Systematic review, meta-analysis and economic modelling of molecular diagnostic tests for antibiotic resistance in tuberculosis

Health Technology Assessment

Volumn 19, Issue 34, 2015, Pages 1-188

  Drobniewski, Francis ^a,b,c,d   Cooke, Mary ^e   Jordan, Jake ^f   Casali, Nicola ^c,d   Mugwagwa, Tendai ^a,c   Broda, Agnieszka ^c,d   Townsend, Catherine ^c   Sivaramakrishnan, Anand ^b   Green, Nathan ^a,c   Jit, Mark ^a,g   Lipman, Marc ^e   Lord, Joanne ^f   White, Peter J ^a,c,h   Abubakar, Ibrahim ^e  

^a PUBLIC HEALTH ENGLAND   (United Kingdom)

^b BARTS HEALTH NHS TRUST   (United Kingdom)

^c IMPERIAL COLLEGE LONDON   (United Kingdom)

^d QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^e UNIVERSITY COLLEGE LONDON   (United Kingdom)

^f BRUNEL UNIVERSITY   (United Kingdom)

^g LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^h Imperial College London School of Public Health ^*  (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

AMIKACIN; AMINOGLYCOSIDE; CAPREOMYCIN; CYCLOSERINE; ETHAMBUTOL; ETHAMBUTOL PLUS ISONIAZID PLUS PYRAZINAMIDE PLUS RIFAMPICIN; ISONIAZID; ISONIAZID PLUS PYRAZINAMIDE PLUS RIFAMPICIN; ISONIAZID PLUS RIFAMPICIN; KANAMYCIN; LEVOFLOXACIN; LINEZOLID; MOXIFLOXACIN; OFLOXACIN; PROTIONAMIDE; PYRAZINAMIDE; PYRIDOXINE; QUINOLINE DERIVED ANTIINFECTIVE AGENT; RIFAMPICIN; STREPTOMYCIN; THIOAMIDE; TUBERCULOSTATIC AGENT;

ANTIBIOTIC RESISTANCE; ANTIBIOTIC SENSITIVITY; ARTICLE; BACTERIUM CULTURE; BIBLIOGRAPHIC DATABASE; BLACK PERSON; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DECENTRALIZATION; DELAYED DIAGNOSIS; DIAGNOSTIC ACCURACY; DIAGNOSTIC PROCEDURE; DIAGNOSTIC TEST ACCURACY STUDY; DISEASE TRANSMISSION; DRUG COST; DRUG RESISTANT TUBERCULOSIS; EASTERN EUROPEAN; ECONOMIC EVALUATION; HEALTH CARE COST; HEALTH CARE DELIVERY; HEALTH IMPACT ASSESSMENT; HEARING IMPAIRMENT; HIGH RISK POPULATION; HUMAN; INTERMETHOD COMPARISON; LIQUID CULTURE; LIVER DISEASE; MATHEMATICAL MODEL; META ANALYSIS; MINIMUM INHIBITORY CONCENTRATION; MOLECULAR DIAGNOSIS; MOLECULAR GENETICS; MORTALITY; MULTIDRUG RESISTANT TUBERCULOSIS; MYCOBACTERIUM TUBERCULOSIS; PATIENT COMPLIANCE; POINT OF CARE TESTING; PREDICTIVE VALUE; PRIMARY MEDICAL CARE; PROBABILITY; QUALITY ADJUSTED LIFE YEAR; QUALITY CONTROL; RADIOMETRY; REAL TIME POLYMERASE CHAIN REACTION; RECEIVER OPERATING CHARACTERISTIC; SCREENING TEST; SENSITIVITY ANALYSIS; SENSITIVITY AND SPECIFICITY; SOUTH ASIAN; SPUTUM SMEAR; SYSTEMATIC ERROR; SYSTEMATIC REVIEW; THERAPY DELAY; TREATMENT DURATION; TREATMENT OUTCOME; TUBERCULOSIS; TUBERCULOSIS RAPID TEST; UNITED KINGDOM; BIOMEDICAL TECHNOLOGY ASSESSMENT; COST BENEFIT ANALYSIS; ECONOMICS; GREAT BRITAIN; MICROBIOLOGICAL EXAMINATION; NATIONAL HEALTH SERVICE; NUCLEIC ACID AMPLIFICATION; PATIENT ATTITUDE; SEQUENCE ANALYSIS; STATISTICAL MODEL; TIME FACTOR; TRANSMISSION; TUBERCULOSIS, MULTIDRUG-RESISTANT; TUBERCULOSIS, PULMONARY;

ANTITUBERCULAR AGENTS; BACTERIOLOGICAL TECHNIQUES; COST-BENEFIT ANALYSIS; DRUG RESISTANCE, MICROBIAL; GREAT BRITAIN; HUMANS; ISONIAZID; MODELS, ECONOMETRIC; NUCLEIC ACID AMPLIFICATION TECHNIQUES; PATIENT ACCEPTANCE OF HEALTH CARE; QUALITY-ADJUSTED LIFE YEARS; RIFAMPIN; SEQUENCE ANALYSIS; STATE MEDICINE; TECHNOLOGY ASSESSMENT, BIOMEDICAL; TIME FACTORS; TUBERCULOSIS, MULTIDRUG-RESISTANT; TUBERCULOSIS, PULMONARY;

EID: 84929152663     PISSN: 13665278     EISSN: 20464924     Source Type: Journal    
DOI: 10.3310/hta19340     Document Type: Article

References (147)

