{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T10:12:51Z","timestamp":1767175971299,"version":"build-2238731810"},"update-to":[{"DOI":"10.12688\/gatesopenres.12842.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2018,9,18]],"date-time":"2018-09-18T00:00:00Z","timestamp":1537228800000}}],"reference-count":16,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2018,9,18]],"date-time":"2018-09-18T00:00:00Z","timestamp":1537228800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPP1061487"],"award-info":[{"award-number":["OPP1061487"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]},{"name":"FIND, Geneva"},{"name":"Global Drug Facility, Stop TB Partnership"}],"content-domain":{"domain":["gatesopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Gates Open Res"],"abstract":"<ns4:p>\n                    <ns4:bold>Background:<\/ns4:bold>\n                    Xpert\u00ae MTB\/RIF, a rapid tuberculosis (TB) molecular test, was endorsed by the World Health Organization in 2010. Since then, 34.4 million cartridges have been procured under concessional pricing. Although the roll out of this diagnostic is promising, previous studies showed low market penetration.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Methods:<\/ns4:bold>\n                    To assess 3-year trends of market penetration of Xpert MTB\/RIF in the public sector, smear and Xpert MTB\/RIF volumes for the year 2016 were evaluated and policies from 2014-2016 within 22 high-burden countries (HBCs) were studied. A structured questionnaire was sent to representatives of 22 HBCs. The questionnaires assessed the total smear and Xpert MTB\/RIF volumes, number of modules and days of operation of GeneXpert machines in National TB Programs (NTPs). Data regarding the use of NTP GeneXpert machines for other diseases and GeneXpert procurement by other disease control programs were collected. Market penetration was estimated by the ratio of total sputum smear volume for initial diagnosis divided by the number of Xpert MTB\/RIF tests procured in the public sector.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Results:<\/ns4:bold>\n                    The survey response rate was 21\/22 (95%). Smear\/Xpert ratios decreased in 17\/21 countries and increased in four countries, since 2014. The median ratio decreased from 32.6 (IQR: 44.6) in 2014 to 6.0 (IQR: 15.4) in 2016. In 2016, the median GeneXpert utilization was 20%, however seven countries (7\/19; 37%) were running tests for other diseases on their NTP-procured GeneXpert systems in 2017, such as HIV, hepatitis-C virus (HCV),\n                    <ns4:italic>Chlamydia trachomatis<\/ns4:italic>\n                    , and\n                    <ns4:italic>Neisseria gonorrhoeae<\/ns4:italic>\n                    . Five (5\/15; 33%) countries reported GeneXpert procurement by HIV or HCV programs in 2016 and\/or 2017.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Conclusions:<\/ns4:bold>\n                    Our results show a positive trend for Xpert MTB\/RIF market penetration in 21 HBC public sectors. However, GeneXpert machines were under-utilized for TB, and inadequately exploited as a multi disease technology.\n                  <\/ns4:p>","DOI":"10.12688\/gatesopenres.12842.2","type":"journal-article","created":{"date-parts":[[2018,9,18]],"date-time":"2018-09-18T10:20:05Z","timestamp":1537266005000},"page":"35","update-policy":"https:\/\/doi.org\/10.12688\/gatesopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":7,"title":["Market penetration of Xpert MTB\/RIF in high tuberculosis burden countries: A trend analysis from 2014 - 2016"],"prefix":"10.12688","volume":"2","author":[{"given":"Danielle","family":"Cazabon","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tripti","family":"Pande","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandra","family":"Kik","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wayne","family":"Van Gemert","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hojoon","family":"Sohn","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudia","family":"Denkinger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhi Zhen","family":"Qin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brenda","family":"Waning","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3667-4536","authenticated-orcid":false,"given":"Madhukar","family":"Pai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2018,9,18]]},"reference":[{"key":"ref-1","article-title":"Global Tuberculosis Report 2017","year":"2017"},{"key":"ref-2","article-title":"Next Generation Xpert MTB\/RIF Ultra assay recommended by WHO","year":"2017"},{"key":"ref-3","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.00918-2017","article-title":"Implementation of Xpert MTB\/RIF in 22 high tuberculosis burden countries: are we making progress?","volume":"50","author":"D Cazabon","year":"2017","journal-title":"Eur Respir J."