Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2021 Jan 15;1(1):CD012768.
doi: 10.1002/14651858.CD012768.pub3.

Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults

Mikashmi Kohli  1 , Ian Schiller  2 , Nandini Dendukuri  2 , Mandy Yao  2 , Keertan Dheda  3   4 , Claudia M Denkinger  5   6 , Samuel G Schumacher  5 , Karen R Steingart  7
Affiliations
Meta-Analysis

Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults

Mikashmi Kohli et al. Cochrane Database Syst Rev. .

Abstract

Background: Xpert MTB/RIF Ultra (Xpert Ultra) and Xpert MTB/RIF are World Health Organization (WHO)-recommended rapid nucleic acid amplification tests (NAATs) widely used for simultaneous detection of Mycobacterium tuberculosis complex and rifampicin resistance in sputum. To extend our previous review on extrapulmonary tuberculosis (Kohli 2018), we performed this update to inform updated WHO policy (WHO Consolidated Guidelines (Module 3) 2020).

Objectives: To estimate diagnostic accuracy of Xpert Ultra and Xpert MTB/RIF for extrapulmonary tuberculosis and rifampicin resistance in adults with presumptive extrapulmonary tuberculosis.

Search methods: Cochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, Science Citation Index, Web of Science, Latin American Caribbean Health Sciences Literature, Scopus, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform, the International Standard Randomized Controlled Trial Number Registry, and ProQuest, 2 August 2019 and 28 January 2020 (Xpert Ultra studies), without language restriction.

Selection criteria: Cross-sectional and cohort studies using non-respiratory specimens. Forms of extrapulmonary tuberculosis: tuberculous meningitis and pleural, lymph node, bone or joint, genitourinary, peritoneal, pericardial, disseminated tuberculosis. Reference standards were culture and a study-defined composite reference standard (tuberculosis detection); phenotypic drug susceptibility testing and line probe assays (rifampicin resistance detection).

Data collection and analysis: Two review authors independently extracted data and assessed risk of bias and applicability using QUADAS-2. For tuberculosis detection, we performed separate analyses by specimen type and reference standard using the bivariate model to estimate pooled sensitivity and specificity with 95% credible intervals (CrIs). We applied a latent class meta-analysis model to three forms of extrapulmonary tuberculosis. We assessed certainty of evidence using GRADE.

Main results: 69 studies: 67 evaluated Xpert MTB/RIF and 11 evaluated Xpert Ultra, of which nine evaluated both tests. Most studies were conducted in China, India, South Africa, and Uganda. Overall, risk of bias was low for patient selection, index test, and flow and timing domains, and low (49%) or unclear (43%) for the reference standard domain. Applicability for the patient selection domain was unclear for most studies because we were unsure of the clinical settings. Cerebrospinal fluid Xpert Ultra (6 studies) Xpert Ultra pooled sensitivity and specificity (95% CrI) against culture were 89.4% (79.1 to 95.6) (89 participants; low-certainty evidence) and 91.2% (83.2 to 95.7) (386 participants; moderate-certainty evidence). Of 1000 people where 100 have tuberculous meningitis, 168 would be Xpert Ultra-positive: of these, 79 (47%) would not have tuberculosis (false-positives) and 832 would be Xpert Ultra-negative: of these, 11 (1%) would have tuberculosis (false-negatives). Xpert MTB/RIF (30 studies) Xpert MTB/RIF pooled sensitivity and specificity against culture were 71.1% (62.8 to 79.1) (571 participants; moderate-certainty evidence) and 96.9% (95.4 to 98.0) (2824 participants; high-certainty evidence). Of 1000 people where 100 have tuberculous meningitis, 99 would be Xpert MTB/RIF-positive: of these, 28 (28%) would not have tuberculosis; and 901 would be Xpert MTB/RIF-negative: of these, 29 (3%) would have tuberculosis. Pleural fluid Xpert Ultra (4 studies) Xpert Ultra pooled sensitivity and specificity against culture were 75.0% (58.0 to 86.4) (158 participants; very low-certainty evidence) and 87.0% (63.1 to 97.9) (240 participants; very low-certainty evidence). Of 1000 people where 100 have pleural tuberculosis, 192 would be Xpert Ultra-positive: of these, 117 (61%) would not have tuberculosis; and 808 would be Xpert Ultra-negative: of these, 25 (3%) would have tuberculosis. Xpert MTB/RIF (25 studies) Xpert MTB/RIF pooled sensitivity and specificity against culture were 49.5% (39.8 to 59.9) (644 participants; low-certainty evidence) and 98.9% (97.6 to 99.7) (2421 participants; high-certainty evidence). Of 1000 people where 100 have pleural tuberculosis, 60 would be Xpert MTB/RIF-positive: of these, 10 (17%) would not have tuberculosis; and 940 would be Xpert MTB/RIF-negative: of these, 50 (5%) would have tuberculosis. Lymph node aspirate Xpert Ultra (1 study) Xpert Ultra sensitivity and specificity (95% confidence interval) against composite reference standard were 70% (51 to 85) (30 participants; very low-certainty evidence) and 100% (92 to 100) (43 participants; low-certainty evidence). Of 1000 people where 100 have lymph node tuberculosis, 70 would be Xpert Ultra-positive and 0 (0%) would not have tuberculosis; 930 would be Xpert Ultra-negative and 30 (3%) would have tuberculosis. Xpert MTB/RIF (4 studies) Xpert MTB/RIF pooled sensitivity and specificity against composite reference standard were 81.6% (61.9 to 93.3) (377 participants; low-certainty evidence) and 96.4% (91.3 to 98.6) (302 participants; low-certainty evidence). Of 1000 people where 100 have lymph node tuberculosis, 118 would be Xpert MTB/RIF-positive and 37 (31%) would not have tuberculosis; 882 would be Xpert MTB/RIF-negative and 19 (2%) would have tuberculosis. In lymph node aspirate, Xpert MTB/RIF pooled specificity against culture was 86.2% (78.0 to 92.3), lower than that against a composite reference standard. Using the latent class model, Xpert MTB/RIF pooled specificity was 99.5% (99.1 to 99.7), similar to that observed with a composite reference standard. Rifampicin resistance Xpert Ultra (4 studies) Xpert Ultra pooled sensitivity and specificity were 100.0% (95.1 to 100.0), (24 participants; low-certainty evidence) and 100.0% (99.0 to 100.0) (105 participants; moderate-certainty evidence). Of 1000 people where 100 have rifampicin resistance, 100 would be Xpert Ultra-positive (resistant): of these, zero (0%) would not have rifampicin resistance; and 900 would be Xpert Ultra-negative (susceptible): of these, zero (0%) would have rifampicin resistance. Xpert MTB/RIF (19 studies) Xpert MTB/RIF pooled sensitivity and specificity were 96.5% (91.9 to 98.8) (148 participants; high-certainty evidence) and 99.1% (98.0 to 99.7) (822 participants; high-certainty evidence). Of 1000 people where 100 have rifampicin resistance, 105 would be Xpert MTB/RIF-positive (resistant): of these, 8 (8%) would not have rifampicin resistance; and 895 would be Xpert MTB/RIF-negative (susceptible): of these, 3 (0.3%) would have rifampicin resistance.

Authors' conclusions: Xpert Ultra and Xpert MTB/RIF may be helpful in diagnosing extrapulmonary tuberculosis. Sensitivity varies across different extrapulmonary specimens: while for most specimens specificity is high, the tests rarely yield a positive result for people without tuberculosis. For tuberculous meningitis, Xpert Ultra had higher sensitivity and lower specificity than Xpert MTB/RIF against culture. Xpert Ultra and Xpert MTB/RIF had similar sensitivity and specificity for rifampicin resistance. Future research should acknowledge the concern associated with culture as a reference standard in paucibacillary specimens and consider ways to address this limitation.

PubMed Disclaimer

Conflict of interest statement

We have no financial involvement with any organization or entity that has a financial interest in, or financial conflict with, the subject matter or materials discussed in the review apart from those disclosed.

MK received funding from USAID, administered by the World Health Organization Global Tuberculosis Programme, Switzerland.

IS received funding from USAID, administered by the World Health Organization Global Tuberculosis Programme, Switzerland.

ND's participation in this project was supported in part by the Canadian Institutes of Health Research.

MY's participation in this project was supported in part by the Canadian Institutes of Health Research.

KD has no interests to declare.

CMD worked for the Foundation for Innovative New Diagnostics (FIND) until April 2019 and has no other interests to declare.

SGS works for FIND. FIND is a not‐for‐profit foundation whose mission is to find diagnostic solutions to overcome diseases of poverty in low‐ and middle‐income countries. FIND works closely with the private and public sectors and receives funding from donors and some of its industry partners. FIND has an independent Scientific Advisory Committee and organizational firewalls that protect it against any undue influences in its work or in publication of its findings. More information on FIND’s policy and guidelines for working with private sector partners can be found at www.finddx.org/ops-gov/.

KRS received funding from USAID, administered by the World Health Organization Global Tuberculosis Programme, Switzerland, and Cochrane infectious Diseases Group, UK. She has received financial support from McGill University, Canada, and the World Health Organization (WHO) Global Tuberculosis Programme, Switzerland for the preparation of systematic reviews and educational materials, consultancy fees from Foundation for Innovative New Diagnostics (FIND), Switzerland (for the preparation of systematic reviews and GRADE tables), honoraria, and travel support to attend WHO guideline meetings.

