Evaluation of Xpert MTB/XDR test for susceptibility testing of Mycobacterium tuberculosis to first and second-line drugs in Uganda
Drug-Resistant Tuberculosis (DR-TB) is one of the major challenges to TB control. This was a blinded, laboratory-based cross-sectional study using sputum samples or culture isolates. Samples were from patients with rifampicin-resistant-TB and/or with high risk for isoniazid (INH) resistance and/or 2...
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| Published in: | PloS one Vol. 18; no. 8; p. e0284545 |
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| Format: | Journal Article |
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| Abstract | Drug-Resistant Tuberculosis (DR-TB) is one of the major challenges to TB control. This was a blinded, laboratory-based cross-sectional study using sputum samples or culture isolates. Samples were from patients with rifampicin-resistant-TB and/or with high risk for isoniazid (INH) resistance and/or 2.sup.nd line fluoroquinolones (FQ) and injectable agents (IAs). The diagnostic accuracy of the Xpert.sup.® MTB/XDR test was compared to MGIT960 and the Hain Genotype.sup.® MTBDRplus and MDRsl assays (LPA) as reference DST methods. Factors for laboratory uptake of the Xpert.sup.® MTB/XDR test were also evaluated. Of the 100 stored sputum samples included in this study, 65/99 (65.6%) were resistant to INH, 5/100 (5.0%) were resistant to FQ and none were resistant to IAs using MGIT960. The sensitivity and specificity, n (%; 95% Confidence Interval, CI) of Xpert.sup.® MTB/XDR test for; INH was 58 (89.2; 79.1-95.5) and 30 (88.2; 72.5-96.6) and for FQ; 4 (80.0; 28.3-99.4) and 95 (100; 96.2-100), respectively. Using LPA as a reference standard, a total of 52/98 (53.1%) were resistant to INH, 3/100 (3.0%) to FQ, and none to IA. The sensitivity and specificity, n (%; 95%CI) of Xpert.sup.® MTB/XDR test compared to LPA for; INH was 50 (96.1; 86.7-99.5) and 34 (74.0; 58.8-85.7) for FQ 3 (100; 29.2-100) and 96 (99.0; 94.3-99.9) respectively. The factors for laboratory uptake and roll-out of the Xpert.sup.® MTB/XDR test included: no training needed for technicians with, and one day for those without, previous Xpert-ultra experience, recording and reporting needs were not different from those of Xpert-ultra, the error rate was 4/100 (4%), one (1%) indeterminate rate and test turn-around-time were 1hr/45 minutes. There is high sensitivity and specificity of Xpert.sup.® MTB/XDR test for isoniazid and fluoroquinolones. There are acceptable Xpert.sup.® MTB/XDR test attributes for the test uptake and roll-out. |
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| AbstractList | Background
Drug-Resistant Tuberculosis (DR-TB) is one of the major challenges to TB control.
Design and methods
This was a blinded, laboratory-based cross-sectional study using sputum samples or culture isolates. Samples were from patients with rifampicin-resistant—TB and/or with high risk for isoniazid (INH) resistance and/or 2 nd line fluoroquinolones (FQ) and injectable agents (IAs). The diagnostic accuracy of the Xpert ® MTB/XDR test was compared to MGIT960 and the Hain Genotype ® MTBDR plus and MDRsl assays (LPA) as reference DST methods. Factors for laboratory uptake of the Xpert ® MTB/XDR test were also evaluated.
