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Meta-Analysis
. 2021 Feb 22;2(2):CD009593.
doi: 10.1002/14651858.CD009593.pub5.

Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis

Jerry S Zifodya  1 , Jonah S Kreniske  2 , Ian Schiller  3 , Mikashmi Kohli  4 , Nandini Dendukuri  3 , Samuel G Schumacher  5 , Eleanor A Ochodo  6   7 , Frederick Haraka  8   9 , Alice A Zwerling  10 , Madhukar Pai  4 , Karen R Steingart  11 , David J Horne  12
Affiliations
Meta-Analysis

Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis

Jerry S Zifodya et al. Cochrane Database Syst Rev. .

Abstract

Background: Xpert MTB/RIF and Xpert MTB/RIF Ultra (Xpert Ultra) are World Health Organization (WHO)-recommended rapid tests that simultaneously detect tuberculosis and rifampicin resistance in people with signs and symptoms of tuberculosis. This review builds on our recent extensive Cochrane Review of Xpert MTB/RIF accuracy.

Objectives: To compare the diagnostic accuracy of Xpert Ultra and Xpert MTB/RIF for the detection of pulmonary tuberculosis and detection of rifampicin resistance in adults with presumptive pulmonary tuberculosis. For pulmonary tuberculosis and rifampicin resistance, we also investigated potential sources of heterogeneity. We also summarized the frequency of Xpert Ultra trace-positive results, and estimated the accuracy of Xpert Ultra after repeat testing in those with trace-positive results.

Search methods: We searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, Science Citation Index, Web of Science, LILACS, Scopus, the WHO ICTRP, the ISRCTN registry, and ProQuest to 28 January 2020 with no language restriction.

Selection criteria: We included diagnostic accuracy studies using respiratory specimens in adults with presumptive pulmonary tuberculosis that directly compared the index tests. For pulmonary tuberculosis detection, the reference standards were culture and a composite reference standard. For rifampicin resistance, the reference standards were culture-based drug susceptibility testing and line probe assays.

Data collection and analysis: Two review authors independently extracted data using a standardized form, including data by smear and HIV status. We assessed risk of bias using QUADAS-2 and QUADAS-C. We performed meta-analyses comparing pooled sensitivities and specificities, separately for pulmonary tuberculosis detection and rifampicin resistance detection, and separately by reference standard. Most analyses used a bivariate random-effects model. For tuberculosis detection, we estimated accuracy in studies in participants who were not selected based on prior microscopy testing or history of tuberculosis. We performed subgroup analyses by smear status, HIV status, and history of tuberculosis. We summarized Xpert Ultra trace results.

Main results: We identified nine studies (3500 participants): seven had unselected participants (2834 participants). All compared Xpert Ultra and Xpert MTB/RIF for pulmonary tuberculosis detection; seven studies used a paired comparative accuracy design, and two studies used a randomized design. Five studies compared Xpert Ultra and Xpert MTB/RIF for rifampicin resistance detection; four studies used a paired design, and one study used a randomized design. Of the nine included studies, seven (78%) were mainly or exclusively in high tuberculosis burden countries. For pulmonary tuberculosis detection, most studies had low risk of bias in all domains. Pulmonary tuberculosis detection Xpert Ultra pooled sensitivity and specificity (95% credible interval) against culture were 90.9% (86.2 to 94.7) and 95.6% (93.0 to 97.4) (7 studies, 2834 participants; high-certainty evidence) versus Xpert MTB/RIF pooled sensitivity and specificity of 84.7% (78.6 to 89.9) and 98.4% (97.0 to 99.3) (7 studies, 2835 participants; high-certainty evidence). The difference in the accuracy of Xpert Ultra minus Xpert MTB/RIF was estimated at 6.3% (0.1 to 12.8) for sensitivity and -2.7% (-5.7 to -0.5) for specificity. If the point estimates for Xpert Ultra and Xpert MTB/RIF are applied to a hypothetical cohort of 1000 patients, where 10% of those presenting with symptoms have pulmonary tuberculosis, Xpert Ultra will miss 9 cases, and Xpert MTB/RIF will miss 15 cases. The number of people wrongly diagnosed with pulmonary tuberculosis would be 40 with Xpert Ultra and 14 with Xpert MTB/RIF. In smear-negative, culture-positive participants, pooled sensitivity was 77.5% (67.6 to 85.6) for Xpert Ultra versus 60.6% (48.4 to 71.7) for Xpert MTB/RIF; pooled specificity was 95.8% (92.9 to 97.7) for Xpert Ultra versus 98.8% (97.7 to 99.5) for Xpert MTB/RIF (6 studies). In people living with HIV, pooled sensitivity was 87.6% (75.4 to 94.1) for Xpert Ultra versus 74.9% (58.7 to 86.2) for Xpert MTB/RIF; pooled specificity was 92.8% (82.3 to 97.0) for Xpert Ultra versus 99.7% (98.6 to 100.0) for Xpert MTB/RIF (3 studies). In participants with a history of tuberculosis, pooled sensitivity was 84.2% (72.5 to 91.7) for Xpert Ultra versus 81.8% (68.7 to 90.0) for Xpert MTB/RIF; pooled specificity was 88.2% (70.5 to 96.6) for Xpert Ultra versus 97.4% (91.7 to 99.5) for Xpert MTB/RIF (4 studies). The proportion of Ultra trace-positive results ranged from 3.0% to 30.4%. Data were insufficient to estimate the accuracy of Xpert Ultra repeat testing in individuals with initial trace-positive results. Rifampicin resistance detection Pooled sensitivity and specificity were 94.9% (88.9 to 97.9) and 99.1% (97.7 to 99.8) (5 studies, 921 participants; high-certainty evidence) for Xpert Ultra versus 95.3% (90.0 to 98.1) and 98.8% (97.2 to 99.6) (5 studies, 930 participants; high-certainty evidence) for Xpert MTB/RIF. The difference in the accuracy of Xpert Ultra minus Xpert MTB/RIF was estimated at -0.3% (-6.9 to 5.7) for sensitivity and 0.3% (-1.2 to 2.0) for specificity. If the point estimates for Xpert Ultra and Xpert MTB/RIF are applied to a hypothetical cohort of 1000 patients, where 10% of those presenting with symptoms have rifampicin resistance, Xpert Ultra will miss 5 cases, and Xpert MTB/RIF will miss 5 cases. The number of people wrongly diagnosed with rifampicin resistance would be 8 with Xpert Ultra and 11 with Xpert MTB/RIF. We identified a higher number of rifampicin resistance indeterminate results with Xpert Ultra, pooled proportion 7.6% (2.4 to 21.0) compared to Xpert MTB/RIF pooled proportion 0.8% (0.2 to 2.4). The estimated difference in the pooled proportion of indeterminate rifampicin resistance results for Xpert Ultra versus Xpert MTB/RIF was 6.7% (1.4 to 20.1).

Authors' conclusions: Xpert Ultra has higher sensitivity and lower specificity than Xpert MTB/RIF for pulmonary tuberculosis, especially in smear-negative participants and people living with HIV. Xpert Ultra specificity was lower than that of Xpert MTB/RIF in participants with a history of tuberculosis. The sensitivity and specificity trade-off would be expected to vary by setting. For detection of rifampicin resistance, Xpert Ultra and Xpert MTB/RIF had similar sensitivity and specificity. Ultra trace-positive results were common. Xpert Ultra and Xpert MTB/RIF provide accurate results and can allow rapid initiation of treatment for rifampicin-resistant and multidrug-resistant tuberculosis.

Trial registration: ClinicalTrials.gov NCT03154320 NCT03187964 NCT03356925 NCT03497195 NCT03712709 NCT04074369 NCT04122404 NCT02758236.

PubMed Disclaimer

Conflict of interest statement

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

JSK has no known conflicts of interest.

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

MK has received funding from USAID, administered by the World Health Organization Global Tuberculosis Programme, Switzerland, for related systematic reviews.

ND has no known conflicts of interest.

SGS is employed by the Foundation for Innovative New Diagnostics (FIND). FIND has conducted studies and published on Xpert MTB/RIF as part of a collaborative project between FIND, a Swiss nonprofit; Cepheid, a US company; and academic partners. The product developed through this partnership was developed under a contract that obligated FIND to pay for development costs and trial costs and Cepheid to make the test available at specified preferential pricing to the public sector in low‐ and middle‐income countries. In addition, FIND conducted studies for the Xpert MTB/RIF Ultra assay, which have also been published.

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

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

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

MP serves on the Scientific Advisory Committee of Foundation for Innovative New Diagnostics (FIND), Geneva. FIND is a nonprofit agency that works on global health diagnostics.

KRS received funding from USAID, administered by the World Health Organization (WHO) Global Tuberculosis Programme, Switzerland. In addition, she has received financial support from Cochrane Infectious Diseases, UK; McGill University, Canada; and the World Health Organization Global Tuberculosis Programme, Switzerland, for the preparation of related 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.

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

The authors have no financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in this review apart from those disclosed.