1. Kim DH, Kim HJ, Park S-K, Kong S-J, Kim YS, Kim T-H, et al. Treatment outcomes and long-term survival in patients with extensively drug-resistant tuberculosis. Am J Respir Crit Care Med 2008;178:1075-82. http://dx.doi.org/10.1164/rccm.200801-132OC
2. Shah NS, Pratt R, Armstrong L, Robison V, Castro KG, Cegielski JP. Extensively drug-resistant tuberculosis in the United States, 1993-2007. JAMA 2008;300:2153-60. http://dx.doi.org/10.1001/jama.300.18.2153
3. Balabanova Y, Nikolayevskyy V, Ignatyeva O, Kontsevaya I, Rutterford CM, Shakhmistova A, et al. Survival of civilian and prisoner drug-sensitive, multi- and extensive drug-resistant tuberculosis cohorts prospectively followed in Russia. PLOS ONE 2011;6:e20531. http://dx.doi.org/10.1371/journal.pone.0020531
4. Balabanova Y, Radiulyte B, Davidaviciene E, Hooper R, Ignatyeva O, Nikolayevskyy V, et al. Survival of drug resistant tuberculosis patients in Lithuania: retrospective national cohort study. BMJ Open 2011;1:e000351. http://dx.doi.org/10.1136/bmjopen-2011-000351
5. Koenig R. Drug-resistant tuberculosis. In South Africa, XDR TB and HIV prove a deadly combination. Science 2008;319:894-7. http://dx.doi.org/10.1126/science.319.5865.894
6. Gandhi NR, Moll A, Sturm AW, Pawinski R, Govender T, Lalloo U, et al. Extensively drug-resistant tuberculosis as a cause of death in patients co-infected with tuberculosis and HIV in a rural area of South Africa. Lancet 2006;368:1575-80. http://dx.doi.org/10.1016/S0140-6736(06)69573-1
7. Udwadia ZF. MDR, XDR, TDR tuberculosis: ominous progression. Thorax 2012;67:286-8. http://dx.doi.org/10.1136/thoraxjnl-2012-201663
8. World Health Organization. Global Tuberculosis Report 2013. Geneva: WHO; 2013.
9. European Centre for Disease Prevention and Control. Tuberculosis Surveillance and Monitoring In Europe. Stockholm: ECDC; 2013.
10. World Health Organization. Prevention and Control Of Multidrug-Resistant Tuberculosis and Extensively Drug-Resistant Tuberculosis. 62nd World Health Assembly, Resolutions and Decisions, WHA 62.15. Geneva: WHO; 2009.
11. Public Health England (PHE). Tuberculosis in the UK. London: PHE; 2013.
12. Breathnach AS, de Ruiter A, Holdsworth GM, Bateman NT, O’Sullivan DG, Rees PJ, et al. An outbreak of multi-drug-resistant tuberculosis in a London teaching hospital. J Hosp Infect 1998;39:111-17. http://dx.doi.org/10.1016/S0195-6701(98)90324-3
13. Ruddy MC, Davies AP, Yates MD, Yates S, Balasegaram S, Drabu Y, et al. Outbreak of isoniazid resistant tuberculosis in north London. Thorax 2004;59:279-85. http://dx.doi.org/10.1136/thx.2003.010405
14. Telenti A, Imboden P, Marchesi F, Lowrie D, Cole S, Colston MJ, et al. Detection of rifampicin-resistance mutations in Mycobacterium tuberculosis. Lancet 1993;341:647-50. http://dx.doi.org/10.1016/0140-6736(93)90417-F
15. Zhang Y, Heym B, Allen B, Young D, Cole S. The catalase-peroxidase gene and isoniazid resistance of Mycobacterium tuberculosis. Nature 1992;358:591-3. http://dx.doi.org/10.1038/358591a0
16. Banerjee A, Dubnau E, Quemard A, Balasubramanian V, Um KS, Wilson T, et al. inhA, a gene encoding a target for isoniazid and ethionamide in Mycobacterium tuberculosis. Science 1994;263:227-30. http://dx.doi.org/10.1126/science.8284673
17. Drobniewski FA, Caws M, Gibson A, Young D. Modern laboratory diagnosis of tuberculosis. Lancet Infect Dis 2003;3:141-7. http://dx.doi.org/10.1016/S1473-3099(03)00544-9
18. Sandgren A, Strong M, Muthukrishnan P, Weiner BK, Church GM, Murray MB. Tuberculosis drug resistance mutation database. PLOS Med 2009;6:e2. http://dx.doi.org/10.1371/journal.pmed.1000002
19. Canetti G, Froman S, Grosset J, Haudoruy P, Langerova M, Mahler HT, et al. Mycobacteria: laboratory methods for testing drug sensitivity and resistance. Bull World Health Organ 1963;29:565-78.
20. Siddiqi S, Rüsch-Gerdes S. MGIT Procedure Manual. Geneva: Foundation for Innovative New Diagnostics; 2006.
21. Hanna BA, Ebrahimzadeh A, Elliott LB, Morgan MA, Novak SM, Rusch-Gerdes S, et al. Multicenter evaluation of the BACTEC MGIT 960 system for recovery of mycobacteria. J Clin Microbiol 1999;37:748-52.
22. Leung E, Minion J, Benedetti A, Pai M, Menzies D. Microcolony culture techniques for tuberculosis diagnosis: a systematic review. Int J Tuberc Lung Dis 2012;16:16-23,i-iii. http://dx.doi.org/10.5588/ijtld.10.0065
23. Moore DAJ, Evans CAW, Gilman RH, Caviedes L, Coronel J, Vivar A, et al. Microscopic-observation drug-susceptibility assay for the diagnosis of TB. N Engl J Med 2006;355:1539-50. http://dx.doi.org/10.1056/NEJMoa055524
24. Toit K, Mitchell S, Balabanova Y, Evans CA, Kummik T, Nikolayevskyy V, et al. The Colour Test for drug susceptibility testing of Mycobacterium tuberculosis strains. Int J Tuberc Lung Dis 2012;16:1113-18. http://dx.doi.org/10.5588/ijtld.11.0609
