Analytical and clinical performance characteristics of the Abbott RealTime MTB RIF/INH Resistance, an assay for the detection of rifampicin and isoniazid resistant Mycobacterium tuberculosis in pulmonary specimens

Tuberculosis

Volumn 101, Issue , 2016, Pages 137-143

  Kostera, Joshua ^a   Leckie, Gregor ^a   Tang, Ning ^a   Lampinen, John ^a   Szostak, Magdalena ^a   Abravaya, Klara ^a   Wang, Hong ^a  

^a Abbott Molecular Inc   (United States)

Author keywords

Isoniazid; Mycobacterium; Reflex; Rifampicin; Sensitivity; Specificity

Indexed keywords

ETHAMBUTOL; ISONIAZID; PYRAZINAMIDE; RIFAMPICIN; STREPTOMYCIN; TUBERCULOSTATIC AGENT;

ABBOTT REALTIME MYCOBACTERIUM TUBERCULOSIS RIFAMPICIN ISONIAZID ASSAY; ANIMAL TISSUE; ANTIBIOTIC RESISTANCE; ANTIBIOTIC SENSITIVITY; ARTICLE; BRONCHOALVEOLAR LAVAGE FLUID; COLONY FORMING UNIT; CONTROLLED STUDY; DIAGNOSTIC VALUE; DRUG RESISTANT TUBERCULOSIS; HUMAN; HUMAN CELL; IMMUNOASSAY ANALYZER; INTERMETHOD COMPARISON; LIMIT OF DETECTION; MOLECULAR DIAGNOSIS; MYCOBACTERIUM TUBERCULOSIS; NONHUMAN; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; SPUTUM ANALYSIS; SPUTUM SMEAR; BACTERIAL COUNT; DRUG EFFECTS; GENETICS; GROWTH, DEVELOPMENT AND AGING; ISOLATION AND PURIFICATION; MICROBIAL SENSITIVITY TEST; MICROBIOLOGY; MULTIDRUG RESISTANCE; MUTATION; PROCEDURES; SPECIMEN HANDLING; TUBERCULOSIS, MULTIDRUG-RESISTANT; TUBERCULOSIS, PULMONARY;

ANTITUBERCULAR AGENTS; COLONY COUNT, MICROBIAL; DRUG RESISTANCE, MULTIPLE, BACTERIAL; HUMANS; ISONIAZID; MICROBIAL SENSITIVITY TESTS; MUTATION; MYCOBACTERIUM TUBERCULOSIS; RIFAMPIN; SENSITIVITY AND SPECIFICITY; SPECIMEN HANDLING; TUBERCULOSIS, MULTIDRUG-RESISTANT; TUBERCULOSIS, PULMONARY;

EID: 84993982026     PISSN: 14729792     EISSN: 1873281X     Source Type: Journal    
DOI: 10.1016/j.tube.2016.09.006     Document Type: Article

References (21)

