The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.
Xpert MTB/RIF Ultra versus Xpert MTB/RIF for the diagnosis of tuberculous meningitis: a prospective, randomised, diagnostic accuracy study
Open accessAbstract
BACKGROUND: Xpert MTB/RIF Ultra (Xpert Ultra) might have higher sensitivity than its predecessor, Xpert MTB/RIF (Xpert), but its role in tuberculous meningitis diagnosis is uncertain. We aimed to compare Xpert Ultra with Xpert for the diagnosis of tuberculous meningitis in HIV-uninfected and HIV-infected adults. METHODS: In this prospective, randomised, diagnostic accuracy study, adults (≥16 years) with suspected tuberculous meningitis from a single centre in Vietnam were randomly assigned to cerebrospinal fluid testing by either Xpert Ultra or Xpert at baseline and, if treated for tuberculous meningitis, after 3-4 weeks of treatment. Test performance (sensitivity, specificity, and positive and negative predictive values) was calculated for Xpert Ultra and Xpert and compared against clinical and mycobacterial culture reference standards. Analyses were done for all patients and by HIV status. FINDINGS: Between Oct 16, 2017, and Feb 10, 2019, 205 patients were randomly assigned to Xpert Ultra (n=103) or Xpert (n=102). The sensitivities of Xpert Ultra and Xpert for tuberculous meningitis diagnosis against a reference standard of definite, probable, and possible tuberculous meningitis were 47·2% (95% CI 34·4-60·3; 25 of 53 patients) for Xpert Ultra and 39·6% (27·6-53·1; 21 of 53) for Xpert (p=0·56); specificities were 100·0% (95% CI 92·0-100·0; 44 of 44) and 100·0% (92·6-100·0; 48 of 48), respectively. In HIV-negative patients, the sensitivity of Xpert Ultra was 38·9% (24·8-55·1; 14 of 36) versus 22·9% (12·1-39·0; eight of 35) by Xpert (p=0·23). In HIV co-infected patients, the sensitivities were 64·3% (38·8-83·7; nine of 14) for Xpert Ultra and 76·9% (49·7-91·8; ten of 13) for Xpert (p=0·77). Negative predictive values were 61·1% (49·6-71·5) for Xpert Ultra and 60·0% (49·0-70·0) for Xpert. Against a reference standard of mycobacterial culture, sensitivities were 90·9% (72·2-97·5; 20 of 22 patients) for Xpert Ultra and 81·8% (61·5-92·7; 18 of 22) for Xpert (p=0·66); specificities were 93·9% (85·4-97·6; 62 of 66) and 96·9% (89·5-91·2; 63 of 65), respectively. Six (22%) of 27 patients had a positive test by Xpert Ultra after 4 weeks of treatment versus two (9%) of 22 patients by Xpert. INTERPRETATION: Xpert Ultra was not statistically superior to Xpert for the diagnosis of tuberculous meningitis in HIV-uninfected and HIV-infected adults. A negative Xpert Ultra or Xpert test does not rule out tuberculous meningitis. New diagnostic strategies are urgently required. FUNDING: Wellcome Trust and the Foundation for Innovative New Diagnostics.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Figures
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Donovan 2020 assessed Xpert Ultra specificity in CSF from more than 100 participants with nontuberculous meningitis and found zero positive Xpert Ultra results in those with a probable or possible diagnosis of tuberculous meningitis and in any participant with a confirmed diagnosis of nontuberculous meningitis.”
From Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults (2021) · cites this paper as Donovan 2020
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
Rapid Molecular Detection of Tuberculosis and Rifampin Resistance
Boehme, C. C., Nabeta, P., Hillemann, D., Nicol, M. P., Shenai, S., Krapp, F., Allen, J., Tahirli, R., Blakemore, R., Rustomjee, R., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa0907847 · Cited by 2,309
Tuberculous meningitis: a uniform case definition for use in clinical research
Marais, S., Thwaites, G., Schoeman, J. F., Török, M. E., Misra, U. K., Prasad, K., Donald, P. R., Wilkinson, R. J., & Marais, B. J. (2010) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(10)70138-9 · Cited by 932
Dorman, S. E., Schumacher, S. G., Alland, D., Nabeta, P., Armstrong, D. T., King, B., Hall, S. L., Chakravorty, S., Cirillo, D. M., Tukvadze, N., et al. (2017) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(17)30691-6 · Cited by 705
Chakravorty, S., Simmons, A. M., Rowneki, M., Parmar, H., Cao, Y., Ryan, J., Banada, P. P., Deshpande, S., Shenai, S., Gall, A., et al. (2017) · mBio · doi:10.1128/mbio.00812-17 · Cited by 668
Denkinger, C. M., Schumacher, S. G., Boehme, C. C., Dendukuri, N., Pai, M., & Steingart, K. R. (2014) · European Respiratory Journal · doi:10.1183/09031936.00007814 · Cited by 527
Tuberculous meningitis: more questions, still too few answers
Thwaites, G. E., van Toorn, R., & Schoeman, J. (2013) · The Lancet Neurology · doi:10.1016/s1474-4422(13)70168-6 · Cited by 482
Bahr, N. C., Nuwagira, E., Evans, E. E., Cresswell, F. V., Bystrom, P. V., Byamukama, A., Bridge, S. C., Bangdiwala, A. S., Meya, D. B., Denkinger, C. M., et al. (2018) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(17)30474-7 · Cited by 308
Improving the Bacteriological Diagnosis of Tuberculous Meningitis
Thwaites, G. E., Chau, T. T. H., & Farrar, J. (2004) · Journal of Clinical Microbiology · doi:10.1128/jcm.42.1.378-379.2004 · Cited by 286
Evaluation of GeneXpert MTB/RIF for Diagnosis of Tuberculous Meningitis
Nhu, N. T. Q., Heemskerk, D., Thu, D. D. A., Chau, T. T. H., Mai, N. T. H., Nghia, H. D. T., Loc, P. P., Ha, D. T. M., Merson, L., Thinh, T. T. V., et al. (2014) · Journal of Clinical Microbiology · doi:10.1128/jcm.01834-13 · Cited by 244
Self-citationHolt, K. E., McAdam, P. R., Thai, P. V. K., Thương, N. T. T., Hà, Đ. T. M., Lan, N. N., Lân, N. H., Nhu, N. T. Q., Hai, H. T., Ha, V. T. N., et al. (2018) · Nature Genetics · doi:10.1038/s41588-018-0117-9 · Cited by 209
Cited by
Sorted by citations
Items 101–153 of 153
Singh, S., & Shrivas, A. (2025) · The Indian Journal of Medical Research · doi:10.25259/ijmr_527_2025 · Cited by 2
Tuberculous meningitis in Bhubaneswar, Odisha, during 2016 to 2022
Mohanty, C., Mohanty, T., Kar, S., Kumar, S., Rout, S. S., Bal, H. B., Barik, S. K., Turuk, J., Das, D., Sundaray, S., et al. (2023) · Indian Journal of Tuberculosis · doi:10.1016/j.ijtb.2023.09.007 · Cited by 2
CNS Infections in Patients Living with HIV/AIDS
Rivera-Villegas, H., Vargas-Morales, M. F., & Sierra-Madero, J. G. (2023) · Current Tropical Medicine Reports · doi:10.1007/s40475-023-00301-z · Cited by 2
Anand, R. P., Tandon, R., & Jha, S. (2024) · Neurology India · doi:10.4103/neuroindia.ni_1476_20 · Cited by 2
Randall, P. J., Mutsvangwa, J., Nliwasa, M., Wilson, L., Makamure, B., Makambwa, E., Meldau, R., Dheda, K. U. J., Munyati, S. S., Siddiqi, O. K., et al. (2024) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofae496 · Cited by 2
