Diagnostic performance of the new version (v2.0) of GenoType MTBDRsl assay for detection of resistance to fluoroquinolones and second-line injectable drugs: A multicenter study

Journal of Clinical Microbiology

Volumn 53, Issue 9, 2015, Pages 2961-2969

  Tagliani, Elisa ^a   Cabibbe, Andrea M ^a   Miotto, Paolo ^a   Borroni, Emanuele ^a   Toro, Juan Carlos ^b   Mansjö, Mikael ^b   Hoffner, Sven ^b   Hillemann, Doris ^c   Zalutskaya, Aksana ^d   Skrahina, Alena ^d   Cirillo, Daniela M ^a  

^a SAN RAFFAELE HOSPITAL   (Italy)

^b SWEDISH INSTITUTE FOR INFECTIOUS DISEASE CONTROL   (Sweden)

^c RESEARCH CENTER BORSTEL   (Germany)

^d National Research and Practical Centre for Pulmonology and Tuberculosis   (Belarus)

Author keywords

[No Author keywords available]

Indexed keywords

AMIKACIN; CAPREOMYCIN; ISONIAZID; KANAMYCIN; LEVOFLOXACIN; MOXIFLOXACIN; OFLOXACIN; QUINOLINE DERIVED ANTIINFECTIVE AGENT; RIFAMPICIN; QUINOLONE DERIVATIVE; TUBERCULOSTATIC AGENT;

ANTIBIOTIC RESISTANCE; ARTICLE; BACTERIUM IDENTIFICATION; BACTERIUM ISOLATE; CONCENTRATION RESPONSE; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC KIT; DIAGNOSTIC TEST ACCURACY STUDY; DRUG SUSCEPTIBILITY TESTING; GENE MUTATION; GENE SEQUENCE; GENOTYPING TECHNIQUE; HUMAN; LABORATORY TEST; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MULTIDRUG RESISTANT TUBERCULOSIS; MYCOBACTERIUM TUBERCULOSIS; NONHUMAN; PHENOTYPE; PREDICTIVE VALUE; PRIORITY JOURNAL; PROMOTER REGION; RELIABILITY; SENSITIVITY AND SPECIFICITY; WILD TYPE; CLINICAL TRIAL; DRUG EFFECTS; EVALUATION STUDY; GENETICS; GENOTYPE; MICROBIAL SENSITIVITY TEST; PROCEDURES;

MYCOBACTERIUM TUBERCULOSIS;

ANTITUBERCULAR AGENTS; DRUG RESISTANCE, BACTERIAL; FLUOROQUINOLONES; GENOTYPE; GENOTYPING TECHNIQUES; HUMANS; MICROBIAL SENSITIVITY TESTS; MYCOBACTERIUM TUBERCULOSIS; SENSITIVITY AND SPECIFICITY;

EID: 84940054531     PISSN: 00951137     EISSN: 1098660X     Source Type: Journal    
DOI: 10.1128/JCM.01257-15     Document Type: Article

References (34)

