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Meta-Analysis
. 2020 Aug 27;8(8):CD013359.
doi: 10.1002/14651858.CD013359.pub2.

Xpert MTB/RIF and Xpert MTB/RIF Ultra assays for active tuberculosis and rifampicin resistance in children

Alexander W Kay  1 , Lucia González Fernández  2 , Yemisi Takwoingi  3 , Michael Eisenhut  4 , Anne K Detjen  5 , Karen R Steingart  6 , Anna M Mandalakas  1
Affiliations
Meta-Analysis

Xpert MTB/RIF and Xpert MTB/RIF Ultra assays for active tuberculosis and rifampicin resistance in children

Alexander W Kay et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Every year, at least one million children become ill with tuberculosis and around 200,000 children die. Xpert MTB/RIF and Xpert Ultra are World Health Organization (WHO)-recommended rapid molecular tests that simultaneously detect tuberculosis and rifampicin resistance in adults and children with signs and symptoms of tuberculosis, at lower health system levels. To inform updated WHO guidelines on molecular assays, we performed a systematic review on the diagnostic accuracy of these tests in children presumed to have active tuberculosis.

Objectives: Primary objectives • To determine the diagnostic accuracy of Xpert MTB/RIF and Xpert Ultra for (a) pulmonary tuberculosis in children presumed to have tuberculosis; (b) tuberculous meningitis in children presumed to have tuberculosis; (c) lymph node tuberculosis in children presumed to have tuberculosis; and (d) rifampicin resistance in children presumed to have tuberculosis - For tuberculosis detection, index tests were used as the initial test, replacing standard practice (i.e. smear microscopy or culture) - For detection of rifampicin resistance, index tests replaced culture-based drug susceptibility testing as the initial test Secondary objectives • To compare the accuracy of Xpert MTB/RIF and Xpert Ultra for each of the four target conditions • To investigate potential sources of heterogeneity in accuracy estimates - For tuberculosis detection, we considered age, disease severity, smear-test status, HIV status, clinical setting, specimen type, high tuberculosis burden, and high tuberculosis/HIV burden - For detection of rifampicin resistance, we considered multi-drug-resistant tuberculosis burden • To compare multiple Xpert MTB/RIF or Xpert Ultra results (repeated testing) with the initial Xpert MTB/RIF or Xpert Ultra result SEARCH METHODS: We searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, Science Citation Index, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, the WHO International Clinical Trials Registry Platform, ClinicalTrials.gov, and the International Standard Randomized Controlled Trials Number (ISRCTN) Registry up to 29 April 2019, without language restrictions.

Selection criteria: Randomized trials, cross-sectional trials, and cohort studies evaluating Xpert MTB/RIF or Xpert Ultra in HIV-positive and HIV-negative children younger than 15 years. Reference standards comprised culture or a composite reference standard for tuberculosis and drug susceptibility testing or MTBDRplus (molecular assay for detection of Mycobacterium tuberculosis and drug resistance) for rifampicin resistance. We included studies evaluating sputum, gastric aspirate, stool, nasopharyngeal or bronchial lavage specimens (pulmonary tuberculosis), cerebrospinal fluid (tuberculous meningitis), fine needle aspirates, or surgical biopsy tissue (lymph node tuberculosis).

Data collection and analysis: Two review authors independently extracted data and assessed study quality using the Quality Assessment of Studies of Diagnostic Accuracy - Revised (QUADAS-2). For each target condition, we used the bivariate model to estimate pooled sensitivity and specificity with 95% confidence intervals (CIs). We stratified all analyses by type of reference standard. We assessed certainty of evidence using the GRADE approach.

Main results: For pulmonary tuberculosis, 299 data sets (68,544 participants) were available for analysis; for tuberculous meningitis, 10 data sets (423 participants) were available; for lymph node tuberculosis, 10 data sets (318 participants) were available; and for rifampicin resistance, 14 data sets (326 participants) were available. Thirty-nine studies (80%) took place in countries with high tuberculosis burden. Risk of bias was low except for the reference standard domain, for which risk of bias was unclear because many studies collected only one specimen for culture. Detection of pulmonary tuberculosis For sputum specimens, Xpert MTB/RIF pooled sensitivity (95% CI) and specificity (95% CI) verified by culture were 64.6% (55.3% to 72.9%) (23 studies, 493 participants; moderate-certainty evidence) and 99.0% (98.1% to 99.5%) (23 studies, 6119 participants; moderate-certainty evidence). For other specimen types (nasopharyngeal aspirate, 4 studies; gastric aspirate, 14 studies; stool, 11 studies), Xpert MTB/RIF pooled sensitivity ranged between 45.7% and 73.0%, and pooled specificity ranged between 98.1% and 99.6%. For sputum specimens, Xpert Ultra pooled sensitivity (95% CI) and specificity (95% CI) verified by culture were 72.8% (64.7% to 79.6%) (3 studies, 136 participants; low-certainty evidence) and 97.5% (95.8% to 98.5%) (3 studies, 551 participants; high-certainty evidence). For nasopharyngeal specimens, Xpert Ultra sensitivity (95% CI) and specificity (95% CI) were 45.7% (28.9% to 63.3%) and 97.5% (93.7% to 99.3%) (1 study, 195 participants). For all specimen types, Xpert MTB/RIF and Xpert Ultra sensitivity were lower against a composite reference standard than against culture. Detection of tuberculous meningitis For cerebrospinal fluid, Xpert MTB/RIF pooled sensitivity and specificity, verified by culture, were 54.0% (95% CI 27.8% to 78.2%) (6 studies, 28 participants; very low-certainty evidence) and 93.8% (95% CI 84.5% to 97.6%) (6 studies, 213 participants; low-certainty evidence). Detection of lymph node tuberculosis For lymph node aspirates or biopsies, Xpert MTB/RIF pooled sensitivity and specificity, verified by culture, were 90.4% (95% CI 55.7% to 98.6%) (6 studies, 68 participants; very low-certainty evidence) and 89.8% (95% CI 71.5% to 96.8%) (6 studies, 142 participants; low-certainty evidence). Detection of rifampicin resistance Xpert MTB/RIF pooled sensitivity and specificity were 90.0% (67.6% to 97.5%) (6 studies, 20 participants; low-certainty evidence) and 98.3% (87.7% to 99.8%) (6 studies, 203 participants; moderate-certainty evidence).

