Evaluation of Cobas TaqMan MTB for Direct Detection of the Mycobacterium tuberculosis Complex in Comparison with Cobas Amplicor MTB

Bloemberg, Guido V.; Voit, Antje; Ritter, Claudia; Deggim, Vanessa; Böttger, Erik C.

doi:10.1128/jcm.00142-13

Cited by 47 publications

(38 citation statements)

References 23 publications

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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).…”

supporting

confidence: 89%

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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supporting

confidence: 89%

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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“…These performance values of the Abbott system were better than those reported in various studies for the Cobas TaqMan MTB assay [8,[14][15][16][17]. The high sensitivity and specificity indicated that the chance of production of false positives and negatives in the Abbott system was low.…”

Section: Discussioncontrasting

confidence: 54%

“…However, due to the low sensitivity of AFB smear and the long turn-around time of mycobacterial culture, PCR-based detection assays have been introduced for rapid detection of MTBC DNA from clinical specimens [6]. Commercial assays such as the Cobas Amplicor MTB or the Cobas TaqMan MTB assay (Roche Diagnostics, Switzerland) have been widely used in clinical mycobacteriology laboratories for direct specimen detection of MTBC DNA in the past 20 years [7,8]. These assays could significantly reduce the diagnostic time from weeks to hours, which can greatly improve patient care and infection control.…”

Section: Introductionmentioning

confidence: 99%

Performance of the new automated Abbott RealTime MTB assay for rapid detection of Mycobacterium tuberculosis complex in respiratory specimens

Chen

She

Kwong

et al. 2015

Eur J Clin Microbiol Infect Dis

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The automated high-throughput Abbott RealTime MTB real-time PCR assay has been recently launched for Mycobacterium tuberculosis complex (MTBC) clinical diagnosis. This study would like to evaluate its performance. We first compared its diagnostic performance with the Roche Cobas TaqMan MTB assay on 214 clinical respiratory specimens. Prospective analysis of a total 520 specimens was then performed to further evaluate the Abbott assay. The Abbott assay showed a lower limit of detection at 22.5 AFB/ml, which was more sensitive than the Cobas assay (167.5 AFB/ml). The two assays demonstrated a significant difference in diagnostic performance (McNemar's test; P = 0.0034), in which the Abbott assay presented significantly higher area under curve (AUC) than the Cobas assay (1.000 vs 0.880; P = 0.0002). The Abbott assay demonstrated extremely low PCR inhibition on clinical respiratory specimens. The automated Abbott assay required only very short manual handling time (0.5 h), which could help to improve the laboratory management. In the prospective analysis, the overall estimates for sensitivity and specificity of the Abbott assay were both 100 % among smear-positive specimens, whereas the smear-negative specimens were 96.7 and 96.1 %, respectively. No cross-reactivity with non-tuberculosis mycobacterial species was observed. The superiority in sensitivity of the Abbott assay for detecting MTBC in smear-negative specimens could further minimize the risk in MTBC false-negative detection. The new Abbott RealTime MTB assay has good diagnostic performance which can be a useful diagnostic tool for rapid MTBC detection in clinical laboratories.

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“…Овај недостатак специфичности могао би бити превладан подизањем граничне вриједности COBAS AMPLICOR MTB Теста, а не биолошким основама за ову потенцијалну унакрсну реактивност. У својој студији, Bloemberg et al су додатно анализирајући групу од 133 клиничка узорка, који су били лажно позитивни на COBAS AMPLICOR MTB Тесту, примјеном real-time COBAS TaqMan MTB Теста, добили укупну подударност између ова два теста од 98.2%, оповргавајући тако могућност опште унакрсне реактивност теста с филогенетски блиским врстама (Bloemberg et al, 2013). Контаминација узорака током лабораторијске обраде такођер може довести до појаве лажно позитивних резултата који утичу на специфичност теста.…”

Section: дискусијаunclassified

РЕТРОСПЕКТИВНА ЕВАЛУАЦИЈА COBAS AMPLICOR MTB ТЕСТА У ДЕТЕКЦИЈИ Mycobacterium tuberculosis ИЗ РЕСПИРАТОРНИХ УЗОРАКА

Халиловић¹,

Нумановић²,

Тихић³

et al. 2016

SBERS

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Traditional methods for detection of mycobacteria are limited by low sensitivity and/or specificity, with the time necessary for the identification of Mycobacterium tuberculosis of several weeks. A number of molecular techniques, including different biomarkers, have been developed for rapid identification of mycobacteria. The aim of this study was to evaluate the reliability of the COBAS AMPLICOR MTB Test in detection of Mycobacterium tuberculosis in respiratory specimens. Samples were decontaminated with N-acetyl-L-cysteine-sodium hydroxide (NALC-NaOH). One drop was used for detection of acid-fast bacilli positive-smears by Ziehl-Neelsen (ZN) staining, 200 µL to inoculate Löwenstein-Jensen (LJ) medium, 500 µL for cultivation in BACTEC MGIT 960 System, and 100 µL for the COBAS AMPLICOR MTB Test, performed according to manufacturer's recommendations. Out of 100 samples, 50 samples were smear-positive and 50 smear-negative. Mycobacterium tuberculosis was isolated from 59 samples by at least one cultivation method. After the analysis of inconsistent results, the overall sensitivity, specificity, positive and negative predictive value of the COBAS AMPLICOR MTB Test were 94.93%, 100%, 100% and 91.89% compared to diagnostic cultures, with an inhibition rate 2%. The values for smear-positive and smear-negative samples were 97.87%, 100%, 100%, 50%, and 83.33%, 100%, 100% and 94.29%, respectively. The greater numbers of positive samples were detected using the COBAS AMPLICOR MTB Test than by direct microscopy. Based on the obtained results, considering the methodological simplicity and completely automatized amplification and detection, the COBAS AMPLICOR MTB Test has proven to be very reliable in the diagnosis of tuberculosis (TB).

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Evaluation of Cobas TaqMan MTB for Direct Detection of the Mycobacterium tuberculosis Complex in Comparison with Cobas Amplicor MTB

Cited by 47 publications

References 23 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

Performance of the new automated Abbott RealTime MTB assay for rapid detection of Mycobacterium tuberculosis complex in respiratory specimens

РЕТРОСПЕКТИВНА ЕВАЛУАЦИЈА COBAS AMPLICOR MTB ТЕСТА У ДЕТЕКЦИЈИ Mycobacterium tuberculosis ИЗ РЕСПИРАТОРНИХ УЗОРАКА

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