Clinical Impact of the Line Probe Assay and Xpert® MTB/RIF Assay in the Presumptive Diagnosis of Drug-Resistant Tuberculosis in Brazil: A Pragmatic Clinical Trial

Kritski, Afrânio Lineu; Oliveira, Maria Martha; Almeida, Isabela Neves de; Ramalho, Daniela Maria de Paula; Andrade, Mônica Kramer de Noronha; Wermelinger, Mônica; Miranda, Pryscila Fernandes Campino; Dalcolmo, Margareth Pretti; Braga, José Ueleres; Brígido, T.; Mesquita, Eliene Denites Duarte; Dias, Claudia; Gambirasio, A. N.; Filho, João Baptista de Oliveira e Souza; Detjen, Anne; Phillips, Patrick P. J.; Langley, Ivor; Fujiwara, Paula I.; Squire, S. Bertel

doi:10.1590/0037-8682-0191-2021

Cited by 3 publications

(2 citation statements)

References 18 publications

(42 reference statements)

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“…MTBDRplus and MTBDRsl assays, with their ability to detect both first‐line and second‐line drug resistance simultaneously, could serve as beacons of hope for TB elimination 2,22 . Prior studies on pulmonary TB revealed that MTBDR assays reduced the proportion of “empirical therapy” patients and boosted up targeted therapy with improvement in DR‐TB management 23 . It was also realized that MTBDRsl could aid in real‐time surveillance of emerging DR‐TB, both pulmonary and EPTB, in endemic country like India 24 .…”

Section: Discussionmentioning

confidence: 99%

“…2,22 Prior studies on pulmonary TB revealed that MTBDR assays reduced the proportion of "empirical therapy" patients and boosted up targeted therapy with improvement in DR-TB management. 23 It was also realized that MTBDRsl could aid in real-time surveillance of emerging DR-TB, both pulmonary and EPTB, in endemic country like India. 24 The present study, to the best of our knowledge, is the first to evaluate the performance of MTBDRplus and MTBDRsl for detecting presence and pattern of drug resistance in a decent cohort of 30 cases of GITB.…”

Section: Discussionmentioning

confidence: 99%

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MTBDRplus and MTBDRsl for simultaneous diagnosis of gastrointestinal tuberculosis and detection of first‐line and second‐line drug resistance

Sharma

et al. 2023

J of Gastro and Hepatol

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Background and Aim: Emergence of drug resistance, especially to second-line drugs, hampers tuberculosis elimination efforts. The present study aimed to evaluate MTBDRplus and MTBDRsl assays for detecting first-line and second-line drug resistance, respectively, in gastrointestinal tuberculosis (GITB). Methods: Thirty ileocecal biopsy specimens, processed in the Department of Microbiology between 2012 and 2022, that showed growth of Mycobacterium tuberculosis on culture were included in the study. DNA, extracted from culture, was subjected to MTBDRplus and MTBDRsl (Hain Lifescience GmbH, Nehren, Germany), following manufacturer's instructions. Their performance was compared against phenotypic drug susceptibility testing (pDST) and gene sequencing. Results: Out of the 30 specimens, 4 (13.33%) were mono-isoniazid resistant, 4 (13.33%) were multidrug resistant (MDR), 2 (6.67%) were pre-extensively drug resistant (pre-XDR), and 2 (6.67%) were mono-fluoroquinolone resistant. The results were 100% concordant with pDST and gene sequencing. Conclusions: In the wake of growing drug resistance in all forms of extrapulmonary tuberculosis, including GITB, MTBDRplus and MTBDRsl are reliable tools for screening of resistance to both first-line and second-line drugs.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

MTBDRplus and MTBDRsl for simultaneous diagnosis of gastrointestinal tuberculosis and detection of first‐line and second‐line drug resistance

Sharma

et al. 2023

J of Gastro and Hepatol

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Estimating the effect of a rifampicin resistant tuberculosis diagnosis by the Xpert MTB/RIF assay on two-year mortality