Authors' conclusions: We found Xpert MTB/RIF sensitivity to vary by specimen type, with gastric aspirate specimens having the highest sensitivity followed by sputum and stool, and nasopharyngeal specimens the lowest; specificity in all specimens was > 98%. Compared with Xpert MTB/RIF, Xpert Ultra sensitivity in sputum was higher and specificity slightly lower. Xpert MTB/RIF was accurate for detection of rifampicin resistance. Xpert MTB/RIF was sensitive for diagnosing lymph node tuberculosis. For children with presumed tuberculous meningitis, treatment decisions should be based on the entirety of clinical information and treatment should not be withheld based solely on an Xpert MTB/RIF result. The small numbers of studies and participants, particularly for Xpert Ultra, limits our confidence in the precision of these estimates.

Trial registration: ClinicalTrials.gov NCT03831906.

PubMed Disclaimer

Conflict of interest statement

AK has conducted prior primary research on tuberculosis diagnostics. The Baylor College of Medicine Children's Foundation‐Swaziland, where Dr. Kay is based, received a discount from Cepheid on Xpert MTB/RIF Ultra cartridges for a tuberculosis case finding programme. The Baylor College of Medicine Children’s Foundation‐Swaziland is separate from Baylor College of Medicine (AK's employer).

LGF has no known conflicts of interest.

YT has no known conflicts of interest.

ME has no known conflicts of interest.

AD has conducted prior primary research on tuberculosis diagnostics and has no known conflicts of interest.

KRS has received financial support for the preparation of systematic reviews and educational materials, consultancy fees from FIND (for the preparation of systematic reviews), honoraria, and travel support to attend WHO guidelines meetings.

AMM has conducted prior primary research on tuberculosis diagnostics and has no known conflicts of interest.

