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

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          Abstract

          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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          The HIV-associated tuberculosis epidemic--when will we act?

          Anthony D. Harries, Rony Zachariah, Elizabeth L. Corbett … (2010)
          Despite policies, strategies, and guidelines, the epidemic of HIV-associated tuberculosis continues to rage, particularly in southern Africa. We focus our attention on the regions with the greatest burden of disease, especially sub-Saharan Africa, and concentrate on prevention of tuberculosis in people with HIV infection, a challenge that has been greatly neglected. We argue for a much more aggressive approach to early diagnosis and treatment of HIV infection in affected communities, and propose urgent assessment of frequent testing for HIV and early start of antiretroviral treatment (ART). This approach should result in short-term and long-term declines in tuberculosis incidence through individual immune reconstitution and reduced HIV transmission. Implementation of the 3Is policy (intensified tuberculosis case finding, infection control, and isoniazid preventive therapy) for prevention of HIV-associated tuberculosis, combined with earlier start of ART, will reduce the burden of tuberculosis in people with HIV infection and provide a safe clinical environment for delivery of ART. Some progress is being made in provision of HIV care to HIV-infected patients with tuberculosis, but too few receive co-trimoxazole prophylaxis and ART. We make practical recommendations about how to improve this situation. Early HIV diagnosis and treatment, the 3Is, and a comprehensive package of HIV care, in association with directly observed therapy, short-course (DOTS) for tuberculosis, form the basis of prevention and control of HIV-associated tuberculosis. This call to action recommends that both HIV and tuberculosis programmes exhort implementation of strategies that are known to be effective, and test innovative strategies that could work. The continuing HIV-associated tuberculosis epidemic needs bold but responsible action, without which the future will simply mirror the past. Copyright 2010 Elsevier Ltd. All rights reserved.
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            Evidence-Based Tuberculosis Diagnosis

            Madhukar Pai, Andrew Ramsay, Richard O'Brien (2008)
            Madhukar Pai and colleagues discuss how systematic reviews on tuberculosis diagnostics can influence research, policy, and clinical practice.
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              Impact and Cost-Effectiveness of Culture for Diagnosis of Tuberculosis in HIV-Infected Brazilian Adults

              David Dowdy, Maria C. S. Lourenço, Solange Cavalcante … (2008)
              Background Culture of Mycobacterium tuberculosis currently represents the closest “gold standard” for diagnosis of tuberculosis (TB), but operational data are scant on the impact and cost-effectiveness of TB culture for human immunodeficiency (HIV-) infected individuals in resource-limited settings. Methodology/Principal Findings We recorded costs, laboratory results, and dates of initiating TB therapy in a centralized TB culture program for HIV-infected patients in Rio de Janeiro, Brazil, constructing a decision-analysis model to estimate the incremental cost-effectiveness of TB culture from the perspective of a public-sector TB control program. Of 217 TB suspects presenting between January 2006 and March 2008, 33 (15%) had culture-confirmed active tuberculosis; 23 (70%) were smear-negative. Among smear-negative, culture-positive patients, 6 (26%) began TB therapy before culture results were available, 11 (48%) began TB therapy after culture result availability, and 6 (26%) did not begin TB therapy within 180 days of presentation. The cost per negative culture was US$17.52 (solid media)–$23.50 (liquid media). Per 1,000 TB suspects and compared with smear alone, TB culture with solid media would avert an estimated eight TB deaths (95% simulation interval [SI]: 4, 15) and 37 disability-adjusted life years (DALYs) (95% SI: 13, 76), at a cost of $36 (95% SI: $25, $50) per TB suspect or $962 (95% SI: $469, $2642) per DALY averted. Replacing solid media with automated liquid culture would avert one further death (95% SI: −1, 4) and eight DALYs (95% SI: −4, 23) at $2751 per DALY (95% SI: $680, dominated). The cost-effectiveness of TB culture was more sensitive to characteristics of the existing TB diagnostic system than to the accuracy or cost of TB culture. Conclusions/Significance TB culture is potentially effective and cost-effective for HIV-positive patients in resource-constrained settings. Reliable transmission of culture results to patients and integration with existing systems are essential.
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                Author and article information

                Contributors
                : Role: Editor
                Journal
                Journal ID (nlm-ta): PLoS One
                Journal ID (publisher-id): plos
                Journal ID (pmc): plosone
                Title: PLoS ONE
                Publisher: Public Library of Science (San Francisco, USA )
                ISSN (Electronic): 1932-6203
                Publication date Collection: 2011
                Publication date (Electronic): 29 June 2011
                Volume: 6
                Issue: 6
                Electronic Location Identifier: e20458
                Affiliations
                [1 ]Division of Infectious Diseases and Tropical Medicine, Medical Center of the University of Munich (LMU), Munich, Germany
                [2 ]National Institute of Medical Research—Mbeya Medical Research Programme, Mbeya, Tanzania
                [3 ]Department of Infection, Windeyer Institute of Medical Sciences, University College London Medical School, London, United Kingdom
                [4 ]Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland
                [5 ]Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland
                New York State Health Department and University at Albany, United States of America
                Author notes

                Conceived and designed the experiments: AR NH KR ES MH JH. Performed the experiments: AR GR-P BM KR ENN. Analyzed the data: AR AZ ES MH. Contributed reagents/materials/analysis tools: CB MP ES JO KD. Wrote the paper: AR AZ NH KR ES MH. Critical appraisal of the manuscript: AR AZ NH GR-P BM KR ENN JO JH KD CB MP ES MH. Finalized the manuscript: AR AZ MH.

                Article
                Publisher ID: PONE-D-11-04517
                DOI: 10.1371/journal.pone.0020458
                PMC ID: 3126807
                PubMed ID: 21738575
                SO-VID: ef493b7e-3e6c-41df-8531-f4091458af37
                Copyright © 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.
                History
                Date received : 5 March 2011
                Date accepted : 21 April 2011
                Page count
                Pages: 8
                Categories
                Subject: Research Article
                Subject: Medicine
                Subject: Diagnostic Medicine
                Subject: Pathology
                Subject: Clinical Pathology
                Subject: Clinical Microbiology
                Subject: Test Evaluation
                Subject: Infectious Diseases
                Subject: Tropical Diseases (Non-Neglected)
                Subject: Tuberculosis
                Subject: Infectious Disease Control
                Subject: Pulmonology
                Subject: Respiratory Infections

                ScienceOpen disciplines: Uncategorized
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                ScienceOpen disciplines: Uncategorized

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