Performance Assessment of the DR. TBDR/NTM IVD Kit for Direct Detection of Mycobacterium tuberculosis Isolates, Including Rifampin-Resistant Isolates, and Nontuberculous Mycobacteria

Lee, Meng-Rui; Cheng, Aristine; Huang, Yu-Tsung; Liu, Chia-Ying; Chung, Kuei-Pin; Wang, Hao-Chien; Liang, Sheng-Kai; Liao, Chun-Hsing; Yu, Chong‐Jen; Hsueh, Po-Ren

doi:10.1128/jcm.01862-12

Cited by 17 publications

(10 citation statements)

References 21 publications

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“…The mixed culture rate (4.4%) was less than that (12%) reported by Shenai et al [ 19 ], but similar to that (3.2%) reported by Lu et al [ 12 ]. Because conventional culture techniques are based on isolation followed by colony identification, they tend to isolate a single species of Mycobacterium with a more rapid growth rate or a dominant cell number in a sample and tend to underestimate the number of isolates among specimens containing more than one Mycobacterium species [ 13 ].…”

Section: Discussionmentioning

confidence: 99%

“…The results of mycobacterial species identification by the BluePoint MycoID plus kit and by the culture method were initially evaluated and compared. When there was a difference in the species identification results obtained by the kit and by the culture method, 16S rRNA sequencing analysis was used for further species identification [ 13 ]. Sequencing analysis of the 16S rRNA gene was performed using two primers F(5’-GAAGAGTTTGATCMTGGCTC-3’ and R(5’-GCGTGGACTACCAGGGTATC-3’) and the resulting sequence was used for a BLAST search [ 14 ].…”

Section: Discrepant Analysismentioning

confidence: 99%

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Performance Assessment of the BluePoint MycoID Plus Kit for Identification of Mycobacterium tuberculosis, Including Rifampin- and Isoniazid-resistant Isolates, and Nontuberculous Mycobacteria

et al. 2015

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The performance of the BluePoint MycoID plus kit (Bio Concept Corporation, Taichung, Taiwan), which was designed to simultaneously detect Mycobacterium tuberculosis (MTB), rifampin- and isoniazid-resistant MTB, and nontuberculous mycobacteria (NTM) was first evaluated with 950 consecutive positive cultures in Mycobacterium Growth Indicator Tube (MGIT) system (BACTEC, MGIT 960 system, Becton-Dickinson, Sparks) from clinical respiratory specimens. The discrepant results between kit and culture-based identification were finally assessed by 16S rRNA gene sequencing and clinical diagnosis. The accuracy rate of this kit for identification of all Mycobacterium species was 96.3% (905/940). For MTB identification, the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the kit were 99.7%, 99.3%, 99.0% and 99.8%, respectively. For rifampicin-resistant MTB identification, the sensitivity, specificity, PPV, and NPV of the kit were 100.0%, 99.4%, 91.3%, and 100.0%, respectively, while the corresponding values of isoniazid-resistant MTB identification were 82.6%, 99.4%, 95.0%, and 97.6%, respectively. In identifying specific NTM species, the kit correctly identified 99.3% of M. abscessus (147/148) complex, 100% of M. fortuitum (32/32), M. gordonae (38/38), M. avium (39/39), M. intracellulare (90/90), M. kansasii (36/36), and M. avium complex species other than M. avium and M. intracellulare (94/94). In conclusions, the diagnostic value of the BluePoint MycoID plus kit was superior to culture method for recoveries and identification of NTM to species level. In addition, the diagnostic accuracy of BluePoint MycoID plus kit in MTB identification was similar to conventional culture method with high accuracy rate of rifampicin-resistant M. tuberculosis identification.

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Section: Discussionmentioning

confidence: 99%

Section: Discrepant Analysismentioning

confidence: 99%

Performance Assessment of the BluePoint MycoID Plus Kit for Identification of Mycobacterium tuberculosis, Including Rifampin- and Isoniazid-resistant Isolates, and Nontuberculous Mycobacteria

et al. 2015

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“…Detailed species differentiation between MAC and M. chelonae-abscessus was also not performed. Though epidemiologically and therapeutically significant, the molecular method is not readily available in many laboratories and may not be practical in clinical practice [29], [30]. Third, this study does not have a control group (for example, patients with pulmonary tuberculosis and patients with other pulmonary diseases).…”