Figures

1
1
AFB: acid‐fast bacilli; CT: computed tomography; LAM: mycobacterial lipoarabinomannan antigen; MRI: magnetic resonance imaging; NAAT: nucleic acid amplification test; TB: tuberculosis; TST: tuberculin skin test. The Clinical Pathway. Clinical suspicion of tuberculosis includes persistent cough, fever, weight loss or failure to thrive, lymphadenitis, irritability, lethargy, headache, vomiting or neurological symptoms, history of possible or confirmed exposure to M tuberculosis, increased risk for tuberculosis disease due to immunocompromising conditions.
1Availability of investigations and tests may be different in high‐ and low‐resource settings and may influence the approach to the diagnosis of child tuberculosis.
2Non‐microbiological confirmation of M tuberculosis does not exclude tuberculosis disease in children; therefore initiation of treatment should be considered empirically if other clinical indications are present.
3Mycobacterial culture results are rarely timely to aid the decision to initiate treatment but can confirm or refute clinical decision‐making if positive.
2
2
Study flow diagram.
3
3
Risk of bias and applicability concerns graph: review authors' judgements about each domain presented as percentages across included studies.
4
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Risk of bias and applicability concerns summary: review authors' judgements about each domain for each included study.
5
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Risk of bias and applicability concerns graph for rifampicin resistance: review authors' judgements about each domain presented as percentages across included studies.
6
6
Forest plots of Xpert MTB/RIF sensitivity and specificity for pulmonary tuberculosis in sputum (culture reference standard). The squares represent the sensitivity and specificity of one study, the black line its confidence interval. FN: false‐negative; FP: false‐positive; TN: true‐negative; TP: true‐positive.
7
7
Forest plots of Xpert MTB/RIF sensitivity and specificity for pulmonary tuberculosis in sputum (composite reference standard). The squares represent the sensitivity and specificity of one study, the black line its confidence interval. FN: false‐negative; FP: false‐positive; TN: true‐negative; TP: true‐positive.
8
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Forest plots of Xpert Ultra sensitivity and specificity for pulmonary tuberculosis by specimen type, reference standard, HIV status, and results of testing using multiple specimens compared to one specimen (culture reference standard). The squares represent the sensitivity and specificity of one study, the black line its confidence interval. FN: false‐negative; FP: false‐positive; TN: true‐negative; TP: true‐positive.
9
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Forest plots of tests Xpert MTB/RIF sensitivity and specificity for pulmonary tuberculosis in gastric aspirate specimens, stool specimens, and nasopharyngeal aspirates (culture reference standard).The squares represent the sensitivity and specificity of one study, the black line its confidence interval. FN: false‐negative; FP: false‐positive; TN: true‐negative; TP: true‐positive.
10
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Forest plots of Xpert MTB/RIF sensitivity and specificity for pulmonary tuberculosis in sputum by smear status (culture reference standard). The squares represent the sensitivity and specificity of one study, the black line its confidence interval. FN: false‐negative; FP: false‐positive; TN: true‐negative; TP: true‐positive.
11
11
Forest plot of Xpert MTB/RIF sensitivity and specificity in sputum specimens, gastric aspirate specimens, and stool specimens in HIV‐positive children (culture reference standard). The squares represent the sensitivity and specificity of one study, the black line its confidence interval. FN: false‐negative; FP: false‐positive; TN: true‐negative; TP: true‐positive.
12
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Forest plots of Xpert MTB/RIF sensitivity and specificity for tuberculous meningitis and lymph node tuberculosis (culture reference standard). The squares represent the sensitivity and specificity of one study, the black line its confidence interval. FN: false‐negative; FP: false‐positive; TN: true‐negative; TP: true‐positive.
13
13
Forest plots of Xpert MTB/RIF sensitivity and specificity for rifampicin resistance. The squares represent the sensitivity and specificity of one study, the black line its confidence interval. FN: false‐negative; FP: false‐positive; TN: true‐negative; TP: true‐positive.
14
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Forest plots of Xpert MTB/RIF sensitivity and specificity for pulmonary tuberculosis in various specimens, multiple Xpert MTB/RIF tests versus one Xpert MTB/RIF test. The squares represent the sensitivity and specificity of one study, the black line its confidence interval. FN: false‐negative; FP: false‐positive; TN: true‐negative; TP: true‐positive.
1
1. Test
Xpert MTB/RIF, sputum, culture
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2. Test
Xpert MTB/RIF, sputum, composite reference standard
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3. Test
Xpert Ultra, sputum, culture
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4. Test
Xpert Ultra, sputum, composite reference standard
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5. Test
Xpert MTB/RIF, gastric aspirate specimen, culture
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6. Test
Xpert MTB/RIF, gastric aspirate specimen, composite reference standard
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7. Test
Xpert MTB/RIF, stool, culture
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8. Test
Xpert MTB/RIF, stool, composite reference standard
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9. Test
Xpert MTB/RIF, nasopharyngeal aspirate, culture
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10. Test
Xpert Ultra, nasopharyngeal aspirate, culture
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11. Test
Xpert MTB/RIF, sputum, culture, direct comparison
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Xpert Ultra, sputum, culture, direct comparison
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13. Test
Xpert MTB/RIF, sputum, smear‐positive, culture
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14. Test
Xpert MTB/RIF, sputum, smear‐negative, culture
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15. Test
Xpert MTB/RIF, sputum, HIV‐positive, culture
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16. Test
