PMID- 30234198
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2572-4754 (Electronic)
IS  - 2572-4754 (Linking)
VI  - 2
DP  - 2018
TI  - Market penetration of Xpert MTB/RIF in high tuberculosis burden countries: A 
      trend analysis from 2014 - 2016.
PG  - 35
LID - 10.12688/gatesopenres.12842.2 [doi]
LID - 35
AB  - Background: Xpert(R) 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. 
      Methods: 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. Results: 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), Chlamydia trachomatis, and 
      Neisseria gonorrhoeae. Five (5/15; 33%) countries reported GeneXpert procurement 
      by HIV or HCV programs in 2016 and/or 2017. Conclusions: 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.
FAU - Cazabon, Danielle
AU  - Cazabon D
AD  - McGill International TB Centre, McGill University, Montreal, QC, Canada.
FAU - Pande, Tripti
AU  - Pande T
AD  - McGill International TB Centre, McGill University, Montreal, QC, Canada.
FAU - Kik, Sandra
AU  - Kik S
AD  - Foundation for Innovative New Diagnostics, FIND, Geneva, Switzerland.
FAU - Van Gemert, Wayne
AU  - Van Gemert W
AD  - Stop TB Partnership, Geneva, Switzerland.
FAU - Sohn, Hojoon
AU  - Sohn H
AD  - Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
FAU - Denkinger, Claudia
AU  - Denkinger C
AD  - Foundation for Innovative New Diagnostics, FIND, Geneva, Switzerland.
FAU - Qin, Zhi Zhen
AU  - Qin ZZ
AD  - Stop TB Partnership, Geneva, Switzerland.
FAU - Waning, Brenda
AU  - Waning B
AD  - Stop TB Partnership, Geneva, Switzerland.
FAU - Pai, Madhukar
AU  - Pai M
AUID- ORCID: 0000-0003-3667-4536
AD  - McGill International TB Centre, McGill University, Montreal, QC, Canada.
AD  - Epidemiology & Biostatistics, McGill University, Montreal, QC, Canada.
LA  - eng
PT  - Journal Article
DEP - 20180918
PL  - United States
TA  - Gates Open Res
JT  - Gates open research
JID - 101717821
PMC - PMC6139378
OTO - NOTNLM
OT  - Xpert MTB/RIF
OT  - access
OT  - diagnostics
OT  - market penetration
OT  - tuberculosis
COIS- Competing interests: SK and CD are employed by FIND. FIND is a not-for-profit 
      foundation that supports the evaluation of publicly prioritized tuberculosis 
      assays and the implementation of WHO-approved (guidance and prequalification) 
      assays using donor grants. FIND has product evaluation agreements with several 
      private sector companies, including Cepheid Inc, that design diagnostics and 
      related products for treatment of tuberculosis and other diseases. These 
      agreements strictly define FIND's independence and neutrality vis-a-vis the 
      companies whose products get evaluated and describe roles and responsibilities. 
      MP previously consulted for the Bill & Melinda Gates Foundation. He serves on the 
      Access Advisory Committee of FIND, Geneva. The other authors have no conflicts to 
      disclose.
EDAT- 2019/09/25 06:00
MHDA- 2019/09/25 06:01
PMCR- 2018/09/18
CRDT- 2019/09/25 06:00
PHST- 2018/09/14 00:00 [accepted]
PHST- 2019/09/25 06:00 [entrez]
PHST- 2019/09/25 06:00 [pubmed]
PHST- 2019/09/25 06:01 [medline]
PHST- 2018/09/18 00:00 [pmc-release]
AID - 10.12688/gatesopenres.12842.2 [doi]
PST - epublish
SO  - Gates Open Res. 2018 Sep 18;2:35. doi: 10.12688/gatesopenres.12842.2. eCollection 
      2018.