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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Rapid molecular detection of tuberculosis and rifampin resistance
New England Journal of Medicine, Volume 363, No. 11, Year 2010
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Description
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.). Copyright © 2010 Massachusetts Medical Society.
Authors & Co-Authors
Boehme, Catharina C.
Switzerland, Geneva
Foundation for Innovative new Diagnostics, Switzerland
Nabeta, Pamela
Switzerland, Geneva
Foundation for Innovative new Diagnostics, Switzerland
Hillemann, Doris
Germany, Borstel
Forschungszentrum Borstel - Zentrum Für Medizin Und Biowissenschaften
Nicol, Mark P.
South Africa, Cape Town
University of Cape Town
Shenai, Shubhada V.
India, Mumbai
P.d. Hinduja National Hospital and Medical Research Centre
Krapp, Fiorella
Peru, Lima
Universidad Peruana Cayetano Heredia, Instituto de Medicina Tropical Alexander Von Humboldt
Allen, Jenny
South Africa, Tygerberg
South African Medical Research Council
Tahirli, Rasim
Azerbaijan, Baku
Special Treatment Institution
Blakemore, Robert
United States, Newark
Rutgers new Jersey Medical School
Rustomjee, Roxana
South Africa, Tygerberg
South African Medical Research Council
Milovic, Ana
South Africa, Cape Town
University of Cape Town
Jones, Martin
United States, Sunnyvale
Cepheid
O'Brien, Sean Michael
United States, Durham
Duke University Medical Center
Persing, David H.
United States, Sunnyvale
Cepheid
Rüsch-Gerdes, Sabine
Germany, Borstel
Forschungszentrum Borstel - Zentrum Für Medizin Und Biowissenschaften
Gotuzzo, Eduardo H.
Peru, Lima
Universidad Peruana Cayetano Heredia, Instituto de Medicina Tropical Alexander Von Humboldt
Rodrigues, Camilla S.
India, Mumbai
P.d. Hinduja National Hospital and Medical Research Centre
Alland, David
United States, Newark
Rutgers new Jersey Medical School
Perkins, Mark D.
Switzerland, Geneva
Foundation for Innovative new Diagnostics, Switzerland
Statistics
Citations: 2,237
Authors: 19
Affiliations: 10
Identifiers
Doi:
10.1056/NEJMoa0907847
ISSN:
00284793
e-ISSN:
15334406
Study Locations
South Africa