Results
Of the 100 stored sputum samples included in this study, 65/99 (65.6%) were resistant to INH, 5/100 (5.0%) were resistant to FQ and none were resistant to IAs using MGIT960. The sensitivity and specificity, n (%; 95% Confidence Interval, CI) of Xpert ® MTB/XDR test for; INH was 58 (89.2; 79.1–95.5) and 30 (88.2; 72.5–96.6) and for FQ; 4 (80.0; 28.3–99.4) and 95 (100; 96.2–100), respectively. Using LPA as a reference standard, a total of 52/98 (53.1%) were resistant to INH, 3/100 (3.0%) to FQ, and none to IA. The sensitivity and specificity, n (%; 95%CI) of Xpert ® MTB/XDR test compared to LPA for; INH was 50 (96.1; 86.7–99.5) and 34 (74.0; 58.8–85.7) for FQ 3 (100; 29.2–100) and 96 (99.0; 94.3–99.9) respectively. The factors for laboratory uptake and roll-out of the Xpert ® MTB/XDR test included: no training needed for technicians with, and one day for those without, previous Xpert-ultra experience, recording and reporting needs were not different from those of Xpert-ultra, the error rate was 4/100 (4%), one (1%) indeterminate rate and test turn-around-time were 1hr/45 minutes.
Conclusion
There is high sensitivity and specificity of Xpert ® MTB/XDR test for isoniazid and fluoroquinolones. There are acceptable Xpert ® MTB/XDR test attributes for the test uptake and roll-out. Background Drug-Resistant Tuberculosis (DR-TB) is one of the major challenges to TB control. Design and methods This was a blinded, laboratory-based cross-sectional study using sputum samples or culture isolates. Samples were from patients with rifampicin-resistant-TB and/or with high risk for isoniazid (INH) resistance and/or 2.sup.nd line fluoroquinolones (FQ) and injectable agents (IAs). The diagnostic accuracy of the Xpert.sup.® MTB/XDR test was compared to MGIT960 and the Hain Genotype.sup.® MTBDRplus and MDRsl assays (LPA) as reference DST methods. Factors for laboratory uptake of the Xpert.sup.® MTB/XDR test were also evaluated. Results Of the 100 stored sputum samples included in this study, 65/99 (65.6%) were resistant to INH, 5/100 (5.0%) were resistant to FQ and none were resistant to IAs using MGIT960. The sensitivity and specificity, n (%; 95% Confidence Interval, CI) of Xpert.sup.® MTB/XDR test for; INH was 58 (89.2; 79.1-95.5) and 30 (88.2; 72.5-96.6) and for FQ; 4 (80.0; 28.3-99.4) and 95 (100; 96.2-100), respectively. Using LPA as a reference standard, a total of 52/98 (53.1%) were resistant to INH, 3/100 (3.0%) to FQ, and none to IA. The sensitivity and specificity, n (%; 95%CI) of Xpert.sup.® MTB/XDR test compared to LPA for; INH was 50 (96.1; 86.7-99.5) and 34 (74.0; 58.8-85.7) for FQ 3 (100; 29.2-100) and 96 (99.0; 94.3-99.9) respectively. The factors for laboratory uptake and roll-out of the Xpert.sup.® MTB/XDR test included: no training needed for technicians with, and one day for those without, previous Xpert-ultra experience, recording and reporting needs were not different from those of Xpert-ultra, the error rate was 4/100 (4%), one (1%) indeterminate rate and test turn-around-time were 1hr/45 minutes. Conclusion There is high sensitivity and specificity of Xpert.sup.® MTB/XDR test for isoniazid and fluoroquinolones. There are acceptable Xpert.sup.® MTB/XDR test attributes for the test uptake and roll-out. Drug-Resistant Tuberculosis (DR-TB) is one of the major challenges to TB control. This was a blinded, laboratory-based cross-sectional study using sputum samples or culture isolates. Samples were from patients with rifampicin-resistant-TB and/or with high risk for isoniazid (INH) resistance and/or 2.sup.nd line fluoroquinolones (FQ) and injectable agents (IAs). The diagnostic accuracy of the Xpert.sup.