Performance evaluation of the Xpert MTB/RIF assay according to its clinical application

Background The Xpert MTB/RIF assay (Xpert assay; Cepheid, Sunnyvale, CA) is becoming the test of choice for the rapid diagnosis of tuberculosis and rifampin (RIF) resistance. The aim of this study was to evaluate the performance of the Xpert assay with respect to its clinical application at a tertia...
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Autor*in:	Huh, Hee Jae [verfasserIn] Jeong, Byeong-Ho Jeon, Kyeongman Koh, Won-Jung Ki, Chang-Seok Lee, Nam Yong

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2014

Schlagwörter:	Mycobacterium tuberculosis Pulmonary tuberculosis Xpert MTB/RIF assay Korea

Anmerkung:	© Huh et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (

Übergeordnetes Werk:	Enthalten in: BMC infectious diseases - London : BioMed Central, 2001, 14(2014), 1 vom: 14. Nov.
Übergeordnetes Werk:	volume:14 ; year:2014 ; number:1 ; day:14 ; month:11

Links:	Volltext

DOI / URN:	10.1186/s12879-014-0589-x

Katalog-ID:	SPR028057155

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520			\|a Background The Xpert MTB/RIF assay (Xpert assay; Cepheid, Sunnyvale, CA) is becoming the test of choice for the rapid diagnosis of tuberculosis and rifampin (RIF) resistance. The aim of this study was to evaluate the performance of the Xpert assay with respect to its clinical application at a tertiary care hospital in Korea, a country with an intermediate tuberculosis burden and high-resource. Methods A total of 303 Xpert assay results from 109 smear-positive and 194 smear-negative respiratory specimens were retrospectively reviewed. Based on patients’ medical records, four categories of clinical applications of the Xpert assay were identified: (1) the diagnosis of pulmonary tuberculosis in patients with a high probability of pulmonary tuberculosis according to their clinical and radiological features; (2) the exclusion of tuberculosis in clinically indeterminate patients for pulmonary tuberculosis; (3) the differentiation of Mycobacterium tuberculsosis (MTB) from nontuberculous mycobacteria in a smear-positive specimen; and (4) the diagnosis of RIF resistance. Standard culture and drug susceptibility tests were used as reference methods. Results The sensitivity of the Xpert assay for MTB detection in category 1 was 89.8% (95% confidence interval [CI], 78.5-95.8%), but 66.7% (95% CI, 12.5-98.2%) in category 2. The positive predictive values ranged from 33.3% (95% CI, 6.0-75.9%) in category 2 to 91.3% and 91.7% in categories 1 and 3, respectively. The negative predictive values were over 90% in all categories. The Xpert assay correctly detected RIF resistance in six of the seven (85.7%) isolates tested. Conclusions The Xpert assay exhibited variable performance according to its clinical application; this finding cautions that careful interpretation for the results of this assay would be needed according to its intended purpose.
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allfields	10.1186/s12879-014-0589-x doi (DE-627)SPR028057155 (SPR)s12879-014-0589-x-e DE-627 ger DE-627 rakwb eng Huh, Hee Jae verfasserin aut Performance evaluation of the Xpert MTB/RIF assay according to its clinical application 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Huh et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background The Xpert MTB/RIF assay (Xpert assay; Cepheid, Sunnyvale, CA) is becoming the test of choice for the rapid diagnosis of tuberculosis and rifampin (RIF) resistance. The aim of this study was to evaluate the performance of the Xpert assay with respect to its clinical application at a tertiary care hospital in Korea, a country with an intermediate tuberculosis burden and high-resource. Methods A total of 303 Xpert assay results from 109 smear-positive and 194 smear-negative respiratory specimens were retrospectively reviewed. Based on patients’ medical records, four categories of clinical applications of the Xpert assay were identified: (1) the diagnosis of pulmonary tuberculosis in patients with a high probability of pulmonary tuberculosis according to their clinical and radiological features; (2) the exclusion of tuberculosis in clinically indeterminate patients for pulmonary tuberculosis; (3) the differentiation of Mycobacterium tuberculsosis (MTB) from nontuberculous mycobacteria in a smear-positive specimen; and (4) the diagnosis of RIF