},{"key":"ref-4","doi-asserted-by":"publisher","first-page":"549-554","DOI":"10.1183\/09031936.00147714","article-title":"How is Xpert MTB\/RIF being implemented in 22 high tuberculosis burden countries?","volume":"45","author":"Z Qin","year":"2015","journal-title":"Eur Respir J."},{"key":"ref-5","article-title":"Global Tuberculosis Report 2015","year":"2015"},{"key":"ref-6","article-title":"Global TB report 2016","year":"2016"},{"key":"ref-7","doi-asserted-by":"publisher","first-page":"e0184270","DOI":"10.1371\/journal.pone.0184270","article-title":"Scaling-up the Xpert MTB\/RIF assay for the detection of tuberculosis and rifampicin resistance in India: An economic analysis.","volume":"12","author":"S Khaparde","year":"2017","journal-title":"PLoS One."},{"key":"ref-8","doi-asserted-by":"publisher","first-page":"e75-e77","DOI":"10.1016\/S2214-109X(14)70366-3","article-title":"The Global Fund in China: success beyond the numbers.","volume":"3","author":"R Minghui","year":"2015","journal-title":"Lancet Glob Health."},{"key":"ref-9","doi-asserted-by":"publisher","first-page":"e0171384","DOI":"10.1371\/journal.pone.0171384","article-title":"Low implementation of Xpert MTB\/RIF among HIV\/TB co-infected adults in the International epidemiologic Databases to Evaluate AIDS (IeDEA) program.","volume":"12","author":"K Clouse","year":"2017","journal-title":"PLoS One."},{"key":"ref-10","doi-asserted-by":"publisher","first-page":"1","DOI":"10.5588\/pha.18.0012","article-title":"Xpert implementation in challenging scenarios: a brand-new car running on the same bumpy old roads.","volume":"8","author":"I Monedero-Recuero","year":"2018","journal-title":"Public Health Action."},{"key":"ref-11","doi-asserted-by":"publisher","first-page":"e754-e755","DOI":"10.1016\/S2214-109X(17)30247-4","article-title":"Use of the GeneXpert tuberculosis system for HIV viral load testing in India.","volume":"5","author":"M Nash","year":"2017","journal-title":"Lancet Glob Health."},{"key":"ref-12","doi-asserted-by":"publisher","first-page":"e0193577","DOI":"10.1371\/journal.pone.0193577","article-title":"Multidisease testing for HIV and TB using the GeneXpert platform: A feasibility study in rural Zimbabwe.","volume":"13","author":"Z Ndlovu","year":"2018","journal-title":"PLoS One."},{"key":"ref-13","doi-asserted-by":"publisher","DOI":"10.1016\/j.jegh.2018.04.005","article-title":"New TB tools need to be affordable in the private sector: The case study of Xpert MTB\/RIF.","author":"N Ponnudurai","year":"2018","journal-title":"J Epidemiol Glob Health."},{"key":"ref-14","article-title":"Case study: catalyzing the market for accurate tuberculosis testing in India\u2019s extensive private sector through IPAQT"},{"key":"ref-15","article-title":"Use of high country burden lists for TB by WHO in the post-2015 era","year":"2015"},{"key":"ref-16","article-title":"Smear Xpert analysis 2018","author":"T Pande","year":"2018"}],"container-title":["Gates Open Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/gatesopenresearch.org\/articles\/2-35\/v2\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2018,9,18]],"date-time":"2018-09-18T10:20:10Z","timestamp":1537266010000},"score":1,"resource":{"primary":{"URL":"https:\/\/gatesopenresearch.org\/articles\/2-35\/v2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,9,18]]},"references-count":16,"URL":"https:\/\/doi.org\/10.12688\/gatesopenres.12842.2","relation":{},"ISSN":["2572-4754"],"issn-type":[{"value":"2572-4754","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,9,18]]},"assertion":[{"value":"Indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/2-35\/v2#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/gatesopenres.13923.r26588, Zibusiso Ndlovu, Southern Africa Medical Unit, Medecins Sans Frontieres (MSF), Cape Town, South Africa, 08 Aug 2018, version 1, indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/2-35\/v1#referee-response-26588","order":0,"name":"referee-response-26588","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Madhukar Pai<\/b>; \n<i>Posted: 14 Sep 2018<\/i>; Introduction: All comments have been addressed in the revised text.&nbsp;&nbsp;  Methods: The 2 first points have been addressed in the revised text.&nbsp; Point 3. This point is well taken. However, this is an assumption and has been acknowledged as a limitation.&nbsp;  Results:&nbsp; The flow has been revised based on the reviewer's suggestions. The grammar\/sentence changes have been addressed based on reviewer suggestions.