De Vos,

Westreich,

Scott

et al. 2023

PLOS Glob Public Health

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Studies assessing patient-centred outcomes of novel rifampicin resistant tuberculosis (RR-TB) diagnostics are rare and mostly apply conventional methods which may not adequately address biases. Even though the Xpert MTB/RIF molecular assay was endorsed a decade ago for simultaneous diagnosis of tuberculosis and RR-TB, the impact of the assay on mortality among people with RR-TB has not yet been assessed. We analysed data of an observational prospective cohort study (EXIT-RIF) performed in South Africa. We applied a causal inference approach using inverse odds of sampling weights to rectify survivor bias and selection bias caused by differing screening guidelines. We also adjusted for confounding using a marginal structural model with inverse probability of treatment weights. We estimated the total effect of an RR-TB diagnosis made by the Xpert assay versus the pre-Xpert diagnostic algorithm (entailing a targeted Line Probe Assay (LPA) among TB-confirmed patients) on two-year mortality and we assessed mediation by RR-treatment initiation. Of the 749 patients diagnosed with RR-TB [247 (33%) by the pre-Xpert diagnostic algorithm and 502 (67%) by the Xpert assay], 42.7% died. Of these, 364 (48.6%) patients died in the pre-Xpert group and 200 (39.8%) in the Xpert group. People diagnosed with RR-TB by the Xpert assay had a higher odds of RR-TB treatment initiation compared to those diagnosed by the targeted LPA-based diagnostic process (OR 2.79; 95%CI 2.19–3.56). Receiving an RR-TB diagnosis by Xpert resulted in a 28% reduction in the odds of mortality within 2 years after presentation to the clinic (ORCI 0.72; 95%CI 0.53–0.99). Causal mediation analysis suggests that the higher rate of RR-TB treatment initiation in people diagnosed by the Xpert assay explains the effect of Xpert on 2-year mortality [natural indirect effect odds ratio 0.90 (95%CI 0.85–0.96). By using causal inference methods in combination with high quality observational data, we could demonstrate that the introduction of the Xpert assay caused a 28% reduction in 2-year odds of mortality of RR-TB. This finding highlights the need for advocacy for a worldwide roll-out of rapid molecular tests. Because the effect is mainly caused by increased RR-TB treatment initiation, health care systems should also ensure timely initiation of effective treatment upon an RR-TB diagnosis.

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The Role of GeneXpert® for Tuberculosis Diagnostics in Brazil: An Examination from a Historical and Epidemiological Perspective

Iúdice,

da Conceição,

de Brito

et al. 2023

TropicalMed

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The rapid molecular test (RMT) performed on the GeneXpert® system is widely used as a control strategy and surveillance technique for tuberculosis (TB). In the region of the Americas, TB incidence is slowly increasing owing to an upward trend in Brazil, which is among the high TB-burden countries (HBCs), ranking in the 19th position. In this context, we aimed to (i) describe the implementation and history of RMT-TB (Xpert® MTB/RIF and Xpert® MTB/RIF Ultra) in Brazil; (ii) to evaluate the national RMT laboratory distribution, TB, and resistance to RIF detection by RMT; and (iii) to correlate these data with Brazilian TB incidence. The quantitative data of Xpert® MTB/RIF and Xpert® MTB/RIF Ultra assays performed in the pulmonary TB investigation from 2014 to 2020 were provided by the Brazilian Ministry of Health. A spatial visualization using ArcGIS software was performed. The Southeast region constituted about half of the RMT laboratories—from 39.4% to 45.9% of the total value over the five regions. Regarding the federal units, the São Paulo state alone represented from 20.2% to 34.1% (5.0 to 8.5 times the value) of RMT laboratories over the years observed. There were significant differences (p < 0.0001) in the frequency of RMT laboratories between all years of the historical series. There was an unequal distribution of RMT laboratories between Brazilian regions and federal units. This alerts us for the surveillance of rapid molecular detection of TB in different parts of the country, with the possibility of improving the distribution of tests in areas of higher incidence in order to achieve the level of disease control recommended by national and worldwide authorities.

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Clinical Impact of the Line Probe Assay and Xpert® MTB/RIF Assay in the Presumptive Diagnosis of Drug-Resistant Tuberculosis in Brazil: A Pragmatic Clinical Trial

Cited by 3 publications

References 18 publications

MTBDRplus and MTBDRsl for simultaneous diagnosis of gastrointestinal tuberculosis and detection of first‐line and second‐line drug resistance

MTBDRplus and MTBDRsl for simultaneous diagnosis of gastrointestinal tuberculosis and detection of first‐line and second‐line drug resistance

Estimating the effect of a rifampicin resistant tuberculosis diagnosis by the Xpert MTB/RIF assay on two-year mortality

The Role of GeneXpert® for Tuberculosis Diagnostics in Brazil: An Examination from a Historical and Epidemiological Perspective

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