resistance. Standard culture and drug susceptibility tests were used as reference methods. Results The sensitivity of the Xpert assay for MTB detection in category 1 was 89.8% (95% confidence interval [CI], 78.5-95.8%), but 66.7% (95% CI, 12.5-98.2%) in category 2. The positive predictive values ranged from 33.3% (95% CI, 6.0-75.9%) in category 2 to 91.3% and 91.7% in categories 1 and 3, respectively. The negative predictive values were over 90% in all categories. The Xpert assay correctly detected RIF resistance in six of the seven (85.7%) isolates tested. Conclusions The Xpert assay exhibited variable performance according to its clinical application; this finding cautions that careful interpretation for the results of this assay would be needed according to its intended purpose. Mycobacterium tuberculosis (dpeaa)DE-He213 Pulmonary tuberculosis (dpeaa)DE-He213 Xpert MTB/RIF assay (dpeaa)DE-He213 Korea (dpeaa)DE-He213 Jeong, Byeong-Ho aut Jeon, Kyeongman aut Koh, Won-Jung aut Ki, Chang-Seok aut Lee, Nam Yong aut Enthalten in BMC infectious diseases London : BioMed Central, 2001 14(2014), 1 vom: 14. Nov. (DE-627)326645381 (DE-600)2041550-3 1471-2334 nnns volume:14 year:2014 number:1 day:14 month:11 https://dx.doi.org/10.1186/s12879-014-0589-x lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2014 1 14 11
spelling	10.1186/s12879-014-0589-x doi (DE-627)SPR028057155 (SPR)s12879-014-0589-x-e DE-627 ger DE-627 rakwb eng Huh, Hee Jae verfasserin aut Performance evaluation of the Xpert MTB/RIF assay according to its clinical application 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Huh et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background The Xpert MTB/RIF assay (Xpert assay; Cepheid, Sunnyvale, CA) is becoming the test of choice for the rapid diagnosis of tuberculosis and rifampin (RIF) resistance. The aim of this study was to evaluate the performance of the Xpert assay with respect to its clinical application at a tertiary care hospital in Korea, a country with an intermediate tuberculosis burden and high-resource. Methods A total of 303 Xpert assay results from 109 smear-positive and 194 smear-negative respiratory specimens were retrospectively reviewed. Based on patients’ medical records, four categories of clinical applications of the Xpert assay were identified: (1) the diagnosis of pulmonary tuberculosis in patients with a high probability of pulmonary tuberculosis according to their clinical and radiological features; (2) the exclusion of tuberculosis in clinically indeterminate patients for pulmonary tuberculosis; (3) the differentiation of Mycobacterium tuberculsosis (MTB) from nontuberculous mycobacteria in a smear-positive specimen; and (4) the diagnosis of RIF resistance. Standard culture and drug susceptibility tests were used as reference methods. Results The sensitivity of the Xpert assay for MTB detection in category 1 was 89.8% (95% confidence interval [CI], 78.5-95.8%), but 66.7% (95% CI, 12.5-98.2%) in category 2. The positive predictive values ranged from 33.3% (95% CI, 6.0-75.9%) in category 2 to 91.3% and 91.7% in categories 1 and 3, respectively. The negative predictive values were over 90% in all categories. The Xpert assay correctly detected RIF resistance in six of the seven (85.7%) isolates tested. Conclusions The Xpert assay exhibited variable performance according to its clinical application; this finding cautions that careful interpretation for the results of this assay would be needed according to its intended purpose. Mycobacterium tuberculosis (dpeaa)DE-He213 Pulmonary tuberculosis (dpeaa)DE-He213 Xpert MTB/RIF assay (dpeaa)DE-He213 Korea (dpeaa)DE-He213 Jeong, Byeong-Ho aut Jeon, Kyeongman aut Koh, Won-Jung aut Ki, Chang-Seok aut Lee, Nam Yong aut Enthalten in BMC infectious diseases London : BioMed Central, 2001 14(2014), 1 vom: 14. Nov. (DE-627)326645381 (DE-600)2041550-3 1471-2334 nnns volume:14 year:2014 number:1 day:14 month:11 https://dx.doi.org/10.1186/s12879-014-0589-x lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2014 1 14 11