Xpert MTB/RIF, sputum, HIV‐negative, culture
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17. Test
Xpert Ultra, sputum, HIV‐positive, culture
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18. Test
Xpert Ultra, sputum, HIV‐negative, culture
19
19. Test
Xpert MTB/RIF, gastric aspirate specimen, HIV‐positive, culture
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20. Test
Xpert MTB/RIF, gastric aspirate specimen, HIV‐negative, culture
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21. Test
Xpert MTB/RIF, stool, HIV‐positive, culture
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22. Test
Xpert MTB/RIF, stool, HIV‐negative, culture
23
23. Test
Xpert MTB/RIF, sputum, 5 to 14 years, culture
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24. Test
Xpert MTB/RIF, sputum, 0 to 4 years, culture
25
25. Test
Xpert MTB/RIF, induced sputum, 5 to 14, culture
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26. Test
Xpert MTB/RIF, induced sputum, 0 to 4 years, culture
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27. Test
Xpert MTB/RIF, gastric aspirate specimen, 0 to 4 years, culture
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28. Test
Xpert MTB/RIF, sputum, culture, high tuberculosis burden, yes
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29. Test
Xpert MTB/RIF, sputum, culture, high tuberculosis burden, no
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30. Test
Xpert MTB/RIF, sputum, inpatients, culture
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31. Test
Xpert MTB/RIF, sputum, outpatients, culture
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32. Test
Xpert MTB/RIF, CSF, culture
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Xpert MTB/RIF, CSF, composite reference standard
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34. Test
Xpert MTB/RIF, lymph node specimen, culture
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35. Test
Xpert MTB/RIF, lymph node specimen, composite reference standard
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36. Test
Xpert MTB/RIF, rifampicin resistance, any specimen
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37. Test
Xpert MTB/RIF, sputum, multiple tests, culture
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38. Test
Xpert MTB/RIF, sputum, initial test, culture
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39. Test
Xpert MTB/RIF, gastric aspirate specimen, multiple tests, culture
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40. Test
Xpert MTB/RIF, gastric aspirate specimen, initial test, culture
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41. Test
Xpert MTB/RIF, stool, multiple tests, culture
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42. Test
Xpert MTB/RIF, stool, initial test, culture
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Xpert MTB/RIF, nasopharyngeal aspirate, multiple tests, culture
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44. Test
Xpert MTB/RIF, nasopharyngeal aspirate, initial test, culture
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45. Test
Xpert Ultra, sputum, multiple tests, culture
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46. Test
Xpert Ultra, sputum, initial test, culture
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47. Test
Xpert Ultra, nasopharyngeal aspirate, multiple tests, culture
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48. Test
Xpert Ultra, nasopharyngeal aspirate, initial test, culture
49
49. Test
Xpert MTB/RIF, sputum, multiple cultures
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50. Test
Xpert MTB/RIF, sputum, single culture
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51. Test
Xpert MTB/RIF, induced sputum, culture
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52. Test
Xpert MTB/RIF, gastric aspirate specimen, 5 to 14, culture
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53. Test
Xpert MTB/RIF, nasopharyngeal aspirate, 5 to 14, culture
54
54. Test
Xpert MTB/RIF, nasopharyngeal aspirate, 0 to 4, culture
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References

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Saini 2018 {published data only}
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Sekadde 2013 {published data only}
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Vadwai 2011 {published data only}
    1. Vadwai V, Boehme C, Nabeta P, Shetty A, Alland D, Rodrigues C. Xpert MTB/RIF: a new pillar in diagnosis of extrapulmonary tuberculosis? Journal of Clinical Microbiology 2011;49(7):2540-5. - PMC - PubMed
Walters 2014 {published data only}
    1. Walters E, Goussard P, Bosch C, Hesseling AC, Gie RP. GeneXpert MTB/RIF on bronchoalveolar lavage samples in children with suspected complicated intrathoracic tuberculosis: a pilot study. Pediatric Pulmonology 2014;49(11):1133-7. - PubMed
Walters 2017a {published data only}
    1. Walters E, Zalm MM, Palmer M, Bosch C, Demers AM, Draper H, et al. Xpert MTB/RIF on stool is useful for the rapid diagnosis of tuberculosis in young children with severe pulmonary disease. Pediatric Infectious Disease Journal 2017;36(9):837-43. - PMC - PubMed
Walters 2018a {published data only}
    1. Walters E, Scott L, Nabeta P, Demers AM, Reubenson G, Bosch C, et al. Molecular detection of Mycobacterium tuberculosis from stools in young children by use of a novel centrifugation-free processing method. Journal of Clinical Microbiology 2018;56(9):pii: e00781-18. - PMC - PubMed
Yin 2014 {published data only}
    1. Yin QQ, Jiao WW, Han R, Jiao AX, Sun L, Tian JL, et al. Rapid diagnosis of childhood pulmonary tuberculosis by Xpert MTB/RIF assay using bronchoalveolar lavage fluid. BioMed Research International 2014;2014:310194. - PMC - PubMed
Zar 2012 {published data only}
    1. Zar HJ, Workman L, Isaacs W, Munro J, Black F, Eley B, et al. Rapid molecular diagnosis of pulmonary tuberculosis in children using nasopharyngeal specimens. Clinical Infectious Diseases 2012;55(8):1088-95. - PMC - PubMed
Zar 2013 {published data only}
    1. Zar HJ, Workman L, Isaacs W, Dheda K, Zemanay W, Nicol MP. Rapid diagnosis of pulmonary tuberculosis in African children in a primary care setting by use of Xpert MTB/RIF on respiratory specimens: a prospective study. Lancet. Global Health 2013;1(2):e97-104. - PubMed
Zar 2019 {published data only}
    1. Zar HJ, Workman LJ, Prins M, Bateman LJ, Mbhele SP, Whitman CB, et al. Tuberculosis diagnosis in children using Xpert Ultra on different respiratory specimens. American Journal of Respiratory and Critical Care Medicine 2019;200(12):1531-8. [DOI: 10.1164/rccm.201904-0772OC] - DOI - PMC - PubMed