Section: Discussionmentioning

confidence: 99%

Factors Associated with Lung Function Decline in Patients with Non-Tuberculous Mycobacterial Pulmonary Disease

et al. 2013

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BackgroundThere is paucity of risk factors on lung function decline among patients with non-tuberculous mycobacteria (NTM) pulmonary disease in literature.MethodsPatients with NTM pulmonary disease between January 2000 and April 2011 were retrospectively selected. Sixty-eight patients had at least two pulmonary function tests within a mean follow-up period of 47 months.ResultsSixty-eight patients were included. They had a median age of 65 years and 65% had impaired lung function (Forced expiratory volume in 1 second [FEV1] <80% of predicted value). The mean FEV1 decline was 48 ml/year. By linear regression, younger age (beta: 0.472, p<0.001), initial FEV1>50% of predicted value (beta: 0.349, p = 0.002), male sex (beta: 0.295, p = 0.018), bronchiectasis pattern (beta: 0.232, p = 0.035), and radiographic score >3 (beta: 0.217, p = 0.049) were associated with greater FEV1 decline. Initial FEV1>50% of predicted value (beta: 0.263, p = 0.032) was also associated with greater FVC annual decline, whereas M. kansasii pulmonary disease was marginally associated with greater annual FVC decline (beta: 0.227, p = 0.062).ConclusionsNTM pulmonary disease is associated with greater decline in lung function in patients who are young, male, with bronchiectasis, and with a high radiographic score. Special attention should be given to patients with these risk factors.

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“…Microarray analysis of M. tuberculosis has facilitated a range of additional studies to provide important contributions on its mechanisms of drug resistance, host–pathogen interactions, in vitro and in vivo gene expression and functional analysis of particular genes . Previously, several in‐house or commercial arrays were designed for differentiating the M. tuberculosis complex from non‐tuberculous mycobacteria and for rapid detection of MDR and mono‐drug‐resistant M. tuberculosis as well as M. tuberculosis that is resistant to second‐line anti‐TB drugs . The TB‐Biochip oligonucleotide microarray system (Engelhardt Institute of Molecular Biology, Moscow, Russia), evaluated by Caoili et al .…”

Section: Introductionmentioning

confidence: 99%

Rapid and accurate detection of rifampin and isoniazid-resistant Mycobacterium tuberculosis using an oligonucleotide array

Huang¹,

Hsu²,

Chang

et al. 2014

Clinical Microbiology and Infection

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To rapidly detect rifampin, isoniazid and multidrug resistance in Mycobacterium tuberculosis isolates, a new system (BluePoint MtbDR, Bio Concept Inc., Taichung, Taiwan) including an oligonucleotide array and an automatic reader was evaluated. The array simultaneously identifies M. tuberculosis and predominant mutations in the rpoB, katG and inhA upstream regulatory region (inhA-r) genes. The system was assessed with 324 clinical M. tuberculosis isolates, including 210 multidrug-resistant, 41 rifampin mono-resistant, 34 isoniazid mono-resistant and 39 fully susceptible isolates. The results were compared with those obtained using the GenoType MTBDRplus test, drug-resistant gene sequencing and conventional drug susceptibility testing. The detection limit of the array was 25 pg DNA. The array and the GenoType MTBDRplus test detected 179 (85.2%) and 182 (86.7%) multidrug-resistant M. tuberculosis strains, respectively. The sensitivities of the array for detecting rifampin and isoniazid resistance were 98.4% and 87.7%, respectively, whereas the sensitivities of the GenoType MTBDRplus test for detecting rifampin and isoniazid resistance were 98.8% and 88.9%, respectively. No significant difference was found between the tests with respect to their sensitivities to detect multidrug resistance (p 0.66), rifampin resistance (p 0.69) or isoniazid resistance (p 0.68). The discrepancies were mainly attributed to rare mutations in inhA-r, which were not included in the array. The array can directly reveal transmission-associated mutations, which are useful for epidemiological investigations. The turnaround time of the array test was 6-7 h. This study confirms the feasibility of using this system for rapid and accurate diagnosis of isoniazid and rifampin resistance in M. tuberculosis.

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Performance Assessment of the DR. TBDR/NTM IVD Kit for Direct Detection of Mycobacterium tuberculosis Isolates, Including Rifampin-Resistant Isolates, and Nontuberculous Mycobacteria

Cited by 17 publications

References 21 publications

Performance Assessment of the BluePoint MycoID Plus Kit for Identification of Mycobacterium tuberculosis, Including Rifampin- and Isoniazid-resistant Isolates, and Nontuberculous Mycobacteria

Performance Assessment of the BluePoint MycoID Plus Kit for Identification of Mycobacterium tuberculosis, Including Rifampin- and Isoniazid-resistant Isolates, and Nontuberculous Mycobacteria

Factors Associated with Lung Function Decline in Patients with Non-Tuberculous Mycobacterial Pulmonary Disease

Rapid and accurate detection of rifampin and isoniazid-resistant Mycobacterium tuberculosis using an oligonucleotide array

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