allfields_unstemmed	10.1186/s12879-014-0589-x doi (DE-627)SPR028057155 (SPR)s12879-014-0589-x-e DE-627 ger DE-627 rakwb eng Huh, Hee Jae verfasserin aut Performance evaluation of the Xpert MTB/RIF assay according to its clinical application 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Huh et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background The Xpert MTB/RIF assay (Xpert assay; Cepheid, Sunnyvale, CA) is becoming the test of choice for the rapid diagnosis of tuberculosis and rifampin (RIF) resistance. The aim of this study was to evaluate the performance of the Xpert assay with respect to its clinical application at a tertiary care hospital in Korea, a country with an intermediate tuberculosis burden and high-resource. Methods A total of 303 Xpert assay results from 109 smear-positive and 194 smear-negative respiratory specimens were retrospectively reviewed. Based on patients’ medical records, four categories of clinical applications of the Xpert assay were identified: (1) the diagnosis of pulmonary tuberculosis in patients with a high probability of pulmonary tuberculosis according to their clinical and radiological features; (2) the exclusion of tuberculosis in clinically indeterminate patients for pulmonary tuberculosis; (3) the differentiation of Mycobacterium tuberculsosis (MTB) from nontuberculous mycobacteria in a smear-positive specimen; and (4) the diagnosis of RIF resistance. Standard culture and drug susceptibility tests were used as reference methods. Results The sensitivity of the Xpert assay for MTB detection in category 1 was 89.8% (95% confidence interval [CI], 78.5-95.8%), but 66.7% (95% CI, 12.5-98.2%) in category 2. The positive predictive values ranged from 33.3% (95% CI, 6.0-75.9%) in category 2 to 91.3% and 91.7% in categories 1 and 3, respectively. The negative predictive values were over 90% in all categories. The Xpert assay correctly detected RIF resistance in six of the seven (85.7%) isolates tested. Conclusions The Xpert assay exhibited variable performance according to its clinical application; this finding cautions that careful interpretation for the results of this assay would be needed according to its intended purpose. Mycobacterium tuberculosis (dpeaa)DE-He213 Pulmonary tuberculosis (dpeaa)DE-He213 Xpert MTB/RIF assay (dpeaa)DE-He213 Korea (dpeaa)DE-He213 Jeong, Byeong-Ho aut Jeon, Kyeongman aut Koh, Won-Jung aut Ki, Chang-Seok aut Lee, Nam Yong aut Enthalten in BMC infectious diseases London : BioMed Central, 2001 14(2014), 1 vom: 14. Nov. (DE-627)326645381 (DE-600)2041550-3 1471-2334 nnns volume:14 year:2014 number:1 day:14 month:11 https://dx.doi.org/10.1186/s12879-014-0589-x lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2014 1 14 11
allfieldsGer	10.1186/s12879-014-0589-x doi (DE-627)SPR028057155 (SPR)s12879-014-0589-x-e DE-627 ger DE-627 rakwb eng Huh, Hee Jae verfasserin aut Performance evaluation of the Xpert MTB/RIF assay according to its clinical application 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Huh et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background The Xpert MTB/RIF assay (Xpert assay; Cepheid, Sunnyvale, CA) is becoming the test of choice for the rapid diagnosis of tuberculosis and rifampin (RIF) resistance. The aim of this study was to evaluate the performance of the Xpert assay with respect to its clinical application at a tertiary care hospital in Korea, a country with an intermediate tuberculosis burden and high-resource. Methods A total of 303 Xpert assay results from 109 smear-positive and 194 smear-negative respiratory specimens were retrospectively reviewed. Based on patients’ medical records, four categories of clinical applications of the Xpert assay were identified: (1) the diagnosis of pulmonary tuberculosis in patients with a high probability of pulmonary tuberculosis according to their clinical and radiological features; (2) the exclusion of tuberculosis in clinically indeterminate patients for pulmonary tuberculosis; (3) the differentiation of Mycobacterium tuberculsosis (MTB) from nontuberculous mycobacteria in a smear-positive specimen; and (4) the diagnosis of RIF resistance. Standard culture and drug susceptibility tests were used as reference methods. Results The sensitivity of the Xpert assay for MTB detection in category 1 was 89.8% (95% confidence interval [CI], 78.5-95.8%), but 66.7% (95% CI, 12.5-98.2%) in category 2. The positive predictive values ranged from 33.3% (95% CI, 6.0-75.9%) in category 2 to 91.3% and 91.7% in categories 1 and 3, respectively. The negative predictive values were over 90% in all categories. The Xpert assay correctly detected RIF resistance in six of the seven (85.7%) isolates tested. Conclusions The Xpert assay exhibited variable performance according to its clinical application; this finding cautions that careful interpretation for the results of this assay would be needed according to its intended purpose. Mycobacterium tuberculosis (dpeaa)DE-He213 Pulmonary tuberculosis (dpeaa)DE-He213 Xpert MTB/RIF assay (dpeaa)DE-He213 Korea (dpeaa)DE-He213 Jeong, Byeong-Ho aut Jeon, Kyeongman aut Koh, Won-Jung aut Ki, Chang-Seok aut Lee, Nam Yong aut Enthalten in BMC infectious diseases London : BioMed Central, 2001 14(2014), 1 vom: 14. Nov. (DE-627)326645381 (DE-600)2041550-3 1471-2334 nnns volume:14 year:2014 number:1 day:14 month:11 https://dx.doi.org/10.1186/s12879-014-0589-x lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2014 1 14 11
