Tuberculosis Diagnostics in 2015: Landscape, Priorities, Needs, and Prospects
Open accessAbstract
In 2015, tuberculosis remains a major global health problem, and drug-resistant tuberculosis is a growing threat. Although tuberculosis diagnosis in many countries is still reliant on older tools, new diagnostics are changing the landscape. Stimulated, in part, by the success and roll out of Xpert MTB/RIF, there is now considerable interest in new technologies. The landscape looks promising, with a robust pipeline of new tools, particularly molecular diagnostics, and well over 50 companies actively engaged in product development. However, new diagnostics are yet to reach scale, and there needs to be greater convergence between diagnostics development and development of shorter-duration tuberculosis drug regimens. Another concern is the relative absence of non-sputum-based diagnostics in the pipeline for children and of biomarker tests for triage, cure, and progression of latent Mycobacterium tuberculosis infection. Several initiatives, described in this supplement, have been launched to further stimulate product development and policy, including assessment of needs and priorities, development of target product profiles, compilation of data on resistance-associated mutations, and assessment of market size and potential for new diagnostics. Advocacy is needed to increase funding for tuberculosis research and development, and governments in high-burden countries must invest more in tuberculosis control to meet post-2015 targets for care, control, and prevention.
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
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?
M. tuberculosis is often not detectable in paucibacillary paediatric specimens, and host biomarkers are not yet in place to reliably identify children with TB disease.
“Mycobacterium tuberculosis (M. tuberculosis) is often not detectable in paucibacillary paediatric specimens and host biomarkers are not yet in place to reliably identify children with TB disease [5, 6].”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Global tuberculosis report (2014)
Gabbasova, L. A., & Who, E. R. E. (2014) · Cited by 12,702 · see citing works
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 · see citing works
Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults
Steingart, K. R., Schiller, I., Horne, D. J. D. L., Pai, M., Boehme, C. C., & Dendukuri, N. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009593.pub3 · Cited by 1,147 · see citing works
Self-citationAdvances in the development of new tuberculosis drugs and treatment regimens
Zumla, A. I., Nahid, P., & Cole, S. T. (2013) · Nature Reviews Drug Discovery · doi:10.1038/nrd4001 · Cited by 895 · see citing works
Pai, N. P., Vadnais, C., Denkinger, C. M., Engel, N., & Pai, M. (2012) · PLoS Medicine · doi:10.1371/journal.pmed.1001306 · Cited by 597 · see citing works
Self-citationDiacon, A. H., Dawson, R., von Groote-Bidlingmaier, F., et al. (2012) · The Lancet · doi:10.1016/s0140-6736(12)61080-0 · Cited by 435 · see citing works
Diagnosis of Childhood Tuberculosis and Host RNA Expression in Africa
Anderson, S. T., Kaforou, M., Brent, A. J., Wright, V. J., Banwell, C. M., Chagaluka, G., Crampin, A. C., Dockrell, H. M., French, N., Hamilton, M. S., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1303657 · Cited by 379 · see citing works
Burden of childhood tuberculosis in 22 high-burden countries: a mathematical modelling study
Dodd, P. J., Gardiner, E., Coghlan, R., & Seddon, J. A. (2014) · The Lancet Global Health · doi:10.1016/s2214-109x(14)70245-1 · Cited by 368 · see citing works
Graham, S. M., Ahmed, T., Amanullah, F., Browning, R., Cárdenas, V., Casenghi, M., Cuevas, L. E., Gale, M., Gie, R. P., Grzemska, M., et al. (2012) · The Journal of Infectious Diseases · doi:10.1093/infdis/jis008 · Cited by 326 · see citing works
Results from early programmatic implementation of Xpert MTB/RIF testing in nine countries
Creswell, J., Codlin, A. J., André, E., Micek, M. A., Bedru, A., Carter, E. J., Yadav, R. P. H., Mosneaga, A., Rai, B., Banu, S., et al. (2014) · BMC Infectious Diseases · doi:10.1186/1471-2334-14-2 · Cited by 176 · see citing works
Defining the Needs for Next Generation Assays for Tuberculosis
Denkinger, C. M., Kik, S. V., Cirillo, D. M., Casenghi, M., Shinnick, T. M., Weyer, K., Gilpin, C., Boehme, C. C., Schito, M. L., Kimerling, M., et al. (2015) · The Journal of Infectious Diseases · doi:10.1093/infdis/jiu821 · Cited by 167 · see citing works
Self-citationRobert Koch: centenary of the discovery of the tubercle bacillus, 1882.