&nbsp; The denominator has become 19 because 2 countries did not respond to this question. These were excluded, and this is explained in the text.&nbsp; Changed the % under utilizing to median % under utilization.&nbsp; Name of the figure is short. The description of the figure remains in the caption.  Discussion:&nbsp; The flow has been revised based on reviewer's suggestions.&nbsp; Have included the median change in number of initial smears for each region in the results.","URL":"https:\/\/gatesopenresearch.org\/articles\/2-35\/v2#referee-comment-3122","order":1,"name":"referee-comment-3122","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/gatesopenres.13923.r26587, Erica Lessem, Treatment Action Group\u00a0(TAG), New York City, NY, USA, 08 Aug 2018, version 1, indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/2-35\/v1#referee-response-26587","order":2,"name":"referee-response-26587","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Madhukar Pai<\/b>; \n<i>Posted: 14 Sep 2018<\/i>; Reviewer 2:Thank you for your comments.1. Great point, however we feel as if this is covered by the following limitations that were included in the text:  It is possible that survey data was reported differently from one year to the next which could have led to inaccurate estimates of initial smears and thus, smear\/Xpert ratios. Data availability was limited in some countries, which could have led to imprecise estimates.  2.&nbsp;This has been added to the text and reference added.3. This is indicated in the caption of the figure: \u201cTrends moving closer to 0 (ratio decreasing) signify a greater use of Xpert compared to smear microscopy for the diagnosis of TB. Trends moving away from 0 (ratio increasing) signify a greater use of smear microscopy compared to Xpert for the diagnosis of TB&quot;.4.&nbsp;Great point brought up by the reviewer. Authors are unsure of the reasons for decrease, but this could be explored further in the next study.5.&nbsp;We tried to collect data from additional countries but the response rate was very low (1\/10 responded after contacting them a maximum of 3 times), therefore we decided to exclude this data. This information has been added to the text.","URL":"https:\/\/gatesopenresearch.org\/articles\/2-35\/v2#referee-comment-3123","order":3,"name":"referee-comment-3123","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/gatesopenres.13923.r26586, Cesar Ugarte Gil, School of Medicine Alberto Hurtado, Institute of Tropical Medicine Alexander von Humboldt, Cayetano Heredia University (UPCH), Lima, Peru, 20 Aug 2018, version 1, indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/2-35\/v1#referee-response-26586","order":4,"name":"referee-response-26586","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Madhukar Pai<\/b>; \n<i>Posted: 14 Sep 2018<\/i>; Than you for your comments.&nbsp;1.&nbsp;Implementation progress of Xpert is represented by the smear\/Xpert ratio, which is already included in Table 1.&nbsp;Factors that could have affected implementation in certain countries are included in the text.&nbsp;2.&nbsp;Addressed this already, based off of Reviewer 1's comments. Included as a limitation.&nbsp;3. Great point. We decided after designing the questionnaire, however, that this study would focus only on GeneXpert and not include results on TB LAM or LAMP.","URL":"https:\/\/gatesopenresearch.org\/articles\/2-35\/v2#referee-comment-3124","order":5,"name":"referee-comment-3124","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/gatesopenres.13923.r26585, Melissa L. Mugambi, Mickey Urdea, Department of Global Health, University of Washington, Seattle, WA, USA, 30 Aug 2018, version 1, indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/2-35\/v1#referee-response-26585","order":6,"name":"referee-response-26585","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Madhukar Pai<\/b>; \n<i>Posted: 14 Sep 2018<\/i>; Thank you for your comments.&nbsp;  1. While we appreciate this comment, we do not feel we can accurately state what amount of increased market penetration will close the gap in TB case detection. Nor what will it cost to close the gap. The data collected does not allow us to estimate this, since the goal of this study is to assess trends over time.&nbsp;  2. We agree!","URL":"https:\/\/gatesopenresearch.org\/articles\/2-35\/v2#referee-comment-3125","order":7,"name":"referee-comment-3125","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work was initially supported by the Bill & Melinda Gates Foundation [OPP1061487]. Subsequent updates were supported by FIND, Geneva, and Global Drug Facility, Stop TB Partnership.","order":8,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}