Figures

1
1
The clinical pathway describes how patients might present and the point in the pathway at which they would be considered for testing with Xpert Ultra or Xpert MTB/RIF. This algorithm for the use of a molecular WHO‐recommended rapid diagnostic (WRD), which includes Xpert Ultra and Xpert MTB/ RIF, comes from the WHO operational handbook on tuberculosis (WHO Operational Handbook Diagnosis (Module 3) 2020). Copyright © [2020] [World Health Organization]: reproduced with permission. Abbreviations: DST: drug susceptibility testing; INH: isoniazid; MDR‐TB: multidrug‐resistant TB; MTB: Mycobacterium tuberculosis; PLHIV: people living with HIV; RIF: rifampicin; TB: tuberculosis; WRD: WHO‐recommended rapid diagnostic, which includes Xpert Ultra and Xpert MTB/RIF.
2
2
3
3
Risk of bias and applicability concerns graph for tuberculosis detection: review authors' judgements about each domain presented as percentages across included studies.
4
4
Risk of bias and applicability concerns summary for tuberculosis detection: review authors' judgements about each domain for each included study.
5
5
Risk of bias and applicability concerns graph for rifampicin resistance detection in comparative studies of Xpert Ultra and Xpert MTB/RIF: review authors' judgements about each domain presented as percentages across included studies.
6
6
Risk of bias and applicability concerns summary for rifampicin resistance detection in comparative studies of Xpert Ultra and Xpert MTB/RIF: review authors' judgements about each domain for each included study.
7
7
Forest plots of Xpert Ultra sensitivity and specificity in cerebrospinal fluid by 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
8
Forest plots of Xpert MTB/RIF sensitivity and specificity in cerebrospinal fluid by 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
9
Forest plots of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity in cerebrospinal fluid, comparative studies. 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
10
Summary plots of the sensitivity and specificity of Xpert Ultra (A) (5 studies) and Xpert MTB/RIF (B) (5 studies) in cerebrospinal fluid for detection of tuberculous meningitis. Each individual study is represented by a shaded square. The size of the square is proportional to the sample size of the study such that larger studies are represented by larger squares. The filled circle is the median pooled estimate for sensitivity and specificity. The solid curves represent the 95% credible region around the summary estimate; the dashed curves represent the 95% prediction region.
11
11
Forest plots of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity in cerebrospinal fluid in HIV‐positive people, with respect to culture. 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
12
Forest plots of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity in pleural fluid and tissue by 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 Ultra and Xpert MTB/RIF sensitivity and specificity in lymph node aspirate by 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.
14
14
Forest plots of Xpert Ultra and Xpert MTB/RIFsensitivity and specificity in lymph node biopsy by 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.
15
15
Forest plots of Xpert MTB/RIF and Xpert Ultra sensitivity and specificity in urine by 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.
16
16
Forest plots of Xpert MTB/RIF sensitivity and specificity for peritoneal TB (fluid and tissue) by 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.
17
17
Forest plots of Xpert Ultra and 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.
18
18
Risk of bias and applicability concerns graph for tuberculous meningitis (cerebrospinal fluid): review authors' judgements about each domain presented as percentages across included studies.
19
19
Risk of bias and applicability concerns graph for pleural tuberculosis (pleural fluid): review authors' judgements about each domain presented as percentages across included studies.
20
20
Risk of bias and applicability concerns graph for lymph node tuberculosis (lymph node aspirate): review authors' judgements about each domain presented as percentages across included studies.
21
21
Summary plots of the sensitivity and specificity of Xpert Ultra (A) (4 studies) and Xpert MTB/RIF (B) (25 studies) in pleural fluid for detection of pleural tuberculosis. Each individual study is represented by a shaded square. The size of the square is proportional to the sample size of the study such that larger studies are represented by larger squares. The filled circle is the median pooled estimate for sensitivity and specificity. The solid curves represent the 95% credible region around the summary estimate; the dashed curves represent the 95% prediction region.
22
22
Forest plots of Xpert MTB/RIF and Xpert Ultra sensitivity and specificity in bone or joint fluid and tissue by 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.
1
1. Test
Cerebrospinal fluid, Xpert Ultra, culture
2
2. Test
Cerebrospinal fluid, Xpert Ultra, composite reference standard
3
3. Test
Cerebrospinal fluid, Xpert MTB/RIF, culture
4
4. Test
Cerebrospinal fluid, Xpert MTB/RIF, composite reference standard
5
5. Test
Cerebrospinal fluid, Xpert Ultra, HIV positive
6
6. Test
Cerebrospinal fluid, Xpert MTB/RIF, HIV positive
7
7. Test
Pleural fluid, Xpert Ultra, culture
8
8. Test
Pleural fluid, Xpert Ultra, composite reference standard
9
9. Test
Pleural fluid, Xpert MTB/RIF, culture
10
10. Test
Pleural fluid, Xpert MTB/RIF, composite reference standard
11
11. Test
Pleural tissue, Xpert MTB/RIF, culture
12
12. Test
Pleural tissue, Xpert MTB/RIF, composite reference standard
13
13. Test
Lymph node aspirate, Xpert Ultra, culture
14
14. Test
Lymph node aspirate, Xpert Ultra, composite reference standard
15
15. Test
Lymph node aspirate, Xpert MTB/RIF, culture
16
16. Test
Lymph node aspirate, Xpert MTB/RIF, composite reference standard
17
17. Test
Lymph node biopsy, Xpert Ultra, culture
18
18. Test
Lymph node biopsy, Xpert Ultra, composite reference standard
19
19. Test
Lymph node biopsy, Xpert MTB/RIF, culture
20
20. Test
Lymph node biopsy, Xpert MTB/RIF, composite
21
21. Test
Urine, Xpert Ultra, culture
22
22. Test
Urine, Xpert MTB/RIF, culture
23
23. Test
Urine, Xpert MTB/RIF, composite reference standard
24
24. Test
Bone or joint aspirate, Xpert Ultra, culture
25
25. Test
Bone or joint aspirate, Xpert Ultra, composite reference standard
26
26. Test
Bone or joint aspirate, Xpert MTB/RIF, culture
27
27. Test
Bone or Joint aspirate, Xpert MTB/RIF, composite reference standard
28
28. Test
Bone or joint tissue, Xpert MTB/RIF, culture
29
29. Test
Peritoneal fluid, Xpert Ultra, culture
30
30. Test
Peritoneal fluid, Xpert MTB/RIF, culture
31
31. Test
Peritoneal tissue, Xpert MTB/RIF, culture
32
32. Test
Pericardial fluid, Xpert MTB/RIF, culture
33
33. Test
Pericardial fluid, Xpert MTB/RIF, composite reference standard
34
34. Test
Blood, Xpert MTB/RIF, culture
35
35. Test
Rifampicin resistance, Xpert Ultra
36
36. Test
Rifampicin resistance, Xpert MTB/RIF
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Ablanedo‐Terrazas 2014 {published data only}
    1. Ablanedo-Terrazas Y, Alvarado-de la Barrera C, Hernandez-Juan R, Ruiz-Cruz M, Reyes-Teran G. Xpert MTB/RIF for diagnosis of tuberculous cervical lymphadenitis in HIV-infected patients. Laryngoscope 2014;124(6):1382-5. - PubMed
Ajbani 2018 {published data only}
    1. Ajbani K, Kazi M, Naik S, Soman R, Shetty A, Rodrigues C. Utility of pyrosequencing for rapid detection of tubercular meningitis (TBM) and associated susceptibility directly from CSF specimens. Tuberculosis 2018;111:54-6. - PubMed
Al‐Ateah 2012 {published data only}
    1. Al-Ateah SM, Al-Dowaidi MM, El-Khizzi NA. Evaluation of direct detection of Mycobacterium tuberculosis complex in respiratory and non-respiratory clinical specimens using the Cepheid Gene Xpert(R) system. Saudi Medical Journal 2012;33(10):1100-5. - PubMed
Antel 2020 {published data only}
    1. Antel K, Oosthuizen J, Malherbe F, Louw VJ, Nicol MP, Maartens G, et al. Diagnostic accuracy of the Xpert MTB/Rif Ultra for tuberculosis adenitis. BMC Infectious Diseases 2020;20(1):33. - PMC - PubMed
Azevedo 2018 {published data only}
    1. Azevedo RG, Dinallo FS, De Laurentis LS, Boulware DR, Vidal JE. Xpert MTB/RIF((R)) 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
Bahr 2015 {published data only}
    1. Bahr NC, Tugume L, Rajasingham R, Kiggundu R, Williams DA, Morawski B, et al. Improved diagnostic sensitivity for tuberculous meningitis with Xpert((R)) MTB/RIF of centrifuged CSF. International Journal of Tuberculosis and Lung Disease 2015;19(10):1209-15. - PMC - PubMed
Bahr 2017 {published data only}
    1. Bahr NC, Nuwagira E, Evans EE, Cresswell FV, Bystrom PV, Byamukama A, et al. Diagnostic accuracy of Xpert MTB/Rif Ultra for TB meningitis in HIV-infected adults: a prospective cohort study. Lancet Infectious Diseases 2017;18(1):68-75. - PMC - PubMed
Bera 2015 {published data only}
    1. Bera C, Michael JS, Burad D, Shirly SB, Gibikote S, Ramakrishna B, et al. Tissue XpertTM MTB/Rif assay is of limited use in diagnosing peritoneal tuberculosis in patients with exudative ascites. Indian Journal of Gastroenterology 2015;34(5):395-8. - PubMed
Biadglegne 2014 {published data only}
    1. Biadglegne F, Mulu A, Rodloff A C, 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
Blaich 2014 {published data only}
    1. Blaich A, Frei R. Performance of the Xpert MTB/RIF assay on nonrespiratory specimens and accuracy of this assay for detection of rifampin resistance in a low-prevalence setting. Journal of Clinical Microbiology 2014;52(2):706. - PMC - PubMed
Causse 2011 {published data only}
    1. Causse M, Ruiz P, Gutierrez-Aroca JB, Casal M. Comparison of two molecular methods for rapid diagnosis of extrapulmonary tuberculosis. Journal of Clinical Microbiology 2011;49(8):3065-7. - PMC - PubMed
Che 2017 {published data only}
    1. Che N, Yang X, Liu Z, Li K, Chen X. Rapid detection of cell-free Mycobacterium tuberculosis DNA in tuberculous pleural effusion. Journal of Clinical Microbiology 2017;55(5):1526-32. - PMC - PubMed
Chen 2019 {published data only}
    1. Chen C, Yang CG, Gao X, Lu ZZ, Tang FX, Cheng J, et al. Community-based active case finding for tuberculosis in rural western China: a cross-sectional study. International Journal of Tuberculosis and Lung Disease 2017;21(11):1134-9. - PMC - PubMed
Chin 2019 {published data only}
    1. Chin JH, Musubire AK, Morgan N, Pellinen J, Grossman S, Bhatt JM, et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis in cerebrospinal fluid. Journal of Clinical Microbiology 2019;57(6):pii: e00249-19. - PMC - PubMed
Christopher 2013 {published data only}
    1. Christopher DJ, Schumacher SG, Michael JS, Luo R, Balamugesh T, Duraikannan P, et al. Performance of Xpert MTB/RIF on pleural tissue for the diagnosis of pleural tuberculosis. European Respiratory Journal 2013;42(5):1427-9. - PubMed
Cresswell 2018 {published data only}
    1. Cresswell FV, Bangdiwala AS, Bahr NC, Trautner E, Nuwagira E, Ellis J, et al. Can improved diagnostics reduce mortality from tuberculous meningitis? Findings from a 6.5-year cohort in Uganda. Wellcome Open Research 2018;3:64. - PMC - PubMed
Cresswell 2020 {published data only}
    1. Cresswell FV, Tugume L, Bahr NC, Kwizera R, Bangdiwala AS, Musubire AK, et al. Xpert MTB/RIF Ultra for the diagnosis of HIV-associated tuberculous meningitis: a prospective validation study. Lancet Infectious Disease 2020;20(3):308-17. - PMC - PubMed
Dhasmana 2014 {published data only}
    1. Dhasmana DJ, Ross C, Bradley CJ, Connell DW, George PM, Singanayagam A, et al. Performance of Xpert MTB/RIF in the diagnosis of tuberculous mediastinal lymphadenopathy by endobronchial ultrasound. Annals of the American Thoracic Society 2014;11(3):392-6. - PMC - PubMed
Dhooria 2016 {published data only}
    1. Dhooria S, Gupta N, Bal A, Sehgal IS, Aggarwal A, Sethi S, et al. Role of Xpert MTB/RIF in differentiating tuberculosis from sarcoidosis in patients with mediastinal lymphadenopathy undergoing EBUS-TBNA: a study of 147 patients. Sarcoidosis Vasculitis and Diffuse Lung Disease 2016;33:258-266. - PubMed
Donovan 2020 {published data only}
    1. Donovan J, Anh Thu DD, Phu NH, Dung VT, Quang TP, Nghia HDT, et al. Xpert MTB/RIF Ultra versus Xpert MTB/RIF for the diagnosis of tuberculous meningitis: a prospective, randomised, diagnostic accuracy study. Lancet Infectious Disease 2020;20:299-307. - PMC - PubMed
Du 2015 {published data only}
    1. Du J, Huang Z, Luo Q, Xiong G, Xu X, Li W, et al. Rapid diagnosis of pleural tuberculosis by Xpert MTB/RIF assay using pleural biopsy and pleural fluid specimens. Journal of Research In Medical Sciences 2015;20(1):26-31. - PMC - PubMed