References to studies excluded from this review

Ali 2017 {published data only}
    1. Ali RH, Ibrahim NY, Elegail AMA, Eltohami NAM, Ebraheem RSM, Ahmed SFM, et al. Evaluation of GeneXpert MTB/RIF and line probe assay for rapid diagnosis of Mycobacterium tuberculosis in Sudanese pulmonary TB patients. Asian Pacific Journal of Tropical Disease 2017;7(7):426-9.
Atashi 2017 {published data only}
    1. Atashi S, Izadi B, Jalilian S, Madani SH, Farahani A, Mohajeri P. Evaluation of GeneXpert MTB/RIF for determination of rifampicin resistance among new tuberculosis cases in west and northwest Iran. New Microbes and New Infections 2017;19:117-20. - PMC - PubMed
Atehortúa Muñoz 2017 {published data only}
    1. Atehortúa Muñoz SL, Muñoz JR, Cárdenas Moreno SV, Ferreira CA, Cornejo Ochoa JW. Xpert MTB/RIF as a diagnostic tool in a cohort of children under 15 years of age with clinical suspicion of pulmonary tuberculosis in a hospital of high complexity in Medellin [Xpert MTB/RIF® como herramienta diagnóstica en una cohorte de niños menores de 15 años con sospecha clínica de tuberculosis pulmonar en un hospital de alta complejidad de Medellín]. Infectio 2017;21(1):25-31.
Azevedo 2018 {published data only}
    1. Azevedo RG, Dinallo FS, De Laurentis LS, Boulware DR, Vidal JE. Xpert MTB/RIF® assay for the diagnosis of HIV-related tuberculous meningitis in Sao Paulo, Brazil. International Journal of Tuberculosis and Lung Disease 2018;22(6):706-7. - PMC - PubMed
Ballif 2015 {published data only}
    1. Ballif M, Renner L, Claude Dusingize J, Leroy V, Ayaya S, Wools-Kaloustian K, et al. Tuberculosis in pediatric antiretroviral therapy programs in low- and middle-income countries: diagnosis and screening practices. Journal of the Pediatric Infectious Diseases Society 2015;4(1):30-8. - PMC - PubMed
Banada 2016 {published data only}
    1. Banada PP, Naidoo U, Deshpande S, Karim F, Flynn JL, O'Malley M, et al. A novel sample processing method for rapid detection of tuberculosis in the stool of pediatric patients using the Xpert MTB/RIF assay. PLoS One 2016;11(3):e0151980. - PMC - PubMed
Biadglegne 2014 {published data only}
    1. Biadglegne F, Mulu A, Rodloff AC, Sack U. Diagnostic performance of the Xpert MTB/RIF assay for tuberculous lymphadenitis on fine needle aspirates from Ethiopia. Tuberculosis (Edinburgh, Scotland) 2014;94(5):502-5. - PubMed
Bojang 2016 {published data only}
    1. Bojang AL, Mendy FS, Tientcheu LD, Otu J, Antonio M, Kampmann B, et al. Comparison of TB-LAMP, GeneXpert MTB/RIF and culture for diagnosis of pulmonary tuberculosis in The Gambia. Journal of Infection 2016;72(3):332-7. - PubMed
Che 2017 {published data only}
    1. Che NY, Huang SJ, Ma Y, Han Y, Liu ZC, Zhang C, et al. Comparison of histological, microbiological, and molecular methods in diagnosis of patients with TBLN having different anti-TB treatment background. Biomedical and Environmental Sciences 2017;30(6):418-25. - PubMed
Cox 2014 {published data only}
    1. Cox HS, Mbhele S, Mohess N, Whitelaw A, Muller O, Zemanay W, et al. Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial. PLoS Medicine 2014;11(11):e1001760. - PMC - PubMed
Cross 2014 {published data only}
    1. Cross GB, Coles K, Nikpour M, Moore OA, Denholm J, McBryde ES, et al. TB incidence and characteristics in the remote gulf province of Papua New Guinea: a prospective study. BMC Infectious Diseases 2014;14:93. - PMC - PubMed
Diallo 2016 {published data only}
    1. Diallo AB, Kollo AI, Camara M, Lo S, Ossoga GW, Mbow M, et al. Performance of GeneXpert MTB/RIF in the diagnosis of extrapulmonary tuberculosis in Dakar: 2010-2015 [Performance du GeneXpert MTB/RIF ® dans le diagnostic de la tuberculose extra-pulmonaire à Dakar: 2010-2015]. Pan African Medical Journal 2016;25:129. - PMC - PubMed
DiNardo 2016 {published data only}
    1. DiNardo AR, Detjen A, Ustero P, Ngo K, Bacha J, Mandalakas AM. Culture is an imperfect and heterogeneous reference standard in pediatric tuberculosis. Tuberculosis (Edinburgh, Scotland) 2016;101S:S105-8. - PMC - PubMed
DiNardo 2018 {published data only}
    1. DiNardo AR, Kay AW, Maphalala G, Harris NM, Fung C, Mtetwa G, et al. Diagnostic and treatment monitoring potential of a stool-based quantitative polymerase chain reaction assay for pulmonary tuberculosis. American Journal of Tropical Medicine and Hygiene 2018;99(2):310-6. - PMC - PubMed
Ejeh 2018 {published data only}
    1. Ejeh EF, Undiandeye A, Akinseye VO, Okon KO, Kazeem HM, Kudi CA, et al. Diagnostic performance of GeneXpert and Ziehl-Neelson microscopy in the detection of tuberculosis in Benue State, Nigeria. Alexandria Journal of Medicine 2018;54(4):529-33.
Gautam 2018 {published data only}
    1. Gautam H, Agrawal SK, Verma SK, Singh UB. Cervical tuberculous lymphadenitis: clinical profile and diagnostic modalities. International Journal of Mycobacteriology 2018;7(3):212-6. - PubMed
Gelalcha 2017 {published data only}
    1. Gelalcha AG, Kebede A, Mamo H. Light-emitting diode fluorescent microscopy and Xpert MTB/RIF® assay for diagnosis of pulmonary tuberculosis among patients attending Ambo hospital, west-central Ethiopia. BMC Infectious Diseases 2017;17(1):613. - PMC - PubMed
Geleta 2015 {published data only}
    1. Geleta DA, Megerssa YC, Gudeta AN, Akalu GT, Debele MT, Tulu KD. Xpert MTB/RIF assay for diagnosis of pulmonary tuberculosis in sputum specimens in remote health care facility. BMC Microbiology 2015;15:220. - PMC - PubMed
Ghariani 2015 {published data only}
    1. Ghariani A, Jaouadi T, Smaoui S, Mehiri E, Marouane C, Kammoun S, et al. Diagnosis of lymph node tuberculosis using the GeneXpert MTB/RIF in Tunisia. International Journal of Mycobacteriology 2015;4(4):270-5. - PubMed
Giang 2015 {published data only}
    1. Giang DC, Duong TN, Ha DTM, Nhan HT, Wolbers M, Nhu NTQ, et al. Prospective evaluation of GeneXpert for the diagnosis of HIV-negative pediatric TB cases. BMC Infectious Diseases 2015;15:70. - PMC - PubMed
Guajardo‐Lara 2018 {published data only}
    1. Guajardo-Lara CE, Saldaña-Ramírez MI, Hernández-Galván NN, Dimas-Adame MA, Ayala-Gaytán JJ, Valdovinos-Chávez SB. MGIT and other methods for diagnosing tuberculosis in a private hospital system with low incidence [MGIT y otros métodos para diagnosticar tuberculosis en un sistema hospitalario privado con baja incidencia]. Revista Médica del Instituto Mexicano del Seguro Social 2018;56(2):158-62. - PubMed
