Diagnostic accuracy of GenoType® MTBDRsl VER 2.0 in detecting second-line drug resistance to M. tuberculosis

Yadav, Rakesh; Saini, Aastha; Kaur, Prabhleen; Behera, Digambar; Sethi, Sunil

doi:10.5588/ijtld.17.0663

Cited by 13 publications

(12 citation statements)

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“…Among the rrs mutations, the most common was rrs MUT1 found in 32 cases, while rrs MUT2 was present in 4 cases. These observations are comparable to the previous studies from India and South Africa [ 6 , 7 ]. We also found the mutations in eis region and the most common was eis MUT2 absent in 15 cases.…”

Section: Discussionsupporting

confidence: 92%

“…The most common mutation detected by Genotype MTBDRsl in FQ-resistant isolates was a change at codon 94. Among codon 94 mutations, the most prominent mutation was gyrA MUT3C in 139 cases, which was comparable to the studies from South Africa, China, and India [6,7,18]. We found the rare gyrA MUT3D mutation in three cases that is absent in most of the studies, including the recent study from China [13].…”

Section: Discussionsupporting

confidence: 85%

“…In our earlier evaluation, we observed a sensitivity and specificity of 97.2% and 99.1%, respectively, for FQ resistance detection by Genotype MTBDRsl Ver 2.0 assay, whereas the sensitivity and specificity for detection of SLID resistance were 89.2-92.5% and 98.5-99.5%, respectively. The detection of extensively drug-resistant TB (XDR TB) was increased compared to the previous version of the assay [7].…”

Section: Introductionmentioning

confidence: 99%

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Second-line Drug Resistance Characterization in Mycobacterium tuberculosis by Genotype MTBDRsl Assay

Sethi¹,

Agarwal²,

Khaneja³

et al. 2020

JEGH

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Tuberculosis (TB) remains a main hurdle for national programs due to increase in drug resistance to antitubercular drugs. World Health Organization (WHO)-endorsed Line Probe Assay, Genotype MTBDRsl Ver 2.0, gives opportunity for rapid diagnosis and molecular characterization of different mutations in drug targets of fluoroquinolone (FQ) and second-line injectable drugs (SLID). We, retrospectively, analyzed the data of Genotype MTBDRsl Ver 2.0 from January 2018 to June 2018. A total of 863 isolates of Mycobacterium tuberculosis, 687 rifampicin resistant and 176 isoniazid resistant only, were screened for drug resistance in FQ and SLID. All the isolates were tested for Genotype MTBDRsl Ver 2.0 according to the manufacturer's instructions. The FQ and SLID resistance were detected in 295 (34.2%) and 70 (8.1%) isolates, respectively. Among newly diagnosed and followup rifampicin-resistant TB (RR TB) patients, the FQ resistance was 25.8% and 44.5%, respectively. The most common mutation (42.7%) in FQ-resistant isolates was MUT3C in gyrA gene. Both SLID and FQ resistance were detected in 59 (6.8%) RR TB isolates. The mono SLID resistance was detected in 12 (1.7%) isolates of RR TB. Genotype MTBDRsl Ver 2.0 assay is a rapid and important tool for the diagnosis and molecular characterization of second-line drug resistance under programmatic conditions.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 85%

Section: Introductionmentioning

confidence: 99%

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Second-line Drug Resistance Characterization in Mycobacterium tuberculosis by Genotype MTBDRsl Assay

Sethi¹,

Agarwal²,

Khaneja³

et al. 2020

JEGH

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“…Notwithstanding the fact that genotypic drug susceptibility testing has a high sensitivity and specificity but is still unable to detect all the resistance, especially in strains with novel or unknown resistance mechanisms [ 40 , 41 ]. In this review, 49 isolates with confirmed phenotypic RIF-resistance do not harbor any known mutation in the rpoB gene, which may be explained by the fact that RIF resistance-conferring mutations are present elsewhere in the rpoB gene (such as a V146F and I572F) [ 42 , 43 ], suggesting that the nature and frequency of mutations in the rpoB gene vary considerably, between different geographical regions [ 44 ], by the fact that not all the mutations are targeted by the probes used [ 45 ], or as it has been reported that molecular assays still have some drawbacks, such as product cross contamination which is a major problem leading to false positive results [ 20 ].…”

Section: Discussionmentioning

confidence: 99%

Mutations Associated with Rifampicin Resistance in Mycobacterium tuberculosis Isolates from Moroccan Patients: Systematic Review