Figures

1
1
The clinical pathway describes how people might present and the point in the pathway at which they would be considered for testing with Xpert MTB/RIF or Xpert Ultra. Abbreviations: DST: drug susceptibility testing; INH: isoniazid; MDR‐TB: multidrug‐resistant tuberculosis; MTB: Mycobacterium tuberculosis; mWRD: molecular WHO‐recommended rapid diagnostic; PLHIV: people living with HIV; RIF: rifampicin; TB: tuberculosis; Ultra: Xpert Ultra; WHO: World Health Organization. 1Persons to be evaluated for TB include adults and children with signs or symptoms suggestive of TB, or with a chest X‐ray with abnormalities suggestive of TB. This algorithm may also be followed for the diagnosis of extrapulmonary TB using CSF, lymph node and other tissue specimens.
2Programs may consider collecting two specimens upfront. The first specimen should be promptly tested using the molecular WRD test. The second specimen may be used for the additional testing described in this algorithm. For persons being evaluated for pulmonary TB, sputum is the preferred specimen. Tissue biopsy samples are difficult or impossible to obtain repeatedly; therefore, they should be tested with as many methods as possible (e.g. molecular WRD, culture, DST or histology).
3Molecular WRD tests appropriate for this algorithm include Xpert MTB/RIF, Xpert Ultra, Truenat MTB, Truenat MTB Plus and TB‐LAMP.
4“MTB detected (not trace)” includes MTB detected as high, moderate, low or very low. These categories apply to the original Xpert MTB/RIF and Xpert Ultra tests. Results of the Truenat MTB and MTB Plus tests and the TB‐LAMP test also fall into the category of “MTB detected (not trace)”. Additional footnotes are explained in WHO Consolidated Guidelines (Module 4) 2020. 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 Consolidated Guidelines (Module 4) 2020). Copyright © [2020] [World Health Organization]: reproduced with permission.
2
2
PRISMA flow diagram of studies in the review. *One publication contributed two distinct studies, which were classified as Mishra 2020a and Mishra 2020b.
3
3
Risk of bias and applicability concerns summary for detection of pulmonary tuberculosis: review authors' judgements about each domain for each included study.
4
4
Risk of bias and applicability concerns summary for detection of rifampicin resistance: review authors' judgements about each domain for each included study.
5
5
Forest plots of Xpert Ultra versus Xpert MTB/RIF sensitivity and specificity for pulmonary tuberculosis in adults, unselected participants by reference standard. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI). TP = true positive; FP = false positive; FN = false negative; TN = true negative
6
6
Summary plot of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity for the detection of pulmonary tuberculosis. Each individual study is represented by a shaded circle. The size of the circle is proportional to the sample size of the study such that larger studies are represented by larger circles. The filled circle is the median pooled estimate for sensitivity and specificity, Xpert Ultra (red) and Xpert MTB/RIF (black). The dotted lines represent the 95% credible region around the summary estimate; the dashed lines represent the 95% prediction region. The range is truncated to consider only those regions of the receiver operator characteristic (ROC) space where data have been observed.
7
7
Forest plots of Xpert Ultra versus Xpert MTB/RIF sensitivity and specificity for the detection of pulmonary tuberculosis by smear status. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI). TP = true positive; FP = false positive; FN = false negative; TN = true negative
8
8
Forest plots of Xpert Ultra versus Xpert MTB/RIF sensitivity and specificity for the detection of pulmonary tuberculosis by HIV status and history of tuberculosis. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI). TP = true positive; FP = false positive; FN = false negative; TN = true negative
9
9
Forest plot of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity for the detection of rifampicin resistance. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI). TP = true positive; FP = false positive; FN = false negative; TN = true negative
10
10
Summary plot of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity for the detection of rifampicin resistance. Each individual study is represented by a shaded circle. The size of the circle is proportional to the sample size of the study such that larger studies are represented by larger circles. The filled circle is the median pooled estimate for sensitivity and specificity, Xpert Ultra (red) and Xpert MTB/RIF (black). The dotted lines represent the 95% credible region around the summary estimate; the dashed lines represent the 95% prediction region. The range is truncated to consider only those regions of the receiver operator characteristic (ROC) space where data have been observed.
11
11
Forest plots of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity for the detection of rifampicin resistance by smear status. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI). TP = true positive; FP = false positive; FN = false negative; TN = true negative
12
12
Forest plots of repeated Xpert Ultra sensitivity and specificity for detection of pulmonary tuberculosis in adults with initial trace result, culture reference standard. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI). TP = true positive; FP = false positive; FN = false negative; TN = true negative
13
13
Bayesian bivariate hierarchical model, likelihood.
14
14
Bayesian bivariate hierarchical model, prior distributions.
15
15
Table. Risk of bias concerns summary for detection of pulmonary tuberculosis: review authors' judgements about each domain for each included study, QUADAS‐C judgements. P: Patient selection, I: Index test, R: Reference standard, FT: Flow and Timing
16
16
Table. Risk of bias concerns summary for detection of rifampicin resistance: review authors' judgements about each domain for each included study, QUADAS‐C judgements. P: Patient selection, I: Index test, R: Reference standard, FT: Flow and Timing
1
1. Test
Xpert Ultra for detection of pulmonary TB
2
2. Test
Xpert MTB/RIF for detection of pulmonary TB
3
3. Test
Xpert Ultra for detection of pulmonary TB, composite reference standard
4
4. Test
Xpert MTB/RIF for detection of pulmonary TB, composite reference standard
5
5. Test
Smear‐negative, Xpert Ultra, culture
6
6. Test
Smear‐negative, Xpert MTB/RIF, culture
7
7. Test
Smear‐positive, Xpert Ultra
8
8. Test
Smear‐positive, Xpert MTB/RIF
9
9. Test
HIV‐positive, Xpert Ultra
10
10. Test
HIV‐positive, Xpert MTB/RIF
11
11. Test
HIV‐negative, Xpert Ultra
12
12. Test
HIV‐negative, Xpert MTB/RIF
13
13. Test
Xpert Ultra, history of TB
14
14. Test
Xpert Ultra, no history of TB
15
15. Test
Xpert MTB/RIF, history of TB
16
16. Test
Xpert MTB/RIF, no history of TB
17
17. Test
Xpert Ultra for detection of rifampicin resistance
18
18. Test
Xpert MTB/RIF for detection of rifampicin resistance
19
19. Test
Xpert Ultra repeated test in adults with initial trace result, microbiological reference standard
20
20. Test
Xpert Ultra for detection of rifampicin resistance, smear‐positive
21
21. Test
Xpert MTB/RIF for detection of rifampicin resistance, smear‐positive
22
22. Test
Xpert Ultra for detection of rifampicin resistance, smear‐negative
23
23. Test
Xpert MTB/RIF for detection of rifampicin resistance, smear‐negative
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Berhanu 2018 {published data only}
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Abong 2019 {published data only}
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Acuna‐Villaorduna 2017 {published data only}
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Ade 2016 {published data only}
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Antonenka 2013 {published data only}
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Aricha 2019 {published data only}
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Atashi 2017 {published data only}
    1. Atashi S, Izadi B, Jalilian S, Madani SH, Farahani A, Mohajeri P. Evaluation of GeneXpert MTB/RIF for determination of rifampicin resistance among new tuberculosis cases in west and northwest Iran. New Microbes and New Infections 2017;19:117-20. - PMC - PubMed
Atehortua 2015 {published data only}
    1. Atehortua S, Ramirez F, Echeverri LM, Penata A, Ospina S. Xpert MTB/RIF test performance assay in respiratory samples at real work settings in a developing country. Biomedica 2015;35(1):125-30. - PubMed
Atuhumuza 2016 {published data only}
    1. Atuhumuza E, Yoon C, Katende J, Asege L, Mwebe S, Andama A, et al. Intensified tuberculosis case-finding among people living with HIV: diagnostic yield of Xpert MTB/RIF, urine lipoarabinomannan and liquid culture. Journal of the International AIDS Society 2016;19:WEAB0202.
Atwine 2015 {published data only}
    1. Atwine D, Nansumba M, Orikiriza P, Riera M, Nackers F, Kamara N, et al. Intra-gastric string test: an effective tool for diagnosing tuberculosis in adults unable to produce sputum. International Journal of Tuberculosis and Lung Disease 2015;19(5):558-64. - PubMed
Auld 2016 {published data only}
    1. Auld SC, Moore BK, Kyle RP, Eng B, Nong K, Pevzner ES, et al. Mixed impact of Xpert® MTB/RIF on tuberculosis diagnosis in Cambodia. Public Health Action 2016;6(2):129-35. - PMC - PubMed
Aurin 2014 {published data only}
    1. Aurin TH, Munshi SK, Kamal SM, Rahman MM, Hossain MS, Marma T, et al. Molecular approaches for detection of the multi-drug resistant tuberculosis (MDR-TB) in Bangladesh. PLOS ONE 2014;9(6):e99810. - PMC - PubMed
Avashia 2016 {published data only}
    1. Avashia S, Choubey S, Mishra S, Kharate A. To study the usefulness of CBNAAT (cartridge based nuclear acid amplification test) in BAL (bronchoalveolar lavage) samples in the diagnosis of smear-negative/non sputum producing patients with suspected tuberculosis. JEMDS: Journal of Evolution of Medical and Dental Sciences 2016;5(1):55-9.
Ayala 2016 {published data only}
    1. Ayala G, Garay J, Aragon M, Decroo T, Zachariah R. Trends in tuberculosis notification and treatment outcomes in prisons: a country-wide assessment in El Salvador from 2009-2014. Revista Panamericana de Salud Pública 2016;39(1):38-43. - 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(1-2):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 GenoType® MTBDRplus assays in Georgia. International Journal of Tuberculosis and Lung Disease 2015;19(6):676-8. - PMC - PubMed
Badal‐Faesen 2017 {published data only}
    1. Badal-Faesen S, Firnhaber C, Kendall MA, Wu X, Grinsztejn B, Escada RO, et al. Impact of larger sputum volume on Xpert® MTB/RIF assay detection of Mycobacterium tuberculosis in smear-negative individuals with suspected tuberculosis. Journal of Clinical Medicine 2017;6(8):e78. [DOI: 10.3390/jcm6080078] - DOI - 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, Winqvist N, Sturegard E, Skogmar S, Reepalu A, Jemal ZH, et al. Detection of lipoarabinomannan in urine for identification of active tuberculosis among HIV-positive adults in Ethiopian health centres. Tropical Medicine & International Health 2014;19(6):734-42. - PubMed
