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

Cho, Won Hyung; Won, Eun Jeong; Choi, Hyun Jung; Kee, Seung‐Jung; Shin, Jong Hee; Ryang, Dong‐Wook; Suh, Soon Pal

doi:10.3343/alm.2015.35.3.356

Cited by 29 publications

(23 citation statements)

References 14 publications

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“…Cho et al . also reported similarly that the diagnostic sensitivities of COBAS TaqMan MTB PCR for smear‐positive, smear‐negative, respiratory and non‐respiratory specimens were 99%, 49%, 71% and 33%, respectively . In our study, 96.5% of specimens had EBUS‐TBNA needle rinse fluid from intrathoracic lymph nodes (paucibacillary specimens) and only 2 patients (1.9%) had smear‐positive specimens in 104 patients with intrathoracic TB lymphadenitis.…”

Section: Discussionsupporting

confidence: 68%

Clinical usefulness of routine AFB culture and MTB PCR of EBUS‐TBNA needle rinse fluid

Jeong

Chon

et al. 2019

Respirology

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Background and objective:We evaluated the usefulness of acid-fast bacilli (AFB) culture and Mycobacterium tuberculosis (MTB) polymerase chain reaction (PCR) of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) needle rinse fluid for diagnosing tuberculous lymphadenitis. Methods: EBUS-TBNA needle rinse fluid was routinely used for AFB culture and MTB PCR. The patients were categorized according to the pre-procedural diagnosis (Group A, suspected/histology-confirmed lung cancer; Group B, extrapulmonary malignancy; and Group C, other benign diseases). Results: Of the 4672 subjects, 104 (2.2%) were diagnosed with tuberculous lymphadenitis; 1.0%, 4.6% and 12.7% of Group A, B and C, respectively. Tuberculous lymphadenitis was diagnosed in 0.2%, 1.0% and 4.5% Group A, B and C patients, respectively, by histopathology. On addition of AFB culture to histopathology, tuberculous lymphadenitis was diagnosed in 1.0%, 4.4% and 10.3% of Group A, B and C patients, respectively (P < 0.001, P = 0.001 and P = 0.005, respectively). On addition of MTB PCR to histopathology, tuberculous lymphadenitis was diagnosed in 0.4%, 1.9% and 8.8%, respectively (Group C; P = 0.029). Conclusion: Routine AFB culture of needle rinse fluid was useful to increase the diagnostic yield of tuberculous lymphadenitis for all subjects who underwent EBUS-TBNA regardless of pre-procedural diagnosis in an intermediate tuberculosis (TB)-burden country. However, MTB PCR was only useful in subjects with pre-procedural diagnosis of benign pulmonary diseases.The routine acid-fast bacilli (AFB) culture of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) needle rinse fluid is useful to increase the diagnostic yield of tuberculous lymphadenitis in an intermediate tuberculosis (TB)burden country.

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Section: Discussionsupporting

confidence: 68%

Clinical usefulness of routine AFB culture and MTB PCR of EBUS‐TBNA needle rinse fluid

Jeong

Chon

et al. 2019

Respirology

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“…However, the sensitivity, specificity, PPV, and NPV of TB/NTM real-time PCR kit can be comparable with previous reports tested with other commercial TB PCR kits in the present study. [ 6 , 16 , 20 – 22 ] Moreover, the diagnostic accuracy of Xpert MTB/RIF assay in this study was accorded to the alleged diagnostic sensitivity and specificity of Xpert MTB/RIF assay on not only sputum but bronchoscopy specimens as well, which has been reported to be approximately 60–94% sensitive and 98–100% specific. [ 8 , 23 – 25 ]…”

Section: Discussionmentioning

confidence: 71%

Discordance between MTB/RIF and Real-Time Tuberculosis-Specific Polymerase Chain Reaction Assay in Bronchial Washing Specimen and Its Clinical Implications

Park

Lee

et al. 2016

PLoS ONE

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The prevalence and clinical implications of discordance between Xpert MTB/RIF assays and the AdvanSure TB/NTM real-time polymerase chain reaction (PCR) for bronchial washing specimens have not been studied in pulmonary TB (PTB) patients. The discordant proportion and its clinical impact were evaluated in 320 patients from the bronchoscopy registry whose bronchial washing specimens were tested simultaneously with Xpert MTB/RIF and the TB/NTM PCR assay for three years, and the accuracy of the assays, including the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), were studied. The clinical risk factors for discordance and false positivity of assays were also studied. Among 130 patients who were clinically diagnosed with PTB, 64 patients showed positive acid-fast bacilli culture results, 56 patients showed positive results in molecular methods and clinician diagnosed PTB without results of microbiology in 10 patients. The sensitivity, specificity, PPV, and NPV were 80.0%, 98.95%, 98.1%, and 87.9%, respectively, for Xpert MTB/RIF and 81.5%, 92.6%, 88.3%, and 88.0%, respectively, for TB/NTM PCR. The discordant proportion was 16.9% and was higher in culture-negative PTB compared to culture-confirmed PTB (24.3% vs. 9.4%, p = 0.024). However, there were no significant differences in the clinical characteristics, regardless of the discordance. The diagnostic yield increased with an additional assay (7.7% for Xpert MTB/RIF and 9.2% for TB/NTM PCR). False positivity was less common in patients tested with Xpert MTB/RIF (1.05% vs. 7.37%, p = 0.0035). No host-related risk factor for false positivity was identified. The Xpert MTB/RIF and TB/NTM PCR assay in bronchial washing specimens can improve the diagnostic yields for PTB, although there were considerable discordant results without any patient-related risk factors.