El‐Din 2019 {published data only}
    1. El-Din MG, Sobh E, Adawy Z, Farghaly N. Diagnostic utility of gene X-pert in the diagnosis of tuberculous pleural effusion. Infectious Diseases 2019;51(3):227-9. - PubMed
Feasey 2013 {published data only}
    1. Feasey NA, Banada PP, Howson W, Sloan DJ, Mdolo A, Boehme C, et al. Evaluation of Xpert MTB/RIF for detection of tuberculosis from blood samples of HIV-infected adults confirms Mycobacterium tuberculosis bacteremia as an indicator of poor prognosis. Journal of Clinical Microbiology 2013;51(7):2311-6. - PMC - PubMed
Friedrich 2011 {published data only}
    1. Friedrich SO, Von Groote-Bidlingmaier F, Diacon AH. Xpert MTB/RIF assay for diagnosis of pleural tuberculosis. Journal of Clinical Microbiology 2011;49(12):4341-2. - 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
Gu 2015 {published data only}
    1. Gu Y, Wang G, Dong W, Li Y, Ma Y, Shang Y, et al. Xpert MTB/RIF and GenoType MTBDRplus assays for the rapid diagnosis of bone and joint tuberculosis. International Journal of Infectious Diseases 2015;36:27-30. - PubMed
Hanif 2011 {published data only}
    1. Hanif SN, Eldeen HS, Ahmad S, Mokaddas E. GeneXpert(R) MTB/RIF for rapid detection of Mycobacterium tuberculosis in pulmonary and extra-pulmonary samples. International Journal of Tuberculosis and Lung Disease 2011;15(9):1274-5. - PubMed
Heemskerk 2018 {published data only}
    1. Heemskerk AD, Donovan J, Thu DD, Marais S, Chaidir L, Dung VT, et al. Improving the microbiological diagnosis of tuberculous meningitis: a prospective, international, multicentre comparison of conventional and modified Ziehl-Neelsen stain, GeneXpert, and culture of cerebrospinal fluid. Journal of Infection 2018;77(6):509-15. - PMC - PubMed
Hillemann 2011 {published data only}
    1. Hillemann D, Rusch-Gerdes S, Boehme C, Richter E. Rapid molecular detection of extrapulmonary tuberculosis by the automated GeneXpert MTB/RIF system. Journal of Clinical Microbiology 2011;49(4):1202-5. - PMC - PubMed
Iram 2015 {published data only}
    1. Iram S, Zeenat A, Hussain S, Wasim Yusuf N, Aslam M. Rapid diagnosis of tuberculosis using Xpert MTB/RIF assay - report from a developing country. Pakistan Journal of Medical Sciences 2015;31(1):105-10. - PMC - PubMed
Kim 2015a {published data only}
    1. Kim YW, Kwak N, Seong MW, Kim EC, Yoo CG, Kim YW, et al. Accuracy of the Xpert(R) MTB/RIF assay for the diagnosis of extra-pulmonary tuberculosis in South Korea. International Journal of Tuberculosis and Lung Disease 2015;19(1):81-6. - PubMed
Li 2017 {published data only}
    1. Li Y, Pang Y, Zhang T, Xian X, Wang X, Yang J, et al. Rapid diagnosis of extrapulmonary tuberculosis with Xpert Mycobacterium tuberculosis/rifampicin assay. Journal of Medical Microbiology 2017;66(7):910-4. - PubMed
Liang 2019 {published data only}
    1. Liang Q, Pang Y, Yang Y, Li H, Guo C, Yang X, et al. An improved algorithm for rapid diagnosis of pleural tuberculosis from pleural effusion by combined testing with GeneXpert MTB/RIF and an anti-LAM antibody-based assay. BMC Infectious Diseases 2019;19(1):548. - PMC - PubMed
Ligthelm 2011 {published data only}
    1. Ligthelm LJ, Nicol MP, Hoek KG, Jacobson R, Van Helden PD, Marais BJ, et al. Xpert MTB/RIF for rapid diagnosis of tuberculous lymphadenitis from fine-needle-aspiration biopsy specimens. Journal of Clinical Microbiology 2011;49(11):3967-70. - PMC - PubMed
Lusiba 2014 {published data only}
    1. Lusiba JK, Nakiyingi L, Kirenga BJ, Kiragga A, Lukande R, Nsereko M, et al. Evaluation of Cepheid's Xpert MTB/Rif test on pleural fluid in the diagnosis of pleural tuberculosis in a high prevalence HIV/TB setting. PLOS One 2014;9(7):e102702. [DOI: 10.1371/journal.pone.0102702] - DOI - PMC - PubMed
Malbruny 2011 {published data only}
    1. Malbruny B, Le Marrec G, Courageux K, Leclercq R, Cattoir V. Rapid and efficient detection of Mycobacterium tuberculosis in respiratory and non-respiratory samples. International Journal of Tuberculosis and Lung Disease 2011;15(4):553-5. - PubMed
Meldau 2014 {published data only}
    1. Meldau R, Peter J, Theron G, Calligaro G, Allwood B, Symons G, et al. Comparison of same day diagnostic tools including Gene Xpert and unstimulated IFN-gamma for the evaluation of pleural tuberculosis: a prospective cohort study. BMC Pulmonary Medicine 2014;14:58. [DOI: 10.1186/1471-2466-14-58] - DOI - PMC - PubMed
Meldau 2019 {published data only}
    1. Meldau R, Randall P, Pooran A, Limberis J, Makambwa E, Dhansay M, et al. Same day tools, including Xpert Ultra and unstimulated IFN-gamma, for the rapid diagnosis of pleural tuberculosis - a prospective observational study. Journal of Clinical Microbiology 2019;57(9):e00614-19. - PMC - PubMed
Metcalf 2018 {published data only}
    1. Metcalf T, Soria J, Montano SM, Ticona E, Evans CA, Huaroto L, et al. Evaluation of the GeneXpert MTB/RIF in patients with presumptive tuberculous meningitis. PLOS One 2018;13(6):e0198695. - PMC - PubMed
Nataraj 2016 {published data only}
    1. Nataraj G, Kanade S, Mehta P. Xpert((R)) MTB/RIF for improved case detection of extra-pulmonary TB in a tertiary care setting in urban India. International Journal of Tuberculosis and Lung Disease 2016;20(7):890-4. - PubMed
Nhu 2014 {published data only}
    1. Nhu NT, Heemskerk D, Thu do DA, Chau TT, Mai NT, Nghia HD, et al. Evaluation of GeneXpert MTB/RIF for diagnosis of tuberculous meningitis. Journal of Clinical Microbiology 2014;52(1):226-33. - PMC - PubMed
Ozkutuk 2014 {published data only}
    1. Ozkutuk N, Surucuoglu S. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary tuberculosis in an intermediate-prevalence setting [Orta Prevalanslı Bölgede Akciğer ve Akciğer DışıTüberküloz Tanısında Xpert MTB/RIF Testinin Değerlendirilmesi]. Mikrobiyoloji Bulteni 2014;48(2):223-32. - PubMed
Pandie 2014 {published data only}
    1. Pandie S, Peter JG, Kerbelker ZS, Meldau R, Theron G, Govender U, et al. Diagnostic accuracy of quantitative PCR (Xpert MTB/RIF) for tuberculous pericarditis compared to adenosine deaminase and unstimulated interferon-gamma in a high burden setting: a prospective study. BMC Medicine 2014;12:101. [DOI: 10.1186/1741-7015-12-101] - DOI - PMC - PubMed
Patel 2013 {published data only}
    1. Patel VB, Theron G, Lenders L, Matinyena B, Connolly C, Singh R, et al. Diagnostic accuracy of quantitative PCR (Xpert MTB/RIF) for tuberculous meningitis in a high burden setting: a prospective study. PLOS Medicine 2013;10(10):e1001536. [DOI: 10.1371/journal.pmed.1001536] - DOI - PMC - PubMed
Peñata 2016 {published data only}
    1. Peñata A, Salazar R, Castano T, Bustamante J, Ospina S. Molecular diagnosis of extrapulmonary tuberculosis and sensitivity to rifampicin with an automated real-time method [Diagnóstico molecular de tuberculosis extrapulmonary sensibilidad a rifampicina con un método automatizado en tiempo real]. Biomedica 2016;36(Suppl 1):78-89. - PubMed
Perez‐Risco 2018 {published data only}
    1. Perez-Risco D, Rodriguez-Temporal D, Valledor-Sanchez I, Alcaide F. Evaluation of the Xpert MTB/RIF Ultra assay for direct detection of Mycobacterium tuberculosis complex in smear-negative extrapulmonary samples. Journal of Clinical Microbiology 2018;56(9):pii: e00659-18. - PMC - PubMed
Rakotoarivelo 2018 {published data only}
    1. Rakotoarivelo R, Ambrosioni J, Rasolofo V, Raberahona M, Rakotosamimanana N, Andrianasolo R, et al. Evaluation of the Xpert MTB/RIF assay for the diagnosis of smear-negative pulmonary and extrapulmonary tuberculosis in Madagascar. International Journal of Infectious Diseases 2018;69:20-5. - PubMed
Rufai 2015 {published data only}
    1. Rufai SB, Singh A, Kumar P, Singh J, Singh S. Performance of Xpert MTB/RIF Assay in diagnosis of pleural tuberculosis by use of pleural fluid samples. Journal of Clinical Microbiology 2015;53(11):3636-8. - PMC - PubMed
Rufai 2017a {published data only}
    1. Rufai SB, Singh S, Singh A, Kumar P, Singh J, Vishal A. Performance of Xpert MTB/RIF on ascitic fluid samples for detection of abdominal tuberculosis. Journal of Laboratory Physicians 2017;9(1):47-52. - PMC - PubMed
Rufai 2017b {published data only}
    1. Rufai SB, Singh A, Singh J, Kumar P, Sankar MM, Singh S. Diagnostic usefulness of Xpert MTB/RIF assay for detection of tuberculous meningitis using cerebrospinal fluid. Journal of Infection 2017;75(2):125-31. - PubMed
Safianowska 2012 {published data only}
    1. Safianowska A, Walkiewicz R, Nejman-Gryz P, Grubek-Jaworska H. Two selected commercially based nucleic acid amplification tests for the diagnosis of tuberculosis. Pneumonologia Alergologia Polska 2012;80(1):6-12. - PubMed
Sarfaraz 2018 {published data only}
    1. Sarfaraz S, Iftikhar S, Memon Y, Zahir N, Hereker FF, Salahuddin N. Histopathological and microbiological findings and diagnostic performance of GeneXpert in clinically suspected tuberculous lymphadenitis. International Journal of Infectious Diseases 2018;76:73-81. - 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
Sharma 2014 {published data only}
    1. Sharma SK, Kohli M, Chaubey J, Yadav RN, Sharma R, Singh BK, et al. Evaluation of Xpert MTB/RIF assay performance in diagnosing extrapulmonary tuberculosis among adults in a tertiary care centre in India. European Respiratory Journal 2014;44(4):1090-3. - PubMed
Sharma 2016 {published data only}
    1. Sharma JB, Kriplani A, Dharmendra S, Chaubey J, Kumar S, Sharma SK. Role of Gene Xpert in diagnosis of female genital tuberculosis: a preliminary report. European Journal of Obstetrics & Gynecology and Reproductive Biology 2016;207:237-8. - PubMed
Sharma 2018 {published data only}
    1. Sharma K, Sharma M, Chaudhary L, Modi M, Goyal M, Sharma N, et al. Comparative evaluation of Xpert MTB/RIF assay with multiplex polymerase chain reaction for the diagnosis of tuberculous meningitis. Tuberculosis (Edinburgh, Scotland) 2018 Dec;113:38-42. - PubMed
Siddiqi 2019 {published data only}
    1. Siddiqi OK, Birbeck GL, Ghebremichael M, Mubanga E, Love S, Buback C, et al. Prospective cohort study on performance of cerebrospinal fluid (CSF) Xpert MTB/RIF, CSF Lipoarabinomannan (LAM) Lateral Flow Assay (LFA), and urine LAM LFA for diagnosis of tuberculous meningitis in Zambia. Journal of Clinical Microbiology 2019;57(8):pii: e00652-19. - PMC - PubMed
Sun 2019 {published data only}
    1. Sun Q, Wang S, Dong W, Jiang G, Huo F, Ma Y, et al. Diagnostic value of Xpert MTB/RIF Ultra for osteoarticular tuberculosis. Journal of Infection 2019 August;79(2):153-8. - PubMed
Suzana 2016 {published data only}
    1. Suzana S, Ninan MM, Gowri M, Venkatesh K, Rupali P, Michael JS. Xpert MTB/Rif for the diagnosis of extrapulmonary tuberculosis - an experience from a tertiary care centre in South India. Tropical Medicine & International Health 2016;21(3):385-92. - PubMed
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. [DOI: 10.1371/journal.pone.0137471] - DOI - PMC - PubMed
Trajman 2014 {published data only}
    1. Trajman A, Da Silva Santos Kleiz de Oliveira EF, Bastos ML, Belo Neto E, Silva EM, Da Silva Lourenco MC, et al. Accuracy of polymerase chain reaction for the diagnosis of pleural tuberculosis. Respiratory Medicine 2014;108(6):918-23. - 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
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
Van Rie 2013 {published data only}
    1. Van Rie A, Page-Shipp L, Mellet K, Scott L, Mkhwnazi M, Jong E, et al. Diagnostic accuracy and effectiveness of the Xpert MTB/RIF assay for the diagnosis of HIV-associated lymph node tuberculosis. European Journal of Clinical Microbiology & Infectious Diseases 2013;32(11):1409-15. - PubMed
Wang 2019 {published data only}
    1. Wang G, Wang S, Jiang G, Yang X, Huang M, Huo F, et al. Xpert MTB/RIF Ultra improved the diagnosis of paucibacillary tuberculosis: a prospective cohort study. Journal of Infection 2019;78(4):311-6. - 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):268-75. - PubMed
Wu 2019 {published data only}
    1. Wu X, Tan G, Gao R, Yao L, Bi D, Guo Y, et al. Assessment of the Xpert MTB/RIF Ultra assay on rapid diagnosis of extrapulmonary tuberculosis. International Journal of Infectious Diseases 2019;81:91-6. - PubMed
Zeka 2011 {published data only}
    1. Zeka AN, Tasbakan S, Cavusoglu C. Evaluation of the GeneXpert MTB/RIF assay for rapid diagnosis of tuberculosis and detection of rifampin resistance in pulmonary and extrapulmonary specimens. Journal of Clinical Microbiology 2011;49(12):4138-41. - PMC - PubMed
Zmak 2013 {published data only}
    1. Zmak L, Jankovic M, Jankovic VK. Evaluation of Xpert MTB/RIF assay for rapid molecular diagnosis of tuberculosis in a two-year period in Croatia. International Journal of Mycobacteriology 2013;2(3):179-82. - PubMed

