Performance evaluation of the Xpert MTB/RIF assay according to its clinical application

BMC Infectious Diseases

Volumn 14, Issue 1, 2014, Pages

  Huh, Hee Jae ^a   Jeong, Byeong Ho ^a   Jeon, Kyeongman ^a   Koh, Won Jung ^a   Ki, Chang Seok ^a   Lee, Nam Yong ^a  

^a Sungkyunkwan University School of Medicine   (South Korea)

Author keywords

Korea; Mycobacterium tuberculosis; Pulmonary tuberculosis; Xpert MTB RIF assay

Indexed keywords

RIFAMPICIN; DIAGNOSTIC KIT;

ADULT; AGED; ANTIBIOTIC RESISTANCE; ARTICLE; AUTOMATION; BACTERIUM CULTURE; CONTROLLED STUDY; DIAGNOSTIC TEST ACCURACY STUDY; DRUG SENSITIVITY; FEMALE; HUMAN; LUNG TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MYCOBACTERIUM TUBERCULOSIS; PREDICTIVE VALUE; REAL TIME POLYMERASE CHAIN REACTION; RETROSPECTIVE STUDY; SENSITIVITY AND SPECIFICITY; SOUTH KOREA; TERTIARY CARE CENTER; XPERT MTB/RIF ASSAY; ADOLESCENT; ATYPICAL MYCOBACTERIUM; BODY FLUID; DIAGNOSTIC KIT; EVALUATION STUDY; ISOLATION AND PURIFICATION; MICROBIOLOGY; MIDDLE AGED; TUBERCULOSIS; TUBERCULOSIS, PULMONARY; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BODY FLUIDS; DRUG RESISTANCE, BACTERIAL; FEMALE; HUMANS; MALE; MIDDLE AGED; MYCOBACTERIUM TUBERCULOSIS; NONTUBERCULOUS MYCOBACTERIA; PREDICTIVE VALUE OF TESTS; REAGENT KITS, DIAGNOSTIC; RETROSPECTIVE STUDIES; RIFAMPIN; SENSITIVITY AND SPECIFICITY; TUBERCULOSIS; TUBERCULOSIS, PULMONARY; YOUNG ADULT;

EID: 84965190880     PISSN: None     EISSN: 14712334     Source Type: Journal    
DOI: 10.1186/s12879-014-0589-x     Document Type: Article

References (32)

1. Banada PP, Sivasubramani SK, Blakemore R, Boehme C, Perkins MD, Fennelly K, Alland D: Containment of bioaerosol infection risk by the Xpert MTB/RIF assay and its applicability to point-of-care settings. J Clin Microbiol 2010, 48(10):3551-3557.
2. Helb D, Jones M, Story E, Boehme C, Wallace E, Ho K, Kop J, Owens MR, Rodgers R, Banada P, Safi H, Blakemore R, Lan NT, Jones-López EC, Levi M, Burday M, Ayakaka I, Mugerwa RD, McMillan B, Winn-Deen E, Christel L, Dailey P, Perkins MD, Persing DH, Alland D: Rapid detection of Mycobacterium tuberculosis and rifampin resistance by use of on-demand, near-patient technology. J Clin Microbiol 2010, 48(1):229-237.
3. Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, Allen J, Tahirli R, Blakemore R, Rustomjee R, Milovic A, Jones M, O'Brien SM, Persing DH, Ruesch-Gerdes S, Gotuzzo E, Rodrigues C, Alland D, Perkins MD: Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med 2010, 363(11):1005-1015.
4. Boehme CC, Nicol MP, Nabeta P, Michael JS, Gotuzzo E, Tahirli R, Gler MT, Blakemore R, Worodria W, Gray C, Huang L, Caceres T, Mehdiyev R, Raymond L, Whitelaw A, Sagadevan K, Alexander H, Albert H, Cobelens F, Cox H, Alland D, Perkins MD: 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(9776):1495-1505.
5. Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K, Ntinginya EN, O'Grady J, Huggett J, Dheda K, Boehme C, Perkins M, Saathoff E, Hoelscher M: Rapid and accurate detection of Mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay-a clinical validation study. PLoS One 2011, 6(6):e20458.
6. Antonenka U, Hofmann-Thiel S, Turaev L, Esenalieva A, Abdulloeva M, Sahalchyk E, Alnour T, Hoffmann H: Comparison of Xpert MTB/RIF with ProbeTec ET DTB and COBAS TaqMan MTB for direct detection of M. tuberculosis complex in respiratory specimens. BMC Infect Dis 2013, 13:280.
7. World Health Organization: Global Tuberculosis Report 2013. Geneva, Switzerland: World Health Organization; 2013.
8. O'Grady J, Bates M, Chilukutu L, Mzyece J, Cheelo B, Chilufya M, Mukonda L, Mumba M, Tembo J, Chomba M, Kapata N, Maeurer M, Rachow A, Clowes P, Hoelscher M, Mwaba P, Zumla A: 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(9):1171-1178.
9. Kim SY, Kim H, Kim SY, Ra EK, Joo SI, Shin S, Seong MW, Yoo CG, Kim EC, Park SS: The Xpert(R) MTB/RIF assay evaluation in South Korea, a country with an intermediate tuberculosis burden. Int J Tuberc Lung Dis 2012, 16(11):1471-1476.
10. Kwak N, Choi SM, Lee J, Park YS, Lee CH, Lee SM, Yoo CG, Kim YW, Han SK, Yim JJ: Diagnostic accuracy and turnaround time of the Xpert MTB/RIF assay in routine clinical practice. PLoS One 2013, 8(10):e77456.
11. Park KS, Kim JY, Lee JW, Hwang YY, Jeon K, Koh WJ, Ki CS, Lee NY: Comparison of the Xpert MTB/RIF and Cobas TaqMan MTB assays for detection of Mycobacterium tuberculosis in respiratory specimens. J Clin Microbiol 2013, 51(10):3225-3227.
12. Kent PT, Kubica GP: Public Health Mycobacteriology: A Guide for the Level III Laboratory. Atlanta, GA: Centers for Disease Control and Prevention, US Public Health Service; 1985.
13. The American Thoracic Society: Diagnostic Standards and Classification of Tuberculosis in Adults and Children. This official statement of the American Thoracic Society and the Centers for Disease Control and Prevention was adopted by the ATS Board of Directors, July 1999. This statement was endorsed by the Council of the Infectious Disease Society of America, September 1999. Am J Respir Crit Care Med 2000, 161(4 Pt 1):1376-1395.
14. Koh WJ, Ko Y, Kim CK, Park KS, Lee NY: Rapid diagnosis of tuberculosis and multidrug resistance using a MGIT 960 system. Ann Lab Med 2012, 32(4):264-269.
15. Bai GH, Park YK, Choi YW, Bai JI, Kim HJ, Chang CL, Lee JK, Kim SJ: Trend of anti-tuberculosis drug resistance in Korea, 1994-2004. Int J Tuberc Lung Dis 2007, 11(5):571-576.
16. Clinical and Laboratory Standards Institute: Interpretive criteria for microorganism identification by DNA target sequencing; approved guideline. In Document MM18-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.
17. Ahmad S, Araj GF, Akbar PK, Fares E, Chugh TD, Mustafa AS: Characterization of rpoB mutations in rifampin-resistant Mycobacterium tuberculosis isolates from the Middle East. Diagn Microbiol Infect Dis 2000, 38(4):227-232.
18. Sohn H, Aero AD, Menzies D, Behr M, Schwartzman K, Alvarez GG, Dan A, McIntosh F, Pai M, Denkinger CM: Xpert MTB/RIF testing in a low tuberculosis incidence, high-resource setting: limitations in accuracy and clinical impact. Clin Infect Dis 2014, 58(7):970-976.
19. Deggim V, Somoskovi A, Voit A, Bottger EC, Bloemberg GV: Integrating the Xpert MTB/RIF assay into a diagnostic workflow for rapid detection of Mycobacterium tuberculosis in a low-prevalence area. J Clin Microbiol 2013, 51(7):2396-2399.
20. Moure R, Martin R, Alcaide F: Effectiveness of an integrated real-time PCR method for detection of the Mycobacterium tuberculosis complex in smear-negative extrapulmonary samples in an area of low tuberculosis prevalence. J Clin Microbiol 2012, 50(2):513-515.
21. Steingart KR, Schiller I, Horne DJ, Pai M, Boehme CC, Dendukuri N: Xpert(R) MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev 2014, 1:CD009593.
22. Theron G, Peter J, van Zyl-Smit R, Mishra H, Streicher E, Murray S, Dawson R, Whitelaw A, Hoelscher M, Sharma S, Pai M, Warren R, Dheda K: Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med 2011, 184(1):132-140.
23. Horne DJ, Pinto LM, Arentz M, Lin SY, Desmond E, Flores LL, Steingart KR, Minion J: Diagnostic accuracy and reproducibility of WHO-endorsed phenotypic drug susceptibility testing methods for first-line and second-line antituberculosis drugs. J Clin Microbiol 2013, 51(2):393-401.
24. Van Deun A, Aung KJ, Bola V, Lebeke R, Hossain MA, de Rijk WB, Rigouts L, Gumusboga A, Torrea G, de Jong BC: Rifampin drug resistance tests for tuberculosis: challenging the gold standard. J Clin Microbiol 2013, 51(8):2633-2640.
25. Somoskovi A, Deggim V, Ciardo D, Bloemberg GV: Diagnostic implications of inconsistent results obtained with the Xpert MTB/Rif assay in detection of Mycobacterium tuberculosis isolates with an rpoB mutation associated with low-level rifampin resistance. J Clin Microbiol 2013, 51(9):3127-3129.
26. Rigouts L, Gumusboga M, de Rijk WB, Nduwamahoro E, Uwizeye C, de Jong B, Van Deun A: Rifampin resistance missed in automated liquid culture system for Mycobacterium tuberculosis isolates with specific rpoB mutations. J ClinMicrobiol 2013, 51(8):2641-2645.
27. Jeon K, Koh WJ, Kwon OJ, Suh GY, Chung MP, Kim H, Lee NY, Park YK, Bai GH: Recovery rate of NTM from AFB smear-positive sputum specimens at a medical centre in South Korea. Int J Tuberc Lung Dis 2005, 9(9):1046-1051.
28. Lee SK, Lee EJ, Kim SK, Chang J, Jeong SH, Kang YA: Changing epidemiology of nontuberculous mycobacterial lung disease in South Korea. Scand J Infect Dis 2012, 44(10):733-738.
29. Lee MK, Seo YH, Jeong JH, Park PW, Kim KH, Ahn JY, Kim JY, Park JW: Nontuberculous mycobacteria isolated from respiratory specimens during recent two years: distribution and clinical significance. Korean J Clin Microbiol 2012, 15(3):98-103.
30. Koh WJ, Chang B, Jeong BH, Jeon K, Kim SY, Lee NY, Ki CS, Kwon OJ: Increasing recovery of nontuberculous mycobacteria from respiratory specimens over a 10-year period in a tertiary referral hospital in South Korea. Tuberc Respir Dis (Seoul) 2013, 75(5):199-204.
31. Lippincott CK, Miller MB, Popowitch EB, Hanrahan CF, Van Rie A: Xpert MTB/RIF assay shortens airborne isolation for hospitalized patients with presumptive tuberculosis in the United States. Clin Infect Dis 2014, 59(2):186-192.
32. Millman AJ, Dowdy DW, Miller CR, Brownell R, Metcalfe JZ, Cattamanchi A, Davis JL: Rapid molecular testing for TB to guide respiratory isolation in the U.S.: a cost-benefit analysis. PLoS One 2013, 8(11):e79669.