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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 terti...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4247199/ https://www.ncbi.nlm.nih.gov/pubmed/25395048 http://dx.doi.org/10.1186/s12879-014-0589-x |
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author | Huh, Hee Jae Jeong, Byeong-Ho Jeon, Kyeongman Koh, Won-Jung Ki, Chang-Seok Lee, Nam Yong |
author_facet | Huh, Hee Jae Jeong, Byeong-Ho Jeon, Kyeongman Koh, Won-Jung Ki, Chang-Seok Lee, Nam Yong |
author_sort | Huh, Hee Jae |
collection | PubMed |
description | 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12879-014-0589-x) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4247199 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-42471992014-11-29 Performance evaluation of the Xpert MTB/RIF assay according to its clinical application Huh, Hee Jae Jeong, Byeong-Ho Jeon, Kyeongman Koh, Won-Jung Ki, Chang-Seok Lee, Nam Yong BMC Infect Dis Research Article 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12879-014-0589-x) contains supplementary material, which is available to authorized users. BioMed Central 2014-11-14 /pmc/articles/PMC4247199/ /pubmed/25395048 http://dx.doi.org/10.1186/s12879-014-0589-x Text en © 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 (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article Huh, Hee Jae Jeong, Byeong-Ho Jeon, Kyeongman Koh, Won-Jung Ki, Chang-Seok Lee, Nam Yong Performance evaluation of the Xpert MTB/RIF assay according to its clinical application |
title | Performance evaluation of the Xpert MTB/RIF assay according to its clinical application |
title_full | Performance evaluation of the Xpert MTB/RIF assay according to its clinical application |
title_fullStr | Performance evaluation of the Xpert MTB/RIF assay according to its clinical application |
title_full_unstemmed | Performance evaluation of the Xpert MTB/RIF assay according to its clinical application |
title_short | Performance evaluation of the Xpert MTB/RIF assay according to its clinical application |
title_sort | performance evaluation of the xpert mtb/rif assay according to its clinical application |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4247199/ https://www.ncbi.nlm.nih.gov/pubmed/25395048 http://dx.doi.org/10.1186/s12879-014-0589-x |
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