® MTB/XDR test was compared to MGIT960 and the Hain Genotype.sup.® MTBDRplus and MDRsl assays (LPA) as reference DST methods. Factors for laboratory uptake of the Xpert.sup.® MTB/XDR test were also evaluated. Of the 100 stored sputum samples included in this study, 65/99 (65.6%) were resistant to INH, 5/100 (5.0%) were resistant to FQ and none were resistant to IAs using MGIT960. The sensitivity and specificity, n (%; 95% Confidence Interval, CI) of Xpert.sup.® MTB/XDR test for; INH was 58 (89.2; 79.1-95.5) and 30 (88.2; 72.5-96.6) and for FQ; 4 (80.0; 28.3-99.4) and 95 (100; 96.2-100), respectively. Using LPA as a reference standard, a total of 52/98 (53.1%) were resistant to INH, 3/100 (3.0%) to FQ, and none to IA. The sensitivity and specificity, n (%; 95%CI) of Xpert.sup.® MTB/XDR test compared to LPA for; INH was 50 (96.1; 86.7-99.5) and 34 (74.0; 58.8-85.7) for FQ 3 (100; 29.2-100) and 96 (99.0; 94.3-99.9) respectively. The factors for laboratory uptake and roll-out of the Xpert.sup.® MTB/XDR test included: no training needed for technicians with, and one day for those without, previous Xpert-ultra experience, recording and reporting needs were not different from those of Xpert-ultra, the error rate was 4/100 (4%), one (1%) indeterminate rate and test turn-around-time were 1hr/45 minutes. There is high sensitivity and specificity of Xpert.sup.® MTB/XDR test for isoniazid and fluoroquinolones. There are acceptable Xpert.sup.® MTB/XDR test attributes for the test uptake and roll-out. BackgroundDrug-Resistant Tuberculosis (DR-TB) is one of the major challenges to TB control.Design and methodsThis was a blinded, laboratory-based cross-sectional study using sputum samples or culture isolates. Samples were from patients with rifampicin-resistant-TB and/or with high risk for isoniazid (INH) resistance and/or 2nd line fluoroquinolones (FQ) and injectable agents (IAs). The diagnostic accuracy of the Xpert® MTB/XDR test was compared to MGIT960 and the Hain Genotype® MTBDRplus and MDRsl assays (LPA) as reference DST methods. Factors for laboratory uptake of the Xpert® MTB/XDR test were also evaluated.ResultsOf the 100 stored sputum samples included in this study, 65/99 (65.6%) were resistant to INH, 5/100 (5.0%) were resistant to FQ and none were resistant to IAs using MGIT960. The sensitivity and specificity, n (%; 95% Confidence Interval, CI) of Xpert® MTB/XDR test for; INH was 58 (89.2; 79.1-95.5) and 30 (88.2; 72.5-96.6) and for FQ; 4 (80.0; 28.3-99.4) and 95 (100; 96.2-100), respectively. Using LPA as a reference standard, a total of 52/98 (53.1%) were resistant to INH, 3/100 (3.0%) to FQ, and none to IA. The sensitivity and specificity, n (%; 95%CI) of Xpert® MTB/XDR test compared to LPA for; INH was 50 (96.1; 86.7-99.5) and 34 (74.0; 58.8-85.7) for FQ 3 (100; 29.2-100) and 96 (99.0; 94.3-99.9) respectively. The factors for laboratory uptake and roll-out of the Xpert® MTB/XDR test included: no training needed for technicians with, and one day for those without, previous Xpert-ultra experience, recording and reporting needs were not different from those of Xpert-ultra, the error rate was 4/100 (4%), one (1%) indeterminate rate and test turn-around-time were 1hr/45 minutes.ConclusionThere is high sensitivity and specificity of Xpert® MTB/XDR test for isoniazid and fluoroquinolones. There are acceptable Xpert® MTB/XDR test attributes for the test uptake and roll-out. Background Drug-Resistant Tuberculosis (DR-TB) is one of the major challenges to TB control. Design and methods This was a blinded, laboratory-based cross-sectional study using sputum samples or culture isolates. Samples were from