Sakula, A. (1982) · Thorax · doi:10.1136/thx.37.4.246 · Cited by 165 · see citing works
First Linezolid-Resistant Clinical Isolates of Mycobacterium tuberculosis
Richter, E., Rüsch–Gerdes, S., & Hillemann, D. (2007) · Antimicrobial Agents and Chemotherapy · doi:10.1128/aac.01113-06 · Cited by 117 · see citing works
Pantoja, A., Fitzpatrick, C., Vassall, A., Weyer, K., & Floyd, K. (2012) · European Respiratory Journal · doi:10.1183/09031936.00147912 · Cited by 105 · see citing works
Raizada, N., Sachdeva, K. S., Sreenivas, A., Vadera, B., Gupta, R. S., Parmar, M., Kulsange, S., Babre, A., Thakur, R., Gray, C. M., et al. (2014) · PLoS ONE · doi:10.1371/journal.pone.0089301 · Cited by 79 · see citing works
Mobile health to improve tuberculosis care and control: a call worth making [Review article]
Denkinger, C. M., Grenier, J.-Y., Stratis, A. K., Akkihal, A., Pant-Pai, N., & Pai, M. (2013) · The International Journal of Tuberculosis and Lung Disease · doi:10.5588/ijtld.12.0638 · Cited by 78 · see citing works
Self-citationTuberculosis diagnostics: which target product profiles should be prioritised?
Kik, S. V., Denkinger, C. M., Casenghi, M., Vadnais, C., & Pai, M. (2014) · European Respiratory Journal · doi:10.1183/09031936.00027714 · Cited by 77 · see citing works
Self-citationXu, D., Deng, D., Li, X., Wei, L., Li, Y., Yang, X., Yu, W., Wang, C., Jiang, T., Li, Z., et al. (2013) · PROTEOMICS · doi:10.1002/pmic.201300383 · Cited by 75 · see citing works
Xu, D., Li, Y., Li, X., et al. (2014) · PROTEOMICS · doi:10.1002/pmic.201400366 · Cited by 75 · see citing works
Replacing smear microscopy for the diagnosis of tuberculosis: what is the market potential?
Kik, S. V., Denkinger, C. M., Chedore, P., & Pai, M. (2014) · European Respiratory Journal · doi:10.1183/09031936.00217313 · Cited by 64 · see citing works
Self-citationAlignment of new tuberculosis drug regimens and drug susceptibility testing: a framework for action
Wells, W. A., Boehme, C. C., Cobelens, F. G. J., Daniels, C., Dowdy, D. W., Gardiner, E., Gheuens, J., Kim, P. S., Kimerling, M. E., Kreiswirth, B. N., et al. (2013) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(13)70025-2 · Cited by 61 · see citing works
Self-citationPaediatric use of second-line anti-tuberculosis agents: A review
Seddon, J. A., Hesseling, A. C., Marais, B. J., McIlleron, H., Peloquin, C. A., Donald, P. R., & Schaaf, H. S. (2011) · Tuberculosis · doi:10.1016/j.tube.2011.11.001 · Cited by 60 · see citing works
How is Xpert MTB/RIF being implemented in 22 high tuberculosis burden countries?
Qin, Z. Z., Pai, M., Gemert, W. V., Sahu, S., Ghiasi, M., & Creswell, J. (2014) · European Respiratory Journal · doi:10.1183/09031936.00147714 · Cited by 57 · see citing works
Self-citationAre peripheral microscopy centres ready for next generation molecular tuberculosis diagnostics?
Denkinger, C. M., Nicolau, I. A., Ramsay, A., Chedore, P., & Pai, M. (2013) · European Respiratory Journal · doi:10.1183/09031936.00081113 · Cited by 52 · see citing works
Self-citationTarget Product Profile of a Molecular Drug-Susceptibility Test for Use in Microscopy Centers
Denkinger, C. M., Dolinger, D. L., Schito, M. L., Wells, W. A., Cobelens, F. G. J., Pai, M., Matteo Zignol, E., Cirillo, D. M., Alland, D., Casenghi, M., et al. (2015) · The Journal of Infectious Diseases · doi:10.1093/infdis/jiu682 · Cited by 41 · see citing works
Self-citationSalamon, H., Yamaguchi, K. D., Cirillo, D. M., Miotto, P., Schito, M. L., Posey, J. E., Starks, A. M., Niemann, S., Alland, D., Hanna, D. L., et al. (2015) · The Journal of Infectious Diseases · doi:10.1093/infdis/jiu816 · Cited by 36 · see citing works
Self-citationDenkinger, C. M., Kik, S. V., & Pai, M. (2013) · Expert Review of Molecular Diagnostics · doi:10.1586/14737159.2013.850034 · Cited by 29 · see citing works
Self-citationCosts of Novel Tuberculosis Diagnostics—Will Countries Be Able to Afford It?