Banu 2014 {published data only}
    1. Banu S, Rahman SM, Khan MS, Ferdous SS, Ahmed S, Gratz J, et al. Discordance across several methods for drug susceptibility testing of drug-resistant Mycobacterium tuberculosis isolates in a single laboratory. Journal of Clinical Microbiology 2014;52(1):156-63. - PMC - PubMed
Barcellini 2019 {published data only}
    1. Barcellini L, Borroni E, Cimaglia C, Girardi E, Matteelli A, Marchese V, et al. App-based symptoms screening with Xpert MTB/RIF Ultra assay used for active tuberculosis detection in migrants at point of arrivals in Italy: the E-DETECT TB intervention analysis. PLOS ONE 2019;14(7):e0218039. - PMC - PubMed
Barkham 2016 {published data only}
    1. Barkham T, Tang WY. GeneXpert - a state of the art commercial PCR assay, misses a fifth of tuberculosis cases. Annals of the Academy of Medicine Singapore 2016;45 (9 Suppl 1):S53.
Barnard 2012 {published data only}
    1. Barnard M, Gey van Pittius NC, Van Helden PD, Bosman M, Coetzee G, Warren RM. The diagnostic performance of the GenoType MTBDRplus version 2 line probe assay is equivalent to that of the Xpert MTB/RIF assay. Journal of Clinical Microbiology 2012;50(11):3712-6. - PMC - PubMed
Bates 2013 {published data only}
    1. Bates M, O'Grady J, Maeurer M, Tembo J, Chilukutu L, Chabala C, et al. Assessment of the Xpert MTB/RIF assay for diagnosis of tuberculosis with gastric lavage aspirates in children in sub-Saharan Africa: a prospective descriptive study. Lancet Infectious Diseases 2013;13(1):36-42. - PubMed
Benjamin 2019 {published data only}
    1. Benjamin A, Cavalcante SC, Jamal LF, Arakaki-Sanchez D, Lima JN, Pilotto JH. Accuracy of Determine TB-LAM Ag to detect TB in HIV infected patients associated with diagnostic methods used in Brazilian public health units. PLOS ONE 2019;14(9):e0221038. - PMC - 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
Biadglegne 2014 {published data only}
    1. Biadglegne F, Rodloff AC, Sack U. A first Insight into high prevalence of undiagnosed smear-negative pulmonary tuberculosis in northern Ethiopian prisons: implications for greater investment and quality control. PLOS ONE 2014;9(9):e106869. - 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
Bimba 2019 {published data only}
    1. Bimba JS, Lawson L, Kontogianni K, Edwards T, Ekpenyong BE, Dodd J. PrimeStore MTM and OMNIgene sputum for the preservation of sputum for Xpert MTB/RIF testing in Nigeria. Journal of Clinical Medicine 2019;8(12):2146. - PMC - PubMed
Bisognin 2018 {published data only}
    1. Bisognin F, Lombardi G, Lombardo D, Re MC, Dal Monte P. Improvement of Mycobacterium tuberculosis detection by Xpert MTB/RIF Ultra: a head-to-head comparison on Xpert-negative samples. PLOS ONE 2018;13(8):e0201934. - PMC - PubMed
Bjerrum 2015 {published data only}
    1. Bjerrum S, Kenu E, Lartey M, Newman MJ, Addo KK, Andersen AB, et al. Diagnostic accuracy of the rapid urine lipoarabinomannan test for pulmonary tuberculosis among HIV-infected adults in Ghana-findings from the DETECT HIV-TB study. BMC Infectious Diseases 2015;15:407. - PMC - PubMed
Boakye‐Appiah 2016 {published data only}
    1. Boakye-Appiah JK, Steinmetz AR, Pupulampu P, Ofori-Yirenkyi S, Tetteh I, Frimpong M, et al. High prevalence of multidrug-resistant tuberculosis among patients with rifampicin resistance using GeneXpert Mycobacterium tuberculosis/rifampicin in Ghana. International Journal of Mycobacteriology 2016;5(2):226-30. - PubMed
Bojang 2016 {published data only}
    1. Bojang AL, Mendy FS, Tientcheu LD, Otu J, Antonio M, Kampmann B, et al. Comparison of TB-LAMP, GeneXpert MTB/RIF and culture for diagnosis of pulmonary tuberculosis in The Gambia. Journal of Infection 2016;72(3):332-7. - PubMed
Bonnet 2017 {published data only}
    1. Bonnet M, San KC, Pho Y, Sok C, Dousset JP, Brant W, et al. Nontuberculous mycobacteria infections at a provincial reference hospital, Cambodia. Emerging Infectious Diseases 2017;23(7):1139-47. - PMC - PubMed
Borodulina 2019 {published data only}
    1. Borodulina EA, Borodulin BE, In'kova AT, Vdoushkina ES, Povalyayeva LV. New possibilities to diagnose pulmonary tuberculosis at a pulmonology inpatient department. Pulmonologiya 2019;29(3):321-6.
Boum 2016 {published data only}
    1. Boum Y 2nd, Kim S, Orikiriza P, Acuña-Villaorduña C, Vinhas S, Bonnet M, et al. Diagnostic accuracy of the small membrane filtration method for diagnosis of pulmonary tuberculosis in a high-HIV-prevalence setting. Journal of Clinical Microbiology 2016;54(6):1520-7. - PMC - PubMed
Bowles 2011 {published data only}
    1. Bowles EC, Freyée B, Van Ingen J, Mulder B, Boeree MJ, Van Soolingen D. Xpert MTB/RIF®, a novel automated polymerase chain reaction-based tool for the diagnosis of tuberculosis. International Journal of Tuberculosis and Lung Disease 2011;15(7):988-9. - 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
Byashalira 2019 {published data only}
    1. Byashalira K, Mbelele P, Semvua H, Chilongola J, Semvua S, Liyoyo A, et al. Clinical outcomes of new algorithm for diagnosis and treatment of tuberculosis sepsis in HIV patients. International Journal of Mycobacteriology 2019;8(4):313-9. - PubMed
Capocci 2016 {published data only}
    1. Capocci S, Sewell J, Smith C, Cropley I, Bhagani S, Morris S, et al. Testing for TB in a contemporary UK HIV clinic - is it really worth it? HIV Medicine 2016;17(Suppl 1):38-9.
Causse 2011 {published data only}
    1. Causse M, Ruiz P, Gutiérrez-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
Cavanaugh 2016 {published data only}
    1. Cavanaugh JS, Modi S, Musau S, McCarthy K, Alexander H, Burmen B, et al. Comparative yield of different diagnostic tests for tuberculosis among people living with HIV in western Kenya. PLOS ONE 2016;11(3):e0152364. - PMC - PubMed
Cayci 2017 {published data only}
    1. Cayci YT, Bilgin K, Coban AY, Birinci A, Durupinar B. An evaluation of false-positive rifampicin resistance on the Xpert MTB/RIF. Memórias do Instituto Oswaldo Cruz 2017;112(11):756-9. - PMC - 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
Chakraborty 2019 {published data only}
    1. Chakraborty A, Ramaswamy S, Shivananjiah AJ, 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
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. European Respiratory Journal Open Research 2019;5(4):00008-2019. - PMC - PubMed
Chishty 2016 {published data only}
    1. Chishty S, Farooqi J, Shafqat Y, Shafiq S, Jabeen K, Hasan R. Performance of Xpert MTB/RIF assay from fluorescent acid fast stained slides. European Respiratory Journal. European Respiratory Society Annual Congress 2016;48(Suppl 60):PA2781.
Ciftçi 2011 {published data only}
    1. Ciftçi IH, Aslan MH, Aşik G. Evaluation of Xpert MTB/RIF results for the detection of Mycobacterium tuberculosis in clinical samples. Mikrobiyoloji bülteni 2011;45(1):43-7. - PubMed
Clouse 2012 {published data only}
    1. Clouse K, Page-Shipp L, Dansey H, Moatlhodi B, Scott L, Bassett J, et al. Implementation of Xpert MTB/RIF for routine point-of-care diagnosis of tuberculosis at the primary care level. South African Medical Journal 2012;102(10):805-7. - PubMed
Cross 2014 {published data only}
    1. Cross GB, Coles K, Nikpour M, Moore OA, Denholm J, McBryde ES, et al. TB incidence and characteristics in the remote gulf province of Papua New Guinea: a prospective study. BMC Infectious Diseases 2014;14:93. - PMC - PubMed
Cross 2015 {published data only}
    1. Cross LJ, Anscombe C, McHugh TD, Abubakar I, Shorten RJ, Thorne N, et al. A rapid and sensitive diagnostic screening assay for detection of mycobacteria including Mycobacterium tuberculosis directly from sputum without extraction. International Journal of Bacteriology 2015;2015:593745. - PMC - PubMed
Dagnra 2015 {published data only}
    1. Dagnra AY, Mlaga KD, Adjoh K, Kadanga E, Disse K, Adekambi T. Prevalence of multidrug-resistant tuberculosis cases among HIV-positive and HIV-negative patients eligible for retreatment regimen in Togo using GeneXpert MTB/RIF. New Microbes and New Infections 2015;8:24-7. - 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
Daum 2015 {published data only}
    1. Daum LT, Peters RP, Fourie PB, Jonkman K, Worthy SA, Rodriguez JD, et al. Molecular detection of Mycobacterium tuberculosis from sputum transported in PrimeStore® from rural settings. International Journal of Tuberculosis and Lung Disease 2015;19(5):552-7. - 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
Dierberg 2016 {published data only}
    1. Dierberg KL, Dorjee K, Salvo F, Cronin WA, Boddy J, Cirillo D, et al. Improved detection of tuberculosis and multidrug-resistant tuberculosis among Tibetan refugees, India. Emerging Infectious Diseases 2016;22(3):463-8. - PMC - PubMed
Dorjee 2012 {published data only}
    1. Dorjee K, Salvo F, Dierberg KL. Xpert® MTB/RIF diagnosed disseminated smear-negative MDR-TB in a sub-district hospital in India. International Journal of Tuberculosis and Lung Disease 2012;16(11):1560-1. - PubMed
Dorman 2012 {published data only}
    1. Dorman SE, Chihota VN, Lewis JJ, Shah M, Clark D, Grant AD, et al. Performance characteristics of the Cepheid Xpert MTB/RIF test in a tuberculosis prevalence survey. PLOS ONE 2012;7(8):e43307. - PMC - PubMed
Dowdy 2011 {published data only}
    1. Dowdy DW, Cattamanchi A, Steingart KR, Pai M. Is scale-up worth it? Challenges in economic analysis of diagnostic tests for tuberculosis. PLOS Medicine 2011;8(7):e1001063. - PMC - PubMed
Eldin 2019 {published data only}
    1. Eldin MT, Hamid HA, Elnady M. Evaluation of GeneXpert as a new diagnostic tool for detection of pulmonary tuberculosis. Egyptian Journal of Chest Diseases and Tuberculosis 2019;68(3):270-3.
Elzein 2019 {published data only}
    1. Elzein FE, Alsherbeeni N, Mursi M, Algoblan SF, Abuzaid AA, Albarrak AM. Isolation and deisolation of patients admitted with presumptive pulmonary tuberculosis. Can it be shortened? Saudi Medical Journal 2019;40(10):1008-12. - 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
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
Fernandez 2017 {published data only}
    1. Fernandez Sanchez M, Lasso JI, Canas A, Morantes Ariza C, Cortes G, Sanchez Duran L, et al. Evaluation of the operating characteristics of GeneXpert MTB/RIF at a national reference center: Hospital Universitario San Ignacio, Bogota, Colombia. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society International Conference 2017;195:A2084.
FIND 2011 {published data only}
    1. Foundation for Innovative Diagnostics. Performance of Xpert MTB/RIF Version G4 assay, Version and date: 1.0/30 Nov 2011, Project: 7210. www.stoptb.org/wg/gli/assets/documents/map/findg4cartridge.pdf (accessed 8 May 2019).
Fong 2017 {published data only}
    1. Fong A, Wei C, Chang AH, Kerndt PR, Shulman IA, Butler-Wu S. Evaluation of the Xpert MTB/RIF assay for the detection of tuberculosis in patients being evaluated for tuberculosis in a large public hospital in the United States. Laboratory Investigation 2017;97 Suppl 1:390A.
Friedrich 2011 {published data only}
    1. Friedrich SO, Von Groote-Bidlingmaier F, Diacon AH. Xpert MTB/RIF assay for the diagnosis of pleural tuberculosis. Journal of Clinical Microbiology 2011;49(12):4341-2. - PMC - PubMed