25. Musser JM. Antimicrobial agent resistance in mycobacteria: molecular genetic insights. Clin Microbiol Rev 1995;8:496-514.
26. Hazbón MH, Brimacombe M, Bobadilla del Valle M, Cavatore M, Guerrero MI, Varma-Basil M, et al. Population genetics study of isoniazid resistance mutations and evolution of multidrug-resistant Mycobacterium tuberculosis. Antimicrob Agents Chemother 2006;50:2640-9. http://dx.doi.org/10.1128/AAC.00112-06
27. Ling DI, Flores LL, Riley LW, Pai M. Commercial nucleic-acid amplification tests for diagnosis of pulmonary tuberculosis in respiratory specimens: meta-analysis and meta-regression. PLOS ONE 2008;3:e1536. http://dx.doi.org/10.1371/journal.pone.0001536
28. Pietzka AT, Indra A, Stoger A, Zeinzinger J, Konrad M, Hasenberger P, et al. Rapid identification of multidrug-resistant Mycobacterium tuberculosis isolates by rpoB gene scanning using high-resolution melting curve PCR analysis. J Antimicrob Chemother 2009;63:1121-7. http://dx.doi.org/10.1093/jac/dkp124
29. Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, et al. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med 2010;363:1005-15. http://dx.doi.org/10.1056/NEJMoa0907847
30. Nagdev KJ, Kashyap RS, Parida MM, Kapgate RC, Purohit HJ, Taori GM, et al. Loop-mediated isothermal amplification for rapid and reliable diagnosis of tuberculous meningitis. J Clin Microbiol 2011;49:1861-5. http://dx.doi.org/10.1128/JCM.00824-10
31. World Health Organization. Molecular Line Probe Assays for Rapid Screening of Patients at Risk of Multidrug-Resistant Tuberculosis. Geneva: WHO; 2008.
32. Morgan M, Kalantri S, Flores L, Pai M. A commercial line probe assay for the rapid detection of rifampicin resistance in Mycobacterium tuberculosis: a systematic review and meta-analysis. BMC Infect Dis 2005;5:62. http://dx.doi.org/10.1186/1471-2334-5-62
33. Viveiros M, Leandro C, Rodrigues L, Almeida J, Bettencourt R, Couto I, et al. Direct application of the INNO-LiPA Rif.TB line-probe assay for rapid identification of Mycobacterium tuberculosis complex strains and detection of rifampin resistance in 360 smear-positive respiratory specimens from an area of high incidence of multidrug-resistant tuberculosis. J Clin Microbiol 2005;43:4880-4. http://dx.doi.org/10.1128/JCM.43.9.4880-4884.2005
34. Mironova S, Pimkina E, Kontsevaya I, Nikolayevskyy V, Balabanova Y, Skenders G, et al. Performance of the GenoType® MTBDRPlus assay in routine settings: a multicenter study. Eur J Clin Microbiol Infect Dis 2012;31:1381-7. http://dx.doi.org/10.1007/s10096-011-1453-1
35. Seoudi N, Mitchell SL, Brown TJ, Dashti F, Amin AK, Drobniewski FA. Rapid molecular detection of tuberculosis and rifampicin drug resistance: retrospective analysis of a national UK molecular service over the last decade. Thorax 2012;67:361-7. http://dx.doi.org/10.1136/thoraxjnl-2011-200610
36. Ignatyeva O, Kontsevaya I, Kovalyov A, Balabanova Y, Nikolayevskyy V, Toit K, et al. Detection of resistance to second-line antituberculosis drugs by use of the GenoType MTBDRsl assay: a multicenter evaluation and feasibility study. J Clin Microbiol 2012;50:1593-7. http://dx.doi.org/10.1128/JCM.00039-12
37. Kontsevaya I, Ignatyeva O, Nikolayevskyy V, Balabanova Y, Kovalyov A, Kritsky A, et al. Diagnostic accuracy of the genotype MTBDRsl assay for rapid diagnosis of extensively drug-resistant tuberculosis in HIV-coinfected patients. J Clin Microbiol 2013;51:243-8. http://dx.doi.org/10.1128/JCM.02513-12
38. Boehme CC, Nicol MP, Nabeta P, Michael JS, Gotuzzo E, Tahirli R, et al. Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet 2011;377:1495-505. http://dx.doi.org/10.1016/S0140-6736(11)60438-8
39. World Health Organization. Automated Real-Time Nucleic Acid Amplification Technology for Rapid and Simultaneous Detection of Tuberculosis and Rifampicin Resistance: Xpert MTB/RIF system. Geneva: WHO; 2011.
40. World Health Organization. WHO Monitoring of Xpert MTB/RIF Roll-Out. Geneva: WHO; 2013.
41. Vassall A, van Kampen S, Sohn H, Michael JS, John KR, den Boon S, et al. Rapid diagnosis of tuberculosis with the Xpert MTB/RIF assay in high burden countries: a cost-effectiveness analysis. PLOS Med 2011;8:e1001120. http://dx.doi.org/10.1371/journal.pmed.1001120
42. Safi H, Lingaraju S, Amin A, Kim S, Jones M, Holmes M, et al. Evolution of high-level ethambutol-resistant tuberculosis through interactingmutations in decaprenylphosphoryl-D-arabinose biosynthetic and utilization pathway genes. Nat Genet 2013;45:1190-7. http://dx.doi.org/10.1038/ng.2743
43. Zhang H, Li D, Zhao L, Fleming J, Lin N, Wang T, et al. Genome sequencing of 161 Mycobacterium tuberculosis isolates from China identifies genes and intergenic regions associated with drug resistance. Nat Genet 2013;45:1255-60. http://dx.doi.org/10.1038/ng.2735