Gulla 2019 {published data only}
    1. Gulla KM, Gunathilaka G, Jat KR, Sankar J, Karan M, Lodha R, et al. Utility and safety of endobronchial ultrasound-guided transbronchial needle aspiration and endoscopic ultrasound with an echobronchoscope-guided fine needle aspiration in children with mediastinal pathology. Pediatric Pulmonology 2019;54(6):881-5. - PubMed
Hakim 2017 {published data only}
    1. Hakim J, Musiime V, Szubert AJ, Mallewa J, Siika A, Agutu C, et al. Enhanced prophylaxis plus antiretroviral therapy for advanced HIV infection in Africa. New England Journal of Medicine 2017;377(3):233-45. - PMC - PubMed
Helb 2010 {published data only}
    1. Helb D, Jones M, Story E, Boehme C, Wallace E, Ho K, et al. Rapid detection of Mycobacterium tuberculosis and rifampin resistance by use of on-demand, near-patient technology. Journal of Clinical Microbiology 2010;48(1):229-37. - PMC - PubMed
Horo 2017 {published data only}
    1. Horo K, N'Guessan R, Koffi MO, Kouamé-N'Takpé N, Koné A, Samaké K, et al. Use of the Xpert® MTB/RIF test in routine screening of new cases of pulmonary tuberculosis in an endemic area. Revue des Maladies Respiratoires 2017;4(7):749-57. - PubMed
Huh 2014 {published data only}
    1. Huh HJ, Jeong B-H, Jeon K, Koh W-J, Ki C-S, Lee NY. Performance evaluation of the Xpert MTB/RIF assay according to its clinical application. BMC Infectious Diseases 2014;14:589. - PMC - PubMed
Kuyinu 2018 {published data only}
    1. Kuyinu YA, Odugbemi BA, Salisu-Olatunji SO, Adepoju FO, Odusanya OO. Characteristics of Mycobacterium tuberculosis positive patients screened for drug-resistant tuberculosis at a tertiary health facility in Lagos, Nigeria. Journal of the National Medical Association 2018;110(1):88-91. - PubMed
Lopez 2019 {published data only}
    1. Lopez AL, Aldaba JG, Morales-Dizon M, Sarol JN, Daag JV, Ama MC, et al. Urine Xpert MTB/RIF for the diagnosis of childhood tuberculosis. International Journal of Infectious Diseases 2019;79:44-6. - PubMed
Lu J 2017 {published data only}
    1. Lu J, Li H, Dong F, Shi J, Yang H, Han S, et al. The feasibility of Xpert MTB/RIF testing to detect rifampicin resistance among childhood tuberculosis for prevalence surveys in Northern China. BioMed Research International 2017;2017:5857369. - PMC - PubMed
Lu Y 2018 {published data only}
    1. Lu Y, Zhu Y, Shen N, Tian L, Sun Z. Evaluating the diagnostic accuracy of the Xpert MTB/RIF assay on bronchoalveolar lavage fluid: a retrospective study. International Journal of Infectious Diseases 2018;71:14-9. - PubMed
Malik 2018 {published data only}
    1. Malik AA, Amanullah F, Codlin AJ, Siddiqui S, Jaswal M, Ahmed JF, et al. Improving childhood tuberculosis detection and treatment through facility-based screening in rural Pakistan. International Journal of Tuberculosis and Lung Disease 2018;22(8):851-7. - PubMed
Marcy 2018 {published data only}
    1. Marcy O, Tejiokem M, Msellati P, Truong Huu K, Do Chau V, Tran Ngoc D, et al. Mortality and its determinants in antiretroviral treatment-naive HIV-infected children with suspected tuberculosis: an observational cohort study. Lancet HIV 2018;5(2):e87-95. - PubMed
Masenga 2017 {published data only}
    1. Masenga SK, Mubila H, Hamooya BM. Rifampicin resistance in mycobacterium tuberculosis patients using GeneXpert at Livingstone Central Hospital for the year 2015: a cross sectional explorative study. BMC Infectious Diseases 2017;17(1):640. - PMC - PubMed
Mekonnen 2015 {published data only}
    1. Mekonnen F, Tessema B, Moges F, Gelaw A, Eshetie S, Kumera G. Multidrug resistant tuberculosis: prevalence and risk factors in districts of Metema and West Armachiho, Northwest Ethiopia. BMC Infectious Diseases 2015;15:461. - PMC - PubMed
Memon 2018 {published data only}
    1. Memon SS, Sinha S, Sharma SK, Kabra SK, Lodha R, Soneja M. Diagnostic accuracy of Xpert Mtb/Rif assay in stool samples in intrathoracic childhood tuberculosis. Journal Tuberculosis and Therapeutics 2018;3(2):115.
Metaferia 2018 {published data only}
    1. Metaferia Y, Seid A, Fenta GM, Gebretsadik D. Assessment of extrapulmonary tuberculosis using Gene Xpert MTB/RIF assay and fluorescent microscopy and its risk factors at Dessie referral hospital, Northeast Ethiopia. BioMed Research International 2018;2018:8207098. - PMC - PubMed
Mijovic 2018 {published data only}
    1. Mijovic H, Al-Nasser Y, Al-Rawahi G, Roberts A. Experience with using rapid molecular testing in diagnosing pulmonary and extra-pulmonary pediatric tuberculosis in a non-endemic setting - a retrospective case series. Paediatrics and Child Health (Canada) 2018;23(Suppl 1):e44-5.
Modi 2016 {published data only}
    1. Modi S, Cavanaugh JS, Shiraishi RW, Alexander HL, McCarthy KD, Burmen B, et al. Performance of clinical screening algorithms for tuberculosis intensified case finding among people living with HIV in Western Kenya. PLoS One 2016;11(12):e0167685. - PMC - PubMed
Mulenga 2015 {published data only}
    1. Mulenga H, Tameris MD, Luabeya KKA, Geldenhuys H, Scriba TJ, Hussey GD, et al. The role of clinical symptoms in the diagnosis of intrathoracic tuberculosis in young children. Pediatric Infectious Disease Journal 2015;34(11):1157-62. - PMC - PubMed
Naidoo 2016 {published data only}
    1. Naidoo P, Dunbar R, Lombard C, du Toit E, Caldwell J, Detjen A, et al. Comparing tuberculosis diagnostic yield in smear/culture and Xpert MTB/RIF-based algorithms using a non-randomised stepped-wedge design. PLoS One 2016;11(3):e0150487. - PMC - PubMed
Nair 2016 {published data only}
    1. Nair SA, Raizada N, Sachdeva KS, Denkinger C, Schumacher S, Dewan P, et al. Factors associated with tuberculosis and rifampicin-resistant tuberculosis amongst symptomatic patients in India: a retrospective analysis. PLoS One 2016;11(2):e0150054. - PMC - PubMed
Nansumba 2016 {published data only}
    1. Nansumba M, Kumbakumba E, Orikiriza P, Muller Y, Nackers F, Debeaudrap P, et al. Detection yield and tolerability of string test for diagnosis of childhood intrathoracic tuberculosis. Paediatric Infectious Disease Journal 2016;35(2):146-51. - PubMed
Nataprawira 2016 {published data only}
    1. Nataprawira HM, Ruslianti V, Solek R, Hawani D, Mianti M, Anggraeni R, et al. Outcome of tuberculous meningitis in children: the first comprehensive retrospective cohort study in Indonesia. International Journal of Tuberculosis and Lung Disease 2016;20(7):909-14. - PubMed
