Validation of the GenoType®MTBDRplus assay for diagnosis of multidrug resistant tuberculosis in South Vietnam

Huyen, Mai N. T.; Tiemersma, Edine; Lan, Nguyễn Thị Ngọc; Cobelens, Frank; Dung, Nguyen Huy; Sy, Dinh Ngoc; Buu, Tran N.; Kremer, Kristin; Hang, Pham Thi Thu; Caws, Maxine; O’Brien, Richard; Soolingen, Dick van

doi:10.1186/1471-2334-10-149

Cited by 57 publications

(57 citation statements)

References 29 publications

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“…This is lower than the 21% to 33% contribution of resistance due to the sole absence of WT probe hybridization reported in India, France, and Vietnam (29)(30)(31). Interestingly, in the current study, no katG-associated INH resistance was due the sole absence of WT probe hybridization at katG as opposed to 6% of results previously reported in India and 9% in Vietnam (29,32).…”

Section: Discussioncontrasting

confidence: 55%

MTBDR plus and MTBDR sl Assays: Absence of Wild-Type Probe Hybridization and Implications for Detection of Drug-Resistant Tuberculosis

et al. 2016

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e Accurate identification of drug-resistant Mycobacterium tuberculosis is imperative for effective treatment and subsequent reduction in disease transmission. Line probe assays rapidly detect mutations associated with resistance and wild-type sequences associated with susceptibility. Examination of molecular-level performance is necessary for improved assay result interpretation and for continued diagnostic development. Using data collected from a large, multisite diagnostic study, probe hybridization results from line probe assays, MTBDRplus and MTBDRsl, were compared to those of sequencing, and the diagnostic performance of each individual mutation and wild-type probe was assessed. Line probe assay results classified as resistant due to the absence of wild-type probe hybridization were compared to those of sequencing to determine if novel mutations were inhibiting wild-type probe hybridization. The contribution of absent wild-type probe hybridization to the detection of drug resistance was assessed via comparison to a phenotypic reference standard. In our study, mutation probes demonstrated significantly higher specificities than wild-type probes and wild-type probes demonstrated marginally higher sensitivities than mutation probes, an ideal combination for detecting the presence of resistance conferring mutations while yielding the fewest number of false-positive results. The absence of wild-type probe hybridization without mutation probe hybridization was determined to be primarily the result of failure of mutation probe hybridization and not the result of novel or rare mutations. Compared to phenotypic culture-based drug susceptibility testing, the absence of wild-type probe hybridization without mutation probe hybridization significantly contributed to the detection of phenotypic rifampin and fluoroquinolone resistance with negligible increases in false-positive results. While the number of incident cases of tuberculosis (TB) has been steadily declining over the past decade, the prevalence of drug-resistant disease threatens to reverse these declines (1, 2). The World Health Organization (WHO) estimated that, in 2014, 3.3% of new and 20% of previously treated TB cases were multidrug-resistant (MDR) or were resistant to isoniazid (INH) and rifampin (RIF) (3). Furthermore, 9.7% of these MDR cases were extensively drug resistant (XDR) or were resistant to at least one fluoroquinolone (FQ) in addition to a second-line injectable drug (SLID), amikacin (AMK), kanamycin (KAN), or capreomycin (CAP). Although detection of M/XDR-TB is imperative for effective disease management, less than half of all MDR-TB cases were detected in 2014 (2-4). This detection gap is due, in part, to the lack of low-cost, rapid, and accurate diagnostic technologies for M/XDR-TB (4-6).Conventional culture-based phenotypic drug susceptibility testing (DST) methods can take months to yield results (7). Molecular-based tests, however, can produce results in Ͻ1 day (5,(8)(9)(10)(11)(12). The WHO has endorsed line probe hybridization and mole...

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Section: Discussioncontrasting

confidence: 55%

MTBDR plus and MTBDR sl Assays: Absence of Wild-Type Probe Hybridization and Implications for Detection of Drug-Resistant Tuberculosis

et al. 2016

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“…et al, has found that by conventional DST, 55 strains were classified as MDR-TB, four strains were rifampicin mono-resistant and 52 strains were susceptible to all first-line drugs. The sensitivity of the GenoType ® MTBDRplus assay was 93.1% for rifampicin, 92.6% for isoniazid and 88.9% for the combination of both; its specificity was 100% [15]. However, the specificity of GenoType ® MTBDRplus assay to detect MDR-TB, in our study, was lower than that found in other studies conducted elsewhere in the world [7,9,15].…”

Section: Performance Of Genotype ® Mtbdrplus: Sensitivity Specificitcontrasting

confidence: 56%

Performance Assessment of the GenoType®MTBDRplus Assay for Rapid Detection of Multidrug-Resistant Tuberculosis among Clinical Isolates in Low Tuberculosis Burden Setting

Uwimana¹,

Kamanzi²,

Mukamukwiye³

et al. 2017

Mycobact Dis

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“…Here most of the costs for molecular testing were influenced by consumable costs, especially the cartilage which accounted for 30% of the total cost. Studies [64], reported that GeneXpert and MTBDRplus are the two WHO recommended platforms for rapid detection of TB and drug-resistant TB and many low and middle-income countries qualify for negotiated discounts on these assays. This has implications in that the costs reported in this study are likely to come down after discount thereby increasing affordability.…”

Section: Discussionmentioning

confidence: 99%

Performance of GeneXpert Assay in Detecting Pulmonary Tuberculosis and Rifampicin Resistance in Patients Attending Kitui County Hospital, Kenya

Pk¹,

Ngugi²,

Dn³

2017

J Trop Dis

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Validation of the GenoType®MTBDRplus assay for diagnosis of multidrug resistant tuberculosis in South Vietnam

Cited by 57 publications

References 29 publications

MTBDR plus and MTBDR sl Assays: Absence of Wild-Type Probe Hybridization and Implications for Detection of Drug-Resistant Tuberculosis

MTBDR plus and MTBDR sl Assays: Absence of Wild-Type Probe Hybridization and Implications for Detection of Drug-Resistant Tuberculosis

Performance Assessment of the GenoType®MTBDRplus Assay for Rapid Detection of Multidrug-Resistant Tuberculosis among Clinical Isolates in Low Tuberculosis Burden Setting

Performance of GeneXpert Assay in Detecting Pulmonary Tuberculosis and Rifampicin Resistance in Patients Attending Kitui County Hospital, Kenya

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