Cited by 2,309Tuberculosis Research and EpidemiologyInfectious Diseases and TuberculosisMycobacterium research and diagnosis

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Rapid Molecular Detection of Tuberculosis and Rifampin Resistance

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Boehme, Catharina C., Nabeta, Pamela, Hillemann, Doris, Nicol, Mark P., Shenai, Shubhada, Krapp, Fiorella, Allen, Jenny, Tahirli, Rasim, Blakemore, Robert, Rustomjee, Roxana, Milovic, Ana, Jones, Martin, O'Brien, Sean M., Persing, David H., Ruesch-Gerdes, Sabine, Gotuzzo, Eduardo, Rodrigues, Camilla, Alland, David, Perkins, Mark D.·2010·New England Journal of Medicine

DOI 10.1056/nejmoa0907847PMC PMC2947799

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Abstract

BACKGROUND: Global control of tuberculosis is hampered by slow, insensitive diagnostic methods, particularly for the detection of drug-resistant forms and in patients with human immunodeficiency virus infection. Early detection is essential to reduce the death rate and interrupt transmission, but the complexity and infrastructure needs of sensitive methods limit their accessibility and effect. METHODS: We assessed the performance of Xpert MTB/RIF, an automated molecular test for Mycobacterium tuberculosis (MTB) and resistance to rifampin (RIF), with fully integrated sample processing in 1730 patients with suspected drug-sensitive or multidrug-resistant pulmonary tuberculosis. Eligible patients in Peru, Azerbaijan, South Africa, and India provided three sputum specimens each. Two specimens were processed with N-acetyl-L-cysteine and sodium hydroxide before microscopy, solid and liquid culture, and the MTB/RIF test, and one specimen was used for direct testing with microscopy and the MTB/RIF test. RESULTS: Among culture-positive patients, a single, direct MTB/RIF test identified 551 of 561 patients with smear-positive tuberculosis (98.2%) and 124 of 171 with smear-negative tuberculosis (72.5%). The test was specific in 604 of 609 patients without tuberculosis (99.2%). Among patients with smear-negative, culture-positive tuberculosis, the addition of a second MTB/RIF test increased sensitivity by 12.6 percentage points and a third by 5.1 percentage points, to a total of 90.2%. As compared with phenotypic drug-susceptibility testing, MTB/RIF testing correctly identified 200 of 205 patients (97.6%) with rifampin-resistant bacteria and 504 of 514 (98.1%) with rifampin-sensitive bacteria. Sequencing resolved all but two cases in favor of the MTB/RIF assay. CONCLUSIONS: The MTB/RIF test provided sensitive detection of tuberculosis and rifampin resistance directly from untreated sputum in less than 2 hours with minimal hands-on time. (Funded by the Foundation for Innovative New Diagnostics.)

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Authors: Boehme, C. C., Nabeta, P., Hillemann, D., Nicol, M. P., Shenai, S., Krapp, F., Allen, J., Tahirli, R., Blakemore, R., Rustomjee, R., Milovic, A., Jones, M., O'Brien, S. M., Persing, D. H., Ruesch-Gerdes, S., Gotuzzo, E., Rodrigues, C., Alland, D., & Perkins, M. D.
Affiliations: FIND (CH)
Research Center Borstel - Leibniz Lung Center (DE)
National Health Laboratory Service (ZA)
Universidad Peruana Cayetano Heredia (PE)
South African Medical Research Council (ZA)
Rutgers New Jersey Medical School (US)
Cepheid (United States) (US)
ORCID: Boehme, Catharina C.
Nabeta, Pamela
Hillemann, Doris
Nicol, Mark P.
Shenai, Shubhada
Krapp, Fiorella
Milovic, Ana
Gotuzzo, Eduardo
Rodrigues, Camilla
Alland, David
Perkins, Mark D.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2010-09-09
Volume: 363
Issue: 11
Pages: 1005-1015
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa0907847
PMC: PMC2947799
OpenAlex: W2154326381
Cited by: 2,309
References: 26
Citations by year: 2026: 72 · 2025: 92 · 2024: 70 · 2023: 68 · 2022: 99 · 2021: 128 · 2020: 119 · 2019: 136 · 2018: 154 · 2017: 169 · 2016: 154 · 2015: 176 · 2014: 184 · 2013: 195 · 2012: 226
FWCI: 140.91
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Rutgers University Community Repository (Rutgers University) (submittedVersion)
Universidad Peruana Cayetano Heredia Institutional Repository (submittedVersion, cc-by-nc-nd)
Funders: National Institute of Allergy and Infectious Diseases (R41AI052523, R01AI080653, R42AI052523, AI52523)
Topics: Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
Health Sciences › Medicine › Infectious Diseases › Infectious Diseases and Tuberculosis
Health Sciences › Medicine › Epidemiology › Mycobacterium research and diagnosis
Keywords: Xpert MTB/RIF, tuberculosis diagnosis, rifampicin resistance, multidrug-resistant tuberculosis, Mycobacterium tuberculosis, rapid molecular detection, sputum examination, smear-negative tuberculosis, drug susceptibility testing, HIV coinfection, Peru, Azerbaijan, South Africa, India
MeSH terms: Adolescent, Adult, Aged, Aged, 80 and over, Antitubercular Agents, Bacterial Proteins, Female, Humans, Male, Microbial Sensitivity Tests, Middle Aged, Mycobacterium tuberculosis, Prospective Studies, Reference Standards, Rifampin, DNA-Directed RNA Polymerases, Sensitivity and Specificity, Sputum, Tuberculosis, Polymerase Chain Reaction, Tuberculosis, Multidrug-Resistant, Drug Resistance, Bacterial, Young Adult

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