Cytochemical analysis of cerebrospinal fluid in tuberculous meningitis versus other etiologies
Hueda-Zavaleta, M., de la Torre, J. C. G., Barletta‐Carrillo, C., Tapia‐Sequeiros, G., Flores, C., Piscoche, C., Miranda, C., Mendoza, A., Sánchez-Tito, M. A., & Benites-Zapata, V. A. (2025) · PLoS ONE · doi:10.1371/journal.pone.0318398 · Cited by 2
Wang, C., Sun, L., Li, Q., & Lu, H. (2022) · Drug Discoveries & Therapeutics · doi:10.5582/ddt.2022.01082 · Cited by 2
Missed Opportunities in the Diagnosis of Tuberculosis Meningitis
Simmons, N., Olsen, M. A. A., Buss, J. L., Bailey, T. C., & Mejía-Chew, C. (2023) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofad050 · Cited by 2
Diagnosing tuberculous meningitis: a testing process
Donovan, J., & Walker, T. M. (2021) · The International Journal of Tuberculosis and Lung Disease · doi:10.5588/ijtld.21.0303 · Cited by 2
Diagnostic Prediction Model for Tuberculous Meningitis: An Individual Participant Data Meta-Analysis
Stadelman, A., Tiffin, N., Ellis, J. P., Cresswell, F. V., Ssebambulidde, K., Nuwagira, E., Richards, L., Lutje, V., Hristea, A., Jipa, R. E., et al. (2024) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.23-0789 · Cited by 3
Boschung, K. F., Wong, P. H. P., Werry, D., Sekirov, I., Turvey, S. L., Cook, V. J., Johnston, J. C., & Connors, W. J. A. (2026) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofag046 · Cited by 1
Hao, X., Hu, Y., Zhou, L., Wang, F., Liu, X., Wang, J., Chen, J., Ji, A., Bai, C., & Liu, J. (2026) · Frontiers in Cellular and Infection Microbiology · doi:10.3389/fcimb.2026.1791663 · Cited by 1
Riquelme, O. T., & Moreno, J. (2023) · Visión Antataura · doi:10.48204/j.vian.v7n1.a3923 · Cited by 1
Newer perspectives - Diagnosis and management of pediatric tuberculosis
Shah, I., & Nalwalla, Z. (2023) · Wadia Journal of Women and Child Health · doi:10.25259/wjwch_37_2023 · Cited by 1
A systematic review on correlates of risk of TB disease in children and adults
Siddhi, P., Raveendranath, R., Puligari, P., Chinnaswamy, A., Song, R., & Welch, S. B. (2022) · Indian Journal of Tuberculosis · doi:10.1016/j.ijtb.2022.05.001 · Cited by 1
MOLECULAR DRUG SUSCEPTIBILITY TEST FOR EARLY DIAGNOSIS FOR DRUG RESISTANT TUBERCULOSIS
Prasad, R. (2023) · Era s journal of medical research · doi:10.24041/ejmr2023.35 · Cited by 1
Guo, B.-F., Ding, M.-X., Xue, J.-R., Yan, D.-N., & Sun, S. (2021) · Research Square · doi:10.21203/rs.3.rs-275456/v1 · Cited by 1
A Systematic Review On Correlates of Risk of TB Disease In Children And AdultsPreprint
Siddhi, P., Raveendranath, R., Chinnaswamy, A., Pulgari, P., Song, R., & Welch, S. B. (2022) · Research Square · doi:10.21203/rs.3.rs-1261861/v1 · Cited by 1
Fang, M., Su, Y.-F., Deng, G., Zhang, P., Liu, H., Mao, Z., Zeng, J., Li, G., Yang, Q., & Wang, Z. (2020) · Research Square · doi:10.21203/rs.3.rs-126541/v1
Meningite tuberculosa: avaliação do desempenho do Xpert MTB/RIF Ultra para o diagnóstico
Silva, S. F. S., de Albuquerque, C. A. N., Alves, S. L. D. Á., de Oliveira, H. A., Lima, R. C. D. M., & Manrique, E. J. C. (2022) · Research Society and Development · doi:10.33448/rsd-v11i3.26889
Fang, M., Su, Y., Deng, G., Zhang, P., Liu, H., Mao, Z., Zeng, J., Li, G., Yang, Q., & Wang, Z. (2020) · Research Square · doi:10.21203/rs.3.rs-136542/v1
Immunological reactivity of animals with tuberculosis under the influence of ionising radiation
