Analytical and clinical performance of Abbott RealTime MTB, an assay for detection of Mycobacterium tuberculosis in pulmonary specimens

Tuberculosis

Volumn 95, Issue 5, 2015, Pages 613-619

  Tang, Ning ^a   Frank, Andrea ^a   Pahalawatta, Vihanga ^a   Lampinen, John ^a   Coblenz Korte, Anke ^a   Dunn, Chad ^a   Li, Cheng ^a   Cloherty, Gavin ^a   Abravaya, Klara ^a   Leckie, Gregor ^a  

^a Abbott Molecular Inc   (United States)

Author keywords

Co infection; Inactivation; Mycobacterium; Reproducibility; Respiratory; Sensitivity; Specificity

Indexed keywords

ABBOTT REALTIIME MYCOBACTERIUM TUBERCULOSIS ASSAY; ARTICLE; ASSAY; BACTERIAL STRAIN; BACTERIUM DETECTION; COLONY FORMING UNIT; CONTROLLED STUDY; CROSS REACTION; LIMIT OF DETECTION; MYCOBACTERIUM TUBERCULOSIS; NONHUMAN; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; TASK PERFORMANCE; BACTERIAL COUNT; CLASSIFICATION; EVALUATION STUDY; GENETICS; HIGH THROUGHPUT SEQUENCING; HUMAN; ISOLATION AND PURIFICATION; MICROBIOLOGICAL EXAMINATION; MICROBIOLOGY; NUCLEIC ACID AMPLIFICATION; PREDICTIVE VALUE; REPRODUCIBILITY; SPUTUM; TUBERCULOSIS, PULMONARY;

BACTERIAL DNA;

BACTERIOLOGICAL TECHNIQUES; COLONY COUNT, MICROBIAL; DNA, BACTERIAL; HIGH-THROUGHPUT NUCLEOTIDE SEQUENCING; HUMANS; LIMIT OF DETECTION; MYCOBACTERIUM TUBERCULOSIS; NUCLEIC ACID AMPLIFICATION TECHNIQUES; PREDICTIVE VALUE OF TESTS; REPRODUCIBILITY OF RESULTS; SPUTUM; TUBERCULOSIS, PULMONARY;

EID: 84940459574     PISSN: 14729792     EISSN: 1873281X     Source Type: Journal    
DOI: 10.1016/j.tube.2015.05.010     Document Type: Article

References (17)

1. World Health Organization (WHO) Global tuberculosis report 2013
2. WHO global report for 2014. http://www.who.int/tb/publications/global-report/en/.
3. Centers for Disease Control (CDC) Updated guidelines for the use of nucleic acid amplification tests in the diagnosis of tuberculosis MMWR 58 2009 7 10
4. N. Tang, S. Huang, J. Salituro, W.-B. Mak, G. Cloherty, J. Johanson, Y.H. Li, G. Schneider, J. Robinson, J. Hackett Jr., P. Swanson, and K. Abravaya Abbott RealTime HIV-1 viral load assay for automated quantitation of HIV-1 RNA in genetically diverse group m subtypes A-H, group O and group N samples J Virol Methods 146 2007 236 245
5. D. Thierry, M.D. Cave, K.D. Eisenach, J.T. Crawford, J.H. Bates, B. Giquel, and J.L. Guesdon IS6110, an IS-like element of Mycobacterium tuberculosis complex Nucleic Acids Res 18 1990 188
6. C. Qi, C. Wallis, V. Pahalawatta, A. Frank, N. Ramdin, R. Viana, A. Abravaya, G. Leckie, and N. Tang Evaluation of the efficiency of the sample inactivation reagent in the Abbott RealTime MTB assay for inactivation of Mycobacterium tuberculosis J Clin Microbiol 2015 [in press]
7. R.M. Warren, N.C. Gey van Pittius, M. Barnard, A. Hesseling, E. Engelke, M. de Kock, M.C. Gutierrez, G.K. Chege, T.C. Victor, E.G. Hoal, and P.D. van Helden Differentiation of Mycobacterium tuberculosis complex by PCR amplification of genomic regions of difference Int J Tuberc Lung Dis 10 2006 818 822
8. A.B. Anderson, and E.B. Hansen Structure and mapping of antigenic domains of protein antigen b, a 38,000-molecular-weight protein of Mycobacterium tuberculosis Infect Immun 57 1989 2481 2488
9. B. Mathema, N.E. Kurepina, P.J. Bifani, and B.N. Kreiswirth Molecular epidemiology of tuberculosis: current insights Clin Microbiol Rev 19 2006 658 685
10. CDC Biosafety in microbiological and biomedical laboratories HHS publication no. (CDC) 21-1112. Revised 5th ed. December 2009 http://www.cdc.gov/biosafety/publications/bmbl.pdf
11. C. Qi, N. Tang, A. Frank, V. Pahalawatta, J. Lampinen, G. Cloherty, and G. Leckie Abstract: effectiveness of the sample inactivation procedure employed by the new Abbott RealTime assay for the detection of Mycobacterium tuberculosis 24th European congress of clinical microbiology and infectious diseases (ECCMID) 2014
12. C.M. Gilpin, D.J. Dawson, G. O'Kane, J.G. Armstrong, and C. Coulter Failure of commercial ligase chain reaction to detect Mycobacterium tuberculosis DNA in sputum samples from a patient with smear-positive pulmonary tuberculosis due to a deletion of the target region J Clin Microbiol 40 2002 2305 2307
13. K.A. Alexander, P.N. Laver, A.L. Michel, M. Williams, P.D. van Helden, R.M. Warren, and N.C. Gey van Pittius Novel Mycobacterium tuberculosis complex pathogen, M. mungi Emerg Infect Dis 16 2010 1296 1299
14. J. van Ingen, Z. Rahim, A. Mulder, M.J. Boeree, R. Simeone, R. Brosch, and D. van Soolingen Characterization of Mycobacterium orygis as M. tuberculosis complex subspecies Emerg Infect Dis 18 2012 653 655
15. Food and Drug Administration, and Center for Devices and Radiological Health Class II special controls guideline: nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex and genetic mutations associated with Mycobacterium tuberculosis complex antibiotic resistance in respiratory specimens Guideline for industry and food and drug administration staff 2014 26
16. UNITAID tuberculosis diagnostic technology landscape semi-annual update 2012
17. H. Getahun, C. Gunneberg, R. Granich, and P. Nunn HIV infection-associated tuberculosis: the epidemiology and the response Clin Infect Dis 50 Suppl. 3 2010 S201 S207