patients with rifampicin-resistant—TB and/or with high risk for isoniazid (INH) resistance and/or 2nd line fluoroquinolones (FQ) and injectable agents (IAs). The diagnostic accuracy of the Xpert® MTB/XDR test was compared to MGIT960 and the Hain Genotype® MTBDRplus and MDRsl assays (LPA) as reference DST methods. Factors for laboratory uptake of the Xpert® MTB/XDR test were also evaluated. Results Of the 100 stored sputum samples included in this study, 65/99 (65.6%) were resistant to INH, 5/100 (5.0%) were resistant to FQ and none were resistant to IAs using MGIT960. The sensitivity and specificity, n (%; 95% Confidence Interval, CI) of Xpert® MTB/XDR test for; INH was 58 (89.2; 79.1–95.5) and 30 (88.2; 72.5–96.6) and for FQ; 4 (80.0; 28.3–99.4) and 95 (100; 96.2–100), respectively. Using LPA as a reference standard, a total of 52/98 (53.1%) were resistant to INH, 3/100 (3.0%) to FQ, and none to IA. The sensitivity and specificity, n (%; 95%CI) of Xpert® MTB/XDR test compared to LPA for; INH was 50 (96.1; 86.7–99.5) and 34 (74.0; 58.8–85.7) for FQ 3 (100; 29.2–100) and 96 (99.0; 94.3–99.9) respectively. The factors for laboratory uptake and roll-out of the Xpert® MTB/XDR test included: no training needed for technicians with, and one day for those without, previous Xpert-ultra experience, recording and reporting needs were not different from those of Xpert-ultra, the error rate was 4/100 (4%), one (1%) indeterminate rate and test turn-around-time were 1hr/45 minutes. Conclusion There is high sensitivity and specificity of Xpert® MTB/XDR test for isoniazid and fluoroquinolones. There are acceptable Xpert® MTB/XDR test attributes for the test uptake and roll-out. |
| Audience | Academic |
| Author | Nyombi, Abdunoor Ssengooba, Willy Katamba, Achilles Semugenze, Derrick Joloba, Moses L Byaruhanga, Raymond Turyahabwe, Stavia Sserubiri, James Kasule, George William |
| AuthorAffiliation | 5 Ministry of Health, National Tuberculosis, and Leprosy Programme, Kampala, Uganda 3 Lung Institute, Makerere University, Kampala, Uganda Rutgers Biomedical and Health Sciences, UNITED STATES 2 Department of Medical Microbiology, Makerere University, Kampala, Uganda 1 Department of Medicine, School of Medicine, Clinical Epidemiology and Biostatistics Unit and Uganda Implementation Research Consortium, Makerere University, Kampala, Uganda 4 Biomedical Research Center, Makerere University, Kampala, Uganda |
| AuthorAffiliation_xml | – name: 1 Department of Medicine, School of Medicine, Clinical Epidemiology and Biostatistics Unit and Uganda Implementation Research Consortium, Makerere University, Kampala, Uganda – name: 4 Biomedical Research Center, Makerere University, Kampala, Uganda – name: 2 Department of Medical Microbiology, Makerere University, Kampala, Uganda – name: Rutgers Biomedical and Health Sciences, UNITED STATES – name: 5 Ministry of Health, National Tuberculosis, and Leprosy Programme, Kampala, Uganda – name: 3 Lung Institute, Makerere University, Kampala, Uganda |
| Author_xml | – sequence: 1 fullname: Katamba, Achilles – sequence: 2 fullname: Ssengooba, Willy – sequence: 3 fullname: Sserubiri, James – sequence: 4 fullname: Semugenze, Derrick – sequence: 5 fullname: Kasule, George William – sequence: 6 fullname: Nyombi, Abdunoor – sequence: 7 fullname: Byaruhanga, Raymond – sequence: 8 fullname: Turyahabwe, Stavia – sequence: 9 fullname: Joloba, Moses L |
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| Copyright | COPYRIGHT 2023 Public Library of Science 2023 Katamba et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2023 Katamba et al 2023 Katamba et al 2023 Katamba et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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| DOI | 10.1371/journal.pone.0284545 |
