpert MTB/RIF联合宏基因组高通量测序在菌阴肺结核中诊断的敏感度、特异性均高于单一检测(P<0.05)。结论XpertMTB/RIF联合宏基因组高通量测序在菌阴肺结核诊断中具有较好的应用价值,值得临床推广使用。
文摘Introduction: The Central African Republic is one of the 30 high Tuberculosis burden countries in the world, with an incidence of 540 cases per 100,000 population and a mortality of 91 deaths per 100,000 population. Since 2020, following WHO recommendations, the National Reference Laboratory for Tuberculosis has been using the Xpert<sup>®</sup> MTB/RIF assay as a first-line diagnostic test for the early detection of Drug Resistance Tuberculosis. The goal of this study was to evaluate the contribution of the Xpert<sup>®</sup> MTB/RIF assay to the surveillance of rifampicin resistance in new and previously treated tuberculosis cases. Materials and Methods: The data relative to the Xpert<sup>®</sup> MTB/RIF assay carried out on various categories of tuberculosis patients registered at the National Reference Laboratory for Tuberculosis in 2020 were analyzed retrospectively. The categories of tuberculosis patients were new cases, failed treatment cases, relapse cases, lost-to-follow-up cases and multidrug-resistant tuberculosis contact cases. Results: A total of 1404 tuberculosis patients were registered at the NRL-TB in 2020;the mean age was 39.2 years (2 - 90 years) and the male-to-female sex ratio was 1.16:1. Overall, 32.7% (454/1404) proved infected with tuberculosis, of which 22.5% (102/454) cases showed resistance to rifampicin. The primary resistance rate was 9.1% (27/298) and the secondary resistance rate was 46.6% (75/161). Treatment failures and relapsed cases were significantly associated with rifampicin resistance (p 0.005). Conclusion: Large-scale use of Xpert<sup>®</sup> MTB/RIF, especially in the provinces of the Central African Republic, will help the Ministry of Health to better control Drug Resistance Tuberculosis in the country.
文摘Background: Tuberculosis (TB) diagnostics, such as Xpert MTB/RIF, is still limited by cost. Testing of pooled samples from presumptive TB patients has been thought as a cost-saving strategy to diagnose TB. We assessed the utility and cost-saving of pooled Xpert MTB/RIF testing strategy for the diagnosis of TB in Mwanza, Tanzania. Methods: Sputum samples from Presumptive TB patients were submitted to TB laboratory for routine diagnosis of TB using Xpert MTB/RIF. The TB results from the individual sputum samples were used as the reference standard and were concealed to the investigating laboratory technicians. The remainder of samples were collected serially and were pooled (5 samples per pool) for testing. The agreement of the results between individual sample testing against pooled sample testing and cost-savings was assessed. Results: A total of 250 sputum samples from presumptive TB patients were analyzed and 50 pools were made with each pool containing 5 samples. Of the 50 sputum pools made, Mycobacterium tuberculosis (MTB) was detected in 17 (34.0%) pools. Results from the individual sputum samples MTB/RIF testing were retrieved for all 250 samples and there were 28 (11.2%) samples in which MTB was detected whereas 222 (88.8%) samples had no MTB detected. Following re-analysis of positive pools, all 28 (100%) individual positive MTB samples were detected within the 17 positive pools, with 1 to 3 individual MTB positive samples per pool. The individual sputum samples were correctly identified by pooled sputum on Xpert MTB/RIF testing, with the sensitivity of 100% and specificity of 100%. Using pooling of sputum samples strategy, we saved 46.0% (115/250) of the cartridges. Conclusion: The pooled sputum testing strategy reduced cartridge costs by 46.0% and has the potential to increase the affordability of Xpert MTB/RIF testing in countries with limited resources, such as Tanzania.
文摘Background The Xpert MTB/RIF showed high sensitivity and specificity in previous studies carried out in different epidemiological and geographical settings and patient populations in high-burden tuberculosis （TB） countries.However,there were little data obtained by validation or demonstration study of the assay in China.In this study,the performance of Xpert MTB/RIF was investigated in two county-level laboratories in Hunan Province,China.Methods Consecutive patients with suspected pulmonary tuberculosis （PTB） and suspicion for multidrug-resistant tuberculosis （MDR-TB） were enrolled.For each patient suspected to have PTB,three sputum specimens （one spot sputum,one night sputum,and one morning sputum） were collected and each sputum was tested with smear microscopy,L（o）wenstein-Jensen （LJ） culture,and Xpert MTB/RIF test.For comparison across subgroups and testing methods,95％ confidence intervals were calculated.All analyses were done with SPSS 16.0,and P ＜0.05 was regarded as significant.Results For case detection,the sensitivity of Xpert MTB/RIF was 100％ for smear-and culture-positive TB and 88.6％ for smear-negative and culture-positive TB; the overall sensitivity was 94.5％ for all culture-positive patients.The specificity was 99.8％.The sensitivity of Xpert MTB/RIF assay was 22.0％ in clinical TB patients and the specificity reached 100.0％ in the group of patients who are infected with nontuberculous mycobacteria.For the detection of rifampin resistance,the sensitivity of MTB/RIF RIF-resistance detection was 92.9％,and the specificity was 98.7％.Of the 26 Xpert MTB/RIF-positive and RIF-resistant patients confirmed by LJ proportion tests,20 （76.9％） patients were infected by MDR-TB.Conclusions The Xpert MTB/RIF assay is a highly sensitive and specific method for diagnosis of TB and RIF resistance,which will enable it to have the potential to be used in county-level laboratories and lead to the reduction of the infectious pool and improvements in TB control in China.Further evaluations in county-level laboratories for implementing the assay are still required.
