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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Rapid and accurate detection of Mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF Assay-A clinical validation study
PLoS ONE, Volume 6, No. 6, Article e20458, Year 2011
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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. © 2011 Rachow et al. 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 credited.
Authors & Co-Authors
Rachow, Andrea
Germany, Munich
Klinikum Der Universität München
Tanzania
National Institute of Medical Research-mbeya Medical Research Programme
Zumla, A. I.
United Kingdom, London
Ucl Medical School
Heinrich, Norbert
Germany, Munich
Klinikum Der Universität München
Rojas-Ponce, Gabriel
Tanzania
National Institute of Medical Research-mbeya Medical Research Programme
Mtafya, Bariki A.
Tanzania
National Institute of Medical Research-mbeya Medical Research Programme
Reither, Klaus
Germany, Munich
Klinikum Der Universität München
Switzerland, Allschwil
Swiss Tropical and Public Health Institute Swiss Tph
Ntinginya, Elias N.
Tanzania
National Institute of Medical Research-mbeya Medical Research Programme
O'Grady, Justin
United Kingdom, London
Ucl Medical School
Huggett, Jim
United Kingdom, London
Ucl Medical School
Dheda, Keertan U.J.
United Kingdom, London
Ucl Medical School
Boehme, Catharina C.
Switzerland, Geneva
Foundation for Innovative new Diagnostics, Switzerland
Perkins, Mark D.
Switzerland, Geneva
Foundation for Innovative new Diagnostics, Switzerland
Saathoff, Elmar
Germany, Munich
Klinikum Der Universität München
Höelscher, Michael
Germany, Munich
Klinikum Der Universität München
Statistics
Citations: 181
Authors: 14
Affiliations: 5
Identifiers
Doi:
10.1371/journal.pone.0020458
e-ISSN:
19326203
Research Areas
Health System And Policy
Infectious Diseases
Study Locations
Tanzania