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Rapid and Accurate Detection of Mycobacterium tuberculosis in Sputum Samples by Cepheid Xpert MTB/RIF Assay—A Clinical Validation Study

BACKGROUND: A crucial impediment to global tuberculosis control is the lack of an accurate, rapid diagnostic test for detection of patients with active TB. A new, rapid diagnostic method, (Cepheid) Xpert MTB/RIF Assay, is an automated sample preparation and real-time PCR instrument, which was shown...

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Autores principales: Rachow, Andrea, Zumla, Alimuddin, Heinrich, Norbert, Rojas-Ponce, Gabriel, Mtafya, Bariki, Reither, Klaus, Ntinginya, Elias N., O'Grady, Justin, Huggett, Jim, Dheda, Keertan, Boehme, Catharina, Perkins, Mark, Saathoff, Elmar, Hoelscher, Michael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3126807/
https://www.ncbi.nlm.nih.gov/pubmed/21738575
http://dx.doi.org/10.1371/journal.pone.0020458
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author Rachow, Andrea
Zumla, Alimuddin
Heinrich, Norbert
Rojas-Ponce, Gabriel
Mtafya, Bariki
Reither, Klaus
Ntinginya, Elias N.
O'Grady, Justin
Huggett, Jim
Dheda, Keertan
Boehme, Catharina
Perkins, Mark
Saathoff, Elmar
Hoelscher, Michael
author_facet Rachow, Andrea
Zumla, Alimuddin
Heinrich, Norbert
Rojas-Ponce, Gabriel
Mtafya, Bariki
Reither, Klaus
Ntinginya, Elias N.
O'Grady, Justin
Huggett, Jim
Dheda, Keertan
Boehme, Catharina
Perkins, Mark
Saathoff, Elmar
Hoelscher, Michael
author_sort Rachow, Andrea
collection PubMed
description BACKGROUND: A crucial impediment to global tuberculosis control is the lack of an accurate, rapid diagnostic test for detection of patients with active TB. A new, rapid diagnostic method, (Cepheid) Xpert MTB/RIF Assay, is an automated sample preparation and real-time PCR instrument, which was shown to have good potential as an alternative to current reference standard sputum microscopy and culture. METHODS: We performed a clinical validation study on diagnostic accuracy of the Xpert MTB/RIF Assay in a TB and HIV endemic setting. Sputum samples from 292 consecutively enrolled adults from Mbeya, Tanzania, with suspected TB were subject to analysis by the Xpert MTB/RIF Assay. The diagnostic performance of Xpert MTB/RIF Assay was compared to standard sputum smear microscopy and culture. Confirmed Mycobacterium tuberculosis in a positive culture was used as a reference standard for TB diagnosis. RESULTS: Xpert MTB/RIF Assay achieved 88.4% (95%CI = 78.4% to 94.9%) sensitivity among patients with a positive culture and 99% (95%CI = 94.7% to 100.0%) specificity in patients who had no TB. HIV status did not affect test performance in 172 HIV-infected patients (58.9% of all participants). Seven additional cases (9.1% of 77) were detected by Xpert MTB/RIF Assay among the group of patients with clinical TB who were culture negative. Within 45 sputum samples which grew non-tuberculous mycobacteria the assay's specificity was 97.8% (95%CI = 88.2% to 99.9%). CONCLUSIONS: The Xpert MTB/RIF Assay is a highly sensitive, specific and rapid method for diagnosing TB which has potential to complement the current reference standard of TB diagnostics and increase its overall sensitivity. Its usefulness in detecting sputum smear and culture negative patients needs further study. Further evaluation in high burden TB and HIV areas under programmatic health care settings to ascertain applicability, cost-effectiveness, robustness and local acceptance are required.