References to studies excluded from this review

Abong 2019 {published data only}
    1. Abong J, Dalay V, Langley I, Tomeny E, Marcelo D, Mendoza V, et al. Use of GeneXpert and the role of an expert panel in improving clinical diagnosis of smear-negative tuberculosis cases. PLOS One 2019;14(12):e0227093. - PMC - PubMed
Adejumo 2018 {published data only}
    1. Adejumo Olusola Adedeji, Olusola-Faleye Bolanle, Adepoju Victor, Bowale Abimbola, Adesola Sunday, Falana Ayodeji, et al. Prevalence of rifampicin resistant tuberculosis and associated factors among presumptive tuberculosis patients in a secondary referral hospital in Lagos Nigeria. African Health Sciences 2018;18(3):472-8. - PMC - PubMed
Afsar 2018 {published data only}
    1. Afsar I, Gunes M, Er H, Sener AG. Comparison of culture, microscopic smear and molecular methods in diagnosis of tuberculosis. Revista Espanola de Quimioterapia 2018;31(5):435-8. - PMC - PubMed
Ahmad 2018 {published data only}
    1. Ahmad R, Changeez M, Khan JS, Qureshi U, Tariq M, Malik S, et al. Diagnostic accuracy of peritoneal fluid GeneXpert in the diagnosis of intestinal tuberculosis, keeping histopathology as the gold standard. Cureus 2018;10(10):e3451. - PMC - PubMed
Akhter 2019 {published data only}
    1. Akhter N, Sumalani KK, Chawla D, Ahmed Rizvi N. Comparison between the diagnostic accuracy of Xpert MTB/Rif assay and culture for pleural tuberculosis using tissue biopsy. ERJ Open Research 2019;5(3):00065-2019. - PMC - PubMed
Ali 2018 {published data only}
    1. Ali A, Munir MA, Sarwar MI, Khaliq S, Munir MK, Rehman S. Tuberculous pleural effusions: efficacy utilization and comparison of various diagnostic techniques. Pakistan Journal of Medical and Health Sciences 2018;12(4):1570-3.
Allahyartorkaman 2019 {published data only}
    1. Allahyartorkaman M, Mirsaeidi M, Hamzehloo G, Amini S, Zakiloo M, Nasiri MJ. Low diagnostic accuracy of Xpert MTB/RIF assay for extrapulmonary tuberculosis: a multicenter surveillance. Scientific Reports 2019;9(1):18515. - PMC - PubMed
Alvarez Uria 2012 {published data only}
    1. Alvarez-Uria G, Azcona JM, Midde M, Naik PK, Reddy S, Reddy R. Rapid diagnosis of pulmonary and extrapulmonary tuberculosis in HIV-infected patients. Comparison of LED fluorescent microscopy and the GeneXpert MTB/RIF assay in a district hospital in India. Tuberculosis Research and Treatment 2012;2012:932862. [DOI: 10.1155/2012/932862] - DOI - PMC - PubMed
Andrey 2015 {published data only}
    1. Andrey DO, Hinrikson H, Renzi G, Hibbs J, Adler D, Schrenzel J. Xpert((R)) MTB/RIF assay sensitivity with different methods of CSF processing for the diagnosis of TB meningitis. International Journal of Tuberculosis and Lung Disease 2015;19(12):1555-6. - PubMed
Armand 2011 {published data only}
    1. Armand S, Vanhuls P, Delcroix G, Courcol R, Lemaitre N. Comparison of the Xpert MTB/RIF test with an IS6110-TaqMan real-time PCR assay for direct detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens. Journal of Clinical Microbiology 2011;49(5):1772-6. - PMC - PubMed
Arockiaraj 2015 {published data only}
    1. Arockiaraj J, Amritanand R, Krishnan V, Sundararaj G, Michael J. GeneXpert polymerase chain reaction (PCR) Test: role in the diagnosis of tubercular spondylodiscitis. Spine Journal 2015;15(10 Suppl 1):200S-201S.
Arockiaraj 2017 {published data only}
    1. Arockiaraj J, Michael JS, Amritanand R, David KS, Krishnan V. The role of Xpert MTB/RIF assay in the diagnosis of tubercular spondylodiscitis. European Spine Journal 2017;26(12):3162-9. - PubMed
Arockiaraj 2019a {published data only}
    1. Arockiaraj J, Karthik R, Michael J S, Amritanand R, David KS, Krishnan V, et al. 'Need of the hour': early diagnosis and management of multidrug resistant tuberculosis of the spine: an analysis of 30 patients from a "high multidrug resistant tuberculosis burden" country. Asian Spine Journal 2019;13(2):265-71. - PMC - PubMed
Arockiaraj 2019b {published data only}
    1. Arockiaraj J, Robert M, Rose W, Amritanand R, David KS, Krishnan V. Early detection and analysis of children with multidrug-resistant tuberculosis of the spine. Asian Spine Journal 2019;13(1):77-85. - PMC - PubMed
Atherton 2018 {published data only}
    1. Atherton RR, Cresswell FV, Ellis J, Skipper C, Tadeo KK, Mugumya G, et al. Detection of Mycobacterium tuberculosis in urine by Xpert MTB/RIF Ultra: a useful adjunctive diagnostic tool in HIV-associated tuberculosis. International Journal of Infectious Diseases 2018;75:92-4. - PMC - PubMed
Aydemir 2019 {published data only}
    1. Aydemir O, Karakece E, Koroglu M, Altindis M, Terzi HA. Comparison of the GeneXpert MTB/RIF test and conventional methods in the diagnosis of Mycobacterium tuberculosis. Clinical Laboratory 2019;65(1):1-6. - PubMed
Bablishvili 2015 {published data only}
    1. Bablishvili N, Tukvadze N, Avaliani Z, Blumberg HM, Kempker RR. A comparison of the Xpert MTB/RIF and GenoTypeMTBDRplus assays in Georgia. International Journal of Tuberculosis and Lung Disease 2015;19(6):676-8. - PMC - PubMed
Bahr 2018a {published data only}
    1. Bahr NC, Halupnick R, Linder G, Kiggundu R, Nabeta HW, Williams DA, et al. Delta-like 1 protein, vitamin D binding protein and fetuin for detection of Mycobacterium tuberculosis meningitis. Biomarkers in Medicine 2018;12(7):707-16. - PMC - PubMed
Bahr 2018b {published data only}
    1. Bahr NC, Nuwagira E, Evans EE, Cresswell FV, Bystrom PV, Byamukama A, et al. Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous meningitis in HIV-infected adults: a prospective cohort study. Lancet Infectious Diseases 2018;18(1):68-75. - PMC - PubMed
Bahr 2019 {published data only}
    1. Bahr NC, Meintjes G, Boulware DR. Inadequate diagnostics: the case to move beyond the bacilli for detection of meningitis due to Mycobacterium tuberculosis. Journal of Medical Microbiology 2019;68(5):755-60. - PMC - PubMed
Baikunje 2019 {published data only}
    1. Baikunje N, Behera D, Rajwanshi A, Sharma M, Sharma A, Sharma K. Comparative evaluation of loop-mediated isothermal amplification (LAMP) assay, GeneXpert MTB/Rif and multiplex PCR for the diagnosis of tubercular lymphadenitis in HIV-infected patients of North India. Molecular and Cellular Probes 2019;48:101459. - PubMed
Bajrami 2016 {published data only}
    1. Bajrami R, Mulliqi G, Kurti A, Lila G, Raka L. Comparison of GeneXpert MTB/RIF and conventional methods for the diagnosis of tuberculosis in Kosovo. Journal of Infection in Developing Countries 2016;10(4):418-22. - PubMed
Balcha 2014 {published data only}
    1. Balcha TT, Sturegard E, Winqvist N, Skogmar S, Reepalu A, Jemal ZH, et al. Intensified tuberculosis case-finding in HIV-positive adults managed at Ethiopian health centers: diagnostic yield of Xpert MTB/RIF compared with smear microscopy and liquid culture. PLOS One 2014;9(1):e85478. [DOI: 10.1371/journal.pone.0085478] - DOI - PMC - PubMed
Bankar 2018 {published data only}
    1. Bankar S, Set R, Sharma D, Shah D, Shastri J. Diagnostic accuracy of Xpert MTB/RIF assay in extrapulmonary tuberculosis. Indian Journal of Medical Microbiology 2018;36(3):357-63. - PubMed
Bemba 2017 {published data only}
    1. Bemba EL, Moukassa D, Ouedraogo AR, Okombi FH, Bopaka RG, Koumeka PP, et al. Performance of GeneXpert MTB / RIF in the diagnosis of pleural tuberculosis in Brazzaville: a preliminary report [Performance du GeneXpert MTB/RIF dans le diagnostic de la tuberculose pleurale à Brazzaville: étude préliminaire]. Health Sciences and Diseases 2017;18(3):21-7.
Ben Saad 2018 {published data only}
    1. Ben Saad S, Kallel N, Gharsalli H, Kwas H, El Gharbi L, Ghedira H, et al. Cold abscess in the immunocompetent subject. Tunisie Medicale 2018;96(5):302-6. - PubMed
Bhardwaj 2019 {published data only}
    1. Bhardwaj A, Khan S, Kumar A, George L, Mehta A, Radhakrishnan K. Assessing the utility of GeneXpert MTB/Rif assay in a tertiary care centre in Southern India with established microscopy and liquid culture facilities. Journal of the Association of Physicians of India 2019;67(8):31-4. - PubMed
Bhatia 2016 {published data only}
    1. Bhatia R, Dayal R, Jindal S, Agarwal D, Goyal A. GeneXpert for diagnosis of tubercular meningitis. Indian Journal of Pediatrics 2016;83(11):1353-5. - PubMed
Bholla 2016 {published data only}
    1. Bholla M, Kapalata N, Masika E, Chande H, Jugheli L, Sasamalo M, et al. Evaluation of Xpert(R) MTB/RIF and Ustar EasyNAT TB IAD for diagnosis of tuberculous lymphadenitis of children in Tanzania: a prospective descriptive study. BMC Infectious Diseases 2016;16:246. [DOI: 10.1186/s12879-016-1578-z] - DOI - PMC - PubMed
Biadglegne 2013 {published data only}
    1. Biadglegne F, Tesfaye W, Sack U, Rodloff AC. Tuberculous lymphadenitis in Northern Ethiopia: in a public health and microbiological perspectives. PLOS One 2013;8(12):e81918. [DOI: 10.1371/journal.pone.0081918] - DOI - PMC - PubMed
Bilgin 2016 {published data only}
    1. Bilgin K, Yanik K, Karadag A, Odabasi H, Tas H, Gunaydin M. Comparison of a real-time polymerase chain reaction-based system and Erlich-Ziehl-Neelsen method with culture in the identification of Mycobacterium tuberculosis. Turkish Journal of Medical Sciences 2016;46(1):203-6. - PubMed
Borraz‐Noriega 2018 {published data only}
    1. Borraz-Noriega D, Robledo-Pascual JC, Torres-Perez JA, Flores-Barrientos OI. Utility of nucleic acids detection GeneXpert tuberculosis (MTB/RIF) in respiratory and non-respiratory hospital reference samples. Medicina Interna de Mexico 2018;34(3):381-7.
Boyles 2018 {published data only}
    1. Boyles T. Xpert Ultra's place in the diagnosis of tuberculous meningitis. Lancet Infectious Diseases 2018;18(3):248-9. - PubMed
Bunsow 2014 {published data only}
    1. Bunsow E, Ruiz-Serrano MJ, Lopez Roa P, Kestler M, Viedma DG, Bouza E. Evaluation of GeneXpert MTB/RIF for the detection of Mycobacterium tuberculosis and resistance to rifampin in clinical specimens. Journal of Infection 2014;68(4):338-43. - PubMed
Celik 2015 {published data only}
    1. Celik C, Gozel MG, Bakici MZ, Berk S, Ozsahin SL, Gulturk E. Applicability of Xpert MTB/RIF assay for routine diagnosis of tuberculosis: a four-year single-center experience. Turkish Journal of Medical Sciences 2015;45(6):1329-34. - PubMed
Chaidir 2018 {published data only}
    1. Chaidir L, Annisa J, Dian S, Parwati I, Alisjahbana A, Purnama F, et al. Microbiological diagnosis of adult tuberculous meningitis in a ten-year cohort in Indonesia. Diagnostic Microbiology and Infectious Disease 2018;91(1):42-6. - PubMed
Chakraborty 2019 {published data only}
    1. Chakraborty A, Ramaswamy S, Shivananjiah A J, Puttaswamy RB, Chikkavenkatappa N. The role of genexpert in the diagnosis of tubercular pleural effusion in India. Advances in Respiratory Medicine 2019;87(5):276-80. - PubMed
Chen 2016 {published data only}
    1. Chen ZF, Lao HL, Li XH, Wang J, Chen Q, Wang ZX, et al. Experimental study of GeneXpert((R)) system in the diagnosis of extra-pulmonary tuberculosis. Chinese Journal of Tuberculosis and Respiratory Diseases 2016;39(7):529-33. - PubMed
Chhajed 2019 {published data only}
    1. Chhajed PN, Vaidya PJ, Mandovra NP, Chavhan VB, Lele TT, Nair R, et al. EBUS-TBNA in the rapid microbiological diagnosis of drug-resistant mediastinal tuberculous lymphadenopathy. ERJ Open Research 2019;5(4):00008-2019. - PMC - PubMed
Christopher 2018 {published data only}
    1. Christopher DJ, Dinakaran S, Gupta R, James P, Isaac B, Thangakunam B. Thoracoscopic pleural biopsy improves yield of Xpert MTB/RIF for diagnosis of pleural tuberculosis. Respirology 2018;23(7):714-7. - PubMed
Coetzee 2014 {published data only}
    1. Coetzee L, Nicol MP, Jacobson R, Schubert PT, Van Helden PD, Warren RM, et al. Rapid diagnosis of pediatric mycobacterial lymphadenitis using fine needle aspiration biopsy. Pediatric Infectious Disease Journal 2014;33(9):893-6. - PubMed
Coleman 2015 {published data only}
    1. Coleman M, Finney LJ, Komrower D, Chitani A, Bates J, Chipungu GA, et al. Markers to differentiate between Kaposi's sarcoma and tuberculous pleural effusions in HIV-positive patients. International Journal of Tuberculosis and Lung Disease 2015;19(2):144-50. - PubMed
Creswell 2019 {published data only}
    1. Creswell J, Qin ZZ, Gurung R, Lamichhane B, Yadav DK, Prasai MK, et al. The performance and yield of tuberculosis testing algorithms using microscopy, chest x-ray, and Xpert MTB/RIF. Journal of Clinical Tuberculosis and Other Mycobacterial Diseases 2019;14:1-6. - PMC - PubMed
Dahale 2019 {published data only}
    1. Dahale AS, Puri AS, Kumar A, Dalal A, Agarwal A, Sachdeva S. Tissue Xpert (R) MTB/RIF assay in peritoneal tuberculosis: to be (done) or not to be (done). Cureus 2019;11(6):e5009. - PMC - PubMed
Das 2019 {published data only}
    1. Das A, Anupurba S, Mishra OP, Banerjee T, Tripathi R. Evaluation of Xpert MTB/RIF assay for diagnosis of tuberculosis in children. Journal of Tropical Pediatrics 2019;65(1):14-20. - PubMed
Deggim 2013 {published data only}
    1. Deggim V, Somoskovi A, Voit A, Bottger EC, Bloemberg GV. Integrating the Xpert MTB/RIF assay into a diagnostic workflow for rapid detection of Mycobacterium tuberculosis in a low-prevalence area. Journal of Clinical Microbiology 2013;51(7):2396-9. - PMC - PubMed
Dharan 2016 {published data only}
    1. Dharan NJ, Blakemore R, Sloutsky A, Kaur D, Alexander RC, Ghajar M, et al. Performance of the G4 Xpert MTB/RIF assay for the detection of Mycobacterium tuberculosis and rifampin resistance: a retrospective case-control study of analytical and clinical samples from high- and low-tuberculosis prevalence settings. BMC Infectious Diseases 2016;16:764. [DOI: 10.1186/s12879-016-2039-4] - DOI - 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. [DOI: 10.11604/pamj.2016.25.129.10065] - DOI - PMC - PubMed
Diop 2016 {published data only}
    1. Diop SA, Massaly A, Ka D, Manga NM, Fortes-Deguenonvo L, Ndour CT, et al. Use of GeneXpert test for the diagnosis of tuberculosis in the department of infectious diseases of FANN University Hospital [Utilisation du test GeneXpert pour le diagnostic de la tuberculose au service desmaladies infectieuses du CHNU de Fann]. Pan African Medical Journal 2016;23:244. [DOI: 10.11604/pamj.2016.23.244.7442] - DOI
Edwards 2016 {published data only}
    1. Edwards S, Glynn P, David MD, Kamesh L. Diagnosing tuberculous peritonitis early in patients on peritoneal dialysis: use of Xpert MTB/RIF assay. Peritoneal Dialysis International 2016;36(4):461. - PMC - PubMed
Ejeta 2018 {published data only}
    1. Ejeta E, Beyene G, Bonsa Z, Abebe G. Xpert MTB/RIF assay for the diagnosis of Mycobacterium tuberculosis and rifampicin resistance in high Human Immunodeficiency Virus setting in Gambella regional state, Southwest Ethiopia. Journal of Clinical Tuberculosis and Other Mycobacterial Diseases 2018;12:14-20. - PMC - PubMed
Erdem 2014 {published data only}
    1. Erdem H, Ozturk-Engin D, Elaldi N, Gulsun S, Sengoz G, Crisan A, et al. The microbiological diagnosis of tuberculous meningitis: results of Haydarpasa-1 study. Clinical Microbiology and Infection 2014;20(10):O600-8. [DOI: 10.1111/1469-0691.12478] - DOI - PubMed
Fanosie 2016 {published data only}
    1. Fanosie A, Gelaw B, Tessema B, Tesfay W, Admasu A, Yitayew G. Mycobacterium tuberculosis complex and HIV co-infection among extrapulmonary tuberculosis suspected cases at the University of Gondar Hospital, Northwestern Ethiopia. PLOS One 2016;11(3):e0150646. [DOI: 10.1371/journal.pone.0150646] - DOI - PMC - PubMed
Fantahun 2019 {published data only}
    1. Fantahun M, Kebede A, Yenew B, Gemechu T, Mamuye Y, Tadesse M, et al. Diagnostic accuracy of Xpert MTB/RIF assay and non-molecular methods for the diagnosis of tuberculosis lymphadenitis. PLOS One 2019;14(9):e0222402. - PMC - PubMed
Floridia 2017 {published data only}
    1. Floridia M, Ciccacci F, Andreotti M, Hassane A, Sidumo Z, Magid NA, et al. Tuberculosis case finding with combined rapid point-of-care assays (Xpert MTB/RIF and Determine TB LAM) in HIV-positive individuals starting antiretroviral therapy in Mozambique. Clinical Infectious Diseases 2017;65(11):1878-83. - PubMed
García 2017 {published data only}
    1. Garcia P, Balcells ME, Castillo C, Miranda C, Geoffroy E, Román JC, et al. Evaluation of Xpert® MTB/RIF technique for Mycobacterium tuberculosis complex detection in extra-respiratory specimens [Evaluation of Xpert(R) MTB/RIF technique for Mycobacterium tuberculosis complex detection in extra-respiratory specimens]. Revista Chilena de Infectologia 2017;34(4):333-9. - PubMed
García Cañete 2017 {published data only}
    1. García Cañete P, Balcells ME, Castillo C, Miranda C, Geoffroy E, Román JC, et al. Evaluation of Xpert® MTB/RIF technique for Mycobacterium tuberculosis complex detection in extra-respiratory specimens. Revista Chilena de Infectologia 2017;34(4):333-9. - PubMed
Gascoyne‐Binzi 2012 {published data only}
    1. Gascoyne-Binzi DM, Robinson GA, English A, Collyns TA. Comparison of on-demand PCR testing for Mycobacterium tuberculosis with culture and batched PCR. Clinical Microbiology and Infection 2012;18:543. [DOI: ]
Gati 2018 {published data only}