44. Farhat MR, Shapiro BJ, Kieser KJ, Sultana R, Jacobson KR, Victor TC, et al. Genomic analysis identifies targets of convergent positive selection in drug-resistant Mycobacterium tuberculosis. Nat Genet 2013;45:1183-9. http://dx.doi.org/10.1038/ng.2747
45. Steingart K, Sohn H, Schiller I, Kloda L, Boehme C, Pai M, et al. Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev 2013;1:CD009593. http://dx.doi.org/10.1002/14651858.CD009593.pub2
46. Ling DI, Zwerling AA, Pai M. GenoType MTBDR assays for the diagnosis of multidrug-resistant tuberculosis: a meta-analysis. Eur Respir J 2008;32:1165-74. http://dx.doi.org/10.1183/09031936.00061808
47. Whiting P, Rutjes AW, Westwood M, Reitsma JB, Leeflang MMG, Sterne JAC, et al. QUADAS-2: a revised tool for the Quality Assessment of Diagnostic Accuracy Studies. Ann Intern Med 2011;155:529-36. http://dx.doi.org/10.7326/0003-4819-155-8-201110180-00009
48. Lijmer JG, Bossuyt PMM, Heisterkamp SH. Exploring sources of heterogeneity in systematic reviews of diagnostic tests. Stat Med 2002;21:1525-37. http://dx.doi.org/10.1002/sim.1185
49. Lijmer JG. Evaluation Of Diagnostic Test From Accuracy To Outcome. Amsterdam: Print Partners; 2001.
50. Higgins JPT, Thompson SG. Controlling the risk of spurious findings from meta-regression. Stat Med 2004;23:1663-82. http://dx.doi.org/10.1002/sim.1752
51. Costeira J, Pina J. Multi-drug resistant tuberculosis and the red queen: diagnosis speed is crucial. Rev Port Pneumol 2007;13:869-77.
52. Drobniewski FA, Watterson SA, Wilson SM, Harris GS. A clinical, microbiological and economic analysis of a national service for the rapid molecular diagnosis of tuberculosis and rifampicin resistance in Mycobacterium tuberculosis. J Med Microbiol 2000;49:271-8.
53. Higuchi T, Fushiwaki T, Tanaka N, Miyake S, Ogura T, Yoshida H, et al. Direct detection of rifampicin resistant Mycobacterium tuberculosis in sputum by line probe assay (LiPA). Kekkaku 2004;79:525-30.
54. Johansen I, Lundgren B, Sosnovskaja A, Thomsen V. Direct detection of multidrug-resistant Mycobacterium tuberculosis in clinical specimens in low- and high-incidence countries by line probe assay. J Clin Microbiol 2003;41:4454-6. http://dx.doi.org/10.1128/JCM.41.9.4454-4456.2003
55. Ogwang S, Asiimwe BB, Traore H, Mumbowa F, Okwera A, Eisenach KD, et al. Comparison of rapid tests for detection of rifampicin-resistant Mycobacterium tuberculosis in Kampala, Uganda. BMC Infect Dis 2009;9:139. http://dx.doi.org/10.1186/1471-2334-9-139.
56. Sam I, Drobniewski F, More P, Kemp M, Brown T. Mycobacterium tuberculosis and rifampin resistance. Emerg Infect Dis 2006;12:752-9. http://dx.doi.org/10.3201/eid1205.041339
57. Skenders G, Fry AM, Prokopovica I, Greckoseja S, Broka L, Metchock B, et al. Multidrug-resistant tuberculosis detection, Latvia. Emerg Infect Dis 2005;11:1461-3. http://dx.doi.org/10.3201/eid1109.041236
58. Kim SY, Kim H, Ra EK, Joo S-I, Shin S, Seong M-W, et al. The Xpert® MTB/RIF assay evaluation in South Korea, a country with an intermediate tuberculosis burden. Int J Tuberc Lung Dis 2012;16:1471-6. http://dx.doi.org/10.5588/ijtld.11.0602
59. Kurbatova EV, Kaminski DA, Erokhin VV, Volchenkov GV, Andreevskaya SN, Chernousova LN, et al. Performance of Cepheid® Xpert MTB/RIF® and TB-Biochip® MDR in two regions of Russia with a high prevalence of drug-resistant tuberculosis. Eur J Clin Microbiol Infect Dis 2013;32:735-43. http://dx.doi.org/10.1007/s10096-012-1798-0
60. Naidoo S. Evaluation of GeneXpertMTB/RIF assay on pulmonary and extra-pulmonary samples in a high-throughput laboratory. Clin Microbiol Infect 2010;16:S604-5.
61. O’Grady J, Bates M, Chilukutu L, Mzyece J, Cheelo B, Chilufya M, et al. Evaluation of the Xpert MTB/RIF assay at a tertiary care referral hospital in a setting where tuberculosis and HIV infection are highly endemic. Clin Infect Dis 2012;55:1171-8. http://dx.doi.org/10.1093/cid/cis631
62. Tukvadze N, Kempker RR, Kalandadze I, Kurbatova E, Leonard MK, Apsindzelashvili R, et al. Use of a molecular diagnostic test in AFB smear positive tuberculosis suspects greatly reduces time to detection of multidrug resistant tuberculosis. PLOS ONE 2012;7:e31563. http://dx.doi.org/10.1371/journal.pone.0031563
63. Lyu J, Kim M, Song JW, Choi C, Oh Y, Lee SD, et al. GenoType® MTBDR plus assay detection of drug-resistant tuberculosis in routine practice in Korea. Int J Tuberc Lung Dis 2013;17:120-4. http://dx.doi.org/10.5588/ijtld.12.0197
64. Hillemann D, Rüsch-Gerdes S, Richter E. Application of the GenoType MTBDR assay directly on sputum specimens. Int J Tuberc Lung Dis 2006;10:1057-9.
65. Farooqi JQ, Khan E, Muhammed S, Alam Z, Ali A, Hasan Z, et al. Original Article Line probe assay for detection of rifampicin and isoniazid resistant tuberculosis in Pakistan. J Pak Med Assoc 2012;62:767-72.
66. Eliseev PI, Maryandyshev AO, Nikishova EI, Tarasova IV, Gorina GP, Chryssanthou E, et al. Epidemiological analyses of tuberculosis in Archangelsk, Russia and implementation of a rapid assay for detection of resistance in this high burden setting. Int J Mycobacteriol 2013;2:103-8. http://dx.doi.org/10.1016/j.ijmyco.2013.04.002
67. Dubois Cauwelaert N, Ramarokoto H, Ravololonandriana P, Richard V, Rasolofo V. DNA extracted from stained sputum smears can be used in the MTBDRplus assay. J ClinMicrobiol 2011;49:3600-3. http://dx.doi.org/10.1128/JCM.00745-11
68. Dorman SE, Chihota VN, Lewis JJ, van der Meulen M, Mathema B, Beylis N, et al. GenoType MTBDRplus for direct detection of Mycobacterium tuberculosis and drug resistance in strains from gold miners in South Africa. J Clin Microbiol 2012;50:1189-94. http://dx.doi.org/10.1128/JCM.05723-11
69. Crudu V, Stratan E, Romancenco E, Allerheiligen V, Hillemann A, Moraru N. First evaluation of an improved assay for molecular genetic detection of tuberculosis as well as rifampin and isoniazid resistances. J Clin Microbiol 2012;50:1264-9. http://dx.doi.org/10.1128/JCM.05903-11
70. Barnard M, Albert H, Coetzee G, O’Brien R, Bosman ME. Rapid molecular screening for multidrug-resistant tuberculosis in a high-volume public health laboratory in South Africa. Am J Respir Crit Care Med 2008;177:787-92. http://dx.doi.org/10.1164/rccm.200709-1436OC
71. Asencios L, Galarza M, Quispe N, Leo E, Valencia E, Acurio M, et al. Molecular test GenoType MTBDRplus, an alternative to rapid detection of multidrug resistance tuberculosis. Rev Peru Med Exp Salud Publica 2012;29:92-8. http://dx.doi.org/10.1590/S1726-46342012000100014
72. Anek-Vorapong R, Sinthuwattanawibool C, Podewils LJ, Mccarthy K, Ngamlert K, Promsarin B, et al. Validation of the GenoType® MTBDR plus assay for detection of MDR-TB in a public health laboratory in Thailand. BMC Infect Dis 2010;10:123. http://dx.doi.org/10.1186/1471-2334-10-123
73. Albert H, Bwanga F, Mukkada S, Nyesiga B, Ademun JP, Lukyamuzi G, et al. Rapid screening of MDR-TB using molecular Line Probe Assay is feasible in Uganda. BMC Infect Dis 2010;10:41. http://dx.doi.org/10.1186/1471-2334-10-41
74. Somoskovi A, Dormandy J, Mitsani D, Rivenburg J, Salfinger M. Use of smear-positive samples to assess the PCR-based genotype MTBDR assay for rapid, direct detection of the Mycobacterium tuberculosis complex as well as its resistance to isoniazid and rifampin. J Clin Microbiol 2006;44:4459-63. http://dx.doi.org/10.1128/JCM.01506-06
75. Lacoma A, García-Sierra N, Prat C, Ruiz-Manzano J, Haba L, Rosés S, et al. GenoType MTBDRplus assay for molecular detection of rifampin and isoniazid resistance in Mycobacterium tuberculosis strains and clinical samples. J Clin Microbiol 2008;46:3660-7. http://dx.doi.org/10.1128/JCM.00618-08
76. Ajbani K, Nikam C, Kazi M, Grey C, Boehme C, Balan K, et al. Evaluation of genotype MTBDRsl assay to detect drug resistance associated with fluoroquinolones, aminoglycosides and ethambutol on clinical sediments. PLOS ONE 2012;7:e49433. http://dx.doi.org/10.1371/journal.pone.0049433
77. Lacoma A, García-Sierra N, Prat C, Maldonado J, Ruiz-Manzano J, Haba L, et al. GenoType MTBDRsl for molecular detection of second-line-drug and ethambutol resistance in Mycobacterium tuberculosis strains and clinical samples. J Clin Microbiol 2012;50:30-6. http://dx.doi.org/10.1128/JCM.05274-11
78. Hillemann D, Rüsch-Gerdes S, Richter E. Feasibility of the GenoType MTBDRsl assay for fluoroquinolone, amikacin-capreomycin, and ethambutol resistance testing of Mycobacterium tuberculosis strains and clinical specimens. J Clin Microbiol 2009;47:1767-72. http://dx.doi.org/10.1128/JCM.00081-09
79. Miotto P, Cabibbe AM, Mantegani P, Borroni E, Fattorini L, Tortoli E, et al. GenoType MTBDRsl performance on clinical samples with diverse genetic background. Eur Respir J 2012;40:690-8. http://dx.doi.org/10.1183/09031936.00164111
80. Barnard M, Warren R, Gey Van Pittius N, van Helden P, Bosman M, Streicher E, et al. GenoType MTBDRsl line probe assay shortens time to diagnosis of extensively drug-resistant tuberculosis in a high-throughput diagnostic laboratory. Am J Respir Crit Care Med 2012;186:1298-305. http://dx.doi.org/10.1164/rccm.201205-0960OC
81. Antonova OV, Gryadunov DA, Lapa SA, Kuz’min AV, Larionova EE, Smirnova TG, et al. Detection of mutations in Mycobacterium tuberculosis genome determining resistance to fluoroquinolones by hybridization on biological microchips. Bull Exp Biol Med 2008;145:108-13. http://dx.doi.org/10.1007/s10517-008-0034-5
82. Calderón-Espinoza RI, Asencios-Solís L, Quispe-Torres N, Yale-Cajahuanca G, Suárez-Nole C, Lecca-García L, et al. [Validación de la reacción en cadena de la polimerasa basada en generador universal de heterodúplex para la identificación de Mycobacterium tuberculosis resistente a rifampicina y multirresistente en Lima, Perú.] Enferm Infecc Microbiol Clin 2006;24:495-9. http://dx.doi.org/10.1157/13092465
83. Cho EH, Bae HK, Kang SK, Lee EH. Detection of isoniazid and rifampicin resistance by sequencing of katG, inhA, and rpoB genes in Korea. Korean J Lab Med 2009;29:455-60. http://dx.doi.org/10.3343/kjlm.2009.29.5.455
84. Choi J-H, Lee KW, Kang H-R, Hwang Y IL, Jang S, Kim D-G, et al. Clinical efficacy of direct DNA sequencing analysis on sputum specimens for early detection of drug-resistant Mycobacterium tuberculosis in a clinical setting. Chest 2010;137:393-400. http://dx.doi.org/10.1378/chest.09-0150
85. García-Sierra N, Lacoma A, Prat C, Haba L, Maldonado J, Ruiz-Manzano J, et al. Pyrosequencing for rapid molecular detection of rifampin and isoniazid resistance in Mycobacterium tuberculosis strains and clinical specimens. J Clin Microbiol 2011;49:3683-6. http://dx.doi.org/10.1128/JCM.01239-11
86. Gryadunov D, Mikhailovich V, Lapa S, Roudinskii N, Donnikov M, Pan’kov S, et al. Evaluation of hybridisation on oligonucleotide microarrays for analysis of drug-resistant Mycobacterium tuberculosis. Clin Microbiol Infect 2005;11:531-9. http://dx.doi.org/10.1111/j.1469-0691.2005.01183.x
87. Guo Y, Zhou Y, Wang C, Zhu L, Wang S, Li Q, et al. Rapid, accurate determination of multidrug resistance in M. tuberculosis isolates and sputum using a biochip system. Int J Tuberc Lung Dis 2009;13:914-20.
88. Pang Y, Xia H, Zhang Z, Li J, Dong Y, Li Q, et al. Multicenter evaluation of genechip for detection of multidrug-resistant Mycobacterium tuberculosis. J Clin Microbiol 2013;51:1707-13. http://dx.doi.org/10.1128/JCM.03436-12
89. Kim B, Lee K, Park B, Kim S, Park E, Park Y, et al. Detection of rifampin-resistant Mycobacterium tuberculosis in sputa by nested PCR-linked single-strand conformation polymorphism and DNA sequencing. J Clin Microbiol 2001;39:2610-17. http://dx.doi.org/10.1128/JCM.39.7.2610-2617.2001
90. Lu W, Chen C, Shao Y, Shi J, Zhong C, Yang D, et al. Evaluation of biochip system in determining isoniazid and rifampicin resistances of Mycobacterium tuberculosis in sputum samples. PLOS ONE 2012;7:e52953. http://dx.doi.org/10.1371/journal.pone.0052953
91. Mikhailovich V, Lapa S, Gryadunov D, Sobolev A, Strizhkov B, Chernyh N, et al. Identification of rifampin-resistant Mycobacterium tuberculosis strains by hybridization, PCR, and ligase detection reaction on oligonucleotide microchips. J Clin Microbiol 2001;39:2531-40. http://dx.doi.org/10.1128/JCM.39.7.2531-2540.2001
92. Mokrousov I, Otten T, Vyshnevskiy B, Narvskaya O. Allele-specific rpoB PCR Assays for detection of rifampin-resistant Mycobacterium tuberculosis in sputum smears. Antimicrob Agents Chemother 2003;47:2231-5. http://dx.doi.org/10.1128/AAC.47.7.2231-2235.2003
93. Nosova EY, Krasnova MA, Galkina KY, Makarova MV, Litvinov VI, Moroz AM. Comparative analysis of TB-Biochip, Xpert MTB/RIF, and GenoType MTBDRplus test systems for rapid determination of mutations responsible for drug resistance of M. tuberculosis complex (in sputum from patients in Moscow region). Mol Biol 2013;47:236-41. http://dx.doi.org/10.1134/S002689331301010X
94. Sheen P, Méndez M, Gilman RH, Peña L, Caviedes L, Zimic MJ, et al. Sputum PCR-single-strand conformational polymorphism test for same-day detection of pyrazinamide resistance in tuberculosis patients. J Clin Microbiol 2009;47:2937-43. http://dx.doi.org/10.1128/JCM.01594-08
95. Siu GKH, Tam YH, Ho PL, Lee ASG, Que TL, Tse CWS, et al. Direct detection of isoniazid-resistant Mycobacterium tuberculosis in respiratory specimens by multiplex allele-specific polymerase chain reaction. Diagn Microbiol Infect Dis 2011;69:51-8. http://dx.doi.org/10.1016/j.diagmicrobio.2010.08.021
96. Vadwai V, Shetty A, Rodrigues C. Multiplex allele specific PCR for rapid detection of extensively drug resistant tuberculosis. Tuberculosis (Edinb) 2012;92:236-42. http://dx.doi.org/10.1016/j.tube.2012.01.004
97. Zhang Z, Li L, Luo F, Cheng P, Wu F, Wu Z, et al. Rapid and accurate detection of RMP- and INH- resistant Mycobacterium tuberculosis in spinal tuberculosis specimens by CapitalBioTM DNA microarray: a prospective validation study. BMC Infect Dis 2012;12:303. http://dx.doi.org/10.1186/1471-2334-12-303
98. Macedo R, Pereira E. Multidrug-resistant tuberculosis: rapid molecular detection with MTBDRplus assay in clinical samples. Rev Port Pneumol 2009;15:353-65. http://dx.doi.org/10.1016/S2173-5115(09)70118-6
99. Nikolayevskyy V, Balabanova Y, Simak T, Malomanova N, Fedorin I, Drobniewski F. Performance of the GenoType MTBDRPlus assay in the diagnosis of tuberculosis and drug resistance in Samara, Russian Federation. BMC Clin Pathol 2009;9:2. http://dx.doi.org/10.1186/1472-6890-9-2
100. Maschmann RDA, Sá Spies F, Nunes LDS, Ribeiro AW, Machado TRM, Zaha A, et al. Performance of the GenoType MTBDRplus assay directly on sputum specimens from Brazilian patients with tuberculosis treatment failure or relapse. J Clin Microbiol 2013;51:1606-8. http://dx.doi.org/10.1128/JCM.00364-13
101. Kontsevaya I, Mironova S, Nikolayevskyy V, Balabanova Y, Mitchell S, Drobniewski F. Evaluation of two molecular assays for rapid detection of Mycobacterium tuberculosis resistance to fluoroquinolones in high-tuberculosis and multidrug-resistance settings. J Clin Microbiol 2011;49:2832-7. http://dx.doi.org/10.1128/JCM.01889-10
102. Al Khalaf MM, Thalib L, Doi SA. Combining heterogenous studies using the random-effects model is a mistake and leads to inconclusive meta-analyses. J Clin Epidemiol 2011;64:119-23. http://dx.doi.org/10.1016/j.jclinepi.2010.01.009
103. Bachmann LM, Puhan MA, ter Riet G, Bossuyt PM. Sample sizes of studies on diagnostic accuracy: literature survey. BMJ 2006;332:1127-9. http://dx.doi.org/10.1136/bmj.38793.637789.2F
104. Grégoire G, Derderian F, Le Lorier J. Selecting the language of the publications included in a meta-analysis: is there a Tower of Babel bias? J Clin Epidemiol 1995;48:159-63. http://dx.doi.org/10.1016/0895-4356(94)00098-B
105. Krüüner A, Yates MD, Drobniewski FA. Evaluation of MGIT 960-based antimicrobial testing and determination of critical concentrations of first- and second-line antimicrobial drugs with drug-resistant clinical strains of Mycobacterium tuberculosis. J Clin Microbiol 2006;44:811-18. http://dx.doi.org/10.1128/JCM.44.3.811-818.2006
106. Drummond M, Sculpher M, Torrance G, O’Brien B, Stoddart G. Methods for The Economic Evaluation of Health Care Programmes. 3rd edn. Oxford: Oxford University Press; 2005.
107. Pitman R, Fisman D, Zaric GS, Postma M, Kretzschmar M, Edmunds J, et al. Dynamic transmission modeling: a report of the ISPOR-SMDM modeling good research practices task force-5. Value Health 2012;15:828-34. http://dx.doi.org/10.1016/j.jval.2012.06.011
108. National Institute for Health and Care Excellence. Tuberculosis: Clinical Diagnosis and Management of Tuberculosis, and Measures for its Prevention and Control. NICE guideline CG117. London: NICE; 2011.
109. European Centre for Disease Prevention and Control (ECDC). ERLN-TB Expert Opinion on the Use of the Rapid Molecular Assays for the Diagnosis of Tuberculosis and Detection of Drug Resistance. Stockholm: ECDC; 2013.
110. Public Health England (PHE). Position Statement: Direct Molecular Testing for Tuberculosis in England, Scotland and Wales. London: PHE; 2013.
111. National Institute for Health and Care Excellence. Methods for Development of NICE Public Health Guidelines. 3rd edn. London: NICE; 2012.
112. Health Protection Agency, Royal College of Pathologists, Association of Clinical Pathologists, Scottish Mycobacterial Reference Laboratory, Public Health Wales, Keele University National Pathology Benchmarking Service. National Audit of TB Diagnostic Laboratories and Description of Molecular Diagnostic Service Provision. London: PHE; 2012.
113. Public Health England (PHE). Tuberculosis Enhanced Survey Data. PHE; 2013.
114. World Health Organization. Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis. Geneva: WHO; 2011.
115. White VL, Moore-Gillon J. Resource implications of patients with multidrug resistant tuberculosis. Thorax 2000;55:962-3. http://dx.doi.org/10.1136/thorax.55.11.962
116. Kruijshaar ME, Lipman M, Essink-Bot M-L, Lozewicz S, Creer D, Dart S, et al. Health status of UK patients with active tuberculosis. Int J Tuberc Lung Dis 2010;14:296-302.
117. Saukkonen JJ, Cohn DL, Jasmer RM, Schenker S, Jereb JA, Nolan CM, et al. An official ATS statement: hepatotoxicity of antituberculosis therapy. Am J Respir Crit Care Med 2006;174:935-52. http://dx.doi.org/10.1164/rccm.200510-1666ST
118. Törün T, Güngör G, Ozmen I, Bölükbaşi Y, Maden E, Biçakçi B, et al. Side effects associated with the treatment of multidrug-resistant tuberculosis. Int J Tuberc Lung Dis 2005;9:1373-7.
119. Melchionda V, Wyatt H, Capocci S, García Medina R, Solamalai A, Katiri S, et al. Amikacin treatment for multidrug resistant tuberculosis: how much monitoring is required? Eur Respir J 2013;42:1148-50. http://dx.doi.org/10.1183/09031936.00184312
120. Veenstra DL, Harris J, Gibson RL, Rosenfeld M, Burke W, Watts C. Pharmacogenomic testing to prevent aminoglycoside-induced hearing loss in cystic fibrosis patients: potential impact on clinical, patient, and economic outcomes. Genet Med 2007;9:695-704. http://dx.doi.org/10.1097/GIM.0b013e318156dd07
121. Office for National Statistics. Interim Life Tables 2008-2010. London: ONS; 2011.
122. Health and Social Care Information Centre (HSCIC). Health Survey for England. Leeds: HSCIC; 2012.
123. National Institute for Health and Care Excellence. Guide to the Methods of Technology Appraisal. London: NICE; 2013.
124. Drobniewski F, Nikolayevskyy V, Maxeiner H, Balabanova Y, Casali N, Kontsevaya I, et al. Rapid diagnostics of tuberculosis and drug resistance in the industrialized world: clinical and public health benefits and barriers to implementation. BMC Med 2013;11:190. http://dx.doi.org/10.1186/1741-7015-11-190
125. Pareek M, Bond M, Shorey J, Seneviratne S, Guy M, White P, et al. Community-based evaluation of immigrant tuberculosis screening using interferon γrelease assays and tuberculin skin testing: observational study and economic analysis. Thorax 2013;68:230-9. http://dx.doi.org/10.1136/thoraxjnl-2011-201542
126. Department of Health. NHS Reference Costs 2011/12. London: Department of Health; 2012.
127. Department of Health. National Tariff. London: Department of Health; 2012.
128. Joint Formulary Committee. British National Formulary. 66th edn. London: BMJ Group and Pharmaceutical Press; 2013.
129. Curtis L. Unit Costs of Health and Social Care 2012. Canterbury: PSSRU, University of Kent; 2012.
130. Saldana L, Abid M, McCarthy N, Hunter N, Inglis R, Anders K. Factors affecting delay in initiation of treatment of tuberculosis in the Thames Valley, UK. Public Health 2013;127:171-7. http://dx.doi.org/10.1016/j.puhe.2012.11.010
131. Barton GR, Bankart J, Davis AC, Summerfield QA. Comparing utility scores before and after hearing-aid provision: results according to the EQ-5D, HUI3 and SF-6D. Appl Health Econ Health Policy 2004;3:103-5. http://dx.doi.org/10.2165/00148365-200403020-00006
132. UK Cochlear Implant Study Group. Criteria of candidacy for unilateral cochlear implantation in postlingually deafened adults II: cost-effectiveness analysis. Ear Hear 2004;25:336-60. http://dx.doi.org/10.1097/01.AUD.0000134550.80305.04
133. Bond M, Mealing S, Anderson R, Elston J, Weiner G, Taylor RS, et al. The effectiveness and cost-effectiveness of cochlear implants for severe to profound deafness in children and adults: a systematic review and economic model. Health Technol Assess 2009;13(41).
134. Yang Y, Longworth L, Brazier J. An assessment of validity and responsiveness of generic measures of health-related quality of life in hearing impairment. Qual Life Res 2013;22:2813-28. http://dx.doi.org/10.1007/s11136-013-0417-6
135. Luo N, Johnson JA, Shaw JW, Feeny D, Coons SJ. Self-reported health status of the general adult U.S. population as assessed by the EQ-5D and Health Utilities Index. Med Care 2005;43:1078-86. http://dx.doi.org/10.1097/01.mlr.0000182493.57090.c1
136. Anderson R, May R. Infectious Diseases of Humans: Dynamics and Control. Oxford: Oxford University Press; 1991.
137. Salomon JA, Lloyd-Smith JO, Getz WM, Resch S, Sánchez MS, Porco TC, et al. Prospects for advancing tuberculosis control efforts through novel therapies. PLOS Med 2006;3:1302-9. http://dx.doi.org/10.1371/journal.pmed.0030273
138. Vynnycky E, Fine PE. The natural history of tuberculosis: the implications of age-dependent risks of disease and the role of reinfection. Epidemiol Infect 1997;119:183-201. http://dx.doi.org/10.1017/S0950268897007917
139. Dye C, Garnett GP, Sleeman K, Williams BG. Prospects for worldwide tuberculosis control under the WHO DOTS strategy. Directly observed short-course therapy. Lancet 1998;352:1886-91. http://dx.doi.org/10.1016/S0140-6736(98)03199-7
140. Office for National Statistics. England and Wales Census. London: ONS; 2011
141. Health Protection Agency (HPA). Tuberculosis In The UK: 2012 Report. London: HPA; 2012.
142. Abubakar I, White P, Jit M, Stagg H, Pimpin L, Aldridge R, et al. Evaluation of the Find and Treat Service for the Control of Tuberculosis amongst Hard to Reach Groups. Final Report Prepared by the Health Protection Agency, Colindale, for the Department of Health. London: Department of Health; 2011.
143. National Tuberculosis Institute [India]. Tuberculosis in a rural population of South India: a five-year epidemiological study. Bull World Health Organ 1974;51:473-88.
144. Abu-Raddad LJ, Sabatelli L, Achterberg JT, Sugimoto JD, Longini IM Jr, Dye C, et al. Epidemiological benefits of more-effective tuberculosis vaccines, drugs, and diagnostics. Proc Natl Acad Sci USA 2009;106:13980-5. http://dx.doi.org/10.1073/pnas.0901720106
145. Arentz M, Sorensen B, Horne DJ, Walson JL. Systematic review of the performance of rapid rifampicin resistance testing for drug-resistant tuberculosis. PLOS ONE 2013;8:e76533. http://dx.doi.org/10.1371/journal.pone.0076533
146. Thompson SG. Why sources of heterogeneity in meta-analysis should be investigated. BMJ 1994;309:1351-5. http://dx.doi.org/10.1136/bmj.309.6965.1351
147. Davis JL, Huang L, Kovacs JA, Masur H, Murray P, Havlir DV, et al. Polymerase chain reaction of secA1 on sputum or oral wash samples for the diagnosis of pulmonary tuberculosis. Clin Infect Dis 2009;48:725-32. http://dx.doi.org/10.1086/597038