Accuracy of the Truenat MTB-RIF Dx assay for detection of rifampicin resistance-associated mutations

Georghiou, Sophia B.; Gomathi, Narayanan Sivaramakrishnan; Rajendran, Priya; Nagalakshmi, Velpula; Prabakaran, L.; Kumar, M; Macé, Aurélien; Tripathy, Srikanth; Rühwald, Morten; Schumacher, Samuel G; Penn-Nicholson, Adam

doi:10.1016/j.tube.2021.102064

Cited by 9 publications

(5 citation statements)

References 5 publications

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“…A recent analytical study using well-characterised M. tuberculosis strains showed that Truenat MTB-RIF Dx detected RIF resistance mutations representing 98.6% accuracy when weighted for global prevalence. Nevertheless, more work is needed to evaluate RIF resistance coverage in clinical settings across different geographies and patient populations [ 28 ]. Given the clear benefit of rapid diagnosis of TB in people living with HIV, further studies will be required to evaluate the accuracy of the Truenat assays in these vulnerable populations in the primary healthcare setting, particularly given the lower than anticipated performance of the Truenat assays in smear-negative culture-positive TB cases.…”

Section: Discussionmentioning

confidence: 99%

A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays

et al. 2021

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BackgroundBringing reliable and accurate tuberculosis (TB) diagnosis closer to patients is a key priority for global TB control. Molbio Diagnostics have developed the Truenat point-of-care molecular assays for detection of TB and rifampicin (RIF) resistance.MethodsWe conducted a prospective multicentre diagnostic accuracy study at 19 primary health care centres and seven reference laboratories in Peru, India, Ethiopia and Papua New Guinea to estimate the diagnostic accuracy of the point-of-care Truenat MTB, MTB Plus and MTB-RIF Dx assays for pulmonary TB using culture and phenotypic drug susceptibility testing as the reference standard, compared to Xpert MTB/RIF or Ultra.ResultsOf 1807 enrolled participants with TB signs/symptoms, 24% were culture positive for Mycobacterium tuberculosis, of which 15% were RIF-resistant. In microscopy centres, the pooled sensitivity of Truenat MTB and Truenat MTB Plus was 73% [95% CI: 67, 78] and 80% [95% CI: 75, 84], respectively. Among smear-negative specimens, sensitivities were 36% [95% CI: 27, 47] and 47% [95% CI: 37, 58], respectively. Sensitivity of Truenat MTB-RIF was 84% [95% CI: 62, 95]. Truenat assays showed high specificity. Head-to-head comparison in the central reference laboratories suggested that the Truenat assays have similar performance to Xpert MTB/RIF.ConclusionWe found performance of Molbio's Truenat MTB, MTB plus and MTB-RIF Dx assays to be comparable to that of the Xpert MTB/RIF assay. Performing the Truenat tests in primary health care centres with very limited infrastructure was feasible. These data supported the development of a WHO policy recommendation of the Molbio assays.

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Section: Discussionmentioning

confidence: 99%

A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays

et al. 2021

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“…The Truenat MTB-RIF-Dx assay performed similarly to MTBDRplus for RIF resistance mutation detection and was comparable to that of the Xpert MTB/RIF assay [109]. Truenat MTB-RIF-Dx does not detect the rpoB Q432K and S441L mutations [110]. However, these mutations are rare, with less than 0.7% frequencies globally [110][111][112].…”

Section: Chip-based Real-time Micro Pcr Assaysmentioning

confidence: 80%

“…Truenat MTB-RIF-Dx does not detect the rpoB Q432K and S441L mutations [110]. However, these mutations are rare, with less than 0.7% frequencies globally [110][111][112].…”

Section: Chip-based Real-time Micro Pcr Assaysmentioning

confidence: 92%

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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Section: Mtb Diagnosismentioning

confidence: 99%

“…Truenat MTB, Truenat MTB Plus, and Truenat MTB-Rif Dx (Molbio Diagnostics) are micro real-time PCR-based assays for Mtb detection that produce results in 1 h [ 50 , 51 ]. Truenat MTB and Truenat MTB Plus detect Mtb bacilli in sputum after DNA extraction, and Truenat MTB-Rif Dx has an optional add-on chip for sequential RIF resistance detection [ 51 ]. In 2019, the WHO reported that the Truenat MTB series displayed comparable sensitivities and specificities with Xpert MTB/RIF and Xpert MTB/RIF Ultra for the detection of TB and RIF resistance [ 52 ].…”

Section: Mtb Diagnosismentioning

confidence: 99%

Review and Updates on the Diagnosis of Tuberculosis

Huang

Lin

Wang

et al. 2022

JCM

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Diagnosis of tuberculosis, and especially the diagnosis of extrapulmonary tuberculosis, still faces challenges in clinical practice. There are several reasons for this. Methods based on the detection of Mycobacterium tuberculosis (Mtb) are insufficiently sensitive, methods based on the detection of Mtb-specific immune responses cannot always differentiate active disease from latent infection, and some of the serological markers of infection with Mtb are insufficiently specific to differentiate tuberculosis from other inflammatory diseases. New tools based on technologies such as flow cytometry, mass spectrometry, high-throughput sequencing, and artificial intelligence have the potential to solve this dilemma. The aim of this review was to provide an updated overview of current efforts to optimize classical diagnostic methods, as well as new molecular and other methodologies, for accurate diagnosis of patients with Mtb infection.

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Accuracy of the Truenat MTB-RIF Dx assay for detection of rifampicin resistance-associated mutations

Cited by 9 publications

References 5 publications

A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays

A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays

Rapid Diagnosis of Drug-Resistant Tuberculosis–Opportunities and Challenges

Review and Updates on the Diagnosis of Tuberculosis

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