Evaluation of the Cobas TaqMan MTB real-time PCR assay for direct detection of Mycobacterium tuberculosis in respiratory specimens

Lee, Meng-Rui; Chung, Kuei-Pin; Wang, Hao-Chien; Lin, Chih-Bin; Yu, Chong‐Jen; Lee, Jen-Jyh; Hsueh, Po-Ren

doi:10.1099/jmm.0.052043-0

Cited by 18 publications

(8 citation statements)

References 27 publications

(49 reference statements)

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“…According to previous studies, the sensitivity and specificity ranges of the Cobas assay are 71.4% to 97.2% and 95.8% to 100%, respectively (6)(7)(8)(9)(10)(11)(12)(13). The sensitivity (78.8%) and specificity (99.5%) of the Cobas assay in this study were also quite similar to those seen in our previous studies (6,7).…”

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confidence: 77%

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Comparison of the Genedia MTB Detection Kit and the Cobas TaqMan MTB Assay for Detection of Mycobacterium tuberculosis in Respiratory Specimens

Huh

Kwon

et al. 2015

J Clin Microbiol

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bThe performance of the Genedia MTB detection kit was compared with that of the Cobas TaqMan MTB test using respiratory specimens. The Genedia and Cobas assays showed comparable sensitivities (81.8% and 78.8%, respectively) and specificities (99.8% and 99.5%, respectively), while the Genedia assay produced fewer invalid results and required less turnaround time and labor.T uberculosis is a worldwide public health concern. According to the 2013 World Health Organization Global Tuberculosis Report, the country of South Korea has an intermediate level of tuberculosis burden, with an incidence rate of 108 per 100,000 inhabitants (1). Rapid diagnoses and drug treatments that prevent person-to-person transmission remain the top priorities in tuberculosis control (2, 3). Therefore, direct detection of Mycobacterium tuberculosis complex DNA using nucleic acid amplification tests has become an important aspect of rapid diagnosis (4).The Genedia MTB detection kit (Genedia assay; Green Cross Medical Science Corp., Chungbuk, Republic of Korea) was recently developed for rapid molecular detection of the M. tuberculosis complex. The Genedia assay is a real-time PCR method targeting IS6110 with TaqMan hydrolysis probes and has been approved by the Korean Ministry of Food and Drug Safety. We compared the performance of this kit to that of the Cobas TaqMan MTB test (Cobas assay; Roche Diagnostics, Basel, Switzerland). The Cobas assay targets the 16S rRNA region and is one of the most widely utilized real-time PCR assays for M. tuberculosis complex detection outside the United States.This study was conducted at a tertiary-care hospital in Seoul, Republic of Korea, and was approved by the Institutional Review Board of the Samsung Medical Center. In total, 629 consecutive respiratory specimens were prospectively collected from patients with suspected pulmonary tuberculosis between November 2013 and August 2014. All specimens were examined by direct microscopy, mycobacterial cultures, and Cobas and Genedia assays, simultaneously.The respiratory specimens were processed with NALC-NaOH (2% N-acetyl-L-cysteine-sodium hydroxide), followed by centrifugation at 3,000 ϫ g for 20 min. An acid-fast bacillus (AFB) smear procedure was performed with an auramine-rhodamine fluorescent stain, followed by confirmation with Ziehl-Neelsen staining. Staining results were graded according to the American Thoracic Society/Centers for Disease Control and Prevention guidelines (5). Specimens were defined as smear positive when the AFB smear grades were between 1 and 4. All specimens were cultured on both solid and liquid media for 6 weeks. Decontaminated samples were inoculated into a mycobacterial growth indicator tube (MGIT 960 system; Becton Dickinson, Sparks, MD) and on 3% Ogawa agar (Shinyang, Seoul, Republic of Korea). Positive cultures were confirmed both by the presence of cord formation and by MPT64 antigen testing (SD Bioline TB Ag MPT64 Rapid test; Standard Diagnostics Inc., Yongin-si, South Korea), a rapid immunochromatographic assay. When ei...

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confidence: 77%

“…There were two false-positive specimens misidentified by the Cobas assay that were smear negative. The low (40.0%) sensitivity with smear-negative specimens is a limitation of these assays (10). Note that there were no invalid results produced by the Genedia assay.…”

mentioning

confidence: 99%

Comparison of the Genedia MTB Detection Kit and the Cobas TaqMan MTB Assay for Detection of Mycobacterium tuberculosis in Respiratory Specimens

Huh

Kwon

et al. 2015

J Clin Microbiol

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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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“…The CobasTaq-Man MTB assay, which includes two major steps of DNA extraction and PCR amplification, is conducted according to the manufacturer's instructions 17 . Studies have shown that the CobasTaqMan MTB assay is at least as sensitive as its predecessor, the CobasAmplicor MTB system 18 19 . Commercial assay such as the CobasAmplicor MTB assay or CobasTaqMan MTB assay has been widely used in clinical mycobacteriology laboratories for direct specimen detection of MTBC DNA in the past 20 years 20 21 .…”

Section: Molecular Methods In Tb Diagnosismentioning

confidence: 99%

Pulmonary Tuberculosis Diagnosis: Where We Are?

et al. 2016

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In recent years, in spite of medical advancement, tuberculosis (TB) remains a worldwide health problem. Although many laboratory methods have been developed to expedite the diagnosis of TB, delays in diagnosis remain a major problem in the clinical practice. Because of the slow growth rate of the causative agent Mycobacterium tuberculosis, isolation, identification, and drug susceptibility testing of this organism and other clinically important mycobacteria can take several weeks or longer. During the past several years, many methods have been developed for direct detection, species identification, and drug susceptibility testing of TB. A good understanding of the effectiveness and practical limitations of these methods is important to improve diagnosis. This review summarizes the currently-used advances in nonmolecular and molecular diagnostics.

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Evaluation of the Cobas TaqMan MTB real-time PCR assay for direct detection of Mycobacterium tuberculosis in respiratory specimens

Cited by 18 publications

References 27 publications

Comparison of the Genedia MTB Detection Kit and the Cobas TaqMan MTB Assay for Detection of Mycobacterium tuberculosis in Respiratory Specimens

Comparison of the Genedia MTB Detection Kit and the Cobas TaqMan MTB Assay for Detection of Mycobacterium tuberculosis in Respiratory Specimens

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

Pulmonary Tuberculosis Diagnosis: Where We Are?

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