allfieldsSound	10.1186/s12879-014-0589-x doi (DE-627)SPR028057155 (SPR)s12879-014-0589-x-e DE-627 ger DE-627 rakwb eng Huh, Hee Jae verfasserin aut Performance evaluation of the Xpert MTB/RIF assay according to its clinical application 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Huh et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background The Xpert MTB/RIF assay (Xpert assay; Cepheid, Sunnyvale, CA) is becoming the test of choice for the rapid diagnosis of tuberculosis and rifampin (RIF) resistance. The aim of this study was to evaluate the performance of the Xpert assay with respect to its clinical application at a tertiary care hospital in Korea, a country with an intermediate tuberculosis burden and high-resource. Methods A total of 303 Xpert assay results from 109 smear-positive and 194 smear-negative respiratory specimens were retrospectively reviewed. Based on patients’ medical records, four categories of clinical applications of the Xpert assay were identified: (1) the diagnosis of pulmonary tuberculosis in patients with a high probability of pulmonary tuberculosis according to their clinical and radiological features; (2) the exclusion of tuberculosis in clinically indeterminate patients for pulmonary tuberculosis; (3) the differentiation of Mycobacterium tuberculsosis (MTB) from nontuberculous mycobacteria in a smear-positive specimen; and (4) the diagnosis of RIF resistance. Standard culture and drug susceptibility tests were used as reference methods. Results The sensitivity of the Xpert assay for MTB detection in category 1 was 89.8% (95% confidence interval [CI], 78.5-95.8%), but 66.7% (95% CI, 12.5-98.2%) in category 2. The positive predictive values ranged from 33.3% (95% CI, 6.0-75.9%) in category 2 to 91.3% and 91.7% in categories 1 and 3, respectively. The negative predictive values were over 90% in all categories. The Xpert assay correctly detected RIF resistance in six of the seven (85.7%) isolates tested. Conclusions The Xpert assay exhibited variable performance according to its clinical application; this finding cautions that careful interpretation for the results of this assay would be needed according to its intended purpose. Mycobacterium tuberculosis (dpeaa)DE-He213 Pulmonary tuberculosis (dpeaa)DE-He213 Xpert MTB/RIF assay (dpeaa)DE-He213 Korea (dpeaa)DE-He213 Jeong, Byeong-Ho aut Jeon, Kyeongman aut Koh, Won-Jung aut Ki, Chang-Seok aut Lee, Nam Yong aut Enthalten in BMC infectious diseases London : BioMed Central, 2001 14(2014), 1 vom: 14. Nov. (DE-627)326645381 (DE-600)2041550-3 1471-2334 nnns volume:14 year:2014 number:1 day:14 month:11 https://dx.doi.org/10.1186/s12879-014-0589-x lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2014 1 14 11
language	English
source	Enthalten in BMC infectious diseases 14(2014), 1 vom: 14. Nov. volume:14 year:2014 number:1 day:14 month:11
sourceStr	Enthalten in BMC infectious diseases 14(2014), 1 vom: 14. Nov. volume:14 year:2014 number:1 day:14 month:11
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Mycobacterium tuberculosis Pulmonary tuberculosis Xpert MTB/RIF assay Korea
isfreeaccess_bool	false
container_title	BMC infectious diseases
authorswithroles_txt_mv	Huh, Hee Jae @@aut@@ Jeong, Byeong-Ho @@aut@@ Jeon, Kyeongman @@aut@@ Koh, Won-Jung @@aut@@ Ki, Chang-Seok @@aut@@ Lee, Nam Yong @@aut@@
publishDateDaySort_date	2014-11-14T00:00:00Z