Gama de Andrade 2017 {published data only}
    1. Gama de Andrade TL, Gouget Ferreira Silvano RG, Pombo March MF, Coelho Soares EC, Couto Sant'anna C, Baroni Aurilio R. The Xpert MTB-RIF to diagnose tuberculosis in adolescents from Rio de Janeiro, Brazil. Pediatric Pulmonology 2017;52(Suppl 46):S164-5.
Garcia‐Basteiro 2019 {published data only}
    1. Garcia-Basteiro AL, Hurtado JC, Castillo P, Fernandes F, Navarro M, Lovane L, et al. Unmasking the hidden tuberculosis mortality burden in a large postmortem study in Maputo Central Hospital, Mozambique. European Respiratory Journal 2019;54(3):1900312. - PMC - PubMed
Gati 2018 {published data only}
    1. Gati S, Chetty R, Wilson D, Achkar JM. 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
Gelalcha 2017 {published data only}
    1. Gelalcha AG, Kebede A, Mamo H. Light-emitting diode fluorescent microscopy and Xpert MTB/RIF(R) assay for diagnosis of pulmonary tuberculosis among patients attending Ambo hospital, west-central Ethiopia. BMC Infectious Diseases 2017;17(1):613. - PMC - PubMed
Gounder 2014 {published data only}
    1. Gounder A, Gounder S, Reid SA. Evaluation of the implementation of the Xpert(R) MTB/RIF assay in Fiji. Public Health Action 2014;4(3):179-83. - PMC - PubMed
Griesel 2016 {published data only}
    1. Griesel R, Stewart A, Van Der Plas H, Sikhondze W, Rangaka M, Maartens G, et al. A clinical prediction rule for the diagnosis of tuberculosis in seriously ill adults. Topics in Antiviral Medicine 2016;24 (E-1):309-10.
Griesel 2017 {published data only}
    1. Griesel R, Stewart A, Van der Plas H, Sikhondze W, Rangaka MX, Nicol MP, et al. Optimizing tuberculosis diagnosis in HIV-infected inpatients meeting the criteria of seriously ill in the WHO algorithm. Clinical Infectious Diseases 2017;66(9):1419-26. - PMC - PubMed
Guenaoui 2016 {published data only}
    1. Guenaoui K, Harir N, Ouardi A, Zeggai S, Sellam F, Bekri F, et al. Use of GeneXpert Mycobacterium tuberculosis/rifampicin for rapid detection of rifampicin resistant Mycobacterium tuberculosis strains of clinically suspected multi-drug resistance tuberculosis cases. Annals of Translational Medicine 2016;4(9):168. - PMC - PubMed
Gupta 2014 {published data only}
    1. Gupta RK, Lawn SD, Booth H, Morris-Jones S. What is the role for Xpert® MTB/RIF in high-resource settings? Experience from a central London hospital. International Journal of Tuberculosis and Lung Disease 2014;18(11):1323-6. - PubMed
Gurbanova 2016 {published data only}
    1. Gurbanova E, Mehdiyev R, Blondal K, Tahirli R, Mirzayev F, Hillemann D, et al. Interpretation of indeterminate RIF-susceptibility results obtained by rapid molecular diagnostics test. European Respiratory Journal. European Respiratory Society Annual Congress 2016;48(Suppl 60):PA1907.
Gurbanova 2017 {published data only}
    1. Gurbanova E, Mehdiyev R, Blondal K, Tahirli R, Mirzayev F, Hillemann D, et al. Mitigation of discordant rifampicin-susceptibility results obtained by Xpert Mycobacterium tuberculosis/Rifampicin and Mycobacterium Growth Indicator Tube. Microbial Drug Resistance 2017;23(8):1045-52. - 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. Mikrobiyoloji bülteni 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
Hai 2019 {published data only}
    1. Hai HT, Vinh DN, Thu DDA, Hanh NT, Phu NH, Srinivasan V, et al. Comparison of the Mycobacterium tuberculosis molecular bacterial load assay, microscopy and GeneXpert versus liquid culture for viable bacterial load quantification before and after starting pulmonary tuberculosis treatment. Tuberculosis (Edinb) 2019;119:101864. - PMC - PubMed
Hanifa 2016 {published data only}
    1. Hanifa Y, Fielding KL, Chihota VN, Adonis L, Charalambous S, Karstaedt A, et al. Diagnostic accuracy of lateral flow urine LAM assay for TB screening of adults with advanced immunosuppression attending routine HIV care in South Africa. PLOS ONE 2016;11(6):e0156866. - PMC - PubMed
Heidebrecht 2016 {published data only}
    1. Heidebrecht CL, Podewils LJ, Pym AS, Cohen T, Mthiyane T, Wilson D. Assessing the utility of Xpert® MTB/RIF as a screening tool for patients admitted to medical wards in South Africa. Scientific Reports 2016;6:19391. - PMC - PubMed
Hillemann 2011 {published data only}
    1. Hillemann D, Rüsch-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
Hiza 2017 {published data only}
    1. Hiza H, Doulla B, Sasamalo M, Hella J, Kamwela L, Mhimbira F, et al. Preservation of sputum samples with cetylpyridinium chloride (CPC) for tuberculosis cultures and Xpert MTB/RIF in a low-income country. BMC Infectious Diseases 2017;17(1):542. - PMC - PubMed
Ho 2016 {published data only}
    1. Ho J, Nguyen PT, Nguyen TA, Tran KH, Nguyen S, Nguyen NV, et al. Reassessment of the positive predictive value and specificity of Xpert MTB/RIF: a diagnostic accuracy study in the context of community-wide screening for tuberculosis. Lancet Infectious Diseases 2016;16(9):1045-51. - PubMed
Hodille 2019 {published data only}
    1. Hodille E, Maisson A, Charlet L, Bauduin C, Genestet C, Fredenucci I, et al. Evaluation of Xpert MTB/RIF Ultra performance for pulmonary tuberculosis diagnosis on smear-negative respiratory samples in a French centre. European Journal of Clinical Microbiology & Infectious Diseases 2019;38(3):601-5. - PubMed
Horo 2017 {published data only}
    1. Horo K, N'Guessan R, Koffi MO, Kouame-N'Takpe N, Kone A, Samake K, et al. Use of the Xpert® MTB/RIF test in routine screening of new cases of pulmonary tuberculosis in an endemic area. Revue des Maladies Respiratoires 2017;34(7):749-57. - PubMed
Hu 2014 {published data only}
    1. Hu P, Bai L, Liu F, Ou X, Zhang Z, Yi S, et al. Evaluation of the Xpert MTB/RIF assay for diagnosis of tuberculosis and rifampin resistance in county-level laboratories in Hunan province, China. Chinese Medical Journal 2014;127(21):3744-50. - PubMed
Huang 2018 {published data only}
    1. Huang H, Zhang Y, Li S, Wang J, Chen J, Pan Z, et al. Rifampicin resistance and multidrug-resistant tuberculosis detection using Xpert MTB/RIF in Wuhan, China: a retrospective study. Microbial Drug Resistance 2018;24(5):675-9. [DOI: 10.1089/mdr.2017.0114] - DOI - PubMed
Huerga 2017 {published data only}
    1. Huerga H, Ferlazzo G, Bevilacqua P, Kirubi B, Ardizzoni E, Wanjala S, et al. Incremental yield of including determine-TB LAM assay in diagnostic algorithms for hospitalized and ambulatory HIV-positive patients in Kenya. PLOS ONE 2017;12(1):e0170976. [DOI: 10.1371/journal.pone.0170976] - DOI - PMC - 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;55:175-82.
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
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
Jafari 2013 {published data only}
    1. Jafari C, Ernst M, Kalsdorf B, Lange C. Comparison of molecular and immunological methods for the rapid diagnosis of smear-negative tuberculosis. International Journal of Tuberculosis and Lung Disease 2013;17(11):1459-65. - PubMed
Jin 2019 {published data only}
    1. Jin Y, Wang HQ, Fan JG, Pang J, Zhang PY, Li T. Evaluation of GeneXpert MTB/RIF and BACTEC-MGIT 960 for the detection of tuberculosis among pneumoconiosis-associated tuberculosis patients. Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi 2019;37(9):690-3. - 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 2016 {published data only}
    1. Jipa R, Manea E, Cernat R, Iringo K, Vat AA, Arbune M, et al. Drug-resistant tuberculosis in HIV infected patients. BMC Infectious Diseases 2016;16(4):A107.
Jones‐Lopez 2014 {published data only}
    1. Jones-Lopez E, Manabe YC, Palaci M, Kayiza C, Armstrong D, Nakiyingi L, et al. Prospective cross-sectional evaluation of the small membrane filtration method for diagnosis of pulmonary tuberculosis. Journal of Clinical Microbiology 2014;52(7):2513-20. - PMC - PubMed
Kang 2016 {published data only}
    1. Kang JY, Hyung Woo K, Sanghoon J, Jaeha L, Shinyoung K, Chan Kwon P, et al. Clinical features of discordant result between molecular and phenotypic susceptibility tests in tuberculosis patients. Respirology 2016;21(Suppl 3):200.
Kaur 2016 {published data only}
    1. Kaur R, Kachroo K, Sharma JK, Vatturi SM, Dang A. Diagnostic accuracy of Xpert test in tuberculosis detection: a systematic review and meta-analysis. Journal of Global Infectious Diseases 2016;8(1):32-40. - PMC - PubMed
Kayigire 2013 {published data only}
    1. Kayigire XA, Friedrich SO, Venter A, Dawson R, Gillespie SH, Boeree MJ, et al. Direct comparison of Xpert MTB/RIF assay with liquid and solid mycobacterial culture for quantification of early bactericidal activity. Journal of Clinical Microbiology 2013;51(6):1894-8. - PMC - PubMed
Kazemian 2019 {published data only}
    1. Kazemian H, Kardan-Yamchi J, Bahador A, Khonsari S, Nasehi M, Hamzehloo G, et al. Efficacy of line probe assay in detection of drug-resistant pulmonary tuberculosis in comparison with GeneXpert and phenotypic methods in Iran and genetic analysis of isolates by MIRU-VNTR. Infection and Drug Resistance 2019;12:3585-93. - PMC - PubMed
Kelly‐Cirino 2017 {published data only}
    1. Kelly-Cirino CD, Musisi E, Byanyima P, Kaswabuli S, Andama A, Sessolo A, et al. Investigation of OMNIgene.SPUTUM performance in delayed tuberculosis testing by smear, culture, and Xpert MTB/RIF assays in Uganda. Journal of Epidemiology and Global Health 2017;7(2):103-9. - PMC - 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 2013 {published data only}
    1. Kerkhoff AD, Wood R, Lowe DM, Vogt M, Lawn SD. Blood neutrophil counts in HIV-infected patients with pulmonary tuberculosis: association with sputum mycobacterial load. PLOS ONE 2013;8(7):e67956. - PMC - PubMed
Kerkhoff 2014 {published data only}
    1. Kerkhoff AD, Wood R, Vogt M, Lawn SD. Predictive value of anemia for tuberculosis in HIV-infected patients in Sub-Saharan Africa: an indication for routine microbiological investigation using new rapid assays. Journal of Acquired Immune Deficiency Syndromes 2014;66(1):33-40. - 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
Khalil 2015 {published data only}
    1. Khalil KF, Butt T. Diagnostic yield of bronchoalveolar lavage gene Xpert in smear-negative and sputum-scarce pulmonary tuberculosis. Journal of the College of Physicians and Surgeons Pakistan 2015;25(2):115-8. - PubMed
Khan 2016 {published data only}
    1. Khan SU, Rahman H, Ayaz S, Qasim M, Jabbar A, Khurshid M, et al. GeneXpert assay for rapid detection of Mycobacterium tuberculosis complex in respiratory specimens from a high TB endemic area of Pakistan. Microbial Pathogenesis 2016;95:82-5. - PubMed
Kim 2012 {published data only}
    1. Kim SY, Kim H, Kim SY, Ra EK, Joo SI, Shin S, et al. The Xpert® MTB/RIF assay evaluation in South Korea, a country with an intermediate tuberculosis burden. International Journal of Tuberculosis and Lung Disease 2012;16(11):1471-6. - PubMed
Kim CH 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 CH 2015 {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 XpertMTB/RIF assay. Annals of Clinical and Laboratory Science 2015;45(1):32-8. - PubMed
Kim MJ 2015 {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 YW 2015 {published data only}
