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Erschienen in: European Journal of Clinical Microbiology & Infectious Diseases 8/2020

31.03.2020 | Brief Report

Evaluation of Xpert MTB/RIF Ultra assay for rapid diagnosis of pulmonary and extra-pulmonary tuberculosis in an Italian center

verfasst von: Melissa Menichini, Nicoletta Lari, Antonella Lupetti, Laura Rindi

Erschienen in: European Journal of Clinical Microbiology & Infectious Diseases | Ausgabe 8/2020

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Excerpt

Tuberculosis (TB) is a major infectious disease worldwide. In 2018, the World Health Organization (WHO) estimated 1.3 million deaths and 10.0 million new cases [1]. Rapid detection of Mycobacterium tuberculosis and determination of resistance, based on nucleic acid amplification techniques carried out directly on clinical samples, are essential for early diagnosis and treatment [2, 3]. Since 2010, the WHO recommended the use of Xpert MTB/RIF (Xpert) assay (Cepheid, Sunnyvale, CA, USA), which could simultaneously detect MTBC and RIF resistance conferred by the rpoB gene mutations within 2 h [47]. Recently, the new version Xpert MTB/RIF Ultra (Ultra) has been developed in order to overcome some limitations of the Xpert assay [8]. The aim of the present study was to evaluate the performance of the Ultra assay for pulmonary and extra-pulmonary samples in a region of Italy with low TB incidence. …
Literatur
2.
Zurück zum Zitat Forbes BA, Hall GS, Miller MB, Novak SM, Rowlinson M-C, Salfinger M, Somoskövi A, Warshauer DM, Wilson ML (2018) Practice guidelines for clinical microbiology laboratories: mycobacteria. Clin Microbiol Rev 31(2):e00038–e00017CrossRef Forbes BA, Hall GS, Miller MB, Novak SM, Rowlinson M-C, Salfinger M, Somoskövi A, Warshauer DM, Wilson ML (2018) Practice guidelines for clinical microbiology laboratories: mycobacteria. Clin Microbiol Rev 31(2):e00038–e00017CrossRef
3.
Zurück zum Zitat Centers for Disease Control and Prevention (CDC) (2009) Updated guidelines for the use of nucleic acid amplification tests in the diagnosis of tuberculosis. MMWR Morb Mortal Wkly Rep 58:7–10 Centers for Disease Control and Prevention (CDC) (2009) Updated guidelines for the use of nucleic acid amplification tests in the diagnosis of tuberculosis. MMWR Morb Mortal Wkly Rep 58:7–10
4.
Zurück zum Zitat Boehme C, Nabeta P, Hillemann D, Nicol M, 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 (2010) Rapid molecular detection of tuberculosis and rifampicin resistance. N Engl J Med 363:1005–1015CrossRef Boehme C, Nabeta P, Hillemann D, Nicol M, 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 (2010) Rapid molecular detection of tuberculosis and rifampicin resistance. N Engl J Med 363:1005–1015CrossRef
5.
Zurück zum Zitat Theron G, Peter J, Calligaro G, Meldau R, Hanrahan C, Khalfey H, Matinyenya B, Muchinga T, Smith L, Pandie S, Lenders L, Patel V, Mayosi BM, Dheda K (2014) Determinants of PCR performance (Xpert MTB/RIF), including bacterial load and inhibition, for TB diagnosis using specimens from different body compartments. Sci Rep 4:5658CrossRef Theron G, Peter J, Calligaro G, Meldau R, Hanrahan C, Khalfey H, Matinyenya B, Muchinga T, Smith L, Pandie S, Lenders L, Patel V, Mayosi BM, Dheda K (2014) Determinants of PCR performance (Xpert MTB/RIF), including bacterial load and inhibition, for TB diagnosis using specimens from different body compartments. Sci Rep 4:5658CrossRef
