Rapid Molecular Detection of Tuberculosis and Rifampin Resistance
By C. Boehme, P. Nabeta, D. Hillemann, M. Nicol, S. Shenai, F. Krapp, J. Allen, Rasim Tahirli, R. Blakemore, R. Rustomjee and 9 more. New England Journal of Medicine, 2010
2,407 citations recorded by the source corpus.
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.)
Subfields: Infectious Diseases, Media Technology, Surgery
View Paper: https://www.semanticscholar.org/paper/d935388f0cf741f6d4acba36efbca5a16aefa585
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Citations in the corpus
- Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children (2017, methodology): “These assays are promising, but are not yet commercially available [146, 159, 160].”
- The immune response in tuberculosis. (2013, background): “tuberculosis and rifampicin resistance that gives a result within hours (33).”
- Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry: a Fundamental Shift in the Routine Practice of Clinical Microbiology (2013, methodology): “tuberculosis directly from clinical specimens (149), but rapid detection of other species from colonies is common, though not all inclusive, via GenProbe methods (150, 151).”
- WHO guidelines for the programmatic management of drug-resistant tuberculosis: 2011 update (2011, background): “This is an important consideration given that access to Xpert MTB/RIF is expected to expand substantially in low resource countries(17).”
- Current Nucleic Acid Extraction Methods and Their Implications to Point-of-Care Diagnostics (2017, methodology): “(4) Microfluidics and “lab-on-a-chip” cartridges DNA, RNA Sensitive and specific Incompatibility of common NAE chemicals [80]”
- HIV and Tuberculosis: a Deadly Human Syndemic (2011, methodology): “In South African study populations with HIV prevalence rates of 71 to 76%, Xpert MTB/RIF testing of three sputum samples (one direct and two concentrated) has a sensitivity of greater than 95% for all culture-positive TB cases, with 99 to 100% sensitivity for smear-positive, culture-positive TB; 87 ”