Assessment of the Quantitative Ability of AdvanSure TB/NTM Real-Time PCR in Respiratory Specimens by Comparison with Phenotypic Methods

Lee, Hyeyoung; Park, Kang Gyun; Lee, Gundong; Park, Joonhong; Park, Yong Gyu; Park, Yeon-Joon

doi:10.3343/alm.2014.34.1.51

Cited by 15 publications

(12 citation statements)

References 11 publications

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“…In the 654 subjects, RT-PCR assays were conducted using both sputum and bronchoscopic aspirate samples. RT-PCR was performed using the AdvanSure TB/NTM RT-PCR kit (LG Life Science, Seoul, Korea) according to the manufacturer's instructions 13 , 15 . Three channels were used in the RT-PCR reaction ( M. tuberculosis complex, mycobacteria, internal control).…”

Section: Methodsmentioning

confidence: 99%

The Effectiveness of Real-Time PCR Assay, Compared with Microbiologic Results for the Diagnosis of Pulmonary Tuberculosis

Kim

Lee

et al. 2015

Tuberc Respir Dis

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BackgroundThe incidence of tuberculosis (TB) in Korea is relatively high compared to the other Organisation for Economic Co-operation and Development (OECD) countries, with a prevalence of 71 per 100,000 in 2012, although the incidence is declining. Real-time polymerase chain reaction (PCR) has been introduced for the rapid diagnosis of TB. Recently, its advantage lies in higher sensitivity and specificity for the diagnosis of TB. This study evaluated the clinical accuracy of real-time PCR using respiratory specimens in a clinical setting.MethodsReal-time PCR assays using sputum specimens and/or bronchoscopic aspirates from 2,877 subjects were reviewed retrospectively; 2,859 subjects were enrolled. The diagnosis of TB was determined by positive microbiology, pathological findings of TB in the lung and pleura, or clinical suspicion of active TB following anti-TB medication for more than 6 months with a favorable response.ResultsSensitivity, specificity, and accuracy were 44%, 99%, and 86% from sputum, and 65%, 97%, and 87% from bronchoscopic aspirates, respectively. For overall respiratory specimens, sensitivity was 59%, specificity was 98%, and accuracy increased to 89%.ConclusionPositivity in real-time PCR using any respiratory specimens suggests the possibility of active TB in clinically suspected cases, guiding to start anti-TB medication. Real-time PCR from selective bronchoscopic aspirates enhances the diagnostic yield much more when added to sputum examination.

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Section: Methodsmentioning

confidence: 99%

The Effectiveness of Real-Time PCR Assay, Compared with Microbiologic Results for the Diagnosis of Pulmonary Tuberculosis

Kim

Lee

et al. 2015

Tuberc Respir Dis

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“…The AdvanSure tuberculosis/non-tuberculous mycobacteria (TB/NTM) real-time PCR kit (LG Life Sciences, Seoul, Korea) also allows for the identification of clinically important MTB and NTM [ 5 ]. Several studies have shown the efficiency of this kit; however, these evaluations were performed in a limited number of cases [ 5 , 6 , 7 , 8 ]. We compared the clinical performance of AdvanSure TB/NTM real-time PCR and COBAS TaqMan MTB PCR assays in a wide spectrum of clinical specimens obtained over a two-year period (2011-2012).…”

mentioning

confidence: 99%

“…Several studies have assessed the performance of COBAS TaqMan assay [ 4 , 8 , 9 , 10 , 11 , 12 ]; however, only a few studies have assessed the performance of AdvanSure assay [ 5 , 6 , 7 , 8 ]. In general, other studies have found greater sensitivity estimates than those observed in our study, which could probably be attributed to the limited number of samples and different sample compositions used in those studies.…”

mentioning

confidence: 99%

Comparison of AdvanSure TB/NTM PCR and COBAS TaqMan MTB PCR for Detection of Mycobacterium tuberculosis Complex in Routine Clinical Practice

et al. 2015

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The AdvanSure tuberculosis/non-tuberculous mycobacterium (TB/NTM) PCR (LG Life Science, Korea) and COBAS TaqMan Mycobacterium tuberculosis (MTB) PCR (Roche Diagnostics, USA) are commonly used in clinical microbiology laboratories. We aimed to evaluate these two commercial real-time PCR assays for detection of MTB in a large set of clinical samples over a two-year period. AdvanSure TB/NTM PCR and COBAS TaqMan MTB PCR were performed on 9,119 (75.2%) and 3,010 (24.8%) of 12,129 (9,728 respiratory and 2,401 non-respiratory) MTB specimens, with 361 (4.0%) and 102 (3.4%) acid-fast bacilli (AFB)-positive results, respectively. In MTB culture, 788 (6.5%) MTB and 514 (4.2%) NTM were identified. The total sensitivity and specificity of the AdvanSure assay were 67.8% (95% confidence interval [CI], 63.9-71.6) and 98.3% (95% CI, 98.0-98.6), while those of the COBAS TaqMan assay were 67.2% (95% CI, 60.0-73.8) and 98.4% (95% CI, 97.9-98.9), respectively. The sensitivities and specificities of the AdvanSure and COBAS TaqMan assays for AFB-positive and AFB-negative samples were comparable. Furthermore, the AdvanSure assay showed fewer invalid results compared with the COBAS TaqMan assay (5.0 vs. 20.4 invalid results/1,000 tests, P<0.001). AdvanSure assay represents a comparable yet more reliable method than COBAS TaqMan for the identification of mycobacteria in routine clinical microbiology.

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“… 69 Lee and colleagues evaluated the quantitative capability of the AdvanSure TB/NTM real-time PCR kit (LG Life Science, Korea) to determine the cycle threshold (Ct) for the mycobacterial burden. 70 A cut-off Ct value of <33.2 best-predicted stain positivity, with a sensitivity of 95.0% and a specificity of 32.0%. These findings suggest the potential use of AdvanSure TB/NTM real-time PCR kits for quantitatively determining mycobacterial burden.…”

Section: Mycobacterial Load Detection Assaymentioning

confidence: 90%

Molecular Diagnosis of Tuberculosis

et al. 2018

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Tuberculosis (TB) is one of the leading causes of adult death in the Asia-Pacific Region, including Indonesia. As an infectious disease caused by Mycobacterium tuberculosis (MTB), TB remains a major public health issue especially in developing nations due to the lack of adequate diagnostic testing facilities. Diagnosis of TB has entered an era of molecular detection that provides faster and more cost-effective methods to diagnose and confirm drug resistance in TB cases, meanwhile, diagnosis by conventional culture systems requires several weeks. New advances in the molecular detection of TB, including the faster and simpler nucleic acid amplification test (NAAT) and whole-genome sequencing (WGS), have resulted in a shorter time for diagnosis and, therefore, faster TB treatments. In this review, we explored the current findings on molecular diagnosis of TB and drug-resistant TB to see how this advancement could be integrated into public health systems in order to control TB.

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Assessment of the Quantitative Ability of AdvanSure TB/NTM Real-Time PCR in Respiratory Specimens by Comparison with Phenotypic Methods

Cited by 15 publications

References 11 publications

The Effectiveness of Real-Time PCR Assay, Compared with Microbiologic Results for the Diagnosis of Pulmonary Tuberculosis

The Effectiveness of Real-Time PCR Assay, Compared with Microbiologic Results for the Diagnosis of Pulmonary Tuberculosis

Comparison of AdvanSure TB/NTM PCR and COBAS TaqMan MTB PCR for Detection of Mycobacterium tuberculosis Complex in Routine Clinical Practice

Molecular Diagnosis of Tuberculosis

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