1. World Health Organization. 2014. Global tuberculosis report 2014. World Health Organization, Geneva, Switzerland.
2. Theron G, Peter J, Richardson M, Barnard M, Donegan S, Warren R, Steingart KR, Dheda K. 2014. The diagnostic accuracy of the Geno-Type() MTBDRsl assay for the detection of resistance to second-line anti-tuberculosis drugs. Cochrane Database Syst Rev 10:CD010705.
3. Kent PT, Kubica GP. 1985. Public health mycobacteriology: a guide for the level III laboratory. U.S Dept of Health and Human Services. Public Health Service, Centers for Disease Control, Atlanta, GA.
4. Kim SJ. 2005. Drug-susceptibility testing in tuberculosis: methods and reliability of results. Eur Respir J 25:564-569. http://dx.doi.org/10.1183/09031936.05.00111304.
5. Hillemann D, Rsch-Gerdes S, Richter E. 2007. Evaluation of the Geno-Type MTBDRplus assay for rifampin and isoniazid susceptibility testing of Mycobacterium tuberculosis strains and clinical specimens. J Clin Microbiol 45:2635-2640. http://dx.doi.org/10.1128/JCM.00521-07.
6. Kiet VS, Lan NT, An DD, Dung NH, Hoa DV, van Vinh Chau N, Chinh NT, Farrar J, Caws M. 2010. Evaluation of the MTBDRsl test for detection of second-line-drug resistance in Mycobacterium tuberculosis. J Clin Microbiol 48:2934-2939. http://dx.doi.org/10.1128/JCM.00201-10.
7. Miotto P, Piana F, Cirillo DM, Migliori GB. 2008. Genotype MTBDRplus: a further step toward rapid identification of drugresistant Mycobacterium tuberculosis. J Clin Microbiol 46:393-394. http://dx.doi.org/10.1128/JCM.01066-07.
8. Ignatyeva O, Kontsevaya I, Kovalyov A, Balabanova Y, Nikolayevskyy V, Toit K, Dragan A, Maxim D, Mironova S, Kummik T, Muntean I, Koshkarova E, Drobniewski F. 2012. Detection of resistance to secondline antituberculosis drugs by use of the genotype MTBDRsl assay: a multicenter evaluation and feasibility study. J Clin Microbiol 50:1593-1597. http://dx.doi.org/10.1128/JCM.00039-12.
9. Miotto P, Cabibbe AM, Mantegani P, Borroni E, Fattorini L, Tortoli E, Migliori GB, Cirillo DM. 2012. GenoType MTBDRsl performance on clinical samples with diverse genetic background. Eur Respir J 40:690-698. http://dx.doi.org/10.1183/09031936.00164111.
10. Kontsevaya I, Ignatyeva O, Nikolayevskyy V, Balabanova Y, Kovalyov A, Kritsky A, Matskevich O, Drobniewski F. 2013. Diagnostic accuracy of the genotype MTBDRsl assay for rapid diagnosis of extensively drugresistant tuberculosis in HIV-coinfected patients. J Clin Microbiol 51: 243-248. http://dx.doi.org/10.1128/JCM.02513-12.
11. Gikalo MB, Nosova EY, Krylova LY, Moroz AM. 2012. The role of eis mutations in the development of kanamycin resistance in Mycobacterium tuberculosis isolates from the Moscow region. J Antimicrob Chemother 67:2107-2109. http://dx.doi.org/10.1093/jac/dks178.
12. Huang WL, Chi TL, Wu MH, Jou R. 2011. Performance assessment of the GenoType MTBDRsl test and DNA sequencing for detection of second-line and ethambutol drug resistance among patients infected with multidrug-resistant Mycobacterium tuberculosis. J Clin Microbiol 49: 2502-2508. http://dx.doi.org/10.1128/JCM.00197-11.
13. Zaunbrecher MA, Sikes RD, Metchock B, Shinnick TM, Posey JE. 2009. Overexpression of the chromosomally encoded aminoglycoside acetyltransferase eis confers kanamycin resistance in Mycobacterium tuberculosis. Proc Natl Acad Sci U S A 106:20004-20009. http://dx.doi.org/10/1073/pnas.0907925106.
14. Engström A, Perskvist N, Werngren J, Hoffner SE, Juréen P. 2011. Comparison of clinical isolates and in vitro selected mutants reveals that tlyA is not a sensitive genetic marker for capreomycin resistance in Mycobacterium tuberculosis. J Antimicrob Chemother 66:1247-1254. http://dx/doi.org/10.1093/jac/dkr109.
15. Bauskenieks M, Pole I, Skenders G, Jansone I, Broka L, Nodieva A, Ozere I, Kalvisa A, Ranka R, Baumanis V. 2015. Genotypic and phenotypic characteristics of aminoglycoside-resistant Mycobacterium tuberculosis isolates in Latvia. Diagn Microbiol Infect Dis 81:177-182. http://dx/doi.org/10.1016/j.diagmicrobio.2014.12.004.
16. World Health Organization. 2013. Expert group meeting report: the use of molecular line probe assay for the detection of resistance to second-line anti-tuberculosis drugs. WHO/HTM/TB/2013.01. World Health Organization, Geneva, Switzerland.
17. World Health Organization. 1998. Laboratory services in tuberculosis control. WHO/TB/98.258. World Health Organization, Geneva, Switzerland.
18. World Health Organization. 2008. Policy guidance on drugsusceptibility testing (DST) of second-line antituberculosis drugs. WHO/ HTM/TB/2008.392. World Health Organization, Geneva, Switzerland.