    1. Gati S, Chetty R, Wilson D, Achkar J M. Utilization and clinical value of diagnostic modalities for tuberculosis in a high HIV prevalence setting. American Journal of Tropical Medicine and Hygiene 2018;99(2):317-22. - PMC - PubMed
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
Gautam 2019 {published data only}
    1. Gautam H, Singla M, Jain R, Lodha R, Kabra SK, Singh UB. Point-of-care urine lipoarabinomannan antigen detection for diagnosis of tuberculosis in children. International Journal of Tuberculosis and Lung Disease 2019;23(6):714-9. - PubMed
Gounden 2018 {published data only}
    1. Gounden S, Perumal R, Magula NP. Extrapulmonary tuberculosis in the setting of HIV hyperendemicity at a tertiary hospital in Durban, South Africa. Southern African Journal of Infectious Diseases 2018;33(3):57-64.
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
Gursoy 2016 {published data only}
    1. Gursoy NC, Yakupogullari Y, Tekerekoglu MS, Otlu B. Evaluation of the diagnostic performance of Xpert MTB/RIF test for the detection of Mycobacterium tuberculosis and rifampin resistance in clinical samples [Klinik örneklerden Mycobacterium tuberculosis saptanması ve rifampin direnci tespitinde Xpert MTB/RIF testinin tanısal performansının değerlendirilmesi]. Mikrobiyoloji Bulteni 2016;50(2):196-204. - PubMed
Habeenzu 2017 {published data only}
    1. Habeenzu C, Nakajima C, Solo E, Bwalya P, Kajino K, Miller M, et al. Evaluation of in-house loop-mediated isothermal amplification for tuberculosis diagnosis compared with Xpert MTB/RIF. Journal of Infection in Developing Countries 2017;11(6):440-4. - PubMed
Habous 2019 {published data only}
    1. Habous M, Elimam MA, Kumar R, Deesi ZA. Evaluation of GeneXpert Mycobacterium tuberculosis/rifampin for the detection of Mycobacterium tuberculosis complex and rifampicin resistance in nonrespiratory clinical specimens. International Journal of Mycobacteriology 2019;8(2):132-7. - PubMed
Hanifa 2017 {published data only}
    1. Hanifa Y, Fielding KL, Chihota VN, Adonis L, Charalambous S, Foster N, et al. A clinical scoring system to prioritise investigation for tuberculosis among adults attending HIV clinics in South Africa. PLOS One 2017;12(8):e0181519. - PMC - PubMed
Held 2014 {published data only}
    1. Held M, Laubscher M, Zar HJ, Dunn RN. GeneXpert polymerase chain reaction for spinal tuberculosis: an accurate and rapid diagnostic test. Bone & Joint Journal 2014;96-b(10):1366-9. - PubMed
Held 2016 {published data only}
    1. Held M, Laubscher M, Mears S, Dix-Peek S, Workman L, Zar H, et al. Diagnostic accuracy of the Xpert MTB/RIF assay for extrapulmonary tuberculosis in children with musculoskeletal infections. Pediatric Infectious Disease Journal 2016;35(11):1165-8. - PMC - PubMed
Held 2017 {published data only}
    1. Held M, Laubscher M, Workman L, Zar HJ, Dunn R. Diagnostic accuracy of GeneXpert MTB/RIF in musculoskeletal tuberculosis: high sensitivity in tissue samples of HIV-infected and HIV-uninfected patients. South African Medical Journal 2017;107(10):854-8. - PubMed
Ioannidis 2010 {published data only}
    1. Ioannidis P, Papaventsis D, Nikolaou S, Karabela S, Konstantinidou E, Marinou I, et al. Tuberculosis resistance detection rate to the two main anti-TB drugs, isoniazid and rifampicin, using molecular techniques: experience of the Hellenic National Reference Center for Mycobacteria. Acta Microbiologica Hellenica 2010;55(2):175-82.
Ioannidis 2011 {published data only}
    1. Ioannidis P, Papaventsis D, Karabela S, Nikolaou S, Panagi M, Raftopoulou E, et al. Cepheid GeneXpert MTB/RIF assay for Mycobacterium tuberculosis detection and rifampin resistance identification in patients with substantial clinical indications of tuberculosis and smear-negative microscopy results. Journal of Clinical Microbiology 2011;49(8):3068-70. - PMC - PubMed
Jain 2017 {published data only}
    1. Jain A, Singh PK, Singh U, Kumar V. Initial screening of extra-pulmonary tuberculosis using the Xpert MTB/RIF assay improves case detection rates. International Journal of Tuberculosis and Lung Disease 2017;21(4):478-80. - PubMed
Jing 2017 {published data only}
    1. Jing H, Lu ZM, Deng YF, Gao DC, Li L, Graviss EA, et al. Evaluation of Xpert MTB/RIF in detection of pulmonary and extrapulmonary tuberculosis cases in China. International Journal of Clinical and Experimental Pathology 2017;10(4):4847-51.
Jipa 2017 {published data only}
    1. Jipa R, Olaru I, Manea E, Merisor S, Hristea A. Rapid clinical score for the diagnosis of tuberculous meningitis: a retrospective cohort study. Annals of Indian Academy of Neurology 2017;20(4):363-6. - PMC - PubMed
Jorstad 2018 {published data only}
    1. Jorstad MD, Marijani M, Dyrhol-Riise AM, Sviland L, Mustafa T. MPT64 antigen detection test improves routine diagnosis of extrapulmonary tuberculosis in a low-resource setting: a study from the tertiary care hospital in Zanzibar. PLOS One 2018;13(5):e0196723. - PMC - PubMed
Joythi 2019 {published data only}
    1. Joythi A, Ratageri V, Illalu S, Fattepur SR, Wari PK. The utility of CSF Xpert MTB/RIF in diagnosis of tubercular meningitis in children. Indian Journal of Pediatrics 2019;86(12):1089-93. - PubMed
Kanade 2018 {published data only}
    1. Kanade S, Nataraj G, Mehta P, Shah D. Pattern of missing probes in rifampicin resistant TB by Xpert MTB/RIF assay at a tertiary care centre in Mumbai. Indian Journal of Tuberculosis 2019;66(1):139-43. - PubMed
Kashyap 2019 {published data only}
    1. Kashyap B, Goyal N, Hyanki P, Singh NP, Khanna A. Cartridge-based nucleic acid amplification test: a novel rapid diagnostic tool to study the burden of tuberculosis from a tertiary care hospital. Tropical Doctor 2019;49(4):274-81. - PubMed
Kendall 2019 {published data only}
    1. Kendall EA, Kamoga C, Kitonsa PJ, Nalutaaya A, Salvatore PP, Robsky K, et al. Empiric treatment of pulmonary TB in the Xpert era: correspondence of sputum culture, Xpert MTB/RIF, and clinical diagnoses. PLOS One 2019;14(7):e0220251. - PMC - PubMed
Kerkhoff 2017 {published data only}
    1. Kerkhoff AD, Barr DA, Schutz C, Burton R, Nicol MP, Lawn SD, et al. Disseminated tuberculosis among hospitalised HIV patients in South Africa: a common condition that can be rapidly diagnosed using urine-based assays. Scientific Reports 2017;7(1):10931. - PMC - PubMed
Khadka 2019 {published data only}
    1. Khadka P, Thapaliya J, Basnet RB, Ghimire GR, Amatya J, Rijal BP. Diagnosis of tuberculosis from smear-negative presumptive TB cases using Xpert MTB/Rif assay: a cross-sectional study from Nepal. BMC Infectious Diseases 2019;19(1):1090. - PMC - PubMed
Khan 2018 {published data only}
    1. Khan AS, Ali S, Khan MT, Ahmed S, Khattak Y, Abduljabbar, et al. Comparison of GeneXpert MTB/RIF assay and LED-FM microscopy for the diagnosis of extrapulmonary tuberculosis in Khyber Pakhtunkhwa, Pakistan. Brazilian Journal of Microbiology 2018;49(4):909-13. - PMC - PubMed
Kilfoil 2015 {published data only}
    1. Kilfoil KM, Mayne E, Scott L, Stevens W. A high burden human immunodeficiency virus and tuberculosis resource limited setting, gains from Including Xpert MTB/RIF in the diagnostic algorithm of fluid specimens submitted for exclusion of lymphoma by immunophenotypic analysis. PLOS One 2015;10(8):e0134404. [DOI: 10.1371/journal.pone.0134404] - DOI - PMC - PubMed
Kim 2014 {published data only}
    1. Kim CH, Woo H, Hyun IG, Kim C, Choi JH, Jang SH, et al. A comparison between the efficiency of the Xpert MTB/RIF assay and nested PCR in identifying Mycobacterium tuberculosis during routine clinical practice. Journal of Thoracic Disease 2014;6(6):625-31. - PMC - PubMed
Kim 2015b {published data only}
    1. Kim MJ, Nam YS, Cho SY, Park TS, Lee HJ. Comparison of the Xpert MTB/RIF Assay and real-time PCR for the detection of Mycobacterium tuberculosis. Annals of Clinical and Laboratory Science 2015;45(3):327-32. - PubMed
Kim 2015c {published data only}
    1. Kim CH, Hyun IG, Hwang YI, Kim DG, Lee CY, Lee MG, et al. Identification of Mycobacterium tuberculosis and rifampin resistance in clinical specimens using the Xpert MTB/RIF assay. Annals of Clinical and Laboratory Science 2015;45(1):32-8. - PubMed
Kotovich 2018 {published data only}
    1. Kotovich DS, Skryagina EM, Gurevich GL, Dyusmikeeva MI, Gorenok DI, Golaydo MM. New diagnostic opportunities when testing biological materials from those with pleural effusion caused by tuberculosis. Tuberculosis and Lung Diseases 2018;96(9):5-10.
Koul 2018 {published data only}
    1. Koul AN, Kassana BA, Rather AR. Utility of GeneXpert in the diagnosis, reliance on urine microscopy and clinical characteristics of genitourinary tuberculosis at a tertiary care hospital. Indian Journal of Medical Microbiology 2018;36(1):93-6. - PubMed
Kumar 2017 {published data only}
    1. Kumar S, Bopanna S, Kedia S, Mouli P, Dhingra R, Padhan R, et al. Evaluation of Xpert MTB/RIF assay performance in the diagnosis of abdominal tuberculosis. Intestinal Research 2017;15(2):187-94. - PMC - PubMed
Kumari 2019 {published data only}
    1. Kumari P, Lavania S, Tyagi S, Dhiman A, Rath D, Anthwal D, et al. A novel aptamer-based test for the rapid and accurate diagnosis of pleural tuberculosis. Analytical Biochemistry 2019;564-565:80-7. - PubMed
Kurbaniyazova 2017 {published data only}
    1. Kurbaniyazova G, Joncevska M, Kalon S, Kalmambetova G, Mohr T, Toktogonova A, et al. Results of Xpert MTB/RIF implementation in Kyrgyzstan. International Journal of Tuberculosis and Lung Disease 2017;21(3):333-7. - PubMed
Kwak 2015 {published data only}
    1. Kwak N, Seong MW, Kim EC, Yoo CG, Kim YW, Han SK, et al. Accuracy of the Xpert MTB/RIF assay for the diagnosis of extrapulmonary tuberculosis in South Korea. International Journal of Tuberculosis and Lung Disease 2015;19(1):81-6. - PubMed
Lawn 2012 {published data only}
    1. Lawn SD, Kerkhoff AD, Vogt M, Wood R. High diagnostic yield of tuberculosis from screening urine samples from HIV-infected patients with advanced immunodeficiency using the Xpert MTB/RIF assay. Journal of Acquired Immune Deficiency Syndromes 2012;60(3):289-94. - PMC - PubMed
Lawn 2013 {published data only}
    1. Lawn SD, Kerkhoff AD, Vogt M, Wood R. HIV-associated tuberculosis: relationship between disease severity and the sensitivity of new sputum-based and urine-based diagnostic assays. BMC Medicine 2013;11:231. [DOI: 10.1186/1741-7015-11-231] - DOI - PMC - PubMed
Lawn 2015 {published data only}
    1. Lawn SD, Kerkhoff AD, Burton R, Schutz C, Van Wyk G, Vogt M, et al. Rapid microbiological screening for tuberculosis in HIV-positive patients on the first day of acute hospital admission by systematic testing of urine samples using Xpert MTB/RIF: a prospective cohort in South Africa. BMC Medicine 2015;13:192. [DOI: 10.1186/s12916-015-0432-2] - DOI - PMC - PubMed
Lawn 2017 {published data only}
    1. Lawn SD, Kerkhoff AD, Burton R, Schutz C, Boulle A, Vogt M, et al. Diagnostic accuracy, incremental yield and prognostic value of Determine TB-LAM for routine diagnostic testing for tuberculosis in HIV-infected patients requiring acute hospital admission in South Africa: a prospective cohort. BMC Medicine 2017;15(1):67. [DOI: 10.1186/s12916-017-0822-8] - DOI - PMC - PubMed
Lee 2017 {published data only}
    1. Lee J, Choi SM, Lee CH, Lee SM, Yim JJ, Yoo CG, et al. The additional role of Xpert MTB/RIF in the diagnosis of intrathoracic tuberculous lymphadenitis. Journal of Infection and Chemotherapy 2017;23(6):381-4. - PubMed
Lemus‐Minor 2018 {published data only}
    1. Lemus-Minor CG, Ovalle-Marroqui DF, Vazquez-Jimenez JG, Reales-Agüero DL, Sepulveda-Alcantara PM, Rodriguez-Sánchez JR, et al. Comparison of the Purelyse - IS6110 nested PCR with the Xpert MTB/RIF test in clinical samples with suspected tuberculosis. Journal of Microbiological Methods 2018;152:48-51. - PubMed
Li 2018 {published data only}
    1. Li Y, Jia W, Lei G, Zhao D, Wang G, Qin S. Diagnostic efficiency of Xpert MTB/RIF assay for osteoarticular tuberculosis in patients with inflammatory arthritis in China. PLOS One 2018;13(6):e0198600. - PMC - PubMed
Li 2020 {published data only}
    1. Li X, Du W, Wang Y, Liu Z, Li K, Chen H, et al. Rapid diagnosis of tuberculosis meningitis by detecting mycobacterium tuberculosis cell-free DNA in cerebrospinal fluid. American Journal of Clinical Pathology 2020;153(1):126-30. - PubMed
Liu 2015 {published data only}
    1. Liu X, Huang Z, Du J. Rapid diagnosis of pleural tuberculosis by Xpert MTB/RIF assay. Zhonghua Jie He He Hu Xi Za Zhi [Chinese Journal of Tuberculosis and Respiratory Diseases] 2015;38(10):741-5. - PubMed
Liu 2019 {published data only}
    1. Liu XH, Xia L, Zhang AM, Zhang Y, Liu YH, Lu SH, et al. Increased diagnostic yield of tuberculous serositis by using serous fluid drainage flocky precipitate (SFDFP) as a testing sample. Scientific Reports 2019;9(1):1480. - PMC - PubMed
Lombardi 2017 {published data only}
    1. Lombardi G, Di Gregori V, Girometti N, Tadolini M, Bisognin F, Dal Monte P. Diagnosis of smear-negative tuberculosis is greatly improved by Xpert MTB/RIF. PLOS One 2017;12(4):e0176186. [DOI: 10.1371/journal.pone.0176186] - DOI - PMC - PubMed
Marouane 2014 {published data only}
    1. Marouane C, Smaoui S, Kammoun S, Slim L, Messadi-Akrout F. Evaluation of GeneXpert MTB/RIF for the detection of Mycobacterium tuberculosis and resistance to rifampin in extra-pulmonary specimens. International Journal of Mycobacteriology 2014;4 Suppl 1:101.
Marouane 2016 {published data only}
    1. Marouane C, Smaoui S, Kammoun S, Slim L, Messadi-Akrout F. Evaluation of molecular detection of extrapulmonary tuberculosis and resistance to rifampicin with GeneXpert(R) MTB/RIF. Medecine et Maladies Infectieuses 2016;46(1):20-4. - PubMed
Massi 2017 {published data only}
    1. Massi MN, Biatko KT, Handayani I, Pratama MY, Septriani S, Nurdin GM, et al. Evaluation of rapid GeneXpert MTB/RIF method using DNA tissue specimens of vertebral bones in patients with suspected spondylitis TB. Journal of Orthopaedics 2017;14(1):189-91. - PMC - PubMed
Mathew 2018 {published data only}
    1. Mathew S, Pradhani MM, Philomina B. Role of molecular diagnostic test in diagnosing pulmonary and extrapulmonary tuberculosis. Journal of Evolution of Medical and Dental Sciences 2018;7(23):2777-81.
Mazzola 2016 {published data only}
    1. Mazzola E, Arosio M, Nava A, Fanti D, Gesu G, Farina C. Performance of real-time PCR Xpert (R)MTB/RIF in diagnosing extrapulmonary tuberculosis. Infezioni in Medicina 2016;24(4):304-9. - PubMed
McMillen 2018 {published data only}
    1. McMillen T, Usiak SC, Chen LH, Gomez L, Ntiamoah P, Hameed MR, et al. Evaluation of the Xpert MTB/RIF performance on tissues: potential impact on airborne infection isolation at a tertiary cancer care center. Infection Control and Hospital Epidemiology 2018;39(4):462-6. - PMC - PubMed
Mechal 2019 {published data only}
    1. Mechal Y, Benaissa E, El Mrimar N, Benlahlou Y, Bssaibis F, Zegmout A, et al. Evaluation of GeneXpert MTB/RIF system performances in the diagnosis of extrapulmonary tuberculosis. BMC infectious Diseases 2019;19(1):1069. - PMC - PubMed
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
Miller 2011 {published data only}
    1. Miller MB, Popowitch EB, Backlund MG, Ager EP. Performance of Xpert MTB/RIF RUO assay and IS6110 real-time PCR for Mycobacterium tuberculosis detection in clinical samples. Journal of Clinical Microbiology 2011;49(10):3458-62. - PMC - PubMed
Mishra 2017 {published data only}
    1. Mishra DR, Bhatta N, Lamsal M, Bhattarai N, Maskey R. Study of diagnostic utility of Xpert MTB/RIF test on pleural fluid in the evaluation of patients presenting with pleural tuberculosis in high prevalence setting. American Journal of Respiratory and Critical Care Medicine 2017;195:A2088. [www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2017.195.1_Meeting...
Moure 2011 {published data only}
    1. Moure R, Muñoz L, Torres M, Santin M, Martín R, Alcaide F. Rapid detection of Mycobacterium tuberculosis complex and rifampin resistance in smear-negative clinical samples by use of an integrated real-time PCR method. Journal of Clinical Microbiology 2011;49(3):1137-9. - PMC - PubMed
Moure 2012 {published data only}
    1. Moure R, Martín R, Alcaide F. Effectiveness of an integrated real-time PCR method for detection of the Mycobacterium tuberculosis complex in smear-negative extrapulmonary samples in an area of low tuberculosis prevalence. Journal of Clinical Microbiology 2012;50(2):513-5. - PMC - PubMed
Negi 2019 {published data only}
    1. Negi SS, Singh P, Chandrakar S, Gaikwad U, Das P, Bhargava A, et al. Diagnostic evaluation of multiplex real time PCR, genexpert MTB/RIF assay and conventional methods in extrapulmonary tuberculosis. Journal of Clinical and Diagnostic Research 2019;13(1):DC12-6.
Nhu 2013 {published data only}
    1. Nhu NT, Ha DT, Anh ND, Thu DD, Duong TN, Quang ND, et al. Evaluation of Xpert MTB/RIF and MODS assay for the diagnosis of pediatric tuberculosis. BMC Infectious Diseases 2013;13:31. [DOI: 10.1186/1471-2334-13-31] - DOI - PMC - PubMed
Omar 2019 {published data only}
