Comparison of Xpert MTB/RIF with ProbeTec ET DTB and COBAS TaqMan MTB for direct detection of M. tuberculosis complex in respiratory specimens

Antonenka, Uladzimir; Hofmann-Thiel, Sabine; Turaev, Laziz; Esenalieva, A; Abdulloeva, Mokhonim; Sahalchyk, Evgeni; Alnour, Tarig M.S.; Hoffmann, Harald

doi:10.1186/1471-2334-13-280

Cited by 43 publications

(34 citation statements)

References 20 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: 77%

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: 77%

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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“…However, commercial and in-house NAATs for infectious diseases utilize different technologies, reaction chemistries, and calibration materials, leading to demonstrable variability in the test results in terms of (i) numerical values (e.g., numbers of genome copies) for quantitative methods or (ii) presence or absence of the pathogen for qualitative methods (3)(4)(5).…”

mentioning

confidence: 99%

Standardization of Nucleic Acid Tests for Clinical Measurements of Bacteria and Viruses

Pavšič

Devonshire²,

Parkes³

et al. 2015

J Clin Microbiol

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f Nucleic acid-based tests for infectious diseases currently used in the clinical laboratory and in point-of-care devices are diverse. Measurement challenges associated with standardization of quantitative viral load testing are discussed in relation to human cytomegalovirus, BK virus, and Epstein-Barr virus, while the importance of defining the performance of qualitative methods is illustrated with Mycobacterium tuberculosis and influenza virus. The development of certified reference materials whose values are traceable to higher-order standards and reference measurement procedures, using, for instance, digital PCR, will further contribute to the understanding of analytical performance characteristics and promote clinical data comparability. Molecular approaches, such as nucleic acid (NA) amplification-based tests (NAATs) and sequence analysis, are increasingly replacing conventional microbiological methods, such as pathogen propagation in culture and techniques for the detection of antigens, for (i) viral load quantification, (ii) the detection of pathogenic viruses and bacteria, (iii) monitoring viral and bacterial resistance to therapeutic agents, and (iv) monitoring transmission across communities, as they often enable faster, more accurate, or more sensitive measurements (1, 2). However, commercial and in-house NAATs for infectious diseases utilize different technologies, reaction chemistries, and calibration materials, leading to demonstrable variability in the test results in terms of (i) numerical values (e.g., numbers of genome copies) for quantitative methods or (ii) presence or absence of the pathogen for qualitative methods (3-5).The In Vitro Diagnostics Directive (IVDD) in Europe has promoted assay standardization in the clinical laboratory community, through requiring manufacturers to provide information about the traceability of their calibrators (for definitions of terms in italics, see Table 1), in compliance with ISO 17511 (6). The concept of metrological traceability in clinical chemistry and laboratory medicine has been comprehensively discussed in several articles (7-9). For small-molecule measurements in clinical chemistry, such as those of blood glucose, creatinine, cortisol, and electrolytes, reference measurement procedures of high metrological quality are available which relate the quantity value of the calibrators and reference materials used in a calibration hierarchy traceable to the International System of Units (SI) as described in ISO 17511 (6, 8). However, for the majority of the more complex biomeasurements, including those based on NA testing and infectious pathogen detection, reference materials whose values are traceable to the SI and reference measurement procedures (with well-understood uncertainty) are not yet available. ISO 17511 indicates recognition of the fact that, for measurements of, for example, viral NAs (for human cytomegalovirus [CMV], human immunodeficiency virus [HIV], and hepatitis B virus [HBV]), typically WHO international standards (IS) are available, w...

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“…A sua utilidade na detecção do bacilo, em amostras com baciloscopia e cultura negativas, necessita de mais estudos. Antonenka et al 33 33 .…”

Section: Discussionunclassified

Teste rápido molecular GeneXpert MTB/RIF para diagnóstico da tuberculose

Maschio-Lima

Belotti

Nardi

et al. 2017

Revista Pan-Amazônica de Saúde

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RESUMOINTRODUÇÃO: Em 2013, no Sistema Único de Saúde, foi implantada uma ferramenta rápida para o diagnóstico da tuberculose (TB), o método GeneXpert MTB/RIF, que detecta a presença do material genético do complexo Mycobacterium tuberculosis e a resistência à rifampicina em uma única reação, fornecendo resultados dentro de 2 h. OBJETIVO: Analisar os resultados da utilização do método GeneXpert para o diagnóstico laboratorial da TB. METODOLOGIA: Realizou-se uma revisão de literatura sobre o método GeneXpert, com a utilização de manuais e artigos, em diferentes idiomas, das fontes MEDLINE, SciELO, LILACS e Google Acadêmico, na qual foram selecionados 60 artigos. RESULTADOS: Dos 49 artigos que relataram o uso de material clínico, 51,0% (N = 25) analisaram amostras provenientes de países considerados prioritários pela Organização Mundial da Saúde. Embora 63,2% (N = 31) dos artigos se reportem a amostras pulmonares, alguns estudos mostraram boa performance do método em amostras extrapulmonares. A sensibilidade do GeneXpert nos estudos analisados variou entre 46,0% e 100,0%. As pesquisas revelaram bom desempenho do método molecular GeneXpert para o diagnóstico da TB. A técnica é considerada simples, com baixos riscos biológicos, com custo equivalente ao de outras técnicas moleculares, e pode ser realizada com treinamento mínimo. CONCLUSÃO: Muitos estudos apontaram a rapidez, a boa sensibilidade e a especificidade desse método. O GeneXpert ainda não elimina a necessidade do uso de métodos bacteriológicos tradicionais. Trabalhos futuros poderão esclarecer algumas divergências entre as pesquisas consultadas, principalmente em relação à resistência à rifampicina.

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Comparison of Xpert MTB/RIF with ProbeTec ET DTB and COBAS TaqMan MTB for direct detection of M. tuberculosis complex in respiratory specimens

Cited by 43 publications

References 20 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

Standardization of Nucleic Acid Tests for Clinical Measurements of Bacteria and Viruses

Teste rápido molecular GeneXpert MTB/RIF para diagnóstico da tuberculose

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