19. Miotto P, Saleri N, Dembelé M, Ouedraogo M, Badoum G, Pinsi G, Migliori GB, Matteelli A, Cirillo DM. 2009. Molecular detection of rifampin and isoniazid resistance to guide chronic TB patient management in Burkina Faso. BMC Infect Dis 9:142. http://dx.doi.org/10.1186/1471-2334-9-142.
20. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Lijmer JG, Moher D, Rennie D, de Vet HC, STARD Group. 2004. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Fam Pract 21:4-10. http://dx.doi.org/10.1093/fampra/cmh103.
21. Dean AG, Sullivan KM, Soe MM. 2014. OpenEpi: open source epidemiologic statistics for public health, version 3.03. www.OpenEpi.com. Last updated 22 September 2014.
22. Rohlin A, Wernersson J, Engwall Y, Wiklund L, Björk J, Nordling M. 2009. Parallel sequencing used in detection of mosaic mutations: comparison with four diagnostic DNA screening techniques. Hum Mutat 30: 1012-1020. http://dx.doi.org/10.1002/humu.20980.
23. Eilertson B, Maruri F, Blackman A, Herrera M, Samuels DC, Sterling TR. 2014. High proportion of heteroresistance in gyrA and gyrB in fluoroquinolone-resistant Mycobacterium tuberculosis clinical isolates. Antimicrob Agents Chemother 58:3270 -3275. http://dx.doi.org/10.1128/AAC.02066-13.
24. Georghiou SB, Magana M, Garfein RS, Catanzaro DG, Catanzaro A, Rodwell TC. 2012. Evaluation of genetic mutations associated with Mycobacterium tuberculosis resistance to amikacin, kanamycin and capreomycin: a systematic review. PLoS One 7:e33275. http://dx.doi.org/10.1371/journal.pone.0033275.
25. Zimenkov DV, Antonova OV, Kuz'min AV, Isaeva YD, Krylova LY, Popov SA, Zasedatelev AS, Mikhailovich VM, Gryadunov DA. 2013. Detection of second-line drug resistance in Mycobacterium tuberculosis using oligonucleotide microarrays. BMC Infect Dis 13:240. http://dx.doi/org/10.1186/1471-2334-13-240.
26. Engström A, Morcillo N, Imperiale B, Hoffner SE, Juréen P. 2012. Detection of first-and second-line drug resistance in Mycobacterium tuberculosis clinical isolates by pyrosequencing. J Clin Microbiol 50:2026-2033. http://dx.doi.org/10.1128/JCM.06664-11.
27. Chakravorty S, Lee JS, Cho EJ, Roh SS, Smith LE, Lee J, Kim CT, Via LE, Cho SN, Barry CE, Alland D. 2015. Genotypic susceptibility testing of Mycobacterium tuberculosis isolates for amikacin and kanamycin resistance by use of a rapid sloppy molecular beacon-based assay identifies more cases of low-level drug resistance than phenotypic Lowenstein-Jensen testing. J Clin Microbiol 53:43-51. http://dx.doi.org/10.1128/JCM/02059-14.
28. Ajbani K, Nikam C, Kazi M, Gray C, Boehme C, Balan K, Shetty A, Rodrigues C. 2012. Evaluation of genotype MTBDRsl assay to detect drug resistance associated with fluoroquinolones, aminoglycosides and ethambutol on clinical sediments. PLoS One 7:e49433. http://dx.doi.org/10/1371/journal.pone.0049433.
29. Hillemann D, Rsch-Gerdes S, Richter E. 2009. Feasibility of the Geno-Type MTBDRsl assay for fluoroquinolone, amikacin-capreomycin, and ethambutol resistance testing of Mycobacterium tuberculosis strains and clinical specimens. J Clin Microbiol 47:1767-1772. http://dx.doi.org/10/1128/JCM.00081-09.
30. Maus CE, Plikaytis BB, Shinnick TM. 2005. Molecular analysis of crossresistance to capreomycin, kanamycin, amikacin, and viomycin in Mycobacterium tuberculosis. Antimicrob Agents Chemother 49:3192-3197. http://dx.doi.org/10.1128/AAC.49.8.3192-3197.2005.
31. Maruri F, Sterling TR, Kaiga AW, Blackman A, van der Heijden YF, Mayer C, Cambau E, Aubry A. 2012. A systematic review of gyrase mutations associated with fluoroquinolone-resistant Mycobacterium tuberculosis and a proposed gyrase numbering system. J Antimicrob Chemother 67:819-831. http://dx.doi.org/10.1093/jac/dkr566.
32. Malik S, Willby M, Sikes D, Tsodikov OV, Posey JE. 2012. New insights into fluoroquinolone resistance in Mycobacterium tuberculosis: functional genetic analysis of gyrA and gyrB mutations. PLoS One 7:e39754. http://dx.doi.org/10.1371/journal.pone.0039754.
33. Nebenzahl-Guimaraes H, Jacobson KR, Farhat MR, Murray MB. 2014. Systematic review of allelic exchange experiments aimed at identifying mutations that confer drug resistance in Mycobacterium tuberculosis. J Antimicrob Chemother 69:331-342. http://dx.doi.org/10.1093/jac/dkt358.
34. Van Deun A, Maug AK, Salim MA, Das PK, Sarker MR, Daru P, Rieder HL. 2010. Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis. Am J Respir Crit Care Med 182:684-692. http://dx.doi.org/10.1164/rccm.201001-0077OC.