    1. Omar A, Elfadl A E, Ahmed Y, Hosny M. Genexpert test and tuberculous pleural effusion: a new diagnostic method for an old medical problem. Egyptian Journal of Chest Diseases and Tuberculosis 2019;68(4):493-7.
Pandey 2017 {published data only}
    1. Pandey S, Congdon J, McInnes B, Pop A, Coulter C. Evaluation of the GeneXpert MTB/RIF assay on extrapulmonary and respiratory samples other than sputum: a low burden country experience. Pathology 2017;49(1):70-4. - PubMed
Paramitha 2018 {published data only}
    1. Paramitha NA, Sribudiani Y, Rizal A. Comparison of positivity rate of MODS, Ziehl-Neelsen Staining, and GeneXpert Methods in M. tuberculosis detection among tuberculous meningitis patients. Majalah Kedokteran Bandung-Mkb-Bandung Medical Journal 2018;50(4):240-6.
Park 2019 {published data only}
    1. Park JH, Jin CE, Koo B, Kwon JS, Cha HH, Kim JY, et al. A simple microfluidic assay for diagnosing tuberculous meningitis in HIV-uninfected patients. Journal of Clinical Microbiology 2019;57(5):pii: e01975-18. - PMC - PubMed
Patel 2014 {published data only}
    1. Patel VB, Connolly C, Singh R, Lenders L, Matinyenya B, Theron G, et al. Comparison of amplicor and GeneXpert MTB/RIF tests for diagnosis of tuberculous meningitis. Journal of Clinical Microbiology 2014;52(10):3777-80. - PMC - PubMed
Patel 2020 {published data only}
    1. Patel J, Upadhyay M, Kundnani V, Merchant Z, Jain S, Kire N, et al. Diagnostic efficacy, sensitivity, and specificity of Xpert MTB/RIF assay for spinal tuberculosis and rifampicin resistance. Spine (Phila Pa 1976) 2020;45(3):163-9. - PubMed
Peter 2012 {published data only}
    1. Peter JG, Theron G, Muchinga TE, Govender U, Dheda K. The diagnostic accuracy of urine-based Xpert MTB/RIF in HIV-infected hospitalized patients who are smear-negative or sputum scarce. PLOS One 2012;7(7):e39966. [DOI: 10.1371/journal.pone.0039966] - DOI - PMC - PubMed
Philip 2017 {published data only}
    1. Philip N, Wilkes C, Yeo TW, Rajahram GS, William T, John DV. Potential use of multiplex PCR in diagnosis of tuberculous meningitis. Tropical Biomedicine 2017;34(4):870-6. - PubMed
Piersimoni 2019 {published data only}
    1. Piersimoni C, Gherardi G, Gracciotti N, Pocognoli A. Comparative evaluation of Xpert MTB/RIF and the new Xpert MTB/RIF ultra with respiratory and extra-pulmonary specimens for tuberculosis case detection in a low incidence setting. Journal of Clinical Tuberculosis and Other Mycobacterial Diseases 2019;15:100094. - 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
Pohl 2016 {published data only}
    1. Pohl C, Rutaihwa LK, Haraka F, Nsubuga M, Aloi F, Ntinginya NE, et al. Limited value of whole blood Xpert (R) MTB/RIF for diagnosing tuberculosis in children. Journal of Infection 2016;73(4):326-35. - PubMed
Porcel 2013 {published data only}
    1. Porcel JM, Palma R, Valdes L, Bielsa S, San-Jose E, Esquerda A. Xpert(R) MTB/RIF in pleural fluid for the diagnosis of tuberculosis. International Journal of Tuberculosis and Lung Disease 2013;17(9):1217-9. - PubMed
Rachow 2012 {published data only}
    1. Rachow A, Clowes P, Saathoff E, Mtafya B, Michael E, Ntinginya EN, et al. Increased and expedited case detection by Xpert MTB/RIF assay in childhood tuberculosis: a prospective cohort study. Clinical Infectious Diseases 2012;54(10):1388-96. - PubMed
Raizada 2015 {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. [DOI: 10.1371/journal.pone.0140375] - DOI - PMC - PubMed
Raizada 2018 {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
Ramamurthy 2016 {published data only}
    1. Ramamurthy K, Bhat S, Shenoy S, Rangnekar A. Xpert Mycobacterium tuberculosis/rifampicin assay: a boon in tuberculosis diagnostics. Asian Journal of Pharmaceutical and Clinical Research 2016;9(5):225-7.
Rathour 2019 {published data only}
    1. Rathour JS, Mantan M, Khanna A, Hanif M. Evaluation of Gene Xpert assay in extrapulmonary tuberculosis in children. Journal of Evolution of Medical and Dental Sciences 2019;8(1):76-80.
Razack 2014 {published data only}
    1. Razack R, Louw M, Wright CA. Diagnostic yield of fine needle aspiration biopsy in HIV-infected adults with suspected mycobacterial lymphadenitis. South African Medical Journal 2014;104(1):27-8. - PubMed
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
Reddy 2017 {published data only}
    1. Reddy R, Alvarez-Uria G. Molecular epidemiology of rifampicin resistance in mycobacterium tuberculosis using the GeneXpert MTB/RIF assay from a rural setting in India. Journal of Pathogens 2017;2017:6738095. - PMC - PubMed
Rindi 2017 {published data only}
    1. Rindi L, Ali G, Fabiani B, Fontanini G, Garzelli C. Detection of Mycobacterium tuberculosis from paraffin-embedded tissues by GeneXpert MTB/RIF. Tuberculosis (Edinb) 2017;106:53-5. - PubMed
Rossato Silva 2018 {published data only}
    1. Rossato Silva D, Sotgiu G, D'Ambrosio L, Rodrigues Pereira G, Silva Barbosa M, Dutra Dias NJ, et al. Diagnostic performances of the Xpert MTB/RIF in Brazil. Respiratory Medicine 2018;134:12-5. - PubMed
Ruiz 2017 {published data only}
    1. Ruiz P, Causse M, Vaquero M, Gutierrez J B, Casal M. Evaluation of a new automated abbott realtime MTB RIF/INH assay for qualitative detection of rifampicin/isoniazid resistance in pulmonary and extra-pulmonary clinical samples of mycobacterium tuberculosis. Infection and Drug Resistance 2017;10:463-7. - PMC - PubMed
Sachdeva 2018 {published data only}
    1. Sachdeva K, Shrivastava T. CBNAAT: a boon for early diagnosis of tuberculosis-head and neck. Indian Journal of Otolaryngology and Head and Neck Surgery 2018;70(4):572-7. - PMC - PubMed
Saeed 2017a {published data only}
    1. Saeed M, Ahmad M, Iram S, Riaz S, Akhtar M, Aslam M. GeneXpert technology. A breakthrough for the diagnosis of tuberculous pericarditis and pleuritis in less than 2 hours. Saudi Medical Journal 2017;38(7):699-705. - PMC - PubMed
Saeed 2017b {published data only}
    1. Saeed M, Iram S, Hussain S, Ahmed A, Akbar M, Aslam M. GeneXpert: a new tool for the rapid detection of rifampicin resistance in mycobacterium tuberculosis. Journal of the Pakistan Medical Association 2017;67(2):270-4. - PubMed
Saeed 2018 {published data only}
    1. Saeed M, Rasheed F, Iram S, Hussain S, Ahmad A, Riaz S, et al. False negativity of Ziehl-Neelsen smear microscopy: is the scale-up the [sic] worth it in developing countries? Journal of the College of Physicians and Surgeons--Pakistan 2018;28(3):201-5. - PubMed
Salvador 2015 {published data only}
    1. Salvador F, Los-Arcos I, Sanchez-Montalva A, Tortola T, Curran A, Villar A, et al. Epidemiology and diagnosis of tuberculous lymphadenitis in a tuberculosis low-burden country. Medicine 2015;94(4):e509. [DOI: 10.1097/MD.0000000000000509] - DOI - PMC - PubMed
Samuel 2018 {published data only}
    1. Samuel B, Michael J, Chandrasingh J, Kumar S, Devasia A, Kekre N. Efficacy and role of Xpert Mycobacterium tuberculosis/rifampicin assay in urinary tuberculosis. Indian Journal of Urology 2018;34(4):268-72. - 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. [DOI: 10.1371/journal.pone.0143025] - DOI - PMC - PubMed
Schutz 2019 {published data only}
    1. Schutz C, Ward A, Burton R, Nicol M P, Blumenthal L, Meintjes G, et al. False rifampicin resistant results using Xpert MTB/RIF on urine samples in hospitalised HIV-infected patients. Southern African Journal of HIV Medicine 2019;20(1):978. - PMC - PubMed
Sekyere 2019 {published data only}
    1. Osei Sekyere J, Maphalala N, Malinga LA, Mbelle NM, Maningi NE. A comparative evaluation of the new Genexpert MTB/RIF Ultra and other rapid diagnostic assays for detecting tuberculosis in pulmonary and extra pulmonary specimens. Scientific Reports 2019;9(1):16587. - PMC - PubMed
Set 2018 {published data only}
    1. Set R, Bankar S, Sharma D, Shah D, Shastri J. Performance of Xpert MTB/RIF for detection of Mycobacterium tuberculosis and rifampicin resistance in pus aspirates. Indian Journal of Tuberculosis 2018;66(4):433-6. - PubMed
Set 2019 {published data only}
    1. Set R, Bankar S, Sharma D, Shah D, Shastri J. Performance of Xpert MTB/RIF for detection of Mycobacterium tuberculosis and rifampicin resistance in pus aspirates. Indian Journal of Tuberculosis 2019;66(4):433-6. - PubMed
Shah 2016a {published data only}
    1. Shah I, Gupta Y, Chhina AS, Shenoi A, Kumar RK, Patel A. Xpert MTB/RIF for diagnosis of tuberculosis and drug resistance in Indian children. Indian Pediatrics 2016;53(9):837-9. - PubMed
Shakeel 2018 {published data only}
    1. Shakeel K, Iram S, Akhtar M, Hussain S, Maryam H, Anwar A. Diagnostic validation of rapid molecular detection of Mycobacterium tuberculosis in pus samples by GeneXpert. Journal of the Pakistan Medical Association 2018;68(1):33-7. - PubMed
Sharma 2017a {published data only}
    1. Sharma SK, Chaubey J, Singh BK, Sharma R, Mittal A, Sharma A. Drug resistance patterns among extra-pulmonary tuberculosis cases in a tertiary care centre in North India. International Journal of Tuberculosis and Lung Disease 2017;21(10):1112-7. - PubMed
Sharma 2019 {published data only}
    1. Sharma K, Gupta A, Sharma M, Sharma A, Bansal R, Sharma SP, et al. The emerging challenge of diagnosing drug-resistant tubercular uveitis: experience of 110 eyes from North India. Ocular Immunology and Inflammation 2019;27:1-8. - PubMed
Singanayagam 2014 {published data only}
    1. Singanayagam A, Donaldson H, Kon OM. GeneXpert™MTB/RIF in low prevalence settings: a UK laboratory perspective. Journal of Infection 2014;69(2):199-200. - 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. [DOI: 10.1371/journal.pone.0149258] - DOI - PMC - PubMed
Smith 2014 {published data only}
    1. Smith P, Van Esch A, Wallace M, Wood R, Bekker LG. GeneXpert TB 8: a point-of-care diagnostic pilot. South African Medical Journal 2014;104(8):524. - PubMed
Solomons 2015 {published data only}
    1. Solomons RS, Visser DH, Friedrich SO, Diacon AH, Hoek KG, Marais BJ, et al. Improved diagnosis of childhood tuberculous meningitis using more than one nucleic acid amplification test. International Journal of Tuberculosis and Lung Disease 2015;19(1):74-80. - PubMed
Solomons 2016 {published data only}
    1. Solomons RS, Visser DH, Marais BJ, Schoeman JF, Van 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
Soomro 2017 {published data only}
    1. Soomro NH, Baig S, Rao N, Zafar AA, Hashmat F, Awan SB, et al. GeneXpert of cervical lymph node specimens in the diagnosis of extrapulmonary TB and rifampicin resistance. Gomal Journal of Medical Sciences 2017;15(1):12-5.
Sumayya 2019 {published data only}
    1. Sumayya, Durga K, Nithyananda BS, Fatima S, Krishnaiah A. Study of CBNAAT and anti-MPT64 detection in cytological and histopathological material for early diagnosis of TB lymphadenitis. Journal of Evolution of Medical and Dental Sciences 2019;8(47):3540-4.
Tahseen 2019 {published data only}
    1. Tahseen S, Ambreen A, Masood F, Qadir M, Hussain A, Jamil M, et al. Primary drug resistance in extra-pulmonary tuberculosis: a hospital-based prospective study from Pakistan. International Journal of Tuberculosis and Lung Diseases 2019;23(8):900-6. - PubMed
Talib 2019 {published data only}
    1. Talib A, Bhatty S, Mehmood K, Naim H, Haider I, Lal H, et al. GeneXpert in stool: diagnostic yield in intestinal tuberculosis. Journal of Clinical Tuberculosis and Mycobacterial Diseases 2019;17:100131. - PMC - PubMed
Tang 2017 {published data only}
    1. Tang L, Feng S, Gao R, Han C, Sun X, Bao Y, et al. A comparative study on the role of Xpert MTB/RIF in testing different types of spinal tuberculosis tissue specimens. Genetic Testing and Molecular Biomarkers 2017;21(12):722-6. - PubMed
Tang 2018 {published data only}
    1. Tang Y, Yin L, Tang S, Zhang H, Lan J. Application of molecular, microbiological, and immunological tests for the diagnosis of bone and joint tuberculosis. Journal of Clinical Laboratory Analysis 2018;32(2):e22260. [DOI: 10.1002/jcla.22260] - DOI - PMC - PubMed
Teo 2011 {published data only}
    1. Teo J, Jureen R, Chiang D, Chan D, Lin R. Comparison of two nucleic acid amplification assays, the Xpert MTB/RIF assay and the amplified mycobacterium tuberculosis direct assay, for detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens. Journal of Clinical Microbiology 2011;49(10):3659-62. - PMC - PubMed
Terzi 2019 {published data only}
    1. Terzi HA, Aydemir O, Karakece E, Koroglu M, Altindis M. Comparison of the GeneXpert(R) MTB/RIF test and conventional methods in the diagnosis of Mycobacterium tuberculosis. Clinical Laboratory 2019;65(1):10.7754/Clin.Lab.2018.180613. [DOI: 10.7754/Clin.Lab.2018.180613] - DOI - PubMed
Theron 2014b {published data only}
    1. Theron G, Peter J, Calligaro G, Meldau R, Hanrahan C, Khalfey H, et al. Determinants of PCR performance (Xpert MTB/RIF), including bacterial load and inhibition, for TB diagnosis using specimens from different body compartments. Scientific Reports 2014;4:5658. [DOI: 10.1038/srep05658] - DOI - PMC - PubMed
Tortoli 2012 {published data only}
    1. Tortoli E, Russo C, Piersimoni C, Mazzola E, Dal Monte P, Pascarella M, et al. Clinical validation of Xpert MTB/RIF for the diagnosis of extrapulmonary tuberculosis. European Respiratory Journal 2012;40(2):442-7. - PubMed
Toure 2017 {published data only}
    1. Toure NO, Wayzani M, Thiam K, Cisse MF, Mbaye FB. Contribution of the Xpert MTB/RIF to the etiological diagnosis of tuberculous pleurisy [Apport de l’Xpert MTB/RIF dans le diagnostic étiologique des pleurésies tuberculeuses]. Revue des Maladies Respiratoires 2017;34(7):758-64. [DOI: 10.1016/j.rmr.2017.01.003] - DOI - PubMed
Uddin 2019 {published data only}
    1. Uddin MJ, Rahim MA, Hasan MN, Mazumder MK, Haq MM, Rahman MA, et al. Etiological evaluation of patients with lymphadenopathy by clinical, histopathological and microbiological assessment. Mymensingh Medical Journal 2019;28(4):854-61. - PubMed
Vallejo 2015 {published data only}
    1. Vallejo VP, Searle MA, Rodriguez DJ, Farga CV. Xpert® MTB/RIF assay for tuberculosis diagnosis [Ensayo Xpert® MTB/RIF en el diagnóstico de tuberculosis]. Revista Chilena de Enfermedades Respiratorias 2015;31(2):127-31.
Verghese 2016 {published data only}
    1. Verghese VP, Thomas L, Michael JS, Rose W, Jeyaseelan V. Accuracy of the Xpert MTB/RIF assay compared to the "gold standard" AFB culture in the diagnosis of tuberculosis in children in India. International Journal of Infectious Diseases 2016;45:343.
Wang 2016a {published data only}
    1. Wang T, Feng GD, Pang Y, Liu JY, Zhou Y, Yang YN, et al. High rate of drug resistance among tuberculous meningitis cases in Shaanxi province, China. Scientific Reports 2016;6:25251. [DOI: 10.1038/srep25251] - DOI - PMC - PubMed
Wang 2016b {published data only}
    1. Wang T, Feng GD, Pang Y, Yang YN, Dai W, Zhang L, et al. Sub-optimal specificity of modified Ziehl-Neelsen staining for quick identification of tuberculous meningitis. Frontiers in Microbiology 2016;7:2096-103. - PMC - PubMed
Wang 2018 {published data only}
    1. Wang G, Dong W, Lan T, Fan J, Tang K, Li Y, et al. Diagnostic accuracy evaluation of the conventional and molecular tests for spinal tuberculosis in a cohort, head-to-head study. Emerging Microbes & Infections 2018;7(1):109. - PMC - PubMed
Wei 2016 {published data only}
    1. Wei G, Mu J, Wang G, Huo F, Dong L, Li Y, et al. The reliability analysis of Xpert-positive result for smear-negative and culture-negative specimen collected from bone and joint tuberculosis suspects. Journal of Thoracic Disease 2016;8(6):1205-9. - PMC - PubMed
Yang 2017 {published data only}
    1. Yang CQ, Liu XY, Du RH, Cao TZ, Dai XY. Diagnosis value with Xpert Mtb/RIF assay for cervical tuberculous lymphadenitis. Lin Chung Er Bi Yan Hou Tou Jing Wai Ke Za Zhi 2017;31(17):1338-40. - PubMed
Yang 2019 {published data only}
    1. Yang X, Che N, Duan H, Liu Z, Li K, Li H, et al. Cell-free Mycobacterium tuberculosis DNA test in pleural effusion for tuberculous pleurisy: a diagnostic accuracy study. Clinical Microbiology and Infection 2019;8:1089.e1-1089.e6. - PubMed
Yu 2020 {published data only}
    1. Yu G, Shen Y, Ye B, Chen D, Xu K. Comparison of CapitalBio Mycobacterium nucleic acid detection test and Xpert MTB/RIF assay for rapid diagnosis of extrapulmonary tuberculosis. Journal of Microbiological Methods 2020;168:105780. - PubMed
Yuan 2016 {published data only}
    1. Yuan M, Lyu Y, Chen ST, Cai C, Li Y, Zhang ZG, et al. Evaluation of Xpert MTB/RIF for the diagnosis of extrapulmonary tuberculosis in China. Biomedical and Environmental Sciences 2016;29(8):599-602. - 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
Zhou 2020 {published data only}
    1. Zhou Z, Zheng Y, Wang L. A comparative study on the value of Xpert MTB/RIF and T-SPOT.TB tests in the diagnosis of bone and joint tuberculosis. Clinica Chimica Acta 2020;500:115-9. - PubMed
Zurcher 2019 {published data only}
    1. Zurcher K, Ballif M, Kiertiburanakul S, Chenal H, Yotebieng M, Grinsztejn B, et al. Diagnosis and clinical outcomes of extrapulmonary tuberculosis in antiretroviral therapy programmes in low- and middle-income countries: a multicohort study. Journal of the International AIDS Society 2019;22(9):e25392. - PMC - PubMed