Ncube 2017 {published data only}
    1. Ncube RT, Takarinda KC, Zishiri C, den Boogaard W, Mlilo N, Chiteve C, et al. Age-stratified tuberculosis treatment outcomes in Zimbabwe: are we paying attention to the most vulnerable? Public Health Action 2017;7(3):212-7. - PMC - PubMed
Nduba 2015 {published data only}
    1. Nduba V, Hoog AH, Mitchell E, Onyango P, Laserson K, Borgdorff M. Prevalence of tuberculosis in adolescents, western Kenya: implications for control programs. International Journal of Infectious Diseases 2015;35:11-7. - PubMed
Ngabonziza 2016 {published data only}
    1. Ngabonziza JCS, Ssengooba W, Mutua F, Torrea G, Dushime A, Gasana M, et al. Diagnostic performance of smear microscopy and incremental yield of Xpert in detection of pulmonary tuberculosis in Rwanda. BMC Infectious Diseases 2016;16(1):660. - PMC - PubMed
Ntinginya 2012 {published data only}
    1. Ntinginya EN, Squire SB, Millington KA, Mtafya B, Saathoff E, Heinrich N, et al. Performance of the Xpert® MTB/RIF assay in an active case-finding strategy: a pilot study from Tanzania. International Journal of Tuberculosis and Lung Disease 2012;16(11):1468-70. - PubMed
Opota 2019 {published data only}
    1. Opota O, Zakham F, Mazza-Stalder J, Nicod L, Greub G, Jaton K. Added value of Xpert MTB/RIF Ultra for diagnosis of pulmonary tuberculosis in a low-prevalence setting. Journal of Clinical Microbiology 2019;57(2):pii: e01717-18. - PMC - PubMed
Pandey 2017 {published data only}
    1. Pandey P, Pant ND, Rijal KR, Shrestha B, Kattel S, Banjara MR, et al. Diagnostic accuracy of GeneXpert MTB/RIF assay in comparison to conventional drug susceptibility testing method for the diagnosis of multidrug-resistant tuberculosis. PLoS One 2017;12(1):e0169798. - PMC - PubMed
Pink 2016 {published data only}
    1. Pink F, Brown TJ, Kranzer K, Drobniewski F. Evaluation of Xpert MTB/RIF for detection of Mycobacterium tuberculosis in cerebrospinal fluid. Journal of Clinical Microbiology 2016;54(3):809-11. - PMC - PubMed
Planting 2014 {published data only}
    1. Planting NS, Visser GL, Nicol MP, Workman L, Isaacs W, Zar HJ. Safety and efficacy of induced sputum in young children hospitalised with suspected pulmonary tuberculosis. International Journal of Tuberculosis and Lung Disease 2014;18(1):8-12. - PubMed
Raizada 2014 {published data only}
    1. Raizada N, Sachdeva KS, Nair SA, Kulsange S, Gupta RS, Thakur R, et al. Enhancing TB case detection: experience in offering upfront Xpert MTB/RIF testing to pediatric presumptive TB and DR TB cases for early rapid diagnosis of drug sensitive and drug resistant TB. PLoS One 2014;9(8):e105346. - PMC - PubMed
Raizada 2015a {published data only}
    1. Raizada N, Sachdeva KS, Swaminathan S, Kulsange S, Khaparde SD, Nair SA, et al. Piloting upfront Xpert MTB/RIF testing on various specimens under programmatic conditions for diagnosis of TB & DR-TB in paediatric population. PLoS One 2015;10(10):e0140375. - PMC - PubMed
Raizada 2015b {published data only}
    1. Raizada N, Sachdeva KS, Sreenivas A, Kulsange S, Gupta RS, Thakur R, et al. Catching the missing million: experiences in enhancing TB & DR-TB detection by providing upfront Xpert MTB/RIF testing for people living with HIV in India. PLoS One 2015;10(2):e0116721. - PMC - PubMed
Raizada 2018b {published data only}
    1. Raizada N, Khaparde SD, Salhotra VS, Rao R, Kalra A, Swaminathan S, et al. Accelerating access to quality TB care for pediatric TB cases through better diagnostic strategy in four major cities of India. PLoS One 2018;13(2):e0193194. - PMC - PubMed
Raizada 2018c {published data only}
    1. Raizada N, Khaparde SD, Rao R, Kalra A, Sarin S, Salhotra VS, et al. Upfront Xpert MTB/RIF testing on various specimen types for presumptive infant TB cases for early and appropriate treatment initiation. PLoS One 2018;13(8):e0202085. - PMC - PubMed
Rathour 2019 {published data only}
    1. Rathour JS, Mantan M, Khanna A, et al. Evaluation of GENE XPERT assay in extrapulmonary tuberculosis in children. Journal of Evolution of Medical and Dental Sciences 2019;8(1):76-80.
Rebecca 2018 {published data only}
    1. Rebecca B, Chacko A, Verghese V, Rose W. Spectrum of pediatric tuberculosis in a tertiary care setting in South India. Journal of Tropical Pediatrics 2018;64(6):544-7. - PubMed
Rivera 2017 {published data only}
    1. Rivera VR, Jean-Juste MA, Gluck SC, Reeder HT, Sainristil J, Julma P, et al. Diagnostic yield of active case finding for tuberculosis and HIV at the household level in slums in Haiti. International Journal of Tuberculosis and Lung Disease 2017;21(11):1140-6. - PMC - PubMed
Sabi 2016 {published data only}
    1. Sabi I, Kabyemera R, Mshana SE, Kidenya BR, Kasanga G, Gerwing-Adima LE, et al. Pulmonary TB bacteriologically confirmed by induced sputum among children at Bugando Medical Centre, Tanzania. International Journal of Tuberculosis and Lung Disease 2016;20(2):228-34. - PubMed
Sachdeva 2015 {published data only}
    1. Sachdeva KS, Raizada N, Sreenivas A, Van't Hoog AH, Van Den Hof S, Dewan PK, et al. Use of Xpert MTB/RIF in decentralized public health settings and its effect on pulmonary TB and DR-TB case finding in India. PLoS One 2015;10(5):e0126065. - PMC - PubMed
Sanchini 2014 {published data only}
    1. Sanchini A, Fiebig L, Drobniewski F, Haas W, Richter E, Katalinic-Jankovic V, et al. Laboratory diagnosis of paediatric tuberculosis in the European Union/European Economic Area: analysis of routine laboratory data, 2007 to 2011. Eurosurveillance 2014;19(11):pii: 20744. - PubMed
Sander 2019 {published data only}
    1. Sander MS, Laah SN, Titahong CN, Lele C, Kinge T, Jong BC, et al. Systematic screening for tuberculosis among hospital outpatients in Cameroon: the role of screening and testing algorithms to improve case detection. Journal of Clinical Tuberculosis and Other Mycobacterial Diseases 2019;15:100095. [DOI: 10.1016/j.jctube.2019.100095] - DOI - PMC - PubMed
Sanjuan‐Jimenez 2015 {published data only}
    1. Sanjuan-Jimenez R, Toro-Peinado I, Bermudez P, Colmenero JD, Morata P. Comparative study of a real-time PCR assay targeting senX3-regX3 versus other molecular strategies commonly used in the diagnosis of tuberculosis. PLoS One 2015;10(11):e0143025. - PMC - PubMed
Schumacher 2016 {published data only}