    1. Kim YW, Seong MW, Kim TS, Yoo CG, Han SK, Yim JJ. Evaluation of Xpert® MTB/RIF assay: diagnosis and treatment outcomes in rifampicin-resistant tuberculosis. International Journal of Tuberculosis and Lung Disease 2015;19(10):1216-21. - PubMed
Kolia‐Diafouka 2019 {published data only}
    1. Kolia-Diafouka P, Carrere-Kremer S, Lounnas M, Bourdin A, Kremer L, Van de Perre P, et al. Detection of Mycobacterium tuberculosis in paucibacillary sputum: performances of the Xpert MTB/RIF ultra compared to the Xpert MTB/RIF, and IS6110 PCR. Diagnostic Microbiology and Infectious Disease 2019;94(4):365-70. - PubMed
Lange 2017 {published data only}
    1. Lange B, Khan P, Kalmambetova G, Al-Darraji HA, Alland D, Antonenka U, et al. Diagnostic accuracy of the Xpert® MTB/RIF cycle threshold level to predict smear positivity: a meta-analysis. International Journal of Tuberculosis and Lung Disease 2017;21(5):493-502. - PubMed
Laskar 2017 {published data only}
    1. Laskar N, Hossain MA, Nasreen SA, Kamal SM, Roy S, Nahar F, et al. Comparative yielding of BACTEC MGIT 960 and GeneXpert MTB/RIF assay for rapid diagnosis of drug resistance tuberculosis from sputum specimen. Mymensingh Medical Journal 2017;26(4):885-91. - PubMed
Lawn 2012a {published data only}
    1. Lawn SD, Kerkhoff AD, Vogt M, Ghebrekristos Y, Whitelaw A, Wood R. Characteristics and early outcomes of patients with Xpert MTB/RIF-negative pulmonary tuberculosis diagnosed during screening before antiretroviral therapy. Clinical Infectious Diseases 2012;54(8):1071-9. - PMC - PubMed
Lawn 2012b {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 2012c {published data only}
    1. Lawn SD, Kerkhoff AD, Vogt M, Wood R. Clinical significance of lipoarabinomannan detection in urine using a low-cost point-of-care diagnostic assay for HIV-associated tuberculosis. AIDS 2012;26(13):1635-43. - 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. - 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. - 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. - PMC - PubMed
Lebina 2016 {published data only}
    1. Lebina L, Fuller N, Osoba T, Scott L, Motlhaoleng K, Rakgokong M, et al. The use of Xpert MTB/RIF for active case finding among TB contacts in North West Province, South Africa. Tuberculosis Research and Treatment 2016;2016:4282313. - PMC - PubMed
Lessells 2017 {published data only}
    1. Lessells RJ, Cooke GS, McGrath N, Nicol MP, Newell ML, Godfrey-Faussett P. Impact of point-of-care Xpert MTB/RIF on tuberculosis treatment initiation. A cluster-randomized trial. American Journal of Respiratory and Critical Care Medicine 2017;196(7):901-10. - PMC - PubMed
Li 2016 {published data only}
    1. Li Q, Bao XD, Liu Y, Ou XC, Pang Y, Zhao YL. Comparison of two molecular assays for detecting smear negative pulmonary tuberculosis. Biomedical and Environmental Sciences 2016;29(4):248-53. - PubMed
Li 2017 {published data only}
    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. - 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
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
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. - PMC - PubMed
Luetkemeyer 2016 {published data only}
    1. Luetkemeyer AF, Firnhaber C, Kendall MA, Wu X, Mazurek GH, Benator DA, et al. Evaluation of Xpert MTB/RIFversus AFB smear and culture to identify pulmonary tuberculosis in patients with suspected tuberculosis from low and higher prevalence settings. Clinical InfectiousDiseases 2016;62(9):1081–8. - PMC - PubMed
Mafort 2017 {published data only}
    1. Mafort TT, Rodrigues LS, Santos A, Reis LVT, Faria LF, Brito GMX, et al. Bronchoalveolar lavage GeneXpert MTB/RIF performance in smear-negative pulmonary tuberculosis - a tertiary care experience in Rio De Janeiro, Brazil. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society International Conference 2017;195:A2085.
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
Marlowe 2011 {published data only}
    1. Marlowe EM, Novak-Weekley SM, Cumpio J, Sharp SE, Momeny MA, Babst A, et al. Evaluation of the Cepheid Xpert MTB/RIF assay for direct detection of Mycobacterium tuberculosis complex in respiratory specimens. Journal of Clinical Microbiology 2011;49(4):1621-3. - PMC - PubMed
Matabane 2015 {published data only}
    1. Matabane MM, Ismail F, Strydom KA, Onwuegbuna O, Omar SV, Ismail N. Performance evaluation of three commercial molecular assays for the detection of Mycobacterium tuberculosis from clinical specimens in a high TB-HIV-burden setting. BMC Infectious Diseases 2015;15:508. - PMC - PubMed
Mave 2017 {published data only}
    1. Mave V, Nimkar S, Prasad H, Kadam D, Meshram S, Lokhande R, et al. Tuberculosis screening among persons with diabetes mellitus in Pune, India. BMC Infectious Diseases 2017;17(1):388. - PMC - PubMed
Maynard‐Smith 2014 {published data only}
    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. - 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
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
Miotto 2012 {published data only}
    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
Mntonintshi 2017 {published data only}
    1. Mntonintshi M, O'Mahony D, Mabunda S, Namugenyi KA. Undiagnosed tuberculosis in patients with HIV infection who present with severe anaemia at a district hospital. African Journal of Primary Health Care and Family Medicine 2017;9(1):e1-6. - PMC - PubMed
Modi 2016 {published data only}
    1. Modi S, Cavanaugh JS, Shiraishi RW, Alexander HL, McCarthy KD, Burmen B, et al. Performance of clinical screening algorithms for tuberculosis intensified case finding among people living with HIV in Western Kenya. PLOS ONE 2016;11(12):e0167685. [DOI: 10.1371/journal.pone.0167685] - DOI - PMC - PubMed
Mokaddas 2016 {published data only}
    1. Mokaddas EM, Saadaldeen H, Ahmad S. Comparison of two molecular methods and an automated liquid culture system for the early detection of Mycobacterium tuberculosis from both pulmonary and extrapulmonary specimens in Kuwait. International Journal of Mycobacteriology 2016;5 Suppl 1:S74-5. - PubMed
More 2017 {published data only}
    1. More SW, Parande MA, Kamble SW, Kamble MS. Profile of drug-resistant tuberculosis in Western Maharashtra. Journal of Family Medicine and Primary Care 2017;6(1):29-33. - PMC - PubMed
Morozova 2016 {published data only}
    1. Morozova TI, Salina T. The results of drug susceptibility testing of Mycobacterium tuberculosis to rifampicin by Xpert MTB/RIF BACTEC MGIT 960 as compared with the method of seeding on solid nutrient media. European Respiratory Journal. European Respiratory Society Annual Congress 2016;48(Suppl 60):PA2783.
Moure 2012 {published data only}
    1. Moure R, Martin 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
Mukherjee 2017 {published data only}
    1. Mukherjee S, Biswas D, Begum S, Ghosh P, Paul A, Sarkar S. Evaluation of cartridge based nucleic acid amplification test in diagnosis of pulmonary tuberculosis. JEMDS: Journal of Evolution of Medical and Dental Sciences 2017;6(74):5281-6.
Mulder 2017 {published data only}
    1. Mulder C, Mgode GF, Ellis H, Valverde E, Beyene N, Cox C, et al. Accuracy of giant African pouched rats for diagnosing tuberculosis: comparison with culture and Xpert® MTB/RIF. International Journal of Tuberculosis and Lung Disease 2017;21(11):1127-33. - PubMed
Muñoz 2013 {published data only}
    1. Muñoz L, Moure R, Porta N, Gonzalez L, Guerra R, Alcaide F, et al. GeneXpert® for smear-negative pulmonary tuberculosis: does it play a role in low-burden countries? Diagnostic Microbiology Infectious Disease 2013;75(3):325-6. - PubMed
Myneedu 2014 {published data only}
    1. Myneedu VP, Behera D, Verma AK, Bhalla M, Singh N, Arora J, et al. Xpert® MTB/RIF assay for tuberculosis diagnosis: evaluation in an Indian setting. International Journal of Tuberculosis and Lung Disease 2014;18(8):958-60. - PubMed
Naidoo 2016 {published data only}
    1. Naidoo P, Dunbar R, Lombard C, Du Toit E, Caldwell J, Detjen A, et al. Comparing tuberculosis diagnostic yield in smear/culture and Xpert1 MTB/RIF-based algorithms using a non-randomised stepped-wedge design. PLOS ONE 2016;11(3):e0150487. - PMC - PubMed
Narasimooloo 2012 {published data only}
    1. Narasimooloo R, Ross A. Delay in commencing treatment for MDR TB at a specialised TB treatment centre in KwaZulu-Natal. South African Medical Journal 2012;102(6 Pt 2):360-2. - PubMed
Ng 2018 {published data only}
    1. Ng KC, Van Deun A, Meehan CJ, Torrea G, Driesen M, Gabriels S, et al. Xpert Ultra can unambiguously identify specific rifampin resistance-conferring mutations. Journal of Clinical Microbiology 2018;56(9):e00686-18. [DOI: 10.1128/JCM.00686-18] - DOI - PMC - PubMed
Nguyen 2018 {published data only}
    1. Nguyen VA, Nguyen HV, Dinh TV, Du HH, Do CN, Marks GB, et al. Evaluation of Loopamp™ MTBC detection kit for diagnosis of pulmonary tuberculosis at a peripheral laboratory in a high burden setting. Diagnostic Microbiology and Infectious Disease 2017;90(3):190-5. - PubMed
Ngwira 2017 {published data only}
    1. Ngwira LG, Khundi M, Barnes GL, Nkhoma A, Murowa M, Cohn S, et al. Screening for tuberculosis with Xpert MTB/RIF versus fluorescent microscopy among people newly diagnosed with HIV in rural Malawi: a cluster-randomized trial. Journal of the International AIDS Society 2017;20:93-4.
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. - PMC - PubMed
Nicol 2011 {published data only}
    1. Nicol MP, Workman L, Isaacs W, Munro J, Black F, Eley B, et al. Accuracy of the Xpert MTB/RIF test for the diagnosis of pulmonary tuberculosis in children admitted to hospital in Cape Town, South Africa: a descriptive study. Lancet Infectious Diseases 2011;11(11):819-24. - PMC - PubMed
Ninan 2016 {published data only}
    1. Ninan MM, Gowri M, Christopher DJ, Rupali P, Michael JS. The diagnostic utility of line probe assays for multidrug-resistant tuberculosis. Pathogens and Global Health 2016;110(4-5):194-9. - PMC - PubMed
Nosova 2013a {published data only}
    1. Nosova EY, Krasnova MA, Galkina KY, Makarova MV, Litvinov VI, Moroz AM. Comparing performance of "TB-BIOCHIP", "Xpert MTB/RIF" and "genotype MTBDRplus" assays for fast identification of mutations in the Mycobacterium tuberculosis complex in sputum from TB patients. Molekuliarnaia Biologiia (Mosk) 2013;47(2):267-74. - PubMed
Nosova 2013b {published data only}
    1. Nosova EY, Krasnova MA, Galkina KY, Makarova MV, Litvinov VI, Moroz AM. Comparative analysis of TB Biochip, Xpert MTB/RIF, and GenoType MTBDRplus test systems for rapid determination of mutations responsible for drug resistance of M-tuberculosis complex (in sputum from patients in Moscow region). Molecular Biology (Moscow) 2013;47(2):236-41.
Ntinginya 2012 {published data only}
    1. Ntinginya EN, Squire SB, Millington KA, Mtafya B, Saathoff E, Heinrich N, et al. Performance of the Xpert® MTB/RIF assay in an active case-finding strategy: a pilot study from Tanzania. International Journal of Tuberculosis and Lung Disease 2012;16(11):1468-70. - PubMed
O'Grady 2012 {published data only}
    1. O'Grady J, Bates M, Chilukutu L, Mzyece J, Cheelo B, Chilufya M, et al. Evaluation of the Xpert MTB/RIF assay at a tertiary care referral hospital in a setting where tuberculosis and HIV infection are highly endemic. Clinical Infectious Diseases 2012;55(9):1171-8. - PubMed