Additional references

American Thoracic Society 2000
    1. American Thoracic Society, the Centers for Disease Control and Prevention, Infectious Disease Society of America. Diagnostic Standards and Classification of Tuberculosis in Adults and Children. This official statement of the American Thoracic Society and the Centers for Disease Control and Prevention was adopted by the ATS Board of Directors, July 1999. This statement was endorsed by the Council of the Infectious Disease Society of America, September 1999. American Journal Respiratory and Critical Care Medicine 2000;161(4 Pt 1):1376-95. - PubMed
Bahr 2016
    1. Bahr NC, Marais S, Caws M, Van Crevel R, Wilkinson RJ, Tyagi JS, et al, Tuberculous Meningitis International Research Consortium. GeneXpert MTB/Rif to diagnose tuberculous meningitis: perhaps the first test but not the last. Clinical Infectious Diseases 2016;62(9):1133-5. - PMC - PubMed
Balshem 2011
    1. Balshem H, Helfand M, Schünemann HJ, Oxman AD, Kunz R, Brozek J, et al. GRADE guidelines: 3. Rating the quality of evidence. Journal of Clinical Epidemiology 2011;64(4):401–6. - PubMed
Banada 2010
    1. Banada PP, Sivasubramani SK, Blakemore R, Boehme C, Perkins MD, Fennelly K, et al. Containment of bioaerosol infection risk by the Xpert MTB/RIF assay and its applicability to point-of-care settings. Journal of Clinical Microbiology 2010;48(10):3551-7. - PMC - PubMed
Begg 1983
    1. Begg CB, Greenes RA. Assessment of diagnostic tests when disease verification is subject to selection bias. Biometrics 1983;39(1):207-15. - PubMed
Bjerrum 2019
    1. Bjerrum S, Schiller I, Dendukuri N, Kohli M, Nathavitharana RR, Zwerling AA, et al. Lateral flow urine lipoarabinomannan assay for detecting active tuberculosis in people living with HIV. Cochrane Database of Systematic Reviews 2019, Issue 10. Art. No: CD011420. [DOI: 10.1002/14651858.CD011420.pub3] - DOI - PMC - PubMed
Blakemore 2010
    1. Blakemore R, Story E, Helb D, Kop J, Banada P, Owens MR, et al. Evaluation of the analytical performance of the Xpert MTB/RIF assay. Journal of Clinical Microbiology 2010;48(7):2495-501. - PMC - PubMed
Boehme 2010
    1. Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, et al. Rapid molecular detection of tuberculosis and rifampin resistance. New England Journal of Medicine 2010;363(11):1005–15. - PMC - PubMed
Bossuyt 2015
    1. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ 2015;351:h5527. [DOI: 10.1136/bmj.h5527] - DOI - PMC - PubMed
Branigan 2019
    1. Branigan D. Pipeline report 2019 tuberculosis diagnostics. www.treatmentactiongroup.org/wp-content/uploads/2019/12/pipeline_tb_diag... (accessed 4 April 2020).
Broger 2020
    1. Broger T, Nicol MP, Székely R, Bjerrum S, Sossen B, Schutz C, et al. Diagnostic accuracy of a novel tuberculosis point-of-care urine lipoarabinomannan assay for people living with HIV: a meta-analysis of individual in- and outpatient data. PLOS Medicine 2020;17(5):e1003113. - PMC - PubMed
CDC 2018
    1. Centers for Disease Control and Prevention. Reported tuberculosis in the United States, 2018. www.cdc.gov/tb/statistics/reports/2018/table15.htm (accessed 29 June 2020).
Cepheid 2018
    1. Cepheid. Brochure: Xpert® MTB/RIF Ultra. www.cepheid.com/en/tests/Critical-Infectious-Diseases/Xpert-MTB-RIF-Ultra (accessed 26 March 2020).
Cepheid 2019
    1. Cepheid. Xpert® MTB/RIF. Two-hour detection of MTB and rifampin resistance mutations. www.cepheid.com/Package%20Insert%20Files/Xpert-MTB-RIF-ENGLISH-Package-I... (accessed 29 March 2020).
Chakravorty 2017
    1. Chakravorty S, Simmons AM, Rowneki M, Parmar H, Cao Y, Ryan J, et al. The new Xpert MTB/RIF Ultra: improving detection of Mycobacterium tuberculosis and resistance to rifampin in an assay suitable for point-of-care testing. MBio 2017;8(4):e00812-17. [DOI: 10.1128/mBio.00812-17] - DOI - PMC - PubMed
Chang 2012
    1. Chang K, Lu W, Wang J, Zhang K, Jia S, Li F, et al. Rapid and effective diagnosis of tuberculosis and rifampicin resistance with Xpert MTB/RIF assay: a meta-analysis. Journal of Infection 2012;64(6):580-8. - PubMed
Chin 2019a
    1. Chin JH, Ssengooba W, Grossman S, Pellinen J, Wadda V. Xpert MTB/RIF Ultra: optimal procedures for the detection of Mycobacterium tuberculosis in cerebrospinal fluid. Journal of Clinical Tuberculosis and Other Mycobactaterial Diseases 2019;14:16-18. - PMC - PubMed
Chow 2002
    1. Chow KM, Chow VC, Hung LC, Wong SM, Szeto CC. Tuberculous peritonitis-associated mortality is high among patients waiting for the results of mycobacterial cultures of ascitic fluid samples. Clinical Infectious Diseases 2002;35(4):409-13. - PubMed
Chu 2006
    1. Chu H, Cole SR. Bivariate meta-analysis of sensitivity and specificity with sparse data: a generalized linear mixed model approach. Journal of Clinical Epidemiology 2006;59(12):1331–2. - PubMed
Conde 2003
    1. Conde MB, Loivos AC, Rezende VM, Soares SL, Mello FC, Reingold AL, et al. Yield of sputum induction in the diagnosis of pleural tuberculosis. American Journal of Respiratory and Critical Care Medicine 2003;167(5):723-5. - PubMed
Covidence 2017 [Computer program]
    1. Veritas Health Innovation Covidence systematic review software. Available at www.covidence.org. Melbourne: Veritas Health Innovation, 2017.
Denkinger 2014
    1. Denkinger CM, Schumacher SG, Boehme CC, Dendukuri N, Pai M, Steingart KR. Xpert MTB/RIF assay for the diagnosis of extrapulmonary tuberculosis: a systematic review and meta-analysis. European Respiratory Journal 2014;44(2):435-46. - PubMed
Diacon 2003
    1. Diacon AH, Van de Wal BW, Wyser C, Smedema JP, Bezuidenhout J, Bolliger CT, et al. Diagnostic tools in tuberculous pleurisy: a direct comparative study. European Respiratory Journal 2003;22(4):589-91. - PubMed
Dinnes 2007
    1. Dinnes J, Deeks J, Kunst H, Gibson A, Cummins E, Waugh N, et al. A systematic review of rapid diagnostic tests for the detection of tuberculosis infection. Health Technology Assessment 2007;11(3):1-196. - PubMed
Di Tanna 2019
    1. Di Tanna GL, Khaki AR, Theron G, McCarthy K, Cox H, Mupfumi L, et al. Effect of Xpert MTB/RIF on clinical outcomes in routine care settings: individual patient data meta-analysis. Lancet Global Health 2019;7:e191-99. - PMC - PubMed
Dorman 2018
    1. Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B, et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infectious Diseases 2018;18(1):76-84. - PMC - PubMed
Drain 2019
    1. Drain PK, Gardiner J, Hannah H, Broger T, Dheda K, Fielding K, et al. Guidance for studies evaluating the accuracy of biomarker-based nonsputum tests to diagnose tuberculosis. Journal of Infectious Diseases 2019;220(Suppl 3):S108-S115. - PubMed
FIND 2017
    1. Foundation for Innovative New Diagnsotics (FIND). Report for WHO: a multicentre non-inferiority diagnostic accuracy study of the Ultra assay compared to the Xpert MTB/RIF assay. www.finddx.org/publication/ultra-report/ (accessed 2 July 2020);(version 1.8):1-82.
Fontanilla 2011
    1. Fontanilla JM, Barnes A, Von Reyn CF. Current diagnosis and management of peripheral tuberculous lymphadenitis. Clinical Infectious Diseases 2011;53(6):555-62. - PubMed
Global Laboratory Initiative 2017
    1. Global Laboratory Initiative. Planning for country transition to Xpert® MTB/RIF Ultra cartridges. www.stoptb.org/wg/gli/assets/documents/gli_ultra.pdf (accessed 2 July 2020).
Global Laboratory Initiative 2019
    1. Global Laboratory Intiaitive. Practical guide to implementing a quality assurance system for Xpert MTB/RIF testing. www.stoptb.org/wg/gli/assets/documents/Xpert-QA-guide-2019.pdf (accessed 7 January 2020).
Golden 2005
    1. Golden MP, Vikram HR. Extrapulmonary tuberculosis: an overview. American Family Physician 2005;72(9):1761-8. - PubMed
Gopinath 2010
    1. Gopinath K, Singh S. Non-tuberculous mycobacteria in TB-endemic countries: are we neglecting the danger? PLOS Neglected Tropical Diseases 2010;4(4):e615. [DOI: 10.1371/journal.pntd.0000615] - DOI - PMC - PubMed
GRADEpro GDT 2015 [Computer program]
    1. McMaster University (developed by Evidence Prime) GRADEpro GDT. Version accessed 2 July 2020. Hamilton (ON): McMaster University (developed by Evidence Prime), 2015. Available at gradepro.org.
Gupta 2015
    1. Gupta RK, Lucas SB, Fielding KL, Lawn SD. Prevalence of tuberculosis in post-mortem studies of HIV-infected adults and children in resource-limited settings: a systematic review and meta-analysis. AIDS 2015;29(15):1987-2002. - PMC - PubMed
Gupta 2018
    1. Gupta R, Talwar P, Talwar P, Khurana S, Kushwaha S, Jalan N, et al. Diagnostic accuracy of nucleic acid amplification based assays for tuberculous meningitis: a meta-analysis. Journal of Infection 2018;77(4):302-13. - PubMed
Gupta‐Wright 2018
    1. Gupta-Wright A, Corbett EL, Van Oosterhout JJ, Wilson D, Grint D, Alufandika-Moyo M, et al. Rapid urine-based screening for tuberculosis in HIV-positive patients admitted to hospital in Africa (STAMP): a pragmatic, multicentre, parallel-group, double-blind, randomised controlled trial. Lancet 2018;392(10144):292-301. [PMID: ] - PMC - PubMed
Haraka 2018
    1. Haraka F, Nathavitharana RR, Schumacher SG, Kakolwa M, Denkinger CM, Gagneux S, et al. Impact of diagnostic test Xpert MTB/RIF® on health outcomes for tuberculosis. Cochrane Database of Systematic Reviews 2018, Issue 2. Art. No: CD012972. [DOI: 10.1002/14651858.CD012972] - DOI - PMC - PubMed
Harbord 2007
    1. Harbord RM, Deeks JJ, Egger M, Whiting P, Sterne JA. A unification of models for meta-analysis of diagnostic accuracy studies. Biostatistics 2007;8(2):239-51. - PubMed
Hartmann 1967
    1. Hartmann G, Honikel KO, Knüsel F, Nüesch J. The specific inhibition of the DNA-directed RNA synthesis by rifamycin. Biochimica et Biophysica Acta 1967;145(3):843–4. - PubMed
Helb 2010
    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
Horne 2019
    1. Horne DJ, Kohli M, Zifodya JS, Schiller I, Dendukuri N, Tollefson D, et al. Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database of Systematic Reviews 2019, Issue 6. Art. No: CD009593. [DOI: 10.1002/14651858.CD009593] - DOI - PMC - PubMed
Iseman 2000
    1. Iseman MD. Extrapulmonary tuberculosis in adults. In: Iseman MD, editors(s). A Clinician’s Guide to Tuberculosis. Philadelphia: Lippincott Williams and Wilkins, 2000:145–97.
Kay 2020
    1. Kay AW, González Fernández L, Takwoingi Y, Eisenhut M, Vu RD, Steingart KR, et al. Xpert MTB/RIF and Xpert MTB/RIF Ultra assays for active tuberculosis and rifampicin resistance in children. Cochrane Database of Systematic Reviews 2020, Issue 8. Art. No: CD013359. [DOI: 10.1002/14651858.CD013359] [PMID: ] - DOI - PMC - PubMed
Kilpatrick 1986
    1. Kilpatrick ME, Girgis NI, Yassin MW, Abu el Ella AA. Tuberculous meningitis-clinical and laboratory review of 100 patients. Journal of Hygiene (London) 1986;96(2):231–8. - PMC - PubMed
Leeflang 2013
    1. Leeflang MM, Rutjes AW, Reitsma JB, Hooft L, Bossuyt PM. Variation of a test's sensitivity and specificity with disease prevalence. Canadian Medical Association Journal 2013;185(11):E537-44. [DOI: 10.1503/cmaj.121286] - DOI - PMC - PubMed
Lewinsohn 2017
    1. Lewinsohn DM, Leonard MK, LoBue PA, Cohn DL, Daley CL, Desmond E, et al. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. Clinical Infectious Diseases 2017;64(2):e1–33. [DOI: 10.1093/cid/ciw694] - DOI - PubMed
Li Y 2017
    1. Li S, Liu B, Peng M, Chen M, Yin W, Tang H, et al. Diagnostic accuracy of Xpert MTB/RIF for tuberculosis detection in different regions with different endemic burden: a systematic review and meta-analysis. PLOS One 2017;12(7):e0180725. [DOI: 10.1371/journal.pone.0180725] - DOI - PMC - PubMed
Lunn 2009
    1. Lunn D, Spiegelhalter D, Thomas A, Best N. The BUGS project: evolution, critique, and future directions. Statistics in Medicine 2009;28(25):3049-67. - PubMed
Macaskill 2010
    1. Macaskill P, Gatsonis C, Deeks JJ, Harbord RM, Takwoingi Y. Chapter 10: Analysing and presenting results. In: Deeks JJ, Bossuyt PM, C Gatsonis (editors). Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy Version 1.0. The Cochrane Collaboration, 2010. Available at: methods.cochrane.org/sdt/handbook-dta-reviews.
Marais 2010
    1. Marais S, Thwaites G, Schoeman JF, Török ME, Misra UK, Prasad K, et al. Tuberculous meningitis: a uniform case definition for use in clinical research. Lancet Infectious Diseases 2010;10(11):803-12. - PubMed
Maynard‐Smith 2014
    1. Maynard-Smith L, Larke N, Peters JA, Lawn SD. Diagnostic accuracy of the Xpert MTB/RIF assay for extrapulmonary and pulmonary tuberculosis when testing non-respiratory samples: a systematic review. BMC Infectious Diseases 2014;14:709. [DOI: 10.1186/s12879-014-0709-7] - DOI - PMC - PubMed
McInnes 2018
    1. McInnes MD, Moher D, Thombs BD, McGrath TA, Bossuyt PM, et al, anad the PRISMA-DTA Group. Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies: the PRISMA-DTA statement [published correction appears in JAMA. 2019 Nov 26;322(20):2026]. JAMA 2018;319(4):388-96. [DOI: 10.1001/jama.2017.19163] - DOI - PubMed
Miotto 2012
    1. Miotto P, Bigoni S, Migliori GB, Matteelli A, Cirillo DM. Early tuberculosis treatment monitoring by Xpert(R) MTB/RIF. European Respiratory Journal 2012;39(5):1269-71. - PubMed
Moher 2009
    1. Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred reporting items for systematic reviews and meta-analyses: the PRISMA Statement. PLOS Medicine 6;7:e1000097. [DOI: 10.1371/journal.pmed1000097] - DOI - PMC - PubMed
Naaktgeboren 2013
    1. Naaktgeboren CA, Bertens LC, Van Smeden M, De Groot JA, Moons KG, Reitsma JB. Value of composite reference standards in diagnostic research. BMJ 2013;347:f5605. - PubMed
Nahid 2016
    1. Nahid P, Dorman SE, Alipanah N, Barry PM, Brozek JL, Cattamanchi A, et al. Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America clinical practice guidelines: treatment of drug-susceptible tuberculosis. Clinical Infectious Diseases 2016;63(7):e147-95. [DOI: 10.1093/cid/ciw376] - DOI - PMC - PubMed
Nathavitharana 2017
    1. Nathavitharana RR, Cudahy PG, Schumacher SG, Steingart KR, Pai M, Denkinger CM. Accuracy of line probe assays for the diagnosis of pulmonary and multidrug-resistant tuberculosis: a systematic review and meta-analysis. European Respiratory Journal 2017;49(1):pii: 1601075. - PMC - PubMed
Nelson 2004
    1. Nelson LJ, Wells CD. Global epidemiology of childhood tuberculosis. International Journal of Tuberculosis and Lung Disease 2004;8(5):636-47. - PubMed
Pai 2004
    1. Pai M, Flores LL, Hubbard A, Riley LW, Colford JM Jr. Nucleic acid amplification tests in the diagnosis of tuberculous pleuritis: a systematic review and meta-analysis. BMC Infectious Diseases 2004;4:6. [DOI: 10.1186/1471-2334-4-6] - DOI - PMC - PubMed
Pai 2008
    1. Pai M, Ling DI. Rapid diagnosis of extrapulmonary tuberculosis using nucleic acid amplification tests: what is the evidence? Future Microbiology 2008;3(1):1-4. - PubMed
Pai 2016