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“…1 ). Twenty-one [ 10 , 24 , 25 , 27 , 29 , 31 , 32 , 39 , 44 , 45 , 47 , 49 , 51 , 52 , 54 , 57 , 60 , 61 , 64 , 66 , 67 ] reported detection of pulmonary TB (PTB), fifteen [ 23 , 30 , 33 , 35 , 37 , 38 , 40 – 42 , 50 , 53 , 55 , 56 , 59 , 62 ] reported detection of extra-pulmonary TB (EPTB) and ten [ 26 , 28 , 34 , 36 , 43 , 46 , 48 , 58 , 63 , 65 ] reported on both types of pathological sample. Table 1 summarises the main characteristics of the included studies.…”

Section: Resultsmentioning

confidence: 99%

Effectiveness of real-time polymerase chain reaction assay for the detection of Mycobacterium tuberculosis in pathological samples: a systematic review and meta-analysis

et al. 2017

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BackgroundRapid and accurate diagnosis of tuberculosis (TB) is key to manage the disease and to control and prevent its transmission. Many established diagnostic methods suffer from low sensitivity or delay of timely results and are inadequate for rapid detection of Mycobacterium tuberculosis (MTB) in pulmonary and extra-pulmonary clinical samples. This study examined whether a real-time polymerase chain reaction (RT-PCR) assay, with a turn-a-round time of 2 h, would prove effective for routine detection of MTB by clinical microbiology laboratories.MethodsA systematic literature search was performed for publications in any language on the detection of MTB in pathological samples by RT-PCR assay. The following sources were used MEDLINE via PubMed, EMBASE, BIOSIS Citation Index, Web of Science, SCOPUS, ISI Web of Knowledge and Cochrane Infectious Diseases Group Specialised Register, grey literature, World Health Organization and Centres for Disease Control and Prevention websites. Forty-six studies met set inclusion criteria. Generated pooled summary estimates (95% CIs) were calculated for overall accuracy and bivariate meta-regression model was used for meta-analysis.ResultsSummary estimates for pulmonary TB (31 studies) were as follows: sensitivity 0.82 (95% CI 0.81–0.83), specificity 0.99 (95% CI 0.99–0.99), positive likelihood ratio 43.00 (28.23–64.81), negative likelihood ratio 0.16 (0.12–0.20), diagnostic odds ratio 324.26 (95% CI 189.08–556.09) and area under curve 0.99. Summary estimates for extra-pulmonary TB (25 studies) were as follows: sensitivity 0.70 (95% CI 0.67–0.72), specificity 0.99 (95% CI 0.99–0.99), positive likelihood ratio 29.82 (17.86–49.78), negative likelihood ratio 0.33 (0.26–0.42), diagnostic odds ratio 125.20 (95% CI 65.75–238.36) and area under curve 0.96.ConclusionsRT-PCR assay demonstrated a high degree of sensitivity for pulmonary TB and good sensitivity for extra-pulmonary TB. It indicated a high degree of specificity for ruling in TB infection from sampling regimes. This was acceptable, but may better as a rule out add-on diagnostic test. RT-PCR assays demonstrate both a high degree of sensitivity in pulmonary samples and rapidity of detection of TB which is an important factor in achieving effective global control and for patient management in terms of initiating early and appropriate anti-tubercular therapy.Systematic review registrationPROSPERO CRD42015027534.Electronic supplementary materialThe online version of this article (10.1186/s13643-017-0608-2) contains supplementary material, which is available to authorized users.

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

Cited by 29 publications

References 14 publications

Clinical usefulness of routine AFB culture and MTB PCR of EBUS‐TBNA needle rinse fluid

Clinical usefulness of routine AFB culture and MTB PCR of EBUS‐TBNA needle rinse fluid

Discordance between MTB/RIF and Real-Time Tuberculosis-Specific Polymerase Chain Reaction Assay in Bronchial Washing Specimen and Its Clinical Implications

Effectiveness of real-time polymerase chain reaction assay for the detection of Mycobacterium tuberculosis in pathological samples: a systematic review and meta-analysis

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