Oliveira 2019 {published data only}
    1. Oliveira MCB, Sant'Anna CC, Luiz RR, Soares ECC, Kritski AL. Contribution of Xpert MTB/RIF to clinical diagnosis in adolescents with tuberculosis in Rio de Janeiro, Brazil. International Journal of Tuberculosis and Lung Disease 2019;23(10):1115-21. - PubMed
Omar 2019 {published data only}
    1. Omar A, Elfadl AE, 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.
Omrani 2014 {published data only}
    1. Omrani AS, Al-Otaibi MF, Al-Ateah SM, Al-Onazi FM, Baig K, El-Khizzi NA, et al. GeneXpert MTB/RIF testing in the management of patients with active tuberculosis; a real life experience from Saudi Arabia. Infection and Chemotherapy 2014;46(1):30-4. - PMC - PubMed
Opota 2016 {published data only}
    1. Opota O, Senn L, Prod'hom G, Mazza-Stalder J, Tissot F, Greub G, et al. Added value of molecular assay Xpert MTB/RIF compared to sputum smear microscopy to assess the risk of tuberculosis transmission in a low-prevalence country. Clinical Microbiology and Infection 2016;22(7):613-9. - PubMed
Osman 2014 {published data only}
    1. Osman M, Simpson JA, Caldwell J, Bosman M, Nicol MP. GeneXpert MTB/RIF version G4 for identification of rifampin-resistant tuberculosis in a programmatic setting. Journal of Clinical Microbiology 2014;52(2):635-7. - PMC - PubMed
Ou 2015 {published data only}
    1. Ou X, Xia H, Li Q, Pang Y, Wang S, Zhao B, et al. A feasibility study of the Xpert MTB/RIF test at the peripheral level laboratory in China. International Journal of Infectious Diseases 2015;31:41-6. - PubMed
Ozkutuk 2014 {published data only}
    1. Ozkutuk N, Surucüoglu S. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary tuberculosis in an intermediate-prevalence setting. Mikrobiyoloji Bulteni 2014;48(2):223-32. - PubMed
Pandey P 2017 {published data only}
    1. Pandey P, Pant ND, Rijal KR, Shrestha B, Kattel S, Banjara MR, et al. Diagnostic accuracy of GeneXpert MTB/RIF assay in comparison to conventional drug susceptibility testing method for the diagnosis of multidrug-resistant tuberculosis. PLOS ONE 2017;12(1):e0169798. - PMC - PubMed
Pandey S 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
Parcell 2017 {published data only}
    1. Parcell BJ, Jarchow-MacDonald AA, Seagar AL, Laurenson IF, Prescott GJ, Lockhart M. Three year evaluation of Xpert MTB/RIF in a low prevalence tuberculosis setting: a Scottish perspective. Journal of Infection 2017;74(5):466-72. - PubMed
Patel 2020 {published data only}
    1. Patel J, Upadhyay M, Kundnani V, Merchant Z, Jain S, Kire N. Diagnostic efficacy, sensitivity, and specificity of Xpert MTB/RIF assay for spinal tuberculosis and rifampicin resistance. Spine 2020;45(3):163-9. - PubMed
Patil 2014 {published data only}
    1. Patil N, Saba H, Marco A, Samant R, Mukasa L. Initial experience with GeneXpert MTB/RIF assay in the Arkansas Tuberculosis Control Program. Australasian Medical Journal 2014;7(5):203-7. - PMC - PubMed
Patil 2017 {published data only}
    1. Patil S, Narwade S, Mirza M. Bronchial wash Gene Xpert MTB/RIF in lower lung field tuberculosis: sensitive, superior, and rapid in comparison with conventional diagnostic techniques. Journal of Translational Internal Medicine 2017;5(3):174-81. - PMC - 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. - PMC - PubMed
Peter 2013 {published data only}
    1. Peter JG, Theron G, Pooran A, Thomas J, Pascoe M, Dheda K. Comparison of two methods for acquisition of sputum samples for diagnosis of suspected tuberculosis in smear-negative or sputum-scarce people: a randomised controlled trial. Lancet Respiratory Medicine 2013;1(6):471-8. - PMC - PubMed
Peter 2015 {published data only}
    1. Peter J, Theron G, Chanda D, Clowes P, Rachow A, Lesosky M, et al. Test characteristics and potential impact of the urine LAM lateral flow assay in HIV-infected outpatients under investigation for TB and able to self-expectorate sputum for diagnostic testing. BMC Infectious Diseases 2015;15:262. - PMC - PubMed
Qureshi 2019 {published data only}
    1. Qureshi S, Sohaila A, Hannan S, Amir Sheikh MD, Qamar FN. Comparison of Xpert MTB/RIF with AFB smear and AFB culture in suspected cases of paediatric tuberculosis in a tertiary care hospital, Karachi. Journal of the Pakistan Medical Association 2019;69(9):1273-8. - 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
Rahman 2016 {published data only}
    1. Rahman A, Sahrin M, Afrin S, Earley K, Ahmed S, Rahman SM, et al. Comparison of Xpert MTB/RIF assay and GenoType MTBDRplus DNA probes for detection of mutations associated with rifampicin resistance in Mycobacterium tuberculosis. PLOS ONE 2016;11(4):e0152694. - PMC - PubMed
Raizada 2015 {published data only}
    1. Raizada N, Sachdeva KS, Sreenivas A, Kulsange S, Gupta RS, Thakur R, et al. Catching the missing million: experiences in enhancing TB & DR-TB detection by providing upfront Xpert MTB/RIF testing for people living with HIV in India. PLOS ONE 2015;10(2):e0116721. - PMC - PubMed
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.
Ramirez 2014 {published data only}
    1. Ramirez HL, Garcia-Clemente MM, Alvarez-Alvarez C, Palacio-Gutierrez JJ, Pando-Sandoval A, Gagatek S, et al. Impact of the Xpert® MTB/RIF molecular test on the late diagnosis of pulmonary tuberculosis. International Journal of Tuberculosis and Lung Disease 2014;18(4):435-7. - PubMed
Rasheed 2019 {published data only}
    1. Rasheed W, Rao NA, Adel H, Baig MS, Adil SO. Diagnostic accuracy of Xpert MTB/RIF in sputum smear-negative pulmonary tuberculosis. Cureus 2019;11(8):e5391. - PMC - PubMed
Rathish 2019 {published data only}
    1. Rathish B, Wilson A, Pillay R, Warrier A, Philips G. A bundled approach to pulmonary tuberculosis testing: experience from a tertiary care centre in South India. Cureus 2019;11(10):e6042. - PMC - PubMed
Rathour 2019 {published data only}
    1. Rathour JS, Mantan M, Khanna A, Hanif M. Evaluation of Gene Xpert assay in extrapulmonary tuberculosis in children. JEMDS: Journal of Evolution of Medical and Dental Sciences 2019;8(1).
Reechaipichitkul 2016 {published data only}
    1. Reechaipichitkul W, Phetsuriyawong A, Chaimanee P, Ananta P. Diagnostic test of sputum GeneXpert MTB/RIF for smear negative pulmonary tuberculosis. Southeast Asian Journal of Tropical Medicine and Public Health 2016;47(3):457-66. - PubMed
Reechaipichitkul 2017 {published data only}
    1. Reechaipichitkul W, Suleesathira T, Chaimanee P. Comparison of GeneXpert MTB/RIF assay with conventional AFB smear for diagnosis of pulmonary tuberculosis in northeastern Thailand. Southeast Asian Journal of Tropical Medicine and Public Health 2017;48(2):313-21. - PubMed
Reed 2016 {published data only}
    1. Reed JL, Walker ZJ, Basu D, Allen V, Nicol MP, Kelso DM, et al. Highly sensitive sequence specific qPCR detection of Mycobacterium tuberculosis complex in respiratory specimens. Tuberculosis (Edinb) 2016;101:114-24. - PubMed
Rees 2018 {published data only}
    1. Rees K, Muditambi N, Maswanganyi M, Railton J, McIntyre JA, Struthers HE, et al. The impact of implementing a Xpert MTB/RIF algorithm on drug-sensitive pulmonary tuberculosis: a retrospective analysis. Epidemiology & Infection 2018;146:246–55. - PMC - PubMed
Reis 2019 {published data only}
    1. Reis AJ, Diniz J, Silva ABS, Silveira J, Basso R, Vieira R, et al. Laboratory tools for tuberculosis control in a setting with a high burden of HIV/AIDS. Journal of Medical Microbiology 2019;68(11):1622-8. - PubMed
Rivera 2019 {published data only}
    1. Rivera VR, Lu L, Ocheretina O, Jean Juste MA, Julma P, Archange D, et al. Diagnostic yield of active case finding for tuberculosis at human immunodeficiency virus testing in Haiti. International Journal of Tuberculosis and Lung Disease 2019;23(11):1217-22. - PMC - PubMed
Rossato 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
Rufai 2014 {published data only}
    1. Rufai SB, Kumar P, Singh A, Prajapati S, Balooni V, Singh S. Comparison of Xpert MTB/RIF with line probe assay for detection of rifampin-monoresistant Mycobacterium tuberculosis. Journal of Clinical Microbiology 2014;52(6):1846-52. - PMC - PubMed
Ruiz 2017 {published data only}
    1. Ruiz P, Causse M, Vaquero M, Gutierrez JB, 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 2015 {published data only}
    1. Sachdeva KS, Raizada N, Sreenivas A, Van't Hoog AH, Van den Hof S, Dewan PK, et al. Use of Xpert MTB/RIF in decentralized public health settings and its effect on pulmonary TB and DR-TB case finding in India. PLOS ONE 2015;10(5):e0126065. - PMC - PubMed
Saeed 2017 {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
Sanchez‐Padilla 2015 {published data only}
    1. Sanchez-Padilla E, Merker M, Beckert P, Jochims F, Dlamini T, Kahn P, et al. Detection of drug-resistant tuberculosis by Xpert MTB/RIF in Swaziland. New England Journal of Medicine 2015;372(12):1181-2. - PubMed
Sauzullo 2016 {published data only}
    1. Sauzullo I, Rodio DM, Facchinetti S, Puggioni G, De Angelis M, Goldoni P, et al. Diagnostic accuracy of Xpert MTB/RIF versus smear microscopy in the early diagnosis tuberculosis in the real life of "Umberto I" Hospital Rome. New Microbiologica 2016;39(4):304-6. - PubMed
Schutz 2019 {published data only}
    1. Schutz C, Ward A, Burton R, Nicol MP, 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
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 2014 {published data only}
    1. Shah M, Ssengooba W, Armstrong D, Nakiyingi L, Holshouser M, Ellner JJ, et al. Comparative performance of urinary lipoarabinomannan assays and Xpert MTB/RIF in HIV-infected individuals. AIDS 2014;28(9):1307-14. - PMC - PubMed
Shah 2020 {published data only}
    1. Shah M, Paradis S, Betz J, Beylis N, Bharadwaj R, Caceres T, et al. Multicenter study of the accuracy of the BD MAX MDR-TB assay for detection of Mycobacterium tuberculosis Complex and mutations associated with resistance to rifampin and isoniazid. Clinical Infectious Diseases 2020;71(5):1161-7. [DOI: 10.1093/cid/ciz932] - DOI - PMC - 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;Oct 3:1-8. - PubMed
Shenai 2013 {published data only}
    1. Shenai S, Amisano D, Ronacher K, Kriel M, Banada PP, Song T, et al. Exploring alternative biomaterials for diagnosis of pulmonary tuberculosis in HIV-negative patients by use of the GeneXpert MTB/RIF assay. Journal of Clinical Microbiology 2013;51(12):4161-6. - PMC - PubMed
Shenoy 2019 {published data only}
    1. Shenoy VP, Kumar A, Chawla K. Diagnostic performance of Xpert MTB /RIF in comparison with LED fluorescence microscopy and culture in suspected cases of pulmonary tuberculosis. Journal of Pure and Applied Microbiology 2019;13(3):1461-5.
Shilpa 2017 {published data only}
    1. Shilpa, Nadagir SD, Jnaneshwara KB, Patil AB, Pendari AG, Chikkaraddi U. Detection of rifampicin resistance in HIV seropositive individuals with suspected pulmonary tuberculosis by using CBNAAT. Journal of Pure and Applied Microbiology 2017;11(1):387-92.
Simone 2019 {published data only}
    1. Simone A. Comparative analysis of the bacilloscopy technique in the diagnosis of pulmonary tuberculosis against GeneXpert in samples of patients in the city of Recife, Pernambuco [Análise comparativa da técnica de baciloscopia no diagnóstico da tuberculose pulmonar frente ao GeneXpert em amostras de pacientes da cidade de Recife, Pernambuco]. Revista Brasileira de Análises Clínicas 2019;51(1):65-9.
