Rapid Molecular Detection of Tuberculosis and Rifampin Resistance
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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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Xpert MTB/RIF is an automated, cartridge-based NAAT for the detection of M. tuberculosis complex and rifampicin drug-resistance from sputum and other specimens, with a turnaround time of less than two hours.
“Xpert® MTB/RIF (Cepheid, Sunnyvale, USA) is an automated, cartridge-based NAAT for the detection of M. tuberculosis complex and rifampicin drug-resistance from sputum and other specimens, with a turnaround time of less than two hours [19, 20].”
From Evaluation of Xpert® MTB/RIF and Ustar EasyNAT™ TB IAD for diagnosis of tuberculous lymphadenitis of children in Tanzania: a prospective descriptive study (2016) · cites this paper as [19]
The Abstract (Conclusions) and Discussion describe an automated, cartridge-based molecular test that detects M. tuberculosis and rifampin resistance from sputum, with results in less than two hours. The Methods describe testing sputum specimens only; our copy does not support the extension to “other specimens.” Page numbers are not available in the indexed copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredPrevious studies reported 98-100% agreement in detection of rifampicin resistance strains using the Xpert test and phenotypic drug susceptibility test.
“Previous studies reported 98–100% agreement in detection of rifampicin resistance strains using the Xpert test and phenotypic drug susceptibility test [13,14,18,26].”
From GeneXpert MTB/RIF Assay for the Diagnosis of Tuberculous Lymphadenitis on Concentrated Fine Needle Aspirates in High Tuberculosis Burden Settings (2015) · cites this paper as [26]
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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
- 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
- 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 › Surgery › 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
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