XtracTB Assay, a Mycobacterium tuberculosis molecular screening test with sensitivity approaching culture

Reed, Jennifer L.; Basu, Debby; Butzler, Matthew A.; McFall, Sally M.

doi:10.1038/s41598-017-03930-3

Cited by 26 publications

(22 citation statements)

References 28 publications

(53 reference statements)

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“…This is possibly because the limit of detection (LOD) for culture and PCR are different. Culture needs a minimum of 10 genomic copies of MTB DNA to be positive (LOD 10–100 cfu/mL), compared to RT-PCR using IS6110 that needs only 5 genomic copies of MTB DNA (LOD 5 cfu/mL) [21]. …”

Section: Discussionmentioning

confidence: 99%

Reactive Lymphoid Hyperplasia or Tubercular Lymphadenitis: Can Real-Time PCR on Fine-Needle Aspirates Help Physicians in Concluding the Diagnosis?

Gupta¹,

Bhake²

2018

Acta Cytologica

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Background: Enlarged lymph nodes in adult patients often present a diagnostic challenge. In the absence of granuloma or necrosis, the cytology/tissue findings are misleading and relate the enlarged lymph nodes to reactive lymphoid hyperplasia (RLH), because granuloma formation is an immunological response that usually takes 14–100 days to develop. This study assesses the role of real-time (RT)-PCR in the diagnosis of the Mycobacterium complex (MTBC) in lymph node aspirates compared with culture in cases of RLH. Methods: A cross-sectional study was conducted on 112 patients, aged 15–74 years, with a diagnosis of RLH on cytology. RT-PCR for MTBC detection and culture on Löwenstein-Jensen medium for tubercular bacilli was done on lymph node aspirates. Comparative values with reference to culture were calculated. The χ² value, positive predictive value (PPV), negative predictive value (NPV), and likelihood ratios (LR) were calculated. Results: Out of 112 RLH cases, 35 (31%) were positive on both RT-PCR and culture. RT-PCR was positive in 43 cases and culture was positive in 44 cases. The χ² test was found to be highly significant. PPV, NPV, positive LR, and negative LR were 81.4%, 87%, 6.76, and 0.23, respectively. Conclusion: RT-PCR for MTBC proves to be useful in arriving at a conclusive diagnosis in patients with a cytological diagnosis of RLH.

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Section: Discussionmentioning

confidence: 99%

Reactive Lymphoid Hyperplasia or Tubercular Lymphadenitis: Can Real-Time PCR on Fine-Needle Aspirates Help Physicians in Concluding the Diagnosis?

Gupta¹,

Bhake²

2018

Acta Cytologica

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“…The results provide a glimpse of potential TB patient response. Since the detection limit of SSM is 10 4 CFU/mL, while that of culture is reported to be 10 CFU/mL [29], the samples were classified into two groups: (1) Low bacterial load at 10 0 -10 3 CFU/mL and (2) high bacterial load at 10 4 CFU/mL or higher, as shown in Table 3. A sample positive in culture but negative in SSM must have a low bacterial load at 10 0 -10 3 CFU/mL.…”

Section: Ncba To Profile Tb Populationmentioning

confidence: 99%

Nanoparticle-Based Biosensing Assay for Universally Accessible Low-Cost TB Detection with Comparable Sensitivity as Culture

et al. 2019

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Tuberculosis (TB) is the leading cause of death globally, surpassing HIV. Furthermore, multidrug-resistant and extensively drug-resistant TB have become global public health threats. Care of TB patients starts with quality, accessible, and affordable diagnosis. The study presents a novel technique called nanoparticle-based colorimetric biosensing assay (NCBA) based on the principles of magnetically activated cell enrichment. A total of 1108 sputum samples were subjected to sputum smear microscopy (SSM), NCBA, and standard culture. SSM and NCBA were completed in 20 min; culture was completed in 8 weeks. Results show that NCBA has matching sensitivity of 100.0% and specificity of 99.7% compared to the gold standard culture method at a cost of $0.50/test based on Peruvian conditions. Sputum smear microscopy has 63.87% sensitivity compared to culture. NCBA has the potential of being used in local health clinics as it only requires a microscope that is widely available in many rural areas. Because NCBA could detect low levels of bacterial load comparable to culture, it could be used for rapid and early TB-onset detection. The gain in time is critical as TB is airborne and highly infectious, minimizing contact exposure. Early detection could lead to early treatment, while the patient's immune system is still high. The low cost makes NCBA affordable and accessible to those who need them the most.

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“…These assays need to have higher levels of accuracy and be easily accessible to both HICs and LMICs. Our team at the Center for Innovation in Global Health Technologies (CIGHT) at Northwestern University has developed a molecular assay that is as sensitive as sputum culture (XtracTB Assay), which we believe will revolutionize molecular diagnostics for TB and greatly improve patient management [14,15]. By adding NTM panels to this new TB molecular assay, we hope to overcome many of the issues described above.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous diagnosis of tuberculous and non-tuberculous mycobacterial diseases: Time for a better patient management

Sarro¹,

Kone²,

Diarra³

et al. 2018

Clin Microbiol Infect Dis

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Tuberculosis (TB) is the deadliest infectious disease in the world which disproportionately affects low-and-middle-income countries (LMICs) where diagnostic resources and treatment options are limited. The incidence of pulmonary non-tuberculous mycobacteria (NTM) disease is also rapidly increasing in these regions traditionally dominated by TB infections. This poses significant diagnostic and treatment challenges, since these two diseases are often indistinguishable clinically or by sputum smear microscopy (SSM), the most commonly used TB diagnostic tool in LMICs. Consequently, NTM-infected patients usually receive unnecessary TB treatment for months. TB patients with NTM co-infections may also be treated incorrectly due to inaccurate SSM and Xpert™ MTB/RIF (M. tuberculosis./rifampin) results. These issues complicate the management of patients and contribute to the worsening of the current TB and NTM epidemiological features including development of drug resistant strains. It is therefore critical to develop improved diagnostic tools to accurately distinguish these two different pathogens that have many similar clinical and epidemiological features but have different treatment regimens. In this review, we will discuss limitations with current diagnostic tools and the need to develop novel techniques that can accurately and simultaneously diagnose TB and NTM disease._

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XtracTB Assay, a Mycobacterium tuberculosis molecular screening test with sensitivity approaching culture

Cited by 26 publications

References 28 publications

Reactive Lymphoid Hyperplasia or Tubercular Lymphadenitis: Can Real-Time PCR on Fine-Needle Aspirates Help Physicians in Concluding the Diagnosis?

Reactive Lymphoid Hyperplasia or Tubercular Lymphadenitis: Can Real-Time PCR on Fine-Needle Aspirates Help Physicians in Concluding the Diagnosis?

Nanoparticle-Based Biosensing Assay for Universally Accessible Low-Cost TB Detection with Comparable Sensitivity as Culture

Simultaneous diagnosis of tuberculous and non-tuberculous mycobacterial diseases: Time for a better patient management

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