Singh 2019 {published data only}
    1. Singh M, Sethi GR, Mantan M, Khanna A, Hanif M. Respiratory specimens for the diagnosis of pediatric pulmonary tuberculosis: a Comparative Assessment. SN Comprehensive Clinical Medicine 2019;1(12):1056-9.
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
Somashekar 2014 {published data only}
    1. Somashekar N, Chadha VK, Praseeja P, Sharada MA, Chandrakala GR, Srivastava R, et al. Role of pre-Xpert(R) screening using chest X-ray in early diagnosis of smear-negative pulmonary tuberculosis. International Journal of Tuberculosis and Lung Disease 2014;18(10):1243-4. - PubMed
Somily 2016 {published data only}
    1. Somily AM, Barry MA, Habib HA, Alotaibi FE, Al-Zamil FA, Khan MA, et al. Evaluation of GeneXpert MTB/RIF for detection of Mycobacterium tuberculosis complex and rpo B gene in respiratory and non-respiratory clinical specimens at a tertiary care teaching hospital in Saudi Arabia. Saudi Medical Journal 2016;37(12):1404-7. - PMC - PubMed
Strydom 2015 {published data only}
    1. Strydom K, Ismail F, Matabane MM, Onwuegbuna O, Omar SV, Ismail N. Comparison of three commercial molecular assays for detection of rifampin and isoniazid resistance among Mycobacterium tuberculosis isolates in a high-HIV-prevalence setting. Journal of Clinical Microbiology 2015;53(9):3032-4. - PMC - PubMed
Sumalani 2019 {published data only}
    1. Sumalani KK, Akhter N, Chawla D, Rizvi NA. Diagnostic yield of sputum induction in patients with pleural tuberculosis at a tertiary care hospital in Karachi. International Journal of Tuberculosis and Lung Disease 2019;23(11):1213-6. - PubMed
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.
Sun 2019 {published data only}
    1. Sun L, Qi X, Liu F, Wu X, Yin Q, Guo Y, et al. A test for more accurate diagnosis of pulmonary tuberculosis. Pediatrics 2019;144(5):e20190262. - PubMed
Sureshbabu 2016 {published data only}
    1. Sureshbabu R, Lakshmi Murali A, Palaniswamy M. Molecular diagnosis of drug resistance tuberculosis in the districts of Tamilnadu. International Journal of Pharma and Bio Sciences 2016;7(4):B42-6.
Tadesse 2016 {published data only}
    1. Tadesse M, Aragaw D, Dimah B, Efa F, Abebe G. Xpert MTB/RIF for rapid detection of rifampicin-resistant Mycobacterium tuberculosis from pulmonary tuberculosis patients in southwest Ethiopia. International Journal of Mycobacteriology 2016;5 Suppl 1:S48-9. - PubMed
Tahseen 2016 {published data only}
    1. Tahseen S, Qadeer E, Khanzada FM, Rizvi AH, Dean A, Van Deun A, et al. Use of Xpert® MTB/RIF assay in the first national anti-tuberculosis drug resistance survey in Pakistan. International Journal of Tuberculosis and Lung Disease 2016;20(4):448-55. - PubMed
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 Disease 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 Other Mycobacterial Diseases 2019;17:100131. - PMC - PubMed
Tan 2017 {published data only}
    1. Tan Y, Li Q, Wang Q, Sun H, Chen J, Cai X, et al. Evaluation of the MTBDRplus 2.0 assay for the detection of multidrug resistance among persons with presumptive pulmonary TB in China. Science Reports 2017;7(1):3364. - PMC - PubMed
Taylor 2012 {published data only}
    1. Taylor N, Gaur RL, Baron EJ, Banaei N. Can a simple flotation method lower the limit of detection of Mycobacterium tuberculosis in extrapulmonary samples analyzed by the GeneXpert MTB/RIF assay? Journal of Clinical Microbiology 2012;50(7):2272-6. - 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 and the amplified Mycobacterium tuberculosis Direct assay, for the detection of Mycobacterium tuberculosis in respiratory and non-respiratory specimens. Journal of Clinical Microbiology 2011;49(10):3659-62. - PMC - PubMed
Theron 2012 {published data only}
    1. Theron G, Peter J, Lenders L, Van Zyl-Smit R, Meldau R, Govender U, et al. Correlation of mycobacterium tuberculosis specific and non-specific quantitative Th1 T-cell responses with bacillary load in a high burden setting. PLOS ONE 2012;7(5):e37436. - PMC - PubMed
Theron 2014a {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. Science Reports 2014;4:5658. - PMC - PubMed
Theron 2016 {published data only}
    1. Theron G, Venter R, Calligaro G, Smith L, Limberis J, Meldau R, et al. Xpert MTB/RIF results in patients with previous tuberculosis: can we distinguish true from false positive results? Clinical Infectious Diseases 2016;62(8):995-1001. - PMC - PubMed
Theron 2018 {published data only}
    1. Theron G, Venter R, Smith L, Esmail A, Randall P, Sood V, et al. False positive Xpert MTB/RIF results in re-tested patients with previous tuberculosis: frequency, profile, and prospective clinical outcomes. Journal of Clinical Microbiology 2018;56(3):e01696-17. - PMC - PubMed
Thibbadee 2016 {published data only}
    1. Thibbadee C. Evaluation of decentralised use of the Xpert MTB/RRIF test for diagnosis of tuberculosis and multidrug resistance in Rayong hospital, Thailand. Respirology 2016;21 (Suppl 3):198.
Thit 2017 {published data only}
    1. Thit SS, Aung NM, Htet ZW, Boyd MA, Saw HA, Anstey NM, et al. The clinical utility of the urine-based lateral flow lipoarabinomannan assay in HIV-infected adults in Myanmar: an observational study. BMC Medicine 2017;15(1):145. - PMC - PubMed
To 2017 {published data only}
    1. To KW, Kam KM, Lee SS, Chan KP, Yip T, Lo R, et al. Clinical application of GeneXpert on BAL samples in management of TB in intermediate burden area. Chest 2017;152 (4 Suppl 1):A194.
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
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
Udgirkar 2019 {published data only}
    1. Udgirkar S, Jain S, Pawar S, Chandnani S, Contractor Q, Rathi P. Clinical profile, drug resistance pattern and treatment outcomes of abdominal tuberculosis patients in western India. Archives of Gastroenterology 2019;56(2):178-83. - PubMed
Ullah 2016 {published data only}
    1. Ullah I, Shah AA, Basit A, Ali M, Khan A, Ullah U, et al. Rifampicin resistance mutations in the 81 bp RRDR of rpoB gene in Mycobacterium tuberculosis clinical isolates using Xpert MTB/RIF in Khyber Pakhtunkhwa, Pakistan: a retrospective study. BMC Infectious Diseases 2016;16:413. - PMC - 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 Kampen 2015 {published data only}
    1. Van Kampen SC, Tursynbayeva A, Koptleuova A, Murzakhmetova Z, Bigalieva L, Aubakirova M, et al. Effect of introducing Xpert MTB/RIF to test and treat individuals at risk of multidrug-resistant tuberculosis in Kazakhstan: a prospective cohort study. PLOS ONE 2015;10(7):e0132514. - PMC - PubMed
Van Rie 2011 {published data only}
    1. Van Rie A. A single Xpert MTB/RIF test of sputum for diagnosis of tuberculosis and multidrug resistance shows high sensitivity and specificity and reduces diagnosis and treatment delays. BMJ Evidence-Based Medicine 2011;16(6):174-5. - PubMed
Walters 2012 {published data only}
    1. Walters E, Gie RP, Hesseling AC, Friedrich SO, Diacon AH. Rapid diagnosis of pediatric intrathoracic tuberculosis from stool samples using the Xpert MTB/RIF Assay: a pilot study. Pediatric Infectious Disease Journal 2012;31(12):1316. - PubMed
Walusimbi 2013 {published data only}
    1. Walusimbi S, Bwanga F, De Costa A, Haile M, Joloba M, Hoffner S. Meta-analysis to compare the accuracy of GeneXpert, MODS and the WHO 2007 algorithm for diagnosis of smear-negative pulmonary tuberculosis. BMC Infectious Diseases 2013;13:507. - PMC - PubMed
Wang 2015 {published data only}
    1. Wang XW, Pappoe F, Huang Y, Cheng XW, Xu DF, Wang H, et al. Xpert MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in children: a meta-analysis. Clinical Laboratory 2015;61(11):1775-85. - PubMed
Wang 2016 {published data only}
    1. Wang SF, Ou XC, Li Q, Zheng HW, Wang YF, Zhao YL. The Abbott RealTime MTB assay and the Cepheid GeneXpert assay show comparable performance for the detection of Mycobacterium tuberculosis in sputum specimens. International Journal of Infectious Diseases 2016;45:78-80. - PubMed
Williamson 2012 {published data only}
    1. Williamson DA, Roberts SA, Bower JE, Vaughan R, Newton S, Lowe O, et al. Clinical failures associated with rpoB mutations in phenotypically occult multidrug-resistant Mycobacterium tuberculosis. International Journal of Tuberculosis and Lung Disease 2012;16(2):216-20. - PubMed
Wood 2012 {published data only}
    1. Wood R, Racow K, Bekker LG, Middelkoop K, Vogt M, Kreiswirth BN, et al. Lipoarabinomannan in urine during tuberculosis treatment: association with host and pathogen factors and mycobacteriuria. BMC Infectious Diseases 2012;12:47. - PMC - PubMed
Xie 2017 {published data only}
    1. Xie YL, Chakravorty S, Armstrong DT, Hall SL, Via LE, Song T, et al. Evaluation of a rapid molecular drug-susceptibility test for tuberculosis. New England Journal of Medicine 2017;377(11):1043-54. - PMC - PubMed
Yadav 2017 {published data only}
    1. Yadav R, Sharma N, Khaneja R, Agarwal P, Kanga A, Behera D, et al. Evaluation of the TB-LAMP assay for the rapid diagnosis of pulmonary tuberculosis in northern India. International Journal of Tuberculosis and Lung Disease 2017;21(10):1150-3. - PubMed
Yan 2016 {published data only}
    1. Yan L, Xiao H, Zhang Q. Systematic review: Comparison of Xpert MTB/RIF, LAMP and SAT methods for the diagnosis of pulmonary tuberculosis. Tuberculosis (Edinb) 2016;96:75-86. - PubMed
Yang X 2020 {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 2020;26(8):1089.e1-1089.e6. - PubMed
Yeong 2019 {published data only}
    1. Yeong C, Byrne AL, Cho JG, Sintchenko V, Crighton T, Marais BJ. Use of GeneXpert MTB/RIF(R) on a single pooled sputum specimen to exclude pulmonary tuberculosis among hospital inpatients placed in respiratory isolation. International Journal of Infectious Diseases 2019;92:175-80. - 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
Zar 2012 {published data only}
    1. Zar HJ, Workman L, Isaacs W, Munro J, Black F, Eley B, et al. Rapid molecular diagnosis of pulmonary tuberculosis in children using nasopharyngeal specimens. Clinical Infectious Diseases 2012;55(8):1088-95. - PMC - PubMed
Zar 2019 {published data only}
    1. Zar HJ, Workman LJ, Prins M, Bateman LJ, Mbhele SP, Whitman CB, et al. Tuberculosis diagnosis in children using Xpert Ultra on different respiratory specimens. Amercian Journal of Respiratory and Critical Care Medicine 2019;200(12):1531-8. - PMC - PubMed
Zemlyansky 2016 {published data only}
    1. Zemlyansky OA, Tyurina EB, Bashkirev AA, Kalyuzhnaya EV, Zemlyanskaya LO. Experience and efficiency of laboratory diagnosis of tuberculosis with PCR detector system GeneXpert in Belgorod region. International Journal of Pharmacy and Technology 2016;8(4):27072-9.
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
Zimba 2019 {published data only}
    1. Zimba O, Tamuhla T, Basotli J, Letsibogo G, Pals S, Mathebula U, et al. The effect of sputum quality and volume on the yield of bacteriologically-confirmed TB by Xpert MTB/RIF and smear. Pan African Medical Journal 2019;33:110. - PMC - 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