Eddabra

Neffa²

2020

Interdisciplinary Perspectives on Infectious Diseases

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Background. In recent years, the treatment of tuberculosis has been threatened by the increasing number of patients with drug resistance, especially rifampicin resistance, which is the most effective first-line antibiotic against Mycobacterium tuberculosis. Methods. We performed a systematic review of the literature by searching the PubMed database for studies of rifampicin-resistant Mycobacterium tuberculosis (MTB) isolates from Moroccan patients, published between 2010 and 2020. The aim of this review was to quantify the frequency of the most common mutations associated with rifampicin resistance, to describe the frequency at which these mutations co-occur. Identified studies were critically appraised according to the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. Results. 6 studies met our inclusion criteria. Results show that 99.36% of MTB isolates had a single-point mutation, and the most commonly mutated codon of rpoB gene is 531 with 70.33% of phenotypically resistant strains. However, 10.38% of MTB strains phenotypically resistant to RIF did not exhibit any mutation in the rpoB gene. Conclusion. Identification of a resistance-associated mutation to rifampicin can be a good marker of drug-resistant TB, but lack of a mutation in the target sequence must be interpreted with caution.

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“…[37–45] This performance is also similar for genotype MTBDRsl version 2.0 in detecting mutations on rrs and eis promoter regions, predictive of phenotypic resistance to amikacin and kanamycin, and gyrA and gyrB genes for FQs [Table 1]. [46–48] Compared to the Xpert® MTB/RIF platforms, the GenoType MTBDR assays are more labor intensive. They require a skilled laboratorian, adequate laboratory infrastructure compatible with at least BSL2, biosafety cabinets, three separate rooms to accommodate all steps and minimize cross-contamination risk, constant power supply, refrigerator or freezer to store reagents and centrifuges.…”

Section: Resultsmentioning

confidence: 96%

Meta-narrative review of molecular methods for diagnosis and monitoring of multidrug-resistant tuberculosis treatment in adults

Mbelele

Mohamed

Sauli

et al. 2018

Int J Mycobacteriol

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Early and accurate diagnosis and rigorous clinical and microbiological monitoring of multidrug-resistant tuberculosis (MDR-TB) treatment can curb morbidity and mortality. While others are still under evaluation, the World Health Organization has recommended few novel molecular methods for MDR-TB diagnosis only. We present current molecular methods for diagnosis and monitoring of MDR-TB treatment in TB-endemic settings. A systematic meta-narrative review was conducted according to the RAMESES recommendations. Electronic databases were searched for relevant articles published in English language from January 2013 to June 2018. Based on predefined criteria, two independent reviewers extracted the key messages from relevant articles. Disagreement between them was resolved through discussion and the involvement of a third reviewer, if needed. Key messages were synthesized to create the meta-narratives for method’s accuracy, drug-susceptibility capability, and laboratory infrastructure required. We included 33 articles out of 1213 records retrieved, of which 16 (48%) and 12 (36%) were conducted in high- and low-TB-endemic settings, respectively. Xpert® MTB/RIF, GenoType MTBDRplus, GenoType MTBDRsl, FlouroType™ MTBDR, TB TaqMan® array card, and DNA sequencers can accurately guide effective treatment regimens. Molecular bacterial load assay quantifies mycobactericidal impact of these regimens. Although they present inherent advantages compared to the current standard of care, they carry important limitations to implementation and/or scale-up. Therefore, considerable effort must now be directed to implementation and health systems research to maximize these forecasted benefits for individual patient’s health outcomes.

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Diagnostic accuracy of GenoType^® MTBDRsl VER 2.0 in detecting second-line drug resistance to M. tuberculosis

Abstract: The MTBDRsl VER 2.0 assay showed very high sensitivity and specificity for the detection of second-line drug resistance, suggesting it has potential for the rapid, early detection of such cases.

Cited by 13 publications

References 0 publications

Second-line Drug Resistance Characterization in Mycobacterium tuberculosis by Genotype MTBDRsl Assay

Second-line Drug Resistance Characterization in Mycobacterium tuberculosis by Genotype MTBDRsl Assay

Mutations Associated with Rifampicin Resistance in Mycobacterium tuberculosis Isolates from Moroccan Patients: Systematic Review

Meta-narrative review of molecular methods for diagnosis and monitoring of multidrug-resistant tuberculosis treatment in adults

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