6.
Zurück zum Zitat Detjen AK, DiNardo AR, Leyden J, Steingart KR, Menzies D, Schiller I, Dendukuri N, Mandalakas AM (2015) Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in children: a systematic review and meta-analysis. Lancet Respir Med 3:451–461CrossRef Detjen AK, DiNardo AR, Leyden J, Steingart KR, Menzies D, Schiller I, Dendukuri N, Mandalakas AM (2015) Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in children: a systematic review and meta-analysis. Lancet Respir Med 3:451–461CrossRef
7.
Zurück zum Zitat Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, Bekker LG, Wood R (2011) Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med 8(7):e1001067CrossRef Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, Bekker LG, Wood R (2011) Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med 8(7):e1001067CrossRef
8.
Zurück zum Zitat Chakravorty S, Simmons AM, Rowneki M, Parmar H, Cao Y, Ryan J, Banada PP, Deshpande S, Shenai S, Gall A, Glass J, Krieswirth B, Schumacher SG, Nabeta P, Tukvadze N, Rodrigues C, Skrahina A, Tagliani E, Cirillo DM, Davidow A, Denkinger CM, Persing D, Kwiatkowski R, Jones M, Alland D (2017) The new Xpert MTB/RIF Ultra: improving detection of Mycobacterium tuberculosis and resistance to rifampin in an assay suitable for point-of-care testing. mBio 8:e00812–e00817CrossRef Chakravorty S, Simmons AM, Rowneki M, Parmar H, Cao Y, Ryan J, Banada PP, Deshpande S, Shenai S, Gall A, Glass J, Krieswirth B, Schumacher SG, Nabeta P, Tukvadze N, Rodrigues C, Skrahina A, Tagliani E, Cirillo DM, Davidow A, Denkinger CM, Persing D, Kwiatkowski R, Jones M, Alland D (2017) The new Xpert MTB/RIF Ultra: improving detection of Mycobacterium tuberculosis and resistance to rifampin in an assay suitable for point-of-care testing. mBio 8:e00812–e00817CrossRef
9.
Zurück zum Zitat Clinical and Laboratory Standards Institute (2011) Susceptibility testing of mycobacteria, nocardiae, and other aerobic actinomycetes. 2nd ed. Wayne: CLSI; Approved standard. CLSI document M24-A2 Clinical and Laboratory Standards Institute (2011) Susceptibility testing of mycobacteria, nocardiae, and other aerobic actinomycetes. 2nd ed. Wayne: CLSI; Approved standard. CLSI document M24-A2
10.
Zurück zum Zitat Cepheid (2017) Xpert MTB/RIF ULTRA assay (package insert). Sunnyvale Cepheid (2017) Xpert MTB/RIF ULTRA assay (package insert). Sunnyvale
11.
Zurück zum Zitat Rindi L, Garzelli C (2016) Increase in non-tuberculous mycobacteria isolated from humans in Tuscany, Italy, from 2004 to 2014. BMC Infect Dis 16:44CrossRef Rindi L, Garzelli C (2016) Increase in non-tuberculous mycobacteria isolated from humans in Tuscany, Italy, from 2004 to 2014. BMC Infect Dis 16:44CrossRef
12.