    1. Pai M, Behr M, Dowdy D, Dheda K, Divangahi M, Boehme CC, et al. Tuberculosis. Nature Reviews. Disease Primers 2016;2:16076. [DOI: 10.1038/nrdp.2016.76] - DOI - PubMed
Pang 2019
    1. Pang Y, An J, Shu W, Huo F, Chu N, Gao M, et al. Epidemiology of extrapulmonary tuberculosis among inpatients, China, 2008-2017. Emerging Infectious Diseases 2019;25:457-64. - PMC - PubMed
Penz 2015
    1. Penz E, Boffa J, Roberts DJ, Fisher D, Cooper R, Ronksley PE, et al. Diagnostic accuracy of the Xpert® MTB/RIF assay for extra-pulmonary tuberculosis: a meta-analysis. International Journal of Tuberculosis and Lung Disease 2015;19(3):278-84. - PubMed
Perkins 2007
    1. Perkins MD, Cunningham J. Facing the crisis: improving the diagnosis of tuberculosis in the HIV era. Journal of Infectious Diseases 2007;196 Suppl 1:S15–27. - PubMed
Peter 2016
    1. Peter JG, Zijenah LS, Chanda D, Clowes P, Lesosky M, Gina P, et al. Effect on mortality of point-of-care, urine-based lipoarabinomannan testing to guide tuberculosis treatment initiation in HIV-positive hospital inpatients: a pragmatic, parallel-group, multicountry, open-label, randomised controlled trial. Lancet 2016;387(10024):1187-97. - PubMed
Pormohammad 2019
    1. Pormohammad A, Nasiri MJ, McHugh TD, Riahi SM, Bahr NC. A systematic review and meta-analysis of the diagnostic accuracy of nucleic acid amplification tests for tuberculous meningitis. Journal of Clinical Microbiology 2019;57(6):e01113-18. - PMC - PubMed
R Core Team 2019 [Computer program]
    1. R Foundation for Statistical Computing R Core Team (2019). R: A language and environment for statistical computing. Version accessed after 12 June 2020. Vienna, Austria: R Foundation for Statistical Computing, 2019. Available at r-project.org/.
Reitsma 2005
    1. Reitsma JB, Glas AS, Rutjes AW, Scholten RJ, Bossuyt PM, Zwinderman AH. Bivariate analysis of sensitivity and specificity produces informative summary measures in diagnostic reviews. Journal of Clinical Epidemiology 2005;58(10):982-90. - PubMed
Reuter 2009
    1. Reuter H, Wood R, Schaaf HS, Donald PR. Overview of extrapulmonary tuberculosis in adults and children. In: Schaaf HS, Zumla A, editors(s). Tuberculosis: A Comprehensive Clinical Reference. 1st edition. Amsterdam: Elsevier Science Publishers, 2009:377-90.
RevMan 2014 [Computer program]
    1. Nordic Cochrane Centre, The Cochrane Collaboration Review Manager 5 (RevMan 5). Version 5.3. Copenhagen: Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
Sandgren 2013
    1. Sandgren A, Hollo V, Van der Werf MJ. Extrapulmonary tuberculosis in the European Union and European economic area, 2002 to 2011. Euro Surveillance 2013;18(12):pii: 20431. - PubMed
Schiller 2016
    1. Schiller I, Van Smeden M, Hadgu A, Libman M, Reitsma JB, Dendukuri N. Bias due to composite reference standards in diagnostic accuracy studies. Statistics in Medicine 2016;35(9):1454-70. - PubMed
Schumacher 2016
    1. Schumacher S, Van Smeden M, Dendukuri N, Joseph L, Nicol M, 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
Schumacher 2019
    1. Schumacher SG, Denkinger CM. The impact of Xpert MTB/RIF-do we have a final answer? Lancet Global Health 2019;7(2):e161-e162. - PubMed
Schünemann 2008
    1. Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ 2008;336(7653):1106-10. - PMC - PubMed
Schünemann 2016
    1. Schünemann HJ, Mustafa R, Brozek J, Santesso N, Alonso-Coello P, Guyatt G, et al. GRADE Working Group. GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health. Journal of Clinical Epidemiology 2016;76:89-98. [DOI: 10.1016/j.jclinepi.2016.01.032] - DOI - PubMed
Schünemann 2020a
    1. Schünemann HJ, Mustafa R, Brozek J, Steingart KR, Leeflang M, Murad MH, et al. GRADE guidelines: 21 part 1. Study design, risk of bias and indirectness in rating the certainty across a body of evidence for test accuracy. Journal of Clinical Epidemiology 2020;122:129-41. [DOI: 10.1016/j.jclinepi.2019.12.020] - DOI - PubMed
Schünemann 2020b
    1. Schünemann HJ, Mustafa R, Brozek J, Steingart KR, Leeflang M, Murad MH, et al. GRADE guidelines: 21 part 2. Inconsistency, Imprecision, publication bias and other domains for rating the certainty of evidence for test accuracy and presenting it in evidence profiles and summary of findings tables. Journal of Clinical Epidemiology 2020;122:142-52. [DOI: 10.1016/j.jclinepi.2019.12.021] - DOI - PubMed
Sehgal 2016
    1. Sehgal IS, Dhooria S, Aggarwal AN, Behera D, Agarwal R. Diagnostic performance of Xpert MTB/RIF in tuberculous pleural effusion: systematic review and meta-analysis. Journal of Clinical Microbiology 2016;54(4):1133-6. - PMC - PubMed
Shah 2016b
    1. Shah M, Hanrahan C, Wang ZY, Dendukuri N, Lawn SD, Denkinger CM, et al. Lateral flow urine lipoarabinomannan assay for detecting active tuberculosis in HIV-positive adults. Cochrane Database of Systematic Reviews 2016, Issue 5. Art. No: CD011420. [DOI: 10.1002/14651858.CD011420.pub2] - DOI - PMC - PubMed
Shapiro 2020
    1. Shapiro AE, Ross JM, Schiller I, Kohli M, Dendukuri N, Steingart KR, et al. Xpert MTB/RIF and Xpert Ultra assays for pulmonary tuberculosis and rifampicin resistance in adults irrespective of signs or symptoms of pulmonary tuberculosis. Cochrane Database of Systematic Reviews 2020, Issue 7. Art. No: CD013694. [DOI: 10.1002/14651858.CD013694] - DOI - PMC - PubMed
Sharma 2004
    1. Sharma SK, Mohan A. Extrapulmonary tuberculosis. Indian Journal of Medical Research 2004;120(4):316-53. - PubMed
Sharma 2017b
    1. Sharma SK, Ryan H, Khaparde S, Sachdeva KS, Singh AD, Mohan A, et al. Index-TB guidelines: guidelines on extrapulmonary tuberculosis for India. Indian Journal of Medical Research 2017;145(4):448-63. - PMC - PubMed
Shen 2019
    1. Shen Y, Yu G, Zhong F, Kong X. Diagnostic accuracy of the Xpert MTB/RIF assay for bone and joint tuberculosis: a meta-analysis. PLOS One 2019;14(8):e0221427. - PMC - PubMed
Shu 2011
    1. Shu CC, Wang JT, Wang JY, Lee LN, Yu CJ. In-hospital outcome of patients with culture-confirmed tuberculous pleurisy: clinical impact of pulmonary involvement. BMC Infectious Diseases 2011;11:46. [DOI: 10.1186/1471-2334-11-46] - DOI - PMC - PubMed
Small 2011
    1. Small PM, Pai M. Tuberculosis diagnosis - time for a game change. New England Journal of Medicine 2011;363(111):1070–1. - PubMed
Stata 2017 [Computer program]
    1. Stata Statistical Software: Release 15. StataCorp. College Station, TX: StataCorp LP, 2017.
Steingart 2014
    1. Steingart KR, Schiller I, Horne DJ, Pai M, Boehme CC, Dendukuri N. Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database of Systematic Reviews 2014, Issue 1. Art. No: CD009593. [DOI: 10.1002/14651858.CD009593.pub3] - DOI - PMC - PubMed
Takwoingi 2013
    1. Takwoingi Y, Leeflang MM, Deeks JJ. Empirical evidence of the importance of comparative studies of diagnostic test accuracy. Annals of Internal Medicine 2013;158(7):544-54. - PubMed
Telenti 1993
    1. Telenti A, Imboden P, Marchesi F, Lowrie D, Cole S, Colston MJ, et al. Detection of rifampicin-resistance mutations in Mycobacterium tuberculosis. Lancet 1993;341(8846):647-50. - PubMed
Theron 2014a
    1. Theron G, Zijenah L, Chanda D, Clowes P, Rachow A, Lesosky M, et al. Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: a multicentre, randomised, controlled trial. Lancet 2014;383(9915):424-35. - PubMed
Thwaites 2013
    1. Thwaites GE, Van Toorn R, Schoeman J. Tuberculous meningitis: more questions, still too few answers. Lancet Neurology 2013;12(10):999-1010. - PubMed
Unitaid 2017
    1. Boyle D. Tuberculosis Diagnostics Technology and Market Landscape. 5th edition. Vernier: World Health Organization Unitaid Secretariat, 2017.
Van Smeden 2014
    1. Smeden M, Naaktgeboren CA, Reitsma JB, Moons KG, De Groot JA. Latent class models in diagnostic studies when there is no reference standard - a systematic review. American Journal of Epidemiology 2014;179(4):423-31. - PubMed
Vonasek 2020
    1. Vonasek B, Ness T, Takwoingi Y, Kay AW, Wyk SS, Ouellette L, et al. Screening tests for active pulmonary tuberculosis in children. Cochrane Database of Systematic Reviews 2020, Issue 7. Art. No: CD013693. [DOI: 10.1002/14651858.CD013693] - DOI - PMC - PubMed
Walzl 2018
    1. Walzl G, McNerney R, Du Plessis N, Bates M, McHugh TD, Chegou NN, et al. Tuberculosis: advances and challenges in development of new diagnostics and biomarkers. Lancet Infectious Diseases 2018;18(7):e199-e210. - PubMed
Webster 2014
    1. Webster AS, Shandera WX. The extrapulmonary dissemination of tuberculosis: a meta-analysis. International Journal of Mycobacteriology 2014;3:9-16. - PubMed
Whiting 2011
    1. Whiting PF, Rutjes AW, Westwood ME, Mallett S, Deeks JJ, Reitsma JB, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Annals of Internal Medicine 2011;155(8):529–36. - PubMed
WHO 2010
    1. World Health Organization. Guidelines for treatment of tuberculosis, fourth edition. who.int/tb/publications/2010/9789241547833/en/ 2010 (accessed 2 July 2020).
WHO 2011
    1. World Health Organization. Rapid implementation of the Xpert MTB/RIF diagnostic test. Technical and operational ‘How-to’. Practical considerations. who.int/tb/publications/tb-amplificationtechnology-implementation/en/ 2011 (accessed 2 July 2020).
WHO 2012
    1. World Health Organization. Updated interim critical concentrations for first-line and second-line DST (as of May 2012). www.stoptb.org/wg/gli/assets/documents/Updated%20critical%20concentratio... 2012 (accessed 2 July 2020).
WHO 2014
    1. World Health Organization. Xpert MTB/RIF implementation manual. Technical and operational ‘how-to’ practical considerations. apps.who.int/iris/bitstream/10665/112469/1/9789241506700_eng.pdf 2014 (accessed 2 July 2020).
WHO 2017
    1. World Health Organization. Guidelines for the treatment of drug-susceptible tuberculosis and patient care (2017 update). www.who.int/tb/publications/2017/dstb_guidance_2017/en/ 2017 (accessed 1 April 2020).
WHO 2018
    1. World Health Organization. Technical report on critical concentrations for drug susceptibility testing of medicines used in the treatment of drug-resistant tuberculosis (WHO/CDS/TB/2018.5). who.int/tb/publications/2018/WHO_technical_report_concentrations_TB_drug... (accessed 2 July 2020).
WHO Compendium 2018
    1. World Health Organization. Compendium of WHO guidelines and associated standards: ensuring optimum delivery of the cascade of care for patients with tuberculosis, second edition. www.who.int/tb/publications/Compendium_WHO_guidelines_TB_2017/en/ (accessed 2 July 2020).
WHO Consolidated Guidelines (Module 3) 2020
    1. World Health Organization. WHO consolidated guidelines on tuberculosis. Module 3: diagnosis – rapid diagnostics for tuberculosis detection. Licence: CC BY-NC-SA 3.0 IGO. who.int/publications/i/item/who-consolidated-guidelines-on-tuberculosis-... 2020 (accessed 2 July 2020).
WHO Consolidated Guidelines (Module 4) 2020
    1. World Health Organization. WHO consolidated guidelines on tuberculosis. Module 4: treatment - drug-resistant tuberculosis treatment. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO. who.int/publications/i/item/9789240007048 (accessed 2 July 2020).
WHO END TB 2014
    1. World Health Organization. The END TB strategy. www.who.int/tb/strategy/end-tb/en/ 2014 (accessed 1 April 2020).
WHO Global TB Report 2020
    1. World Health Organization. Global Tuberculosis Report 2020. Licence: CC BY-NC-SA 3.0 IGO. Geneva: World Health Organization, 2020.
WHO Operational Handbook Diagnosis (Module 3) 2020
    1. World Health Organization. WHO operational handbook on tuberculosis. Module 3: diagnosis - rapid diagnostics for tuberculosis detection. Licence: CC BY-NC-SA 3.0 IGO. who.int/publications/i/item/who-operational-handbook-on-tuberculosis-mod... (accessed 6 August 2020).
WHO Xpert MTB/RIF Policy 2011
    1. World Health Organization. Policy statement: automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF system. WHO/HTM/TB/2011.4. www.who.int/tb/publications/tb-amplificationtechnology-statement/en/ 2011 (accessed 2 July 2020). - PubMed
WHO Xpert MTB/RIF Policy Update 2013
    1. World Health Organization. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF system for the diagnosis of pulmonary and extrapulmonary TB in adults and children: policy update. WHO/HTM/TB/2013.14. apps.who.int/iris/handle/10665/112472 2013 (accessed 2 July 2020).
WHO Xpert Ultra 2017
    1. World Health Organization. WHO meeting report of a technical expert consultation: non-inferiority analysis of Xpert MTB/RIF Ultra compared to Xpert MTB/RIF. WHO/HTM/TB/2017.04. www.who.int/tb/publications/2017/XpertUltra/en/ 2017 (accessed 2 July 2020).
Woodard 1982
    1. Woodard BH, Rosenberg SI, Farnham R, Adams DO. Incidence and nature of primary granulomatous inflammation in surgically removed material. American Journal of Surgical Pathology 1982;6(2):119-29. - PubMed
Woods 2001
    1. Woods GL. Molecular techniques in mycobacterial detection. In: Archives of Pathology & Laboratory Medicine. Vol. 125. Geneva: World Health Organization, 2001:122-6. - PubMed
World Bank 2020
    1. World Bank. World bank list of economies. datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-coun... 2019 (accessed 2 July 2020).
Wright 2009a
    1. Wright CA, Bezuidenhout J. Histopathology and cytopathology. In: Schaaf HS, Zumla A, editors(s). Tuberculosis: A Comprehensive Clinical Reference. 1st edition. Amsterdam: Elsevier Science Publishers, 2009:205-15.
Wright 2009b
    1. Wright CA, Hesseling AC, Bamford C, Burgess SM, Warren R, Marais BJ. Fine-needle aspiration biopsy: a first-line diagnostic procedure in paediatric tuberculosis suspects with peripheral lymphadenopathy? International Journal of Tuberculosis and Lung Disease 2009;13(11):1373-9. - PubMed
Yu 2019
    1. Yu G, Zhong F, Ye B, Xu X, Chen D, Shen Y. Diagnostic accuracy of the Xpert MTB/RIF assay for lymph node tuberculosis: a systematic review and meta-analysis. BioMed Research International 2019;2019:4878240. - PMC - PubMed
Zhang 2020
    1. Zhang M, Xue M, He JQ. Diagnostic accuracy of the new Xpert MTB/RIF Ultra for tuberculosis disease: a preliminary systematic review and meta-analysis. International Journal of Infectious Diseases 2020;90:35-45. - PubMed

References to other published versions of this review

Kohli 2017
    1. Kohli M, Schiller I, Dendukuri N, Ryan H, Dheda K, Denkinger CM, Schumacher SG, Steingart KR. Xpert® MTB/RIF assay for extrapulmonary tuberculosis and rifampicin resistance. Cochrane Database of Systematic Reviews 2017, Issue 8. Art. No: CD012768. [DOI: 10.1002/14651858.CD012768] - DOI - PMC - PubMed
Kohli 2018
    1. Kohli M, Schiller I, Dendukuri N, Dheda K, Denkinger CM, Schumacher SG, et al. Xpert® MTB/RIF assay for extrapulmonary tuberculosis and rifampicin resistance. Cochrane Database of Systematic Reviews 2018, Issue 8. Art. No: CD012768. [DOI: 10.1002/14651858.CD012768.pub2] - DOI - PMC - PubMed

Publication types

MeSH terms

LinkOut - more resources