References to ongoing studies

ChiCTR180001479 {published data only}
    1. ChiCTR1800014792. Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous bronchoalveolar lavage fluid in HIV-infected adults: a prospective cohort study [Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous bronchoalveolar lavage fluid in HIV-infected adults: a prospective cohort study]. http://www.chictr.org.cn/showproj.aspx?proj=25172 (first received 5 February 2018).
ChiCTR1800014792 {published data only}
    1. ChiCTR1800014792. Study on the accuracy of fecal Xpert_MTB/RIF_Ultra test in diagnosis of childhood tuberculosis [Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous bronchoalveolar lavage fluid in HIV-infected adults: a prospective cohort study]. http://www.chictr.org.cn/showproj.aspx?proj=25233 (first received 12 February 2018).
ChiCTR1900026491 {unpublished data only}
    1. ChiCTR1900026491. The diagnostic value of medical thoracoscopy combined with Xpert MTB/RIF Ultra in smear and culture negative pulmonary tuberculosis [The diagnostic value of medical thoracoscopy combined with Xpert MTB/RIF Ultra in smear and culture negative pulmonary tuberculosis]. http://www.chictr.org.cn/showproj.aspx?proj=44194 (first received 12 October 2019).
ISRCTN77241966 {published data only}
    1. ISRCTN77241966. Evaluation of GeneXpert Ultra and digital chest radiography for diagnosing tuberculosis [Utility of the Xpert® MTB/RIF Ultra assay with the GeneXpert®Omni System and digital chest radiography for diagnosis of tuberculosis in high HIV prevalence settings: protocol for a randomised control trial]. www.isrctn.com/ISRCTN77241966 (first received 9 February 2019).
NCT03154320 {published data only}
    1. NCT03154320. A trial of same-day testing and treatment to improve outcomes among symptomatic patients newly diagnosed with HIV [A trial of same-day testing and treatment to improve outcomes among symptomatic patients newly diagnosed with HIV]. clinicaltrials.gov/ct2/show/NCT03154320 (first received 16 May 2017).
NCT03187964 {published data only}
    1. NCT03187964. Xpert Ultra and Xpert HIV-VL in people living with HIV (Ultra HIV) [Xpert Ultra and Xpert HIV-VL in people living with HIV (Ultra HIV)]. clinicaltrials.gov/ct2/show/NCT03187964 (first received 15 June 2017).
NCT03356925 {published data only}
    1. NCT03356925. Improving tuberculosis diagnosis and treatment through basic, applied and health systems research (BAR) [Improving tuberculosis diagnosis and treatment through basic, applied and health systems research (BAR)]. clinicaltrials.gov/ct2/show/NCT03356925 (first received 29 November 2017).
NCT03497195 {published data only}
    1. NCT03497195. Achieving tuberculosis (TB) control In Zambia (TB) [Comparison of 2 diagnostic tools (chest X-ray with computer-assisted diagnosis versus C-reactive protein) and Xpert Ultra for active community-based tuberculosis case detection]. clinicaltrials.gov/ct2/show/NCT03497195 (first received 13 April 2018).
NCT03712709 {unpublished data only}
    1. NCT03712709. Clinical evaluation of the Truenat point-of-care tuberculosis diagnostic test [Clinical evaluation of the Truenat point-of-care tuberculosis diagnostic test]. clinicaltrials.gov/ct2/show/NCT03712709 (first received 19 October 2018).
NCT04074369 {unpublished data only}
    1. NCT04074369. Evaluation of CRISPR-based test for the rapid identification of TB in pulmonary tuberculosis suspects [Evaluation of CRISPR-based test for the rapid identification of TB in pulmonary tuberculosis suspects]. clinicaltrials.gov/ct2/show/NCT04074369 (first received 30 August 2019).
NCT04122404 {unpublished data only}
    1. NCT04122404. POC strategies to improve TB care in advanced HIV disease (TBPOC) [Point-of-care strategies to improve tuberculosis care among severely immunosuppressed HIV-infected patients]. clinicaltrials.gov/ct2/show/NCT04122404 (first received 10 October 2019). [NCT04122404]
NCT058236 {unpublished data only}
    1. NTC02758236. Tuberculosis research of INA-RESPOND on drug resistance (TRIPOD) [Tuberculosis research of INA-RESPOND on drug resistance]. clinicaltrials.gov/ct2/show/NCT02758236 (first received 2 May 2016).

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