Zurück zum Zitat Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B, Hall SL, Chakravorty S, Cirillo DM, Tukvadze N, Bablishvili N, Stevens W, Scott L, Rodrigues C, Kazi MI, Joloba M, Nakiyingi L, Nicol MP, Ghebrekristos Y, Anyango I, Murithi W, Dietze R, Peres RL, Skrahina A, Auchynka V, Chopra KK, Hanif M, Liu X, Yuan X, Boehme CC, Ellner JJ, Denkinger CM, study team (2018) Xpert MTB/RIF ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infect Dis 18:76–84CrossRef Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B, Hall SL, Chakravorty S, Cirillo DM, Tukvadze N, Bablishvili N, Stevens W, Scott L, Rodrigues C, Kazi MI, Joloba M, Nakiyingi L, Nicol MP, Ghebrekristos Y, Anyango I, Murithi W, Dietze R, Peres RL, Skrahina A, Auchynka V, Chopra KK, Hanif M, Liu X, Yuan X, Boehme CC, Ellner JJ, Denkinger CM, study team (2018) Xpert MTB/RIF ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infect Dis 18:76–84CrossRef
13.
Zurück zum Zitat Opota O, Zakham F, Mazza-Stalder J, Nicod L, Greub G, Jaton K (2019) Added value of Xpert MTB/RIF Ultra for diagnosis of pulmonary tuberculosis in a low-prevalence setting. J Clin Microbiol 57(2):e01717–e01718PubMedPubMedCentral Opota O, Zakham F, Mazza-Stalder J, Nicod L, Greub G, Jaton K (2019) Added value of Xpert MTB/RIF Ultra for diagnosis of pulmonary tuberculosis in a low-prevalence setting. J Clin Microbiol 57(2):e01717–e01718PubMedPubMedCentral
14.
Zurück zum Zitat Osei Sekyere J, Maphalala N, Malinga LA, Mbelle NM, Maningi NE (2019) A comparative evaluation of the new Genexpert MTB/RIF Ultra and other rapid diagnostic assays for detecting tuberculosis in pulmonary and extra pulmonary specimens. Sci Rep 9:16587CrossRef Osei Sekyere J, Maphalala N, Malinga LA, Mbelle NM, Maningi NE (2019) A comparative evaluation of the new Genexpert MTB/RIF Ultra and other rapid diagnostic assays for detecting tuberculosis in pulmonary and extra pulmonary specimens. Sci Rep 9:16587CrossRef
15.
Zurück zum Zitat Perez-Risco D, Rodriguez-Temporal D, Valledor-Sanchez I, Alcaide F (2018) Evaluation of the Xpert MTB/RIF Ultra assay for direct detection of Mycobacterium tuberculosis complex in smear-negative extrapulmonary samples. J Clin Microbiol 56(9):e00659–e00618CrossRef Perez-Risco D, Rodriguez-Temporal D, Valledor-Sanchez I, Alcaide F (2018) Evaluation of the Xpert MTB/RIF Ultra assay for direct detection of Mycobacterium tuberculosis complex in smear-negative extrapulmonary samples. J Clin Microbiol 56(9):e00659–e00618CrossRef
16.
Zurück zum Zitat Wu X, Tan G, Gao R, Yao L, Bi D, Guo Y, Yu F, Fan L (2019) Assessment of the Xpert MTB/RIF Ultra assay on rapid diagnosis of extrapulmonary tuberculosis. Int J Infect Dis 81:91–96CrossRef Wu X, Tan G, Gao R, Yao L, Bi D, Guo Y, Yu F, Fan L (2019) Assessment of the Xpert MTB/RIF Ultra assay on rapid diagnosis of extrapulmonary tuberculosis. Int J Infect Dis 81:91–96CrossRef
17.
Zurück zum Zitat Hodille E, Maisson A, Charlet L, Bauduin C, Genestet C, Fredenucci I, Rasigade JP, Lina G, Dumitrescu O (2019) Evaluation of Xpert MTB/RIF Ultra performance for pulmonary tuberculosis diagnosis on smear-negative respiratory samples in a French centre. Eur J Clin Microbiol Infect Dis 38:601–605CrossRef Hodille E, Maisson A, Charlet L, Bauduin C, Genestet C, Fredenucci I, Rasigade JP, Lina G, Dumitrescu O (2019) Evaluation of Xpert MTB/RIF Ultra performance for pulmonary tuberculosis diagnosis on smear-negative respiratory samples in a French centre. Eur J Clin Microbiol Infect Dis 38:601–605CrossRef
