Implementation of GenoType MTBDRplus Reduces Time to Multidrug-Resistant Tuberculosis Therapy Initiation in South Africa

Jacobson, Karen R; Theron, Danie; Kendall, Emily A.; Franke, Molly F.; Barnard, Marinus; Helden, Paul D. van; Victor, Tommie C.; Streicher, Elizabeth M.; Murray, Megan; Warren, Robin M.

doi:10.1093/cid/cis920

Cited by 79 publications

(89 citation statements)

References 16 publications

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“…Molecular methods offer fast accurate detection of resistance mutations by line probe assays, DNA sequencing, or multiplex (real-time) PCR assays. One of the few commercially available tests is the Genotype MTBDRplus assay (Hain Lifescience GmbH, Germany), which was endorsed by the World Health Organization (WHO) in 2008 and was recently extended for the detection of second-line drug resistance mutations (Genotype MTBDRsl) (4)(5)(6)(7)(8). The more recently endorsed Xpert MTB/RIF assay (Cepheid, USA) facilitates rapid detection of the M. tuberculosis complex (9) but is limited to detection of rifampin resistance mutations in rpoB (10,11).…”

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confidence: 99%

Evaluation of the AID TB Resistance Line Probe Assay for Rapid Detection of Genetic Alterations Associated with Drug Resistance in Mycobacterium tuberculosis Strains

et al. 2014

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cThe rapid accurate detection of drug resistance mutations in Mycobacterium tuberculosis is essential for optimizing the treatment of tuberculosis and limiting the emergence and spread of drug-resistant strains. The TB Resistance line probe assay from Autoimmun Diagnostika GmbH (AID) (Strassburg, Germany) was designed to detect the most prevalent mutations that confer resistance to isoniazid, rifampin, streptomycin, amikacin, capreomycin, fluoroquinolones, and ethambutol. This assay detected resistance mutations in clinical M. tuberculosis isolates from areas with low and high levels of endemicity (Switzerland, n ‫؍‬ 104; South Africa, n ‫؍‬ 52) and in selected Mycobacterium bovis BCG 1721 mutant strains (n ‫؍‬ 5) with 100% accuracy. Subsequently, the line probe assay was shown to be capable of rapid genetic assessment of drug resistance in MGIT broth cultures, the results of which were in 100% agreement with those of DNA sequencing and phenotypic drug susceptibility testing. Finally, the line probe assay was assessed for direct screening of smear-positive clinical specimens. Screening of 98 clinical specimens demonstrated that the test gave interpretable results for >95% of them. Antibiotic resistance mutations detected in the clinical samples were confirmed by DNA sequencing. We conclude that the AID TB Resistance line probe assay is an accurate tool for the rapid detection of resistance mutations in cultured isolates and in smear-positive clinical specimens.

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Evaluation of the AID TB Resistance Line Probe Assay for Rapid Detection of Genetic Alterations Associated with Drug Resistance in Mycobacterium tuberculosis Strains

et al. 2014

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“…These systems offer benefits such as reduced time to detect resistance (from effectively 106 days with conventional DST to 20 days with line-probe assay and less than 1 day with the Xpert MTB/RIF assay), [57] thus allowing for more rapid initiation of MDR tuberculosis treatment [58][59][60]. Liquid culture and line-probe assays can be implemented in national and regional reference laboratories, and the Xpert MTB/RIF assay (an automated, cartridge-based, real-time PCR assay) in more peripheral sites such as sub-district laboratories.…”

Section: Phenotypic Methodsmentioning

confidence: 99%

“…One option for a peripheral laboratory test is to focus on excluding all patients who are likely to be resistant; high sensitivity becomes the goal and specificity becomes less important. A test with lower specificity can be acceptable if the prevalence of resistance is high, if an effective and safe alternative regimen (e.g., 2HRZE/4RH for PaMZ) is available, or if used as a triage test [15,33,34,59]. …”

Section: Future Challengesmentioning

confidence: 99%

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Anti-Tuberculous Drugs and Susceptibility Testing Methods: Current Knowledge and Future Challenges

Alqahtani¹

2013

J Mycobac Dis

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The emergence of multi-drug resistant tuberculosis (MDR-TB) outbreaks during 1990s and more recently the highly lethal strains of extensively drug-resistant TB (XDR-TB) is hampering efforts to control and manage tuberculosis (TB), and also threatening World Health Organization's target of TB elimination by 2050. The TB community has promoted a full pipeline of candidate for the new TB drugs at all phases of development. The majority of candidates are in preclinical and early clinical development. The challenge of conducting these trials, especially that they will be conducted in resource-poor locations with limited infrastructure or trials experience will be considerable. New tuberculosis drug regimens are creating new priorities for drug susceptibility testing (DST) and surveillance. To minimize turnaround time, rapid and sensitive DST will need to be prioritized, but developers of these assays will need better data about the molecular mechanisms of drug resistance. Investment to develop costeffective and robust DST methods for peripheral laboratories or to create rapid, reliable sample transport systems to support centralized DST is questionable. Optimization of treatment regimens together with rapid diagnosis and DST for first-and second-line drugs as well as newer TB drugs, will greatly improve the prognosis and clinical outcome of TB patients.

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“…In 2008, the World Health Organization (WHO) recommended that rapid DST with PCR-based techniques should be considered when diagnosing TB [11,13]. The GenoType MTBDRplus assay (Hain Lifescience GmbH, Nehren, Germany) has already been endorsed by WHO for detecting rifampicin and isoniazid resistance [11,14,15]. Although the GenoType MTBDRsl assay (Hain Lifescience GmbH) was developed for detecting fluoroquinolone, amikacin/capreomycin, and ethambutol resistance, the usefulness of this assay in detecting XDR-TB has not been clarified in clinical practice [16,17].…”

Section: Introductionmentioning

confidence: 99%

Performance of REBA MTB-XDR to detect extensively drug-resistant tuberculosis in an intermediate-burden country

Lee

Kang

Jung

et al. 2015

Journal of Infection and Chemotherapy

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Implementation of GenoType MTBDRplus Reduces Time to Multidrug-Resistant Tuberculosis Therapy Initiation in South Africa

Cited by 79 publications

References 16 publications

Evaluation of the AID TB Resistance Line Probe Assay for Rapid Detection of Genetic Alterations Associated with Drug Resistance in Mycobacterium tuberculosis Strains

Evaluation of the AID TB Resistance Line Probe Assay for Rapid Detection of Genetic Alterations Associated with Drug Resistance in Mycobacterium tuberculosis Strains

Anti-Tuberculous Drugs and Susceptibility Testing Methods: Current Knowledge and Future Challenges

Performance of REBA MTB-XDR to detect extensively drug-resistant tuberculosis in an intermediate-burden country

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