Clinical Evaluation of BD MAX MDR-TB Assay for Direct Detection of Mycobacterium tuberculosis Complex and Resistance Markers

Hofmann-Thiel, Sabine; Plesnik, Sara; Mihalic, Marina; Heiß-Neumann, Marion; Avsar, Korkut; Beutler, Markus; Hoffmann, Harald

doi:10.1016/j.jmoldx.2020.06.013

Cited by 9 publications

(8 citation statements)

References 25 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…79 Similar reports of the diagnostic accuracy of the BD MAX MDR-TB assay have been reported from a diversity of geographic and TB prevalence settings. [79][80][81][82][83][84] Overall, the BD MAX™ MDR-TB assay is automated and integrated and requires a stable source of electricity; 24 specimens can be tested in one run and the turnaround time from the start of testing to the result is four hours. This platform is expected to be most suitable for use in high throughput central laboratories where minimal operator hands-on time is desirable.…”

Section: Moderate Complexity Automated Naatsmentioning

confidence: 99%

Rapid Molecular Assays for the Diagnosis of Drug-Resistant Tuberculosis

Nandlal¹,

Perumal²,

Naidoo³

2022

IDR

View full text Add to dashboard Cite

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.

show abstract

Section: Moderate Complexity Automated Naatsmentioning

confidence: 99%

Rapid Molecular Assays for the Diagnosis of Drug-Resistant Tuberculosis

Nandlal¹,

Perumal²,

Naidoo³

2022

IDR

View full text Add to dashboard Cite

show abstract

“…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

View full text Add to dashboard Cite

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.

show abstract

“…Among these, the BD MAX MDR-TB assay (BD MAX; BD, Franklin Lakes, NJ, USA) showed high sensitivity and specificity for the detection of TB and INH/RIF resistance in a multicenter large-scale study [ 15 ]. Additionally, the diagnostic performance of BD MAX has been evaluated using the preserved samples [ 16 - 18 ]. However, to date, compared to TB-polymerase chain reaction (PCR) and LPA, data on BD MAX performance in clinical practice for detecting TB and INH/RIF resistance remains insufficient.…”

Section: Introductionmentioning

confidence: 99%

Performance of the BD MAX MDR-TB assay in a clinical setting and its impact on the clinical course of patients with pulmonary tuberculosis: a retrospective before-after study

Ko,

Yoon,

Lee

2024

JYMS

View full text Add to dashboard Cite

Background: Missing isoniazid (INH) resistance during tuberculosis (TB) diagnosis can worsen the outcomes of INH-resistant TB. The BD MAX MDR-TB assay (BD MAX) facilitates the rapid detection of TB and INH and rifampin (RIF) resistance; however, data related to its performance in clinical setting remain limited. Moreover, its effect on treatment outcomes has not yet been studied.Methods: We compared the performance of BD MAX for the detection of INH/RIF resistances to that of the line probe assay (LPA) in patients with pulmonary TB (PTB), using the results of a phenotypic drug sensitivity test as a reference standard. The treatment outcomes of patients who used BD MAX were compared with those of patients who did not.Results: Of the 83 patients included in the study, the BD MAX was used for an initial PTB diagnosis in 39 patients. The sensitivity of BD MAX for detecting PTB was 79.5%. The sensitivity and specificity of BD MAX for INH resistance were both 100%, whereas these were 50.0% and 95.8%, respectively, for RIF resistance. The sensitivity and specificity of BD MAX were comparable to those of LPA. The BD MAX group had a shorter time interval from specimen request to the initiation of anti-TB drugs (2.0 days vs. 5.5 days, p=0.001).Conclusion: BD MAX showed comparable performance to conventional tests for detecting PTB and INH/RIF resistances. The implementation of BD MAX as a diagnostic tool for PTB resulted in a shorter turnaround time for the initiation of PTB treatment.

show abstract

Clinical Evaluation of BD MAX MDR-TB Assay for Direct Detection of Mycobacterium tuberculosis Complex and Resistance Markers

Cited by 9 publications

References 25 publications

Rapid Molecular Assays for the Diagnosis of Drug-Resistant Tuberculosis

Rapid Molecular Assays for the Diagnosis of Drug-Resistant Tuberculosis

Estimating tuberculosis drug resistance amplification rates in high-burden settings

Performance of the BD MAX MDR-TB assay in a clinical setting and its impact on the clinical course of patients with pulmonary tuberculosis: a retrospective before-after study

Contact Info

Product

Resources

About