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| Editor | Banada, Padmapriya P |
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| References | S Mahomed (pone.0284545.ref017) 2020; 20 CF Hanrahan (pone.0284545.ref005) 2016; 3 A Penn-Nicholson (pone.0284545.ref009) 2022; 22 S Truden (pone.0284545.ref018) 2023 K Naidoo (pone.0284545.ref002) 2022; 22 L Nandlal (pone.0284545.ref012) 2022; 15 JMW Pinhata (pone.0284545.ref016) 2021; 40 C Nikam (pone.0284545.ref011) 2013; 8 pone.0284545.ref004 pone.0284545.ref003 pone.0284545.ref001 G Torrea (pone.0284545.ref007) 2019; 9 W Ssengooba (pone.0284545.ref015) 2016; 40 JS Mallick (pone.0284545.ref013) 2022; 4 E Hsiang (pone.0284545.ref006) 2016; 20 L Ji (pone.0284545.ref014) 2022; 10 SB Georghiou (pone.0284545.ref008) 2021; 101 S Pillay (pone.0284545.ref010) 2022; 5 |
| References_xml | – volume: 101 start-page: 115397 issue: 1 year: 2021 ident: pone.0284545.ref008 article-title: Analytical performance of the Xpert MTB/XDR(R) assay for tuberculosis and expanded resistance detection publication-title: Diagn Microbiol Infect Dis doi: 10.1016/j.diagmicrobio.2021.115397 contributor: fullname: SB Georghiou – volume: 10 start-page: 1047965 year: 2022 ident: pone.0284545.ref014 article-title: Whole-genome sequencing to characterize the genetic structure and transmission risk of Mycobacterium tuberculosis in Yichang city of China publication-title: Front Public Health doi: 10.3389/fpubh.2022.1047965 contributor: fullname: L Ji – volume: 40 start-page: 2551 issue: 12 year: 2021 ident: pone.0284545.ref016 article-title: Correlating genetic mutations with isoniazid phenotypic levels of resistance in Mycobacterium tuberculosis isolates from patients with drug-resistant tuberculosis in a high burden setting publication-title: Eur J Clin Microbiol Infect Dis doi: 10.1007/s10096-021-04316-0 contributor: fullname: JMW Pinhata – volume: 4 start-page: dlac029 issue: 2 year: 2022 ident: pone.0284545.ref013 article-title: Acquired bedaquiline resistance during the treatment of drug-resistant tuberculosis: a systematic review publication-title: JAC Antimicrob Resist doi: 10.1093/jacamr/dlac029 contributor: fullname: JS Mallick – volume: 20 start-page: 100176 year: 2020 ident: pone.0284545.ref017 article-title: Discordant line probe genotypic testing vs culture-based drug susceptibility phenotypic testing in TB endemic KwaZulu-Natal: Impact on bedside clinical decision making publication-title: J Clin Tuberc Other Mycobact Dis doi: 10.1016/j.jctube.2020.100176 contributor: fullname: S Mahomed – volume: 9 start-page: 11826 issue: 1 year: 2019 ident: pone.0284545.ref007 article-title: Variable ability of rapid tests to detect Mycobacterium tuberculosis rpoB mutations conferring phenotypically occult rifampicin resistance publication-title: Scientific reports doi: 10.1038/s41598-019-48401-z contributor: fullname: G Torrea – volume: 5 start-page: CD014841 year: 2022 ident: pone.0284545.ref010 article-title: Xpert MTB/XDR for detection of pulmonary tuberculosis and resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin publication-title: Cochrane Database Syst Rev contributor: fullname: S Pillay – volume: 3 start-page: ofw068 issue: 2 year: 2016 ident: pone.0284545.ref005 article-title: Implementation of Xpert MTB/RIF in Uganda: Missed Opportunities to Improve Diagnosis of Tuberculosis publication-title: Open Forum Infect Dis doi: 10.1093/ofid/ofw068 contributor: fullname: CF Hanrahan – ident: pone.0284545.ref003 – volume: 15 start-page: 4971 year: 2022 ident: pone.0284545.ref012 article-title: Rapid Molecular Assays for the Diagnosis of Drug-Resistant Tuberculosis publication-title: Infect Drug Resist doi: 10.2147/IDR.S381643 contributor: fullname: L Nandlal – volume: 22 start-page: e121 issue: 4 year: 2022 ident: pone.0284545.ref002 article-title: Can the GeneXpert MTB/XDR deliver on the promise of expanded, near-patient tuberculosis drug-susceptibility testing? publication-title: Lancet Infect Dis doi: 10.1016/S1473-3099(21)00613-7 contributor: fullname: K Naidoo – ident: pone.0284545.ref004 – volume: 8 start-page: e51121 issue: 1 year: 2013 ident: pone.0284545.ref011 article-title: Rapid diagnosis of Mycobacterium tuberculosis with Truenat MTB: a near-care approach publication-title: PLoS One doi: 10.1371/journal.pone.0051121 contributor: fullname: C Nikam – volume: 20 start-page: 1212 issue: 9 year: 2016 ident: pone.0284545.ref006 article-title: Higher cost of implementing Xpert((R)) MTB/RIF in Ugandan peripheral settings: implications for cost-effectiveness publication-title: Int J Tuberc Lung Dis doi: 10.5588/ijtld.16.0200 contributor: fullname: E Hsiang – ident: pone.0284545.ref001 – volume: 40 start-page: 8 year: 2016 ident: pone.0284545.ref015 article-title: Whole genome sequencing to complement tuberculosis drug resistance surveys in Uganda publication-title: Infect Genet Evol doi: 10.1016/j.meegid.2016.02.019 contributor: fullname: W Ssengooba – volume: 22 start-page: 242 issue: 2 year: 2022 ident: pone.0284545.ref009 article-title: Detection of isoniazid, fluoroquinolone, ethionamide, amikacin, kanamycin, and capreomycin resistance by the Xpert MTB/XDR assay: a cross-sectional multicentre diagnostic accuracy study publication-title: Lancet Infect Dis doi: 10.1016/S1473-3099(21)00452-7 contributor: fullname: A Penn-Nicholson – start-page: e0276122 year: 2023 ident: pone.0284545.ref018 article-title: Drug-Resistant Tuberculosis on the Balkan Peninsula: Determination of Drug Resistance Mechanisms with Xpert MTB/XDR and Whole-Genome Sequencing Analysis publication-title: Microbiol Spectr doi: 10.1128/spectrum.02761-22 contributor: fullname: S Truden |
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| Snippet | Background Drug-Resistant Tuberculosis (DR-TB) is one of the major challenges to TB control. Design and methods This was a blinded, laboratory-based... Drug-Resistant Tuberculosis (DR-TB) is one of the major challenges to TB control. This was a blinded, laboratory-based cross-sectional study using sputum... BACKGROUNDDrug-Resistant Tuberculosis (DR-TB) is one of the major challenges to TB control. DESIGN AND METHODSThis was a blinded, laboratory-based... BackgroundDrug-Resistant Tuberculosis (DR-TB) is one of the major challenges to TB control.Design and methodsThis was a blinded, laboratory-based... Background Drug-Resistant Tuberculosis (DR-TB) is one of the major challenges to TB control. Design and methods This was a blinded, laboratory-based... |
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| SubjectTerms | Antibiotics Biology and Life Sciences Care and treatment Comparative analysis Diagnosis Diagnostic tests Disease susceptibility Drug resistance Drugs Endorsements Evaluation Fluoroquinolones Genotypes Isoniazid Medical diagnosis Medicine and Health Sciences Mycobacterium tuberculosis Research ethics Rifampin Sensitivity Sputum Technicians Testing laboratories Tuberculosis |
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| Title | Evaluation of Xpert MTB/XDR test for susceptibility testing of Mycobacterium tuberculosis to first and second-line drugs in Uganda |
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