    1. Schumacher SG, Smeden M, Dendukuri N, Joseph L, Nicol MP, Pai M, et al. Diagnostic test accuracy in childhood pulmonary tuberculosis: a Bayesian latent class analysis. American Journal of Epidemiology 2016;184(9):690-700. - PMC - PubMed
Scott 2014 {published data only}
    1. Scott LE, Beylis N, Nicol M, Nkuna G, Molapo S, Berrie L, et al. Diagnostic accuracy of Xpert MTB/RIF for extrapulmonary tuberculosis specimens: establishing a laboratory testing algorithm for South Africa. Journal of Clinical Microbiology 2014;52(6):1818-23. - PMC - PubMed
Shah 2016a {published data only}
    1. Shah I, Gupta Y. Xpert MTB/RIF for diagnosis of tuberculosis and drug resistance in Indian children. Indian Pediatrics 2016;53(9):837-8. - PubMed
Shah 2018 {published data only}
    1. Shah MA, Shah I. Increasing prevalence of pediatric drug-resistant tuberculosis in Mumbai, India, and Its outcome. Pediatric Infectious Disease Journal 2018;37(12):1261-3. - PubMed
Shah 2019 {published data only}
    1. Shah I, Bhamre R, Shetty NS. Accuracy of Xpert® Mycobacterium tuberculosis/rifampicin assay in diagnosis of pulmonary tuberculosis. Infectious Diseases 2019;51(7):550-3. - PubMed
Sharma 2015 {published data only}
    1. Sharma SK, Kohli M, Yadav RN, Chaubey J, Bhasin D, Sreenivas V, et al. Evaluating the diagnostic accuracy of Xpert MTB/RIF assay in pulmonary tuberculosis. PLoS One 2015;10(10):e0141011. - PMC - PubMed
Sieiro 2018 {published data only}
    1. Sieiro TLA, Aurílio RB, Soares ECC, Chiang SS, Sant Anna CC. The role of the Xpert MTB/RIF assay among adolescents suspected of pulmonary tuberculosis in Rio de Janeiro, Brazil. Revista da Sociedade Brasileira de Medicina Tropical 2018;51(2):234-6. - PubMed
Singh 2015 {published data only}
    1. Singh S, Singh A, Prajapati S, Kabra SK, Lodha R, Mukherjee A, et al. Xpert MTB/RIF assay can be used on archived gastric aspirate and induced sputum samples for sensitive diagnosis of paediatric tuberculosis. BMC Microbiology 2015;15:191. - PMC - PubMed
Singh UB 2016 {published data only}
    1. Singh UB, Pandey P, Mehta G, Bhatnagar AK, Mohan A, Goyal V, et al. Genotypic, phenotypic and clinical validation of GeneXpert in extra-pulmonary and pulmonary tuberculosis in India. PLoS One 2016;11(2):e0149258. - PMC - PubMed
Solomons 2016 {published data only}
    1. Solomons RS, Visser DH, Marais BJ, Schoeman JF, Furth AM. Diagnostic accuracy of a uniform research case definition for TBM in children: a prospective study. International Journal of Tuberculosis and Lung Disease 2016;20(7):903-8. - PubMed
Sureshbabu 2016 {published data only}
    1. Sureshbabu R, Lakshmi Murali A, Palaniswamy M. Molecular diagnosis of drug resistance tuberculosis In the Districts Of Tamilnadu. International Journal of Pharma and Bio Sciences 2016;7(4):B42-B6.
Tadesse 2015 {published data only}
    1. Tadesse M, Abebe G, Abdissa K, Aragaw D, Abdella K, Bekele A, et al. GeneXpert MTB/RIF Assay for the diagnosis of tuberculous lymphadenitis on concentrated fine needle aspirates in high tuberculosis burden settings. PLoS One 2015;10(9):e0137471. - PMC - PubMed
Tafur 2018 {published data only}
    1. Tafur KT, Coit J, Leon SR, Pinedo C, Chiang SS, Contreras C, et al. Feasibility of the string test for tuberculosis diagnosis in children between 4 and 14 years old. BMC Infectious Diseases 2018;18:574. - PMC - PubMed
Tang 2017 {published data only}
    1. Tang T, Liu F, Lu X, Huang Q. Evaluation of GeneXpert MTB/RIF for detecting Mycobacterium tuberculosis in a hospital in China. Journal of International Medical Research 2017;45(2):816-22. - PMC - PubMed
Theron 2011 {published data only}
    1. Theron G, Peter J, Zyl-Smit R, Mishra H, Streicher E, Murray S, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. American Journal of Respiratory and Critical Care Medicine 2011;184(1):132-40. - PubMed
Triasih 2015 {published data only}
    1. Triasih R, Robertson C, Duke T, Graham SM. Risk of infection and disease with Mycobacterium tuberculosis among children identified through prospective community-based contact screening in Indonesia. Tropical Medicine & International Health 2015;20(6):737-43. - PubMed
Ullah 2017 {published data only}
    1. Ullah I, Javaid A, Masud H, Ali M, Basit A, Ahmad W, et al. Rapid detection of Mycobacterium tuberculosis and rifampicin resistance in extrapulmonary tuberculosis and sputum smear negative pulmonary suspects using Xpert MTB/RIF. Journal of Medical Microbiology 2017;66(4):412-8. - PubMed
Walters 2012 {published data only}
    1. Walters E, Gie RP, Hesseling AC, Friedrich SO, Diacon AH, Gie RP. Rapid diagnosis of pediatric intrathoracic tuberculosis from stool samples using the Xpert MTB/RIF assay: a pilot study. Pediatric Infectious Disease Journal 2012;31(12):1316. - PubMed
Walters 2017b {published data only}
    1. Walters E, Demers AM, Zalm MM, Whitelaw A, Palmer M, Bosch C, et al. Stool culture for diagnosis of pulmonary tuberculosis in children. Journal of Clinical Microbiology 2017;55(12):3355-65. - PMC - PubMed
Walters 2018b {published data only}
    1. Walters E, Zalm MM, Demers AM, Whitelaw A, Palmer M, Bosch C, et al. Specimen pooling as a diagnostic strategy for microbiologic confirmation in children with intrathoracic tuberculosis. Paediatric Infectious Disease Journal 2018;38(6):e128-31. - PMC - PubMed
Zhang 2016 {published data only}
    1. Zhang AM, Li F, Liu XH, Xia L, Lu SH. [Application of Gene Xpert Mycobacterium tuberculosis DNA and resistance to rifampicin assay in the rapid detection of tuberculosis in children]. Chinese Journal of Pediatrics [Zhonghua er ke za zhi] 2016;54(5):370-4. - PubMed

References to ongoing studies

ChiCTR1800015075 {unpublished data only}
    1. ChiCTR1800015075. Diagnostic accuracy of Xpert MTB/RIF Ultra assay on diagnosing pediatric pulmonary tuberculosis. chictr.org.cn/showprojen.aspx?proj=25233 (study execute time 1 January 2018). [ChiCTR1800015075]
NCT03831906 {unpublished data only}
    1. NCT03831906. TB-speed pneumonia [Impact of systematic early tuberculosis (TB) detection using Xpert MTB/RIF Ultra in children with severe pneumonia in high tuberculosis burden countries]. clinicaltrials.gov/ct2/show/NCT03831906 (first posted 6 February 2019). [NCT03831906]

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References to other published versions of this review

Kay 2019
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