Evaluation of the performance of the BD MAX MDR-TB test in the diagnosis of <i>Mycobacterium tuberculosis</i> complex in extrapulmonary and pulmonary samples

Sağıroğlu, Pınar; Atalay, Mustafa Altay

doi:10.1080/14737159.2021.1997594

Cited by 7 publications

(6 citation statements)

References 15 publications

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“…For detecting INH and RIF resistance, sensitivity and specificity were 71.4% and 96.8%, and 100% and 93.9%, respectively. 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.…”

Section: Moderate Complexity Automated Naatssupporting

confidence: 62%

“…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 Naatssupporting

confidence: 62%

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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: 62%

Section: Moderate Complexity Automated Naatssupporting

confidence: 62%

Rapid Molecular Assays for the Diagnosis of Drug-Resistant Tuberculosis

Nandlal¹,

Perumal²,

Naidoo³

2022

IDR

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“…1 TB is usually divided into two main categories depending on the MTB infection site: pulmonary TB (PTB) and extrapulmonary TB (EPTB). 2 Tuberculous pericarditis (TBP) is a relatively rare form of EPTB, but it is usually severe and could lead to cardiac tamponade, constrictive pericarditis, and even death. 3 Due to the AIDS epidemic, the incidence of TBP has increased and is the leading cause of pericarditis in areas with a high TB burden.…”

Section: Introductionmentioning

confidence: 99%

Comparison of the Diagnostic Accuracy of Xpert MTB/RIF and CapitalBio Mycobacterium RT-PCR Detection Assay for Tuberculous Pericarditis

Yu¹,

Wang²,

Shen³

et al. 2022

IDR

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Purpose We evaluated CapitalBio Mycobacterium RT-PCR assay diagnosing tuberculous pericarditis (TBP), performed a head-to-head comparison with Xpert MTB/RIF, and assessed the impact of a parallel test (positive result for either of these two tests). Methods We reviewed suspected TBP patients with Xpert MTB/RIF, CapitalBio Mycobacterium RT-PCR assay, and Mycobacterium tuberculosis (MTB) culture. We analyzed sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC). Results Seventy-four patients were included. Overall sensitivity, specificity, PPV, NPV, and AUC of CapitalBio Mycobacterium RT-PCR assay compared with culture were 50%, 91.1%, 64.3%, 85%, and 0.71, respectively. Overall sensitivity, specificity, PPV, NPV, and AUC of Xpert MTB/RIF for TBP were 61.1%, 91.1%, 68.8%, 87.9%, and 0.76. Parallel test values were 72.2%, 91.1%, 72.2%, 91.1%, and 0.82. The diagnostic accuracy of Xpert MTB/RIF was higher than CapitalBio Mycobacterium RT-PCR assay but was not significant ( P > 0.05). The parallel test could improve diagnostic accuracy, but it was not significant compared to single tests ( P > 0.05). Conclusion CapitalBio Mycobacterium RT-PCR assay had a moderate diagnostic accuracy, similar to Xpert MTB/RIF. The parallel test maximized diagnostic efficacy, but differences were not significant. CapitalBio Mycobacterium RT-PCR assay and Xpert MTB/RIF for TBP could be an initial option for early diagnosis.

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“…Multiplex PCR techniques have also been devised to swiftly and simultaneously detect multiple pathogens in clinical specimens, along with the identification of AMR genes within the pathogens. Examples of multiplex PCR techniques for detecting AMR genes encompass the RespiFinder SMART 22 assay [52], the SuperBug ID assay [53], the Allplex™ Gastrointestinal Panel Assay [54], and the BD MAX™ MDR-TB assay [55].…”

Section: Polymerase Chain Reaction (Pcr) and Multiplex Pcrmentioning

confidence: 99%

Current and Future Technologies for the Detection of Antibiotic-Resistant Bacteria

Yamin,

Uskoković,

Wakil

et al. 2023

Diagnostics

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Antibiotic resistance is a global public health concern, posing a significant threat to the effectiveness of antibiotics in treating bacterial infections. The accurate and timely detection of antibiotic-resistant bacteria is crucial for implementing appropriate treatment strategies and preventing the spread of resistant strains. This manuscript provides an overview of the current and emerging technologies used for the detection of antibiotic-resistant bacteria. We discuss traditional culture-based methods, molecular techniques, and innovative approaches, highlighting their advantages, limitations, and potential future applications. By understanding the strengths and limitations of these technologies, researchers and healthcare professionals can make informed decisions in combating antibiotic resistance and improving patient outcomes.

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Evaluation of the performance of the BD MAX MDR-TB test in the diagnosis of Mycobacterium tuberculosis complex in extrapulmonary and pulmonary samples

Cited by 7 publications

References 15 publications

Rapid Molecular Assays for the Diagnosis of Drug-Resistant Tuberculosis

Rapid Molecular Assays for the Diagnosis of Drug-Resistant Tuberculosis

Comparison of the Diagnostic Accuracy of Xpert MTB/RIF and CapitalBio Mycobacterium RT-PCR Detection Assay for Tuberculous Pericarditis

Current and Future Technologies for the Detection of Antibiotic-Resistant Bacteria

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