Market penetration of Xpert MTB/RIF in high tuberculosis burden countries: A trend analysis from 2014 - 2016

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Abstract

Background: Xpert® 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 assessed 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 (Q1:14.3, Q3: 58.9) in 2014 to 6.0 (Q1: 1.6, Q3: 17.0) in 2016. Nineteen countries (19/19; 100%) were not using GeneXpert machines to their full capacity, 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.

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Multidisease testing for HIV and TB using the GeneXpert platform: A feasibility study in rural Zimbabwe

Zibusiso Ndlovu, Emmanuel Fajardo, Elton Mbofana … (2018)

Background HIV Viral Load and Early Infant Diagnosis technologies in many high burden settings are restricted to centralized laboratory testing, leading to long result turnaround times and patient attrition. GeneXpert (Cepheid, CA, USA) is a polyvalent near point-of-care platform and is widely implemented for Xpert MTB/RIF diagnosis. This study sought to evaluate the operational feasibility of integrated HIV VL, EID and MTB/RIF testing in new GeneXpert platforms. Methods Whole blood samples were collected from consenting patients due for routine HIV VL testing and DBS samples from infants due for EID testing, at three rural health facilities in Zimbabwe. Sputum samples were collected from all individuals suspected of TB. GeneXpert testing was reserved for all EID, all TB suspects and priority HIV VL at each site. Blood samples were further sent to centralized laboratories for confirmatory testing. GeneXpert polyvalent testing results and patient outcomes, including infrastructural and logistical requirements are reported. The study was conducted over a 10-month period. Results The fully automated GeneXpert testing device, required minimal training and biosafety considerations. A total of 1,302 HIV VL, 277 EID and 1,581 MTB/RIF samples were tested on a four module GeneXpert platform in each study site. Xpert HIV-1 VL testing was prioritized for patients who presented with advanced HIV disease, pregnant women, adolescents and suspected ART failures patients. On average, the study sites had a GeneXpert utilization rate of 50.4% (Gutu Mission Hospital), 63.5% (Murambinda Mission Hospital) and 17.5% (Chimombe Rural Health Centre) per month. GeneXpert polyvalent testing error rates remained lower than 4% in all sites. Decentralized EID and VL testing on Xpert had shorter overall median TAT (1 day [IQR: 0–4] and 1 day [IQR: 0–1] respectively) compared to centralized testing (17 days [IQR: 13–21] and 26 days [IQR: 23–32] respectively). Among patients with VL >1000 copies/ml (73/640; 11.4%) at GMH health facility, median time to enhanced adherence counselling was 8 days and majority of those with documented outcomes had re-suppressed VL (20/32; 62.5%). Median time to ART initiation among Xpert EID positive infants at GMH was 1 day [IQR: 0–1]. Conclusion Implementation of near point-of-care GeneXpert platform for integrated multi-disease testing within district and sub-district healthcare settings is feasible and will increase access to VL, and EID testing to priority populations. Quality management systems including monitoring of performance indicators, together with regular on-site supervision are crucial, and near-POC test results must be promptly actioned-on by clinicians for patient management.

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Implementation of Xpert MTB/RIF in 22 high tuberculosis burden countries: are we making progress?

Danielle Cazabon, Anita Suresh, Collins Oghor … (2017)

By the end of 2016, approximately 23 million Xpert MTB/RIF® (Xpert; Cepheid, Sunnyvale, CA, USA) cartridges for tuberculosis (TB) diagnosis had been procured by the public sector in 130 countries at concessional pricing [1], but smear microscopy continues to be the most widely used test for TB [2]. To understand the true market penetration of Xpert in TB high burden countries (HBCs), we surveyed National TB Programmes (NTPs) or their partnering organisations in 22 HBCs to obtain Xpert data from 2015 and to assess dynamic trends from 2014 to 2015. These 22 countries had been previously surveyed by us in 2014 [3].

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Low implementation of Xpert MTB/RIF among HIV/TB co-infected adults in the International epidemiologic Databases to Evaluate AIDS (IeDEA) program

Kate Clouse, Meridith Blevins, Mary Lou Lindegren … (2017)

Objective Xpert MTB/RIF is recommended by the World Health Organization (WHO) as the initial tuberculosis (TB) diagnostic test in individuals suspected of HIV-associated TB. We sought to evaluate field implementation of Xpert among a cohort of HIV/TB co-infected individuals, including availability, utilization and outcomes. Design Observational cohort study (patient-level data) and cross-sectional study (site-level Xpert availability data). Methods Data were collected at 30 participating International epidemiologic Databases to Evaluate AIDS (IeDEA) sites in 18 countries from January 2012-January 2016. All patients were HIV-infected and diagnosed with TB, either bacteriologically or clinically, and followed until a determination of TB treatment outcome. We used multivariable modified Poisson regression to estimate adjