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Head-to-Head Comparison between Xpert MTB/RIF Assay and Real-Time Polymerase Chain Reaction Assay Using Bronchial Washing Specimens for Tuberculosis Diagnosis

  • Son, Eunjeong (Department of Internal Medicine, Pusan National University Yangsan Hospital) ;
  • Jang, Jinook (Department of Internal Medicine, Pusan National University Yangsan Hospital) ;
  • Kim, Taehwa (Department of Internal Medicine, Pusan National University Yangsan Hospital) ;
  • Jang, Jin Ho (Department of Internal Medicine, Pusan National University Yangsan Hospital) ;
  • Chung, Jae Heun (Department of Internal Medicine, Pusan National University Yangsan Hospital) ;
  • Seol, Hee Yun (Department of Internal Medicine, Pusan National University Yangsan Hospital) ;
  • Yeo, Hye Ju (Department of Internal Medicine, Pusan National University Yangsan Hospital) ;
  • Yoon, Seong Hoon (Department of Internal Medicine, Pusan National University Yangsan Hospital) ;
  • Lee, Seung Eun (Department of Internal Medicine, Pusan National University Yangsan Hospital) ;
  • Cho, Woo Hyun (Department of Internal Medicine, Pusan National University Yangsan Hospital) ;
  • Kim, Yun Seong (Department of Internal Medicine, Pusan National University Yangsan Hospital) ;
  • Jeon, Doosoo (Department of Internal Medicine, Pusan National University Yangsan Hospital)
  • Received : 2021.07.01
  • Accepted : 2021.11.02
  • Published : 2022.01.31

Abstract

Background: With the introduction of Xpert MTB/RIF assay (Xpert), its incorporation into tuberculosis (TB) diagnostic algorithm has become an important issue. The aim of this study was to evaluate the performance of the Xpert assay in comparison with a commercial polymerase chain reaction (PCR) assay. Methods: Medical records of patients having results of both Xpert and AdvanSure TB/NTM real-time PCR (AdvanSure) assays using the same bronchial washing specimens were retrospectively reviewed. Results: Of the 1,297 patients included in this study, 205 (15.8%) were diagnosed with pulmonary TB. Using mycobacterial culture as the reference method, sensitivity of the Xpert assay using smear-positive specimens was 97.5%, which was comparable to that of the AdvanSure assay (96.3%, p=0.193). However, the sensitivity of the Xpert assay using smear-negative specimens was 70.6%, which was significantly higher than that of the AdvanSure assay (52.9%, p=0.018). Usng phenotypic drug susceptibility testing as the reference method, sensitivity and specificity for detecting rifampicin resistance were 100% and 99.1%, respectively. Moreover, a median turnaround time of the Xpert assay was 1 day, which was significantly shorter than 3 days of the AdvanSure assay (p<0.001). Conclusion: In comparison with the AdvanSure assay, the Xpert assay had a higher sensitivity using smear-negative specimens, a shorter turnaround time, and could reliably predict rifampin resistance. Therefore, the Xpert assay might be preferentially recommended over TB-PCR in Korean TB diagnostic algorithm.

Keywords

References

  1. MacLean E, Kohli M, Weber SF, Suresh A, Schumacher SG, Denkinger CM, et al. Advances in molecular diagnosis of tuberculosis. J Clin Microbiol 2020;58:e01582-19.
  2. Centers for Disease Control and Prevention. Nucleic acid amplification tests for tuberculosis. MMWR Morb Mortal Wkly Rep 1996;45:950-2.
  3. 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. https://doi.org/10.1056/NEJMoa0907847
  4. 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;2014:CD009593.
  5. Li S, Liu B, Peng M, Chen M, Yin W, Tang H, et al. Diagnostic accuracy of Xpert MTB/RIF for tuberculosis detection in different regions with different endemic burden: a systematic review and meta-analysis. PLoS One 2017;12:e0180725. https://doi.org/10.1371/journal.pone.0180725
  6. Agizew T, Boyd R, Auld AF, Payton L, Pals SL, Lekone P, et al. Treatment outcomes, diagnostic and therapeutic impact: Xpert vs. smear: a systematic review and meta-analysis. Int J Tuberc Lung Dis 2019;23:82-92. https://doi.org/10.5588/ijtld.18.0203
  7. Di Tanna GL, Khaki AR, Theron G, McCarthy K, Cox H, Mupfumi L, et al. Effect of Xpert MTB/RIF on clinical outcomes in routine care settings: individual patient data meta-analysis. Lancet Glob Health 2019;7:e191-9. https://doi.org/10.1016/S2214-109X(18)30458-3
  8. Cazabon D, Suresh A, Oghor C, Qin ZZ, Kik SV, Denkinger CM, et al. Implementation of Xpert MTB/RIF in 22 high tuberculosis burden countries: are we making progress? Eur Respir J 2017;50:1700918. https://doi.org/10.1183/13993003.00918-2017
  9. World Health Organization. Molecular assays intended as initial tests for the diagnosis of pulmonary and extrapulmonary TB and rifampicin resistance: rapid communication. Policy update [Internet]. Geneva: World Health Organization; 2020 [cited 2021 Jun 10]. Available from: https://www.who.int/publications/i/item/9789240000339.
  10. Joint Committee for the Revision of Korean Guidelines for Tuberculosis, Korean Centers for Disease Control and Prevention. Korean guidelines for tuberculosis. 2nd ed. [Internet]. Seoul and Cheongju: Joint Committee for the Revision of Korean Guidelines for Tuberculosis, Korea Centers for Disease Control and Prevention; 2014 [cited 2021 Jun 10]. Available from: https://www.lungkorea.org/bbs/index.html?code=guide&category=&gubun=&page=4&number=3480&mode=view&keyfield=&key=.
  11. Joint Committee for the Revision of Korean Guidelines for Tuberculosis, Korean Centers for Disease Control and Prevention. Korean guidelines for tuberculosis. 3rd ed. [Internet]. Seoul and Cheongju: Joint Committee for the Revision of Korean Guidelines for Tuberculosis, Korea Centers for Disease Control and Prevention; 2017 [cited 2021 Jun 10]. Available from: https://www.lungkorea.org/bbs/index.html?code=guide&category=&gubun=&page=2&number=7563&mode=view&keyfield=&key=.
  12. Greco S, Girardi E, Navarra A, Saltini C. Current evidence on diagnostic accuracy of commercially based nucleic acid amplification tests for the diagnosis of pulmonary tuberculosis. Thorax 2006;61:783-90. https://doi.org/10.1136/thx.2005.054908
  13. Park KS, Kim JY, Lee JW, Hwang YY, Jeon K, Koh WJ, et al. Comparison of the Xpert MTB/RIF and Cobas TaqMan MTB assays for detection of Mycobacterium tuberculosis in respiratory specimens. J Clin Microbiol 2013;51:3225-7. https://doi.org/10.1128/JCM.01335-13
  14. Ko Y, Lee HK, Lee YS, Kim MY, Shin JH, Shim EJ, et al. Accuracy of Xpert((R)) MTB/RIF assay compared with AdvanSure TB/NTM real-time PCR using bronchoscopy specimens. Int J Tuberc Lung Dis 2016;20:115-20. https://doi.org/10.5588/ijtld.15.0227
  15. Kim MJ, Nam YS, Cho SY, Park TS, Lee HJ. Comparison of the Xpert MTB/RIF assay and real-time PCR for the detection of Mycobacterium tuberculosis. Ann Clin Lab Sci 2015;45:327-32.
  16. Teo J, Jureen R, Chiang D, Chan D, Lin R. Comparison of two nucleic acid amplification assays, the Xpert MTB/RIF assay and the amplified Mycobacterium Tuberculosis Direct assay, for detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens. J Clin Microbiol 2011;49:3659-62. https://doi.org/10.1128/JCM.00211-11
  17. Jo YS, Park JH, Lee JK, Heo EY, Chung HS, Kim DK. Discordance between MTB/RIF and real-time tuberculosisspecific polymerase chain reaction assay in bronchial washing specimen and its clinical implications. PLoS One 2016;11:e0164923. https://doi.org/10.1371/journal.pone.0164923
  18. Miller MB, Popowitch EB, Backlund MG, Ager EP. Performance of Xpert MTB/RIF RUO assay and IS6110 real-time PCR for Mycobacterium tuberculosis detection in clinical samples. J Clin Microbiol 2011;49:3458-62. https://doi.org/10.1128/JCM.05212-11
  19. Scott LE, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, et al. Comparison of Xpert MTB/RIF with other nucleic acid technologies for diagnosing pulmonary tuberculosis in a high HIV prevalence setting: a prospective study. PLoS Med 2011;8:e1001061. https://doi.org/10.1371/journal.pmed.1001061
  20. Kim CH, Woo H, Hyun IG, Kim C, Choi JH, Jang SH, et al. A comparison between the efficiency of the Xpert MTB/RIF assay and nested PCR in identifying Mycobacterium tuberculosis during routine clinical practice. J Thorac Dis 2014;6:625-31.
  21. Zifodya JS, Kreniske JS, Schiller I, Kohli M, Dendukuri N, Schumacher SG, et al. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. Cochrane Database Syst Rev 2021;2:CD009593.
  22. Xie YL, Chakravorty S, Armstrong DT, Hall SL, Via LE, Song T, et al. Evaluation of a rapid molecular drug-susceptibility test for tuberculosis. N Engl J Med 2017;377:1043-54. https://doi.org/10.1056/NEJMoa1614915
  23. Jo KW, Lee S, Kang MR, Sung H, Kim MN, Shim TS. Frequency and type of disputed rpoB mutations in Mycobacterium tuberculosis isolates from South Korea. Tuberc Respir Dis 2017;80:270-6. https://doi.org/10.4046/trd.2017.80.3.270
  24. Yadav RN, Kumar Singh B, Sharma R, Chaubey J, Sinha S, Jorwal P. Comparative performance of Line Probe Assay (Version 2) and Xpert MTB/RIF Assay for early diagnosis of rifampicin-resistant pulmonary tuberculosis. Tuberc Respir Dis 2021;84:237-44. https://doi.org/10.4046/trd.2020.0171
  25. Zong K, Luo C, Zhou H, Jiang Y, Li S. Xpert MTB/RIF assay for the diagnosis of rifampicin resistance in different regions: a meta-analysis. BMC Microbiol 2019;19:177. https://doi.org/10.1186/s12866-019-1516-5
  26. Shankar SU, Kumar AM, Venkateshmurthy NS, Nair D, Kingsbury R, R P, et al. Implementation of the new integrated algorithm for diagnosis of drug-resistant tuberculosis in Karnataka State, India: How well are we doing? PLoS One 2021;16:e0244785. https://doi.org/10.1371/journal.pone.0244785
  27. Chiang TY, Fan SY, Jou R. Performance of an Xpert-based diagnostic algorithm for the rapid detection of drug-resistant tuberculosis among high-risk populations in a low-incidence setting. PLoS One 2018;13:e0200755. https://doi.org/10.1371/journal.pone.0200755