The limitations of the Cepheid GeneXpert® Mtb/Rif assay for the diagnosis and management of polyresistant pulmonary tuberculosis

Hopmeier, Dahlia; Lampejo, Temi; Rycroft, Julian Anthony; Tiberi, Simon; Melzer, Mark

doi:10.1016/j.clinpr.2020.100038

Cited by 5 publications

(4 citation statements)

References 9 publications

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“…Much higher sensitivity and specificity were shown for RIF. Sensitivity was 95.7% (95% CI 91.79–96.15%) and specificity was 95.7% (95% CI 85.16–99.47%) which were similar to the 95% pooled sensitivity and 98% pooled specificity values of Xpert MTB/RIF assay [6] and 96–98.7% sensitivity and 88.9 to 99% specificity values of MTBDRplus assays reported by the previous studies [7] , [8] , [9] . In comparison with sequencing results of RRDR it showed 98.7% concordance.…”

Section: Discussionsupporting

confidence: 84%

“…Xpert MTB/RIF assay is a cartridge based nucleic acid amplification test which detects TB and RR-TB rapidly but it has limitation for ruling out rifampicin (RIF) sensitive polyresistant TB. The World Health Organization (WHO) endorsed LPAs for rapid molecular detection of MDR-TB, FQ and SLID resistance but there is requirement of laboratory infrastructure and trained persons to perform the tests [6] , [7] , [8] , [9] .…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Evaluation of TBMDR® and XDRA® for the detection of multidrug resistant and pre-extensively drug resistant tuberculosis

Cho¹,

Lee²,

Lim³

et al. 2022

Journal of Clinical Tuberculosis and Other Mycobacterial Diseas

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Section: Discussionsupporting

confidence: 84%

Section: Introductionmentioning

confidence: 99%

Evaluation of TBMDR® and XDRA® for the detection of multidrug resistant and pre-extensively drug resistant tuberculosis

Cho¹,

Lee²,

Lim³

et al. 2022

Journal of Clinical Tuberculosis and Other Mycobacterial Diseas

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“…Moreover, Xpert MTB/RIF does not detect INH resistance, despite this form of resistance being present in 8% of TB cases worldwide [81]. Nevertheless, to circumvent some limitations observed with Xpert MTB/RIF, such as the reported false-positive Xpert MTB/RIF results caused by the silent mutations (e.g., at codon 514 of the rpoB gene) [82], the false-negative results due to failure to detect mutations conferring resistance to RIF outside the rpoB hotspot region [83], and the inability to detect INH resistance, Xpert MTB/RIF Ultra and MTB/XDR assays were introduced [84].…”

Section: Genoscholar Assays (Nipro Corporation Osaka Japan)mentioning

confidence: 99%

Rapid Diagnosis of Drug-Resistant Tuberculosis–Opportunities and Challenges

Naidoo,

Perumal,

Ngema

et al. 2023

Pathogens

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Global tuberculosis (TB) eradication is undermined by increasing prevalence of emerging resistance to available drugs, fuelling ongoing demand for more complex diagnostic and treatment strategies. Early detection of TB drug resistance coupled with therapeutic decision making guided by rapid characterisation of pre-treatment and treatment emergent resistance remains the most effective strategy for averting Drug-Resistant TB (DR-TB) transmission, reducing DR-TB associated mortality, and improving patient outcomes. Solid- and liquid-based mycobacterial culture methods remain the gold standard for Mycobacterium tuberculosis (MTB) detection and drug susceptibility testing (DST). Unfortunately, delays to result return, and associated technical challenges from requirements for specialised resource and capacity, have limited DST use and availability in many high TB burden resource-limited countries. There is increasing availability of a variety of rapid nucleic acid-based diagnostic assays with adequate sensitivity and specificity to detect gene mutations associated with resistance to one or more drugs. While a few of these assays produce comprehensive calls for resistance to several first- and second-line drugs, there is still no endorsed genotypic drug susceptibility test assay for bedaquiline, pretomanid, and delamanid. The global implementation of regimens comprising these novel drugs in the absence of rapid phenotypic drug resistance profiling has generated a new set of diagnostic challenges and heralded a return to culture-based phenotypic DST. In this review, we describe the available tools for rapid diagnosis of drug-resistant tuberculosis and discuss the associated opportunities and challenges.

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“…The high cost and the requirement of special laboratory settings and well-trained staffs also partially restrict the application of IGRAs. The Xpert Mtb/RIF assay, a new rapid diagnostic test based on nucleic acid amplification, works very well in diagnostic of Mtb and rifampicin resistance in 2 h ( El-Samadony et al, 2017 ), but it is not only restricted by its relatively low sensitivity and high false positivity rates in same specific conditions ( Arend and van Soolingen, 2018 ), but also show limitations for the diagnosis and management of polyresistant pulmonary tuberculosis ( Hopmeier et al, 2020 ).…”

Section: Introductionmentioning

confidence: 99%

Current progress of functional nanobiosensors for potential tuberculosis diagnosis: The novel way for TB control?

Yang

Fan²,

Ma³

et al. 2022

Front. Bioeng. Biotechnol.

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Tuberculosis (TB), induced by the foxy Mycobacterium tuberculosis (Mtb), is still one of the top killers worldwide among infectious diseases. Although several antibiotics have been developed to significantly relieve the tuberculosis epidemics worldwide, there are still several important scientific challenges for tuberculosis. As one of the most critical issues for tuberculosis control, the accurate and timely diagnosis of tuberculosis is critical for the following therapy of tuberculosis and thus responsible for the effective control of drug-resistant tuberculosis. Current tuberculosis diagnostic methods in clinic are still facing the difficulties that they can’t provide the rapid diagnostic results with high sensitivity and accuracy, which therefore requires the development of more effective novel diagnostic strategies. In recent decades, nanomaterials have been proved to show promising potentials for novel nanobiosensor construction based on their outstanding physical, chemical and biological properties. Taking these promising advantages, nanomaterial-based biosensors show the potential to allow the rapid, sensitive and accurate tuberculosis diagnosis. Here, aiming to increase the development of more effective tuberculosis diagnostic strategy, we summarized the current progress of nanobiosensors for potential tuberculosis diagnosis application. We discussed the different kind diagnostic targets for tuberculosis diagnosis based on nanobiosensors, ranging from the detection of bacterial components from M. tuberculosis, such as DNA and proteins, to the host immunological responses, such as specific cytokine production, and to the direct whole cell detection of M. tuberculosis. We believe that this review would enhance our understandings of nanobiosensors for potential tuberculosis diagnosis, and further promote the future research on nanobiosensor-based tuberculosis diagnosis to benefit the more effective control of tuberculosis epidemic.

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The limitations of the Cepheid GeneXpert® Mtb/Rif assay for the diagnosis and management of polyresistant pulmonary tuberculosis

Cited by 5 publications

References 9 publications

Evaluation of TBMDR® and XDRA® for the detection of multidrug resistant and pre-extensively drug resistant tuberculosis

Evaluation of TBMDR® and XDRA® for the detection of multidrug resistant and pre-extensively drug resistant tuberculosis

Rapid Diagnosis of Drug-Resistant Tuberculosis–Opportunities and Challenges

Current progress of functional nanobiosensors for potential tuberculosis diagnosis: The novel way for TB control?

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