Kassich, V., Kasianenko, O., Klishchova, Z., Касяненко, С. М., & Олександрович, М. М. (2023) · Scientific Horizons · doi:10.48077/scihor3.2023.24
Analytical Optimization of GeneXpert Ultra for Detection of Tuberculosis in CSF Samples
Campodónico, V. L., Armstrong, D. T., Olinger, G. G., Merritt, E. A., Howard, R., Lemmon, M. M., & Parrish, N. M. (2023) · Journal of Tuberculosis Research · doi:10.4236/jtr.2023.113013
Okudera, R., Hongo, Y., Ishihara, K., Ito, K., Ikewaki, K., & Suzuki, K. (2023) · Rinsho Shinkeigaku · doi:10.5692/clinicalneurol.cn-001866
Filho, L. C. F., Aranha, M. F. D. A. C., Cabeça, R. A. S., Massoud, R. O., Cohen, S. B., Fernandes, L. M. P., de Oliveira, R. D. C. S., & Cohen, P. B. (2023) · Arquivos de Ciências da Saúde da UNIPAR · doi:10.25110/arqsaude.v27i10.2023-012
The role and implications of RNAscope and mRNA in the diagnosis of tuberculosis
Nakiboneka, R., & Sabiiti, W. (2024) · EBioMedicine · doi:10.1016/j.ebiom.2024.105230
Strategic diagnosis- Unraveling Tuberculosis- A comprehensive approach
Wazahat, R. (2024) · Indian Journal of Tuberculosis · doi:10.1016/j.ijtb.2024.08.004
Hueda-Zavaleta, M., de la Torre, J. C. G., Minchón-Vizconde, D., Barletta‐Carrillo, C., Corzo, C. A. C., Tapia‐Sequeiros, G., Flores, C., Piscoche, C., Miranda, C., Mendoza, A., et al. (2024) · Therapeutic Advances in Infectious Disease · doi:10.1177/20499361241304516
jha, S. N., Gupta, N. R., Kumar, T. P., Chawla, K., Shenoy, V. P., Varma, M. D., & Manu, M. K. (2025) · Transactions of the Royal Society of Tropical Medicine and Hygiene · doi:10.1093/trstmh/traf002
Commentary on Acute Sodium Fluctuation in Altered Consciousness: A Puzzle or a Key to Diagnosis?
Geaghan, S. M. (2025) · The Journal of Applied Laboratory Medicine · doi:10.1093/jalm/jfaf016
Jia, H., Liu, F., Sun, S., Zhang, Y., Wang, F., Yang, X., Zhang, B., & Fan, S.-Y. (2025) · SSRN Electronic Journal · doi:10.2139/ssrn.5247127
The identification of tuberculosis using CRISPR technique: A systematic review and meta-analysis
Ghoreshi, Z., Ali‐Hassanzadeh, M., Mashayekhi‐Sardoo, H., Askarpour, H., & Arefinia, N. (2025) · Diagnostic Microbiology and Infectious Disease · doi:10.1016/j.diagmicrobio.2025.117183
Binila Chacko, I., Platt, S. E. C., Tong, S. Y. C., Hai, D. H. T., & Vijayaraghavan, B. K. T. (2025) · Elsevier eBooks · doi:10.1016/b978-0-443-11611-7.00021-9
Yang, X., Zhou, S., Chang, Z., Xi, X., Li, J., Miao, M., Chen, Y., Chen, W., Zhang, H., Ding, R., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26687130
Yang, X., Zhou, S., Chang, Z., Xi, X., Li, J., Miao, M., Chen, Y., Chen, W., Zhang, H., Ding, R., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26687124
Yang, X., Zhou, S., Chang, Z., Xi, X., Li, J., Miao, M., Chen, Y., Chen, W., Zhang, H., Ding, R., et al. (2024) · Figshare · doi:10.6084/m9.figshare.25322985
Yang, X., Zhou, S., Chang, Z., Xi, X., Li, J., Miao, M., Chen, Y., Chen, W., Zhang, H., Ding, R., et al. (2024) · Figshare · doi:10.6084/m9.figshare.25322869
Dong, T. H. K., Donovan, J., Ngoc, N. M., Thu, D. D. A., Nghia, H. D. T., Oanh, P. K. N., Phu, N. H., Hang, V. T. T., Vinh Chau, N. V., Thuong Thuong, N. T., et al. (2024) · Figshare · doi:10.6084/m9.figshare.25157304
Yang, X., Zhou, S., Chang, Z., Xi, X., Li, J., Miao, M., Chen, Y., Chen, W., Zhang, H., Ding, R., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26687127