1. [1] World Health Organization (WHO), Global tuberculosis report., 2014.
2. [2] WHO, Molecular line probe assays for rapid screening of patients at risk for multi-drug resistant tuberculosis (MDR-TB). 2008.
3. [3] WHO, Automated Real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MB/RIF system. 2011.
4. [4] WHO, Implementing tuberculosis diagnostics, policy framework. 2015.
5. [5] Updated guidelines for the use of nucleic acid amplification tests in the diagnosis of tuberculosis. Morb Mortal Wkly Rep 58:1 (2009), 7–10.
6. [6] Availability of an assay for detecting Mycobacterium tuberculosis, including rifampin-resistant strains, and considerations for its use. Morb Mortal Wkly Rep 62 (2013), 821–824.
7. [7] Tang, N., Frank, A., Pahalawatta, V., Lampinen, J., Coblenz-Korte, A., Dunn, C., et al. Analytical and clinical performance of Abbott RealTime MTB, an assay for detection of Mycobacterium tuberculosis in pulmonary specimens. Tuberculosis 95 (2015), 613–619.
8. [8] Chen, J.H.K., She, K.K.K., Kwong, T.-C., Wong, O.-Y., Siu, G.K.H., Leung, C.-C., et al. Performance of the new automated Abbott RealTime MTB assay for rapid detection of Mycobacterium tuberculosis complex in respiratory specimens. Eur J Clin Microbiol Infect Dis 34 (2015), 1827–1832.
9. [9] Qi, C., Wallis, C., Pahalawatta, V., Frank, A., Ramdin, N., Viana, R., et al. Evaluation of the efficiency of the sample inactivation reagent in the Abbott RealTime MTB assay for inactivation of Mycobacterium tuberculosis. J Clin Microbiol 53 (2015), 3001–3002.
10. [10] Da Silva, P.E.A., Palomino, J.C., Molecular basis and mechanisms of drug resistance in Mycobacterium tuberculosis: classical and new drugs. J Antimicrob Chemother 66 (2011), 1417–1430.
11. [11] Riska, P.F., Jacobs, W.R. Jr., Alland, D., Molecular determinants of drug resistance in tuberculosis. Int J Tuberc Lung Dis 4 (2000), S4–S10.
12. [12] Guo, H., Seet, Q., Denkin, S., Parsons, L., Zhang, Y., Molecular characterization of isoniazid-resistant clinical isolates of Mycobacterium tuberculosis from the USA. J Med Microbiol 55 (2006), 1527–1532.
13. [13] Warren, R.M., Gey van Pittius, N.C., Barnard, M., Hesseling, A., Engelke, E., de Kock, M., et al. Differentiation of Mycobacterium tuberculosis complex by PCR amplification of genomic regions of difference. Int J Tuberc Lung Dis 10 (2006), 818–822.
14. [14] Alland, David, Steyn, Andries J., Weisbrod, Torin, Aldrich, Kate, Jacobs, William R. Jr., Characterization of the Mycobacterium tuberculosis iniBAC promoter, a promoter that responds to cell wall biosynthesis inhibition. J Bacteriol 182:7 (2000), 1802–1811.
15. [15] Rouse, D.A., Morris, S.L., Molecular mechanisms of isoniazid resistance in Mycobacterium tuberculosis and Mycobacterium bovis. Infect Immun 63:4 (1995 Apr), 1427–1433.
16. [16] Mathema, B., Kurepina, N.E., Bifani, P.J., Kreiswirth, B.N., Molecular epidemiology of tuberculosis: current insights. Clin Microbiol Rev 19 (2006), 658–685.
17. [17] Thierry, D., Cave, M.D., Eisenach, K.D., Crawford, J.T., Bates, J.H., Giquel, B., et al. IS6110, an IS-like element of Mycobacterium tuberculosis complex. Nucleic Acids Res, 18, 1990, 188.
18. [18] Siu, Gilman Kit Hang, Zhang, Ying, Lau, Terrence C.K., Lau, Ricky W.T., Ho, Pak-Leung, Yew, Wing-Wai, et al. Mutations outside the rifampicin resistance-determining region associated with rifampicin resistance in Mycobacterium tuberculosis. J Antimicrob Chemother 66:4 (2011), 730–733.
19. [19] Fasih, Naima, Rafiq, Yasraba, Jabeen, Kausar, Hasan, Rumina, High isoniazid resistance rates in rifampicin susceptible Mycobacterium tuberculosis pulmonary isolates from Pakistan. PLoS One, 7(11), 2012, e50551.
20. [20] Jacobson, Karen R., Theron, Danie, Victor, C. Thomas, Streicher, Elizabeth M., Warren, Robin M., Murray, Megan B., Treatment outcomes of isoniazid-resistant tuberculosis patients, Western Cape Province, South Africa. Clin Infect Dis 53:4 (2011), 369–372.
21. [21] Menzies, D., Benedetti, A., Paydar, A., Royce, S., Pai, M., Burman, W., Vernon, A., Standardized treatment of active tuberculosis in patients with previous treatment and/or with mono-resistance to isoniazid: a systematic review and meta-analysis. PLoS Med, 6(9), 2009, e1000150.