Evaluation of the Roche cobas MTB and MTB-RIF/INH Assays in Samples from Germany and Sierra Leone

Nadarajan, Darshaalini; Hillemann, Doris; Kamara, Rashidatu Fouad; Foray, Lynda; Conteh, Ousman; Merker, Matthias; Niemann, Stefan; Lau, J W; Njoya, Merlin; Kranzer, Katharina; Somoskövi, Ákos; Maurer, Florian P.

doi:10.1128/jcm.02983-20

Cited by 8 publications

(2 citation statements)

References 22 publications

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“…6 Sensitivity and specificity for RIF vs INH resistance detection was 88.4% and 97.6% vs 76.6% and 100.0%, respectively. 85 Similar findings were noted in other comparative studies assessing Cobas MTB-RIF/INH. 86,87 The FluoroType MTBDR (FT-MTBDR; Hain Lifescience) is a new in vitro automated molecular-based assay that simultaneously detects Mtb mutations associated with RIF and INH in a single reaction without the need for reflexing.…”

Section: Moderate Complexity Automated Naatssupporting

confidence: 83%

Rapid Molecular Assays for the Diagnosis of Drug-Resistant Tuberculosis

Nandlal¹,

Perumal²,

Naidoo³

2022

IDR

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The recognition that drug-resistant tuberculosis (DR-TB) poses a major threat to global tuberculosis (TB) control efforts has catalysed the development of new and urgently needed TB diagnostics. The full beneficial impact of the subsequent flood of new TB diagnostic tests into the market can only be realised if these diagnostic tests are readily accessible to TB programs and contribute to improved patient outcomes. Although phenotypic drug-susceptibility testing remains the gold standard, an improved understanding of the relationship between mutations and different levels of drug resistance coupled with the advantages of molecular diagnostics could result in rapid molecular diagnostic tests replacing phenotypic drug-susceptibility testing. Successful diagnostics need to diagnose all forms of drugresistant TB prevalent in each geographic region. Given the finite number and often limited availability of effective drugs for DR-TB, the diagnostic test must be able to detect all clinically important types of resistance to available anti-TB drugs. However, less comprehensive resistance profiling may be sufficient in settings where extensively drug-resistant TB (XDR-TB) and pre-XDR are absent. Rapid molecular diagnostic tests for DR-TB detection suitable for DR-TB endemic settings should be accurate, inexpensive, suitable to be performed on an easily accessible sample, detect prevalent circulating drug-resistant strains, and provide results within a short turnaround time to enable timely treatment initiation. In this review, we appraise the wide range of molecular diagnostics for DR-TB endorsed by the World Health Organisation, discuss the challenges in the development and rollout of rapid molecular DR-TB tests in low-and middle-income countries, and highlight user perspectives and cost-effectiveness factors that influence their utility.

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Section: Moderate Complexity Automated Naatssupporting

confidence: 83%

Rapid Molecular Assays for the Diagnosis of Drug-Resistant Tuberculosis

Nandlal¹,

Perumal²,

Naidoo³

2022

IDR

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“…However, as our work highlights, these algorithms may also be associated with selecting for and further amplifying INH resistance. Alternative molecular tools, such as the line probe assay MTBDR plus [ 45 ], Abbott RealTime MTB RIF/INH (Abbott), FluoroType MTBDR [ 46 ], BD MAX MDR-TB assay [ 47 ], Roche cobas MTB [ 48 ] and whole genome sequencing can identify both RIF and INH resistance, and may offer the programmatic advantages of rapid MDR-TB diagnosis while avoiding this secondary effect [ 49 ]. Further research into the association between specific INH resistance mutations and differential risk of transmission will be helpful in better defining the public health impact of this effect [ 50 ].…”

Section: Discussionmentioning

confidence: 99%

Estimating tuberculosis drug resistance amplification rates in high-burden settings

et al. 2022

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Background Antimicrobial resistance develops following the accrual of mutations in the bacterial genome, and may variably impact organism fitness and hence, transmission risk. Classical representation of tuberculosis (TB) dynamics using a single or two strain (DS/MDR-TB) model typically does not capture elements of this important aspect of TB epidemiology. To understand and estimate the likelihood of resistance spreading in high drug-resistant TB incidence settings, we used epidemiological data to develop a mathematical model of Mycobacterium tuberculosis (Mtb) transmission. Methods A four-strain (drug-susceptible (DS), isoniazid mono-resistant (INH-R), rifampicin mono-resistant (RIF-R) and multidrug-resistant (MDR)) compartmental deterministic Mtb transmission model was developed to explore the progression from DS- to MDR-TB in The Philippines and Viet Nam. The models were calibrated using data from national tuberculosis prevalence (NTP) surveys and drug resistance surveys (DRS). An adaptive Metropolis algorithm was used to estimate the risks of drug resistance amplification among unsuccessfully treated individuals. Results The estimated proportion of INH-R amplification among failing treatments was 0.84 (95% CI 0.79–0.89) for The Philippines and 0.77 (95% CI 0.71–0.84) for Viet Nam. The proportion of RIF-R amplification among failing treatments was 0.05 (95% CI 0.04–0.07) for The Philippines and 0.011 (95% CI 0.010–0.012) for Viet Nam. Conclusion The risk of resistance amplification due to treatment failure for INH was dramatically higher than RIF. We observed RIF-R strains were more likely to be transmitted than acquired through amplification, while both mechanisms of acquisition were important contributors in the case of INH-R. These findings highlight the complexity of drug resistance dynamics in high-incidence settings, and emphasize the importance of prioritizing testing algorithms which allow for early detection of INH-R.

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