Pantoja, A., Kik, S. V., & Denkinger, C. M. (2015) · The Journal of Infectious Diseases · doi:10.1093/infdis/jiu820 · Cited by 27 · see citing works
Market assessment of tuberculosis diagnostics in South Africa, 2012–2013
Analysis, T. D. M. (2015) · The International Journal of Tuberculosis and Lung Disease · doi:10.5588/ijtld.14.0565 · Cited by 23 · see citing works
Market Assessment of Tuberculosis Diagnostics in Brazil in 2012
TB Diagnostics Market Analysis Consortium (2014) · PLoS ONE · doi:10.1371/journal.pone.0104105 · Cited by 16 · see citing works
Diagnostics for tuberculosis: what test developers want to know
Pai, M. (2013) · Expert Review of Molecular Diagnostics · doi:10.1586/erm.13.16 · Cited by 15 · see citing works
Self-citationMarket assessment of tuberculosis diagnostics in China in 2012
Zhao, Y.-L., Pang, Y., Xia, H., et al. (2016) · The International Journal of Tuberculosis and Lung Disease · doi:10.5588/ijtld.15.0156 · Cited by 15 · see citing works
Integrated clinical genomics: new horizon for diagnostic and biomarker discoveries in cancer
Roukos, D. H. (2012) · Expert Review of Molecular Diagnostics · doi:10.1586/erm.12.132 · Cited by 12 · see citing works
Potential Market for Novel Tuberculosis Diagnostics: Worth the Investment?
Kik, S. V., Denkinger, C. M., Carole, J., et al. (2015) · The Journal of Infectious Diseases · doi:10.1093/infdis/jiu817 · Cited by 11 · see citing works
Tuberculosis diagnostics: test developers' FAQs [Editorial]
Pai, M. (2013) · The International Journal of Tuberculosis and Lung Disease · doi:10.5588/ijtld.13.0036 · Cited by 11 · see citing works
Self-citationTime to Symptom Resolution in Young Children Treated for Pulmonary Tuberculosis
Mpofu, N., Moyo, S., Mulenga, H., et al. (2014) · The Pediatric Infectious Disease Journal · doi:10.1097/inf.0000000000000523 · Cited by 8 · see citing works
The use of Kirschner medium in the culture of M. tuberculosis.
Ch, H., & Jc, H. (1954) · PubMed · Cited by 4 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Pai, M., Behr, M. A., Dowdy, D., Dheda, K., Divangahi, M., Boehme, C. C., Ginsberg, A., Swaminathan, S., Spigelman, M., Getahun, H., et al. (2016) · Nature Reviews Disease Primers · doi:10.1038/nrdp.2016.76 · Cited by 1,270 · see citing works
Self-citationBholla, M., Kapalata, N., Masika, E., Chande, H., Jugheli, L., Sasamalo, M., Glass, T. R., Beck, H.-P., & Reither, K. (2016) · BMC Infectious Diseases · doi:10.1186/s12879-016-1578-z · Cited by 31 · see citing works
“tuberculosis) is often not detectable in paucibacillary paediatric specimens and host biomarkers are not yet in place to reliably identify children with TB disease [5, 6].”
Background
- Authors
- Pai, M., & Schito, M.
- Affiliations
- McGill University (CA)
- Henry M. Jackson Foundation (US)
- Venue
- The Journal of Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2015-03-10
- Volume
- 211
- Issue
- suppl_2
- Pages
- S21-S28
- ISSN
- 0022-1899 (ISSN-L)
- 1537-6613
- PMC
- PMC4366576
- OpenAlex
- W2102135808
- Cited by
- 193
- References
- 37
- Citations by year
- 2026: 6 · 2025: 12 · 2024: 11 · 2023: 14 · 2022: 11 · 2021: 10 · 2020: 21 · 2019: 22 · 2018: 13 · 2017: 27 · 2016: 28 · 2015: 18
- FWCI
- 4.32
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Journal of Infectious Diseases (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of Allergy and Infectious Diseases (HHSN272200800014C)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
- Health Sciences › Medicine › Surgery › Infectious Diseases and Tuberculosis
- Health Sciences › Medicine › Epidemiology › Mycobacterium research and diagnosis
- Keywords
- tuberculosis diagnosis, drug-resistant tuberculosis, Xpert MTB/RIF, molecular diagnosis, pediatric tuberculosis, latent tuberculosis infection, biomarkers, target product profile, resistance-associated mutations, tuberculosis control policy
- MeSH terms
- Diagnostic Tests, Routine, Humans, Tuberculosis, Molecular Diagnostic Techniques, Biomedical Research
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