Dong, T. H. K., Donovan, J., Ngoc, N. M., Thu, D. D. A., Nghia, H. D. T., Oanh, P. K. N., Phu, N. H., Hang, V. T. T., Vinh Chau, N. V., Thuong Thuong, N. T., et al. (2024) · Figshare · doi:10.6084/m9.figshare.25157783
Whole blood transcriptional responses associated with bacterial burden in pulmonary tuberculosisPreprint
Nhat, L. T. H., Thai, T. M., Hai, H. T., Van, L. H., Thai, L. N. H., Tram, T. T. B., Thu, D. D. A., Dang, T. M. H., Trung, N. H. D., Thwaites, G. E., et al. (2026) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.64898/2026.01.29.702471
Progress in the Diagnosis and Treatment of Tuberculous Meningitis
Căliman-Sturdza, O. A. (2026) · Infectious diseases · doi:10.5772/intechopen.1014269
Wu, Q., Zhou, Y., Zhou, X., Zhou, H., Chen, J., Zou, Y., Liu, J., Zhou, T., Ouyang, Y., Zhou, G., et al. (2026) · Research Square · doi:10.21203/rs.3.rs-8748153/v1
Sharma, K., Jindal, N., Sharma, M., Mandavdhare, H. S., Gupta, P. C., Sekar, A., Dutta, U., & Sharma, V. (2026) · World Journal of Gastroenterology · doi:10.3748/wjg.v32.i14.116088
Soesanto, K. M., Susilawathi, N. M., & Sudewi, A. A. R. (2026) · Medika Kartika Jurnal Kedokteran dan Kesehatan · doi:10.35990/mk.v9n1.p104-114
George, B. D., & Nair, S. (2026) · Access Microbiology · doi:10.1099/acmi.0.001249.v3
Wong, H. S. C., Shing, K. K. D., Cho, W. F., Shum, R., & Wong, W. Y. (2026) · Infectious Medicine · doi:10.1016/j.imj.2026.100275
Chen, J., Wu, Q., Xiao, X., Chen, S., Hu, J., Wang, Z., & Zeng, W. (2026) · Frontiers in Medicine · doi:10.3389/fmed.2026.1908481
Zeng, W., Xiao, X., Liu, Q., Ouyang, Y., Hu, J., Wang, Z., & Wu, Q. (2026) · Frontiers in Medicine · doi:10.3389/fmed.2026.1905776
Lee, S.-H., Shin, D., & Lee, S. (2026) · Journal of Korean Medical Science · doi:10.3346/jkms.2027.42.e35
Metadata
- Authors
- Donovan, J., Thu, D. D. A., Phu, N. H., Dung, V. T. M., Quang, T. P., Nghia, H. D. T., Oanh, P. K. N., Nhu, T. B., Chau, N. V. V., Ha, V. T. N., Hang, V. T. T., Trinh, D. H. K., Geskus, R. B., Tan, L. V., Thuong, N. T. T., & Thwaites, G. E.
- Affiliations
- University of Oxford (GB)
- Oxford University Clinical Research Unit (VN)
- Hospital for Tropical Diseases (VN)
- Corresponding author
- Donovan, Joseph
- ORCID
- Venue
- The Lancet Infectious Diseases
- Publisher
- Elsevier BV
- Published
- 2020-03
- Volume
- 20
- Issue
- 3
- Pages
- 299-307
- ISSN
- 1473-3099 (ISSN-L)
- PMC
- PMC7045088
- OpenAlex
- W3000453407
- Cited by
- 154
- References
- 21
- Citations by year
- 2026: 15 · 2025: 18 · 2024: 28 · 2023: 29 · 2022: 18 · 2021: 23 · 2020: 23
- FWCI
- 21.23
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The Lancet Infectious Diseases (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Greater South Information System
- Funders
- Wellcome Trust (204904/Z/16/Z, 106680/B/14/Z)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Infectious Diseases and Tuberculosis
- Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
- Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
- Keywords
- tuberculous meningitis, Xpert MTB/RIF Ultra, Xpert MTB/RIF, diagnostic accuracy, cerebrospinal fluid, HIV coinfection, rifampicin resistance, Mycobacterium tuberculosis, molecular diagnosis, sensitivity and specificity, Vietnam, treatment response monitoring
- MeSH terms
- Humans, Predictive Value of Tests, Prospective Studies, Random Allocation, Sensitivity and Specificity, Tuberculosis, Meningeal, Vietnam, HIV Infections, Tuberculosis, Multidrug-Resistant, Molecular Diagnostic Techniques
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