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This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Background The Xpert MTB/RIF assay (Xpert assay; Cepheid, Sunnyvale, CA) is becoming the test of choice for the rapid diagnosis of tuberculosis and rifampin (RIF) resistance. The aim of this study was to evaluate the performance of the Xpert assay with respect to its clinical application at a tertiary care hospital in Korea, a country with an intermediate tuberculosis burden and high-resource. Methods A total of 303 Xpert assay results from 109 smear-positive and 194 smear-negative respiratory specimens were retrospectively reviewed. Based on patients’ medical records, four categories of clinical applications of the Xpert assay were identified: (1) the diagnosis of pulmonary tuberculosis in patients with a high probability of pulmonary tuberculosis according to their clinical and radiological features; (2) the exclusion of tuberculosis in clinically indeterminate patients for pulmonary tuberculosis; (3) the differentiation of Mycobacterium tuberculsosis (MTB) from nontuberculous mycobacteria in a smear-positive specimen; and (4) the diagnosis of RIF resistance. Standard culture and drug susceptibility tests were used as reference methods. Results The sensitivity of the Xpert assay for MTB detection in category 1 was 89.8% (95% confidence interval [CI], 78.5-95.8%), but 66.7% (95% CI, 12.5-98.2%) in category 2. The positive predictive values ranged from 33.3% (95% CI, 6.0-75.9%) in category 2 to 91.3% and 91.7% in categories 1 and 3, respectively. The negative predictive values were over 90% in all categories. 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author	Huh, Hee Jae
spellingShingle	Huh, Hee Jae misc Mycobacterium tuberculosis misc Pulmonary tuberculosis misc Xpert MTB/RIF assay misc Korea Performance evaluation of the Xpert MTB/RIF assay according to its clinical application
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topic_title	Performance evaluation of the Xpert MTB/RIF assay according to its clinical application Mycobacterium tuberculosis (dpeaa)DE-He213 Pulmonary tuberculosis (dpeaa)DE-He213 Xpert MTB/RIF assay (dpeaa)DE-He213 Korea (dpeaa)DE-He213
topic	misc Mycobacterium tuberculosis misc Pulmonary tuberculosis misc Xpert MTB/RIF assay misc Korea
topic_unstemmed	misc Mycobacterium tuberculosis misc Pulmonary tuberculosis misc Xpert MTB/RIF assay misc Korea
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title	Performance evaluation of the Xpert MTB/RIF assay according to its clinical application
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title_full	Performance evaluation of the Xpert MTB/RIF assay according to its clinical application
author_sort	Huh, Hee Jae
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author_browse	Huh, Hee Jae Jeong, Byeong-Ho Jeon, Kyeongman Koh, Won-Jung Ki, Chang-Seok Lee, Nam Yong
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title_sort	performance evaluation of the xpert mtb/rif assay according to its clinical application
title_auth	Performance evaluation of the Xpert MTB/RIF assay according to its clinical application
abstract	Background The Xpert MTB/RIF assay (Xpert assay; Cepheid, Sunnyvale, CA) is becoming the test of choice for the rapid diagnosis of tuberculosis and rifampin (RIF) resistance. The aim of this study was to evaluate the performance of the Xpert assay with respect to its clinical application at a tertiary care hospital in Korea, a country with an intermediate tuberculosis burden and high-resource. Methods A total of 303 Xpert assay results from 109 smear-positive and 194 smear-negative respiratory specimens were retrospectively reviewed. Based on patients’ medical records, four categories of clinical applications of the Xpert assay were identified: (1) the diagnosis of pulmonary tuberculosis in patients with a high probability of pulmonary tuberculosis according to their clinical and radiological features; (2) the exclusion of tuberculosis in clinically indeterminate patients for pulmonary tuberculosis; (3) the differentiation of Mycobacterium tuberculsosis (MTB) from nontuberculous mycobacteria in a smear-positive specimen; and (4) the diagnosis of RIF resistance. Standard culture and drug susceptibility tests were used as reference methods. Results The sensitivity of the Xpert assay for MTB detection in category 1 was 89.8% (95% confidence interval [CI], 78.5-95.8%), but 66.7% (95% CI, 12.5-98.2%) in category 2. The positive predictive values ranged from 33.3% (95% CI, 6.0-75.9%) in category 2 to 91.3% and 91.7% in categories 1 and 3, respectively. The negative predictive values were over 90% in all categories. The Xpert assay correctly detected RIF resistance in six of the seven (85.7%) isolates tested. Conclusions The Xpert assay exhibited variable performance according to its clinical application; this finding cautions that careful interpretation for the results of this assay would be needed according to its intended purpose. © Huh et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (
abstractGer	Background The Xpert MTB/RIF assay (Xpert assay; Cepheid, Sunnyvale, CA) is becoming the test of choice for the rapid diagnosis of tuberculosis and rifampin (RIF) resistance. The aim of this study was to evaluate the performance of the Xpert assay with respect to its clinical application at a tertiary care hospital in Korea, a country with an intermediate tuberculosis burden and high-resource. Methods A total of 303 Xpert assay results from 109 smear-positive and 194 smear-negative respiratory specimens were retrospectively reviewed. Based on patients’ medical records, four categories of clinical applications of the Xpert assay were identified: (1) the diagnosis of pulmonary tuberculosis in patients with a high probability of pulmonary tuberculosis according to their clinical and radiological features; (2) the exclusion of tuberculosis in clinically indeterminate patients for pulmonary tuberculosis; (3) the differentiation of Mycobacterium tuberculsosis (MTB) from nontuberculous mycobacteria in a smear-positive specimen; and (4) the diagnosis of RIF resistance. Standard culture and drug susceptibility tests were used as reference methods. Results The sensitivity of the Xpert assay for MTB detection in category 1 was 89.8% (95% confidence interval [CI], 78.5-95.8%), but 66.7% (95% CI, 12.5-98.2%) in category 2. The positive predictive values ranged from 33.3% (95% CI, 6.0-75.9%) in category 2 to 91.3% and 91.7% in categories 1 and 3, respectively. The negative predictive values were over 90% in all categories. The Xpert assay correctly detected RIF resistance in six of the seven (85.7%) isolates tested. Conclusions The Xpert assay exhibited variable performance according to its clinical application; this finding cautions that careful interpretation for the results of this assay would be needed according to its intended purpose. © Huh et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (
abstract_unstemmed	Background The Xpert MTB/RIF assay (Xpert assay; Cepheid, Sunnyvale, CA) is becoming the test of choice for the rapid diagnosis of tuberculosis and rifampin (RIF) resistance. The aim of this study was to evaluate the performance of the Xpert assay with respect to its clinical application at a tertiary care hospital in Korea, a country with an intermediate tuberculosis burden and high-resource. Methods A total of 303 Xpert assay results from 109 smear-positive and 194 smear-negative respiratory specimens were retrospectively reviewed. Based on patients’ medical records, four categories of clinical applications of the Xpert assay were identified: (1) the diagnosis of pulmonary tuberculosis in patients with a high probability of pulmonary tuberculosis according to their clinical and radiological features; (2) the exclusion of tuberculosis in clinically indeterminate patients for pulmonary tuberculosis; (3) the differentiation of Mycobacterium tuberculsosis (MTB) from nontuberculous mycobacteria in a smear-positive specimen; and (4) the diagnosis of RIF resistance. Standard culture and drug susceptibility tests were used as reference methods. Results The sensitivity of the Xpert assay for MTB detection in category 1 was 89.8% (95% confidence interval [CI], 78.5-95.8%), but 66.7% (95% CI, 12.5-98.2%) in category 2. The positive predictive values ranged from 33.3% (95% CI, 6.0-75.9%) in category 2 to 91.3% and 91.7% in categories 1 and 3, respectively. The negative predictive values were over 90% in all categories. The Xpert assay correctly detected RIF resistance in six of the seven (85.7%) isolates tested. Conclusions The Xpert assay exhibited variable performance according to its clinical application; this finding cautions that careful interpretation for the results of this assay would be needed according to its intended purpose. © Huh et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (
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title_short	Performance evaluation of the Xpert MTB/RIF assay according to its clinical application
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Performance evaluation of the Xpert MTB/RIF assay according to its clinical application

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