18.
Zurück zum Zitat Piersimoni C, Gherardi G, Gracciotti N, Pocognoli A (2019) Comparative evaluation of Xpert MTB/RIF and the new Xpert MTB/RIF ultra with respiratory and extra-pulmonary specimens for tuberculosis case detection in a low incidence setting. J Clin Tuberc Other Mycobact Dis 15:100094CrossRef Piersimoni C, Gherardi G, Gracciotti N, Pocognoli A (2019) Comparative evaluation of Xpert MTB/RIF and the new Xpert MTB/RIF ultra with respiratory and extra-pulmonary specimens for tuberculosis case detection in a low incidence setting. J Clin Tuberc Other Mycobact Dis 15:100094CrossRef
19.
Zurück zum Zitat Theron G, Venter R, Smith L, Esmail A, Randall P, Sood V, Oelfese S, Calligaro G, Warren R, Dheda KJ (2018) False-positive Xpert MTB/RIF results in retested patients with previous tuberculosis: frequency, profile, and prospective clinical outcomes. Clin Microbiol 56(3) Theron G, Venter R, Smith L, Esmail A, Randall P, Sood V, Oelfese S, Calligaro G, Warren R, Dheda KJ (2018) False-positive Xpert MTB/RIF results in retested patients with previous tuberculosis: frequency, profile, and prospective clinical outcomes. Clin Microbiol 56(3)
20.
Zurück zum Zitat Kendall EA, Schumacher SG, Denkinger CM, Dowdy DW (2017) Estimated clinical impact of the Xpert MTB/RIF Ultra cartridge for diagnosis of pulmonary tuberculosis: a modeling study. PLoS Med 14(12):e1002472CrossRef Kendall EA, Schumacher SG, Denkinger CM, Dowdy DW (2017) Estimated clinical impact of the Xpert MTB/RIF Ultra cartridge for diagnosis of pulmonary tuberculosis: a modeling study. PLoS Med 14(12):e1002472CrossRef
21.
Zurück zum Zitat Ocheretina O, Byrt E, Mabou MM, Royal-Mardi G, Merveille YM, Rouzier V, Fitzgerald DW, Pape JW (2016) False-positive rifampin resistant results with Xpert MTB/RIF version 4 assay in clinical samples with a low bacterial load. Diagn Microbiol Infect Dis 85:53–55CrossRef Ocheretina O, Byrt E, Mabou MM, Royal-Mardi G, Merveille YM, Rouzier V, Fitzgerald DW, Pape JW (2016) False-positive rifampin resistant results with Xpert MTB/RIF version 4 assay in clinical samples with a low bacterial load. Diagn Microbiol Infect Dis 85:53–55CrossRef
22.
Zurück zum Zitat Williamson DA, Basu I, Bower J, Freeman JT, Henderson G, Roberts SA (2012) An evaluation of the Xpert MTB/RIF assay and detection of false-positive rifampicin resistance in Mycobacterium tuberculosis. Diagn Microbiol Infect Dis 74:207–209CrossRef Williamson DA, Basu I, Bower J, Freeman JT, Henderson G, Roberts SA (2012) An evaluation of the Xpert MTB/RIF assay and detection of false-positive rifampicin resistance in Mycobacterium tuberculosis. Diagn Microbiol Infect Dis 74:207–209CrossRef
Metadaten
Titel
Evaluation of Xpert MTB/RIF Ultra assay for rapid diagnosis of pulmonary and extra-pulmonary tuberculosis in an Italian center
verfasst von
Melissa Menichini
Nicoletta Lari
Antonella Lupetti
Laura Rindi
Publikationsdatum
31.03.2020
Verlag
Springer Berlin Heidelberg
Erschienen in
European Journal of Clinical Microbiology & Infectious Diseases / Ausgabe 8/2020
Print ISSN: 0934-9723
Elektronische ISSN: 1435-4373
DOI
https://doi.org/10.1007/s10096-020-03867-y

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