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spelling pubmed-31268072011-07-07 Rapid and Accurate Detection of Mycobacterium tuberculosis in Sputum Samples by Cepheid Xpert MTB/RIF Assay—A Clinical Validation Study Rachow, Andrea Zumla, Alimuddin Heinrich, Norbert Rojas-Ponce, Gabriel Mtafya, Bariki Reither, Klaus Ntinginya, Elias N. O'Grady, Justin Huggett, Jim Dheda, Keertan Boehme, Catharina Perkins, Mark Saathoff, Elmar Hoelscher, Michael PLoS One Research Article BACKGROUND: A crucial impediment to global tuberculosis control is the lack of an accurate, rapid diagnostic test for detection of patients with active TB. A new, rapid diagnostic method, (Cepheid) Xpert MTB/RIF Assay, is an automated sample preparation and real-time PCR instrument, which was shown to have good potential as an alternative to current reference standard sputum microscopy and culture. METHODS: We performed a clinical validation study on diagnostic accuracy of the Xpert MTB/RIF Assay in a TB and HIV endemic setting. Sputum samples from 292 consecutively enrolled adults from Mbeya, Tanzania, with suspected TB were subject to analysis by the Xpert MTB/RIF Assay. The diagnostic performance of Xpert MTB/RIF Assay was compared to standard sputum smear microscopy and culture. Confirmed Mycobacterium tuberculosis in a positive culture was used as a reference standard for TB diagnosis. RESULTS: Xpert MTB/RIF Assay achieved 88.4% (95%CI = 78.4% to 94.9%) sensitivity among patients with a positive culture and 99% (95%CI = 94.7% to 100.0%) specificity in patients who had no TB. HIV status did not affect test performance in 172 HIV-infected patients (58.9% of all participants). Seven additional cases (9.1% of 77) were detected by Xpert MTB/RIF Assay among the group of patients with clinical TB who were culture negative. Within 45 sputum samples which grew non-tuberculous mycobacteria the assay's specificity was 97.8% (95%CI = 88.2% to 99.9%). CONCLUSIONS: The Xpert MTB/RIF Assay is a highly sensitive, specific and rapid method for diagnosing TB which has potential to complement the current reference standard of TB diagnostics and increase its overall sensitivity. Its usefulness in detecting sputum smear and culture negative patients needs further study. Further evaluation in high burden TB and HIV areas under programmatic health care settings to ascertain applicability, cost-effectiveness, robustness and local acceptance are required. Public Library of Science 2011-06-29 /pmc/articles/PMC3126807/ /pubmed/21738575 http://dx.doi.org/10.1371/journal.pone.0020458 Text en Rachow et al. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Rachow, Andrea
Zumla, Alimuddin
Heinrich, Norbert
Rojas-Ponce, Gabriel
Mtafya, Bariki
Reither, Klaus
Ntinginya, Elias N.
O'Grady, Justin
Huggett, Jim
Dheda, Keertan
Boehme, Catharina
Perkins, Mark
Saathoff, Elmar
Hoelscher, Michael
Rapid and Accurate Detection of Mycobacterium tuberculosis in Sputum Samples by Cepheid Xpert MTB/RIF Assay—A Clinical Validation Study
title Rapid and Accurate Detection of Mycobacterium tuberculosis in Sputum Samples by Cepheid Xpert MTB/RIF Assay—A Clinical Validation Study
title_full Rapid and Accurate Detection of Mycobacterium tuberculosis in Sputum Samples by Cepheid Xpert MTB/RIF Assay—A Clinical Validation Study
title_fullStr Rapid and Accurate Detection of Mycobacterium tuberculosis in Sputum Samples by Cepheid Xpert MTB/RIF Assay—A Clinical Validation Study
title_full_unstemmed Rapid and Accurate Detection of Mycobacterium tuberculosis in Sputum Samples by Cepheid Xpert MTB/RIF Assay—A Clinical Validation Study
title_short Rapid and Accurate Detection of Mycobacterium tuberculosis in Sputum Samples by Cepheid Xpert MTB/RIF Assay—A Clinical Validation Study
title_sort rapid and accurate detection of mycobacterium tuberculosis in sputum samples by cepheid xpert mtb/rif assay—a clinical validation study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3126807/
https://www.ncbi.nlm.nih.gov/pubmed/21738575
http://dx.doi.org/10.1371/journal.pone.0020458
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