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. 2022 Sep 6;9(9):CD013359.
doi: 10.1002/14651858.CD013359.pub3.

Xpert MTB/RIF Ultra assay for tuberculosis disease and rifampicin resistance in children

Alexander W Kay  1 , Tara Ness  1 , Sabine E Verkuijl  2 , Kerri Viney  2 , Annemieke Brands  2 , Tiziana Masini  2 , Lucia González Fernández  1 , Michael Eisenhut  3 , Anne K Detjen  4 , Anna M Mandalakas  1 , Karen R Steingart #  5 , Yemisi Takwoingi #  6
Affiliations

Xpert MTB/RIF Ultra assay for tuberculosis disease and rifampicin resistance in children

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

Abstract

Background: Every year, an estimated one million children and young adolescents become ill with tuberculosis, and around 226,000 of those children die. Xpert MTB/RIF Ultra (Xpert Ultra) is a molecular World Health Organization (WHO)-recommended rapid diagnostic test that simultaneously detects Mycobacterium tuberculosis complex and rifampicin resistance. We previously published a Cochrane Review 'Xpert MTB/RIF and Xpert MTB/RIF Ultra assays for tuberculosis disease and rifampicin resistance in children'. The current review updates evidence on the diagnostic accuracy of Xpert Ultra in children presumed to have tuberculosis disease. Parts of this review update informed the 2022 WHO updated guidance on management of tuberculosis in children and adolescents.

Objectives: To assess the diagnostic accuracy of Xpert Ultra for detecting: pulmonary tuberculosis, tuberculous meningitis, lymph node tuberculosis, and rifampicin resistance, in children with presumed tuberculosis. Secondary objectives To investigate potential sources of heterogeneity in accuracy estimates. For detection of tuberculosis, we considered age, comorbidity (HIV, severe pneumonia, and severe malnutrition), and specimen type as potential sources. To summarize the frequency of Xpert Ultra trace results.

Search methods: We searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, three other databases, and three trial registers without language restrictions to 9 March 2021.

Selection criteria: Cross-sectional and cohort studies and randomized trials that evaluated Xpert Ultra in HIV-positive and HIV-negative children under 15 years of age. We included ongoing studies that helped us address the review objectives. We included studies evaluating sputum, gastric, stool, or nasopharyngeal specimens (pulmonary tuberculosis), cerebrospinal fluid (tuberculous meningitis), and fine needle aspirate or surgical biopsy tissue (lymph node tuberculosis). For detecting tuberculosis, reference standards were microbiological (culture) or composite reference standard; for stool, we also included Xpert Ultra performed on a routine respiratory specimen. For detecting rifampicin resistance, reference standards were drug susceptibility testing or MTBDRplus.

Data collection and analysis: Two review authors independently extracted data and, using QUADAS-2, assessed methodological quality judging risk of bias separately for each target condition and reference standard. For each target condition, we used the bivariate model to estimate summary sensitivity and specificity with 95% confidence intervals (CIs). We stratified all analyses by type of reference standard. We summarized the frequency of Xpert Ultra trace results; trace represents detection of a very low quantity of Mycobacterium tuberculosis DNA. We assessed certainty of evidence using GRADE.

Main results: We identified 14 studies (11 new studies since the previous review). For detection of pulmonary tuberculosis, 335 data sets (25,937 participants) were available for analysis. We did not identify any studies that evaluated Xpert Ultra accuracy for tuberculous meningitis or lymph node tuberculosis. Three studies evaluated Xpert Ultra for detection of rifampicin resistance. Ten studies (71%) took place in countries with a high tuberculosis burden based on WHO classification. Overall, risk of bias was low. Detection of pulmonary tuberculosis Sputum, 5 studies Xpert Ultra summary sensitivity verified by culture was 75.3% (95% CI 64.3 to 83.8; 127 participants; high-certainty evidence), and specificity was 97.1% (95% CI 94.7 to 98.5; 1054 participants; high-certainty evidence). Gastric aspirate, 7 studies Xpert Ultra summary sensitivity verified by culture was 70.4% (95% CI 53.9 to 82.9; 120 participants; moderate-certainty evidence), and specificity was 94.1% (95% CI 84.8 to 97.8; 870 participants; moderate-certainty evidence). Stool, 6 studies Xpert Ultra summary sensitivity verified by culture was 56.1% (95% CI 39.1 to 71.7; 200 participants; moderate-certainty evidence), and specificity was 98.0% (95% CI 93.3 to 99.4; 1232 participants; high certainty-evidence). Nasopharyngeal aspirate, 4 studies Xpert Ultra summary sensitivity verified by culture was 43.7% (95% CI 26.7 to 62.2; 46 participants; very low-certainty evidence), and specificity was 97.5% (95% CI 93.6 to 99.0; 489 participants; high-certainty evidence). Xpert Ultra sensitivity was lower against a composite than a culture reference standard for all specimen types other than nasopharyngeal aspirate, while specificity was similar against both reference standards. Interpretation of results In theory, for a population of 1000 children: • where 100 have pulmonary tuberculosis in sputum (by culture): - 101 would be Xpert Ultra-positive, and of these, 26 (26%) would not have pulmonary tuberculosis (false positive); and - 899 would be Xpert Ultra-negative, and of these, 25 (3%) would have tuberculosis (false negative). • where 100 have pulmonary tuberculosis in gastric aspirate (by culture): - 123 would be Xpert Ultra-positive, and of these, 53 (43%) would not have pulmonary tuberculosis (false positive); and - 877 would be Xpert Ultra-negative, and of these, 30 (3%) would have tuberculosis (false negative). • where 100 have pulmonary tuberculosis in stool (by culture): - 74 would be Xpert Ultra-positive, and of these, 18 (24%) would not have pulmonary tuberculosis (false positive); and - 926 would be Xpert Ultra-negative, and of these, 44 (5%) would have tuberculosis (false negative). • where 100 have pulmonary tuberculosis in nasopharyngeal aspirate (by culture): - 66 would be Xpert Ultra-positive, and of these, 22 (33%) would not have pulmonary tuberculosis (false positive); and - 934 would be Xpert Ultra-negative, and of these, 56 (6%) would have tuberculosis (false negative). Detection of rifampicin resistance Xpert Ultra sensitivity was 100% (3 studies, 3 participants; very low-certainty evidence), and specificity range was 97% to 100% (3 studies, 128 participants; low-certainty evidence). Trace results Xpert Ultra trace results, regarded as positive in children by WHO standards, were common. Xpert Ultra specificity remained high in children, despite the frequency of trace results.

Authors' conclusions: We found Xpert Ultra sensitivity to vary by specimen type, with sputum having the highest sensitivity, followed by gastric aspirate and stool. Nasopharyngeal aspirate had the lowest sensitivity. Xpert Ultra specificity was high against both microbiological and composite reference standards. However, the evidence base is still limited, and findings may be imprecise and vary by study setting. Although we found Xpert Ultra accurate for detection of rifampicin resistance, results were based on a very small number of studies that included only three children with rifampicin resistance. Therefore, findings should be interpreted with caution. Our findings provide support for the use of Xpert Ultra as an initial rapid molecular diagnostic in children being evaluated for tuberculosis.

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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‐Eswatini is separate from Baylor College of Medicine (AK's employer).

TN has no known conflicts of interest.

SEV is a Medical Officer at the World Health Organization Global Tuberculosis Programme, which commissioned this review update for the 2022 WHO consolidated guidelines on the management of tuberculosis in children and adolescents.

KV is a WHO staff member.

AB works as a technical officer at the WHO Global Tuberculoiss Programme, which commissioned this review update for the 2022 WHO consolidated guidelines on the management of tuberculosis in children and adolescents.

TM is a consultant to the WHO.

LGF has no known conflicts of interest.

ME is a CIDG Editor, and has no known conflicts of interest.

AKD has conducted prior primary research on tuberculosis diagnostics and has no known conflicts of interest. She works for UNICEF, and in her role as child health specialist is sometimes involved in developing recommendations for diagnostic approaches to detect childhood illnesses.

AMM has conducted prior primary research on tuberculosis diagnostics and has no known conflicts of interest. She has undertaken work as an independent contractor for Janssen Global Services, Medscape Independent Contractor, and Oxford Immunotec Inc.

KRS has received financial support for the preparation of systematic reviews and educational materials, consultancy fees from the Foundation for Innovative New Diagnostics (FIND) (for the preparation of systematic reviews), honoraria, and travel support to attend WHO guidelines meetings. KRS is a CIDG and DTA Editor.

YT is a Cochrane Editorial Board Member; a CIDG and DTA Editor; and a Statistical Editor for the Cochrane Bone Joint and Muscle Trauma Group.

The authors alone are responsible for the views expressed in this article and they do not necessarily represent the views, decisions or policies of the institutions with which they are affiliated.

Figures

1
1
Clinical pathway of Xpert Ultra in children presumed to have tuberculosis
2
2
Study flow diagram.
aKay 2020.
bStudies only evaluated Xpert MTB/RIF and other reasons: not a diagnostic study; study did not include children; case‐control study; abstract; index test not studied.
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Risk of bias and applicability concerns summary: review authors' judgements about each domain for each included study.
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Forest plots of Xpert Ultra sensitivity and specificity in sputum for pulmonary tuberculosis in children by type of specimen and reference standard. The squares represent the sensitivity and specificity of each study, the black lines their confidence intervals (CIs).
FN: false negative; FP: false positive; TN: true negative; TP: true positive.
5
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Forest plots of Xpert Ultra sensitivity and specificity in sputum and gastric aspirate for pulmonary tuberculosis by age group, culture reference standard. The squares represent the sensitivity and specificity of each study, the black lines their confidence intervals (CIs).
FN: false negative; FP: false positive; TN: true negative; TP: true positive.
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Forest plots of Xpert Ultra sensitivity and specificity in stool and nasopharyngeal specimens for pulmonary tuberculosis by age group, culture reference standard. The squares represent the sensitivity and specificity of each study, the black lines their confidence intervals (CIs).
FN: false negative; FP: false positive; TN: true negative; TP: true positive.
7
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Forest plots of Xpert Ultra sensitivity and specificity for pulmonary tuberculosis by specimen type and HIV status, culture reference standard. The squares represent the sensitivity and specificity of each study, the black lines their confidence intervals (CIs).
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 and comorbidity, culture reference standard. The squares represent the sensitivity and specificity of each study, the black lines their confidence intervals (CIs).
FN: false negative; FP: false positive; TN: true negative; TP: true positive.
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Forest plots of Xpert Ultra sensitivity and specificity for rifampicin resistance. The squares represent the sensitivity and specificity of each study, the black lines their confidence intervals (CIs).
TP: true positive; FP: false positive; FN: false negative; TN: true negative.
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Risk of bias and applicability concerns graph: review authors' judgements about each domain presented as percentages across included studies.
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Xpert Ultra, all specimens, rifampicin resistance
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Barcellini 2019 {published data only}
    1. Barcellini L, Borroni E, Cimaglia C, Girardi E, Matteelli A, Marchese V, et al. App-based symptoms screening with Xpert MTB/RIF Ultra assay used for active tuberculosis detection in migrants at point of arrivals in Italy: the E-DETECT TB intervention analysis. PLOS One 2019;14(7):e0218039. - PMC - PubMed
Jaganath 2021 {published data only}
    1. Jaganath D, Wambi P, Reza TF, Nakafeero J, Aben EO, Kiconco E, et al. A prospective evaluation of Xpert MTB/RIF Ultra for childhood pulmonary tuberculosis in Uganda. Journal of the Pediatric Infectious Diseases Society 2021;10(5):586-92. - PMC - PubMed
Kabir 2020 {published data only}
    1. Kabir S, Rahman SM, Ahmed S, Islam MS, Banu RS, Shewade HD, et al. Xpert Ultra assay on stool to diagnose pulmonary tuberculosis in children. Clinical Infectious Diseases 2020;73(2):226-34. - PMC - PubMed
Liu 2021 {published data only}
    1. Liu XH, Xia L, Song B, Wang H, Qian XQ, Wei JH, et al. Stool-based Xpert MTB/RIF Ultra assay as a tool for detecting pulmonary tuberculosis in children with abnormal chest imaging: a prospective cohort study. Journal of Infection 2021;82(1):84-9. - PubMed
NCT04121026 {unpublished data only}
    1. NCT04121026. Validation of a tuberculosis treatment decision algorithm in HIV-infected children (TB-Speed HIV). clinicaltrials.gov/show/NCT04121026 (first received 9 October 2019).
NCT04203628 {unpublished data only}
    1. NCT04203628. Evaluation of four stool processing methods combined with Xpert MTB/RIF Ultra for diagnosis of intrathoracic paediatric tuberculosis. clinicaltrials.gov/ct2/show/NCT04203628 (first received 18 December 2019).
NCT04240990 {unpublished data only}
    1. NCT04240990. Development of a diagnostic prediction score for tuberculosis in hospitalized children with severe acute malnutrition (TB-Speed SAM). clinicaltrials.gov/show/NCT04240990 (first received 27 January 2020).
NCT04899076 {published data only}
    1. NCT04899076. Stool Processing Kit (SPK) evaluation for paediatric TB. clinicaltrials.gov/ct2/show/NCT04899076 (first received 24 May 2021).
Nicol 2018 {published data only}
    1. Nicol MP, Workman L, Prins M, Bateman L, Ghebrekristos Y, Mbhele S, et al. Accuracy of Xpert MTB/RIF Ultra for the diagnosis of pulmonary tuberculosis in children. Paediatric Infectious Disease Journal 2018;37(10):e261-3. - PubMed
Parigi 2021 {published data only}
    1. Parigi S, Venturini E, Galli L, Chiappini E. Xpert MTB/RIF Ultra performance in diagnosing paediatric pulmonary TB in gastric aspirates. International Journal of Tuberculosis and Lung Disease 2021;25(1):75-7. - PubMed
Sabi 2018 {published data only}
    1. Sabi I, Rachow A, Mapamba D, Clowes P, Ntinginya NE, Sasamalo M, et al. Xpert MTB/RIF Ultra assay for the diagnosis of pulmonary tuberculosis in children: a multicentre comparative accuracy study. Journal of Infection 2018;77(4):321-7. - PubMed
Ssengooba 2020 {published data only}
    1. Ssengooba W, Dieu Iragena J, Nakiyingi L, Mujumbi S, Wobudeya E, Mboizi R, et al. Accuracy of Xpert Ultra in diagnosis of pulmonary tuberculosis among children in Uganda: a substudy from the SHINE trial. Journal of Clinical Microbiology 2020;58(9):e00410-20. - PMC - PubMed
Sun 2020 {published data only}
    1. Sun L, Zhu Y, Fang M, Shi Y, Peng X, Liao Q, et al. Evaluation of Xpert MTB/RIF Ultra assay for diagnosis of childhood tuberculosis: a multicenter accuracy study. Journal of Clinical Microbiology 2020;58(9):e00702-20. - PMC - 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 AM, Eltohami NA, Ebraheem RS, Ahmed SF, 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 KK, 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
NCT03831906 {unpublished data only}
    1. NCT03831906. TB-Speed Pneumonia. clinicaltrials.gov/show/NCT03831906 (first received 6 February 2019).
NCT04038632 {unpublished data only}
    1. NCT04038632. TB-Speed Decentralisation Study. clinicaltrials.gov/show/NCT04038632 (first received 2 August 2019).
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}
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Nicol 2020 {published data only}
    1. Nicol M, Schumacher S, Workman L, Broger T, Baard C, Prins M, et al. Accuracy of a novel urine test, Fujifilm SILVAMP TB LAM, for the diagnosis of pulmonary tuberculosis in children. Clinical Infectious Diseases 2020;72(9):e280-8. - 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 2018a {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 2018b {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, 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 2016b {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 TL, Aurílio RB, Soares EC, 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 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
Sun 2019 {published data only}
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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}
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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 2017 {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 2018 {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
Wang 2020 {published data only}
    1. Wang G, Wang S, Yang X, Sun Q, Jiang G, Huang M, et al. Accuracy of Xpert MTB/RIF Ultra for the diagnosis of pleural TB in a multicenter cohort study. Chest 2020;157(2):268-275. - PubMed
Yadav 2020 {published data only}
    1. Yadav R, Vaidya P, Mathew JL, Singh S, Khaneja R, Agarwal P, et al. Diagnostic accuracy of Xpert MTB/RIF ultra for detection of Mycobacterium tuberculosis in children: a prospective cohort study. Letters in Applied Microbiology 2021;72(3):225-30. - 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. Zhonghua er ke za zhi [Chinese Journal of Pediatrics] 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. www.chictr.org.cn/showprojen.aspx?proj=25233 (first received 6 March 2018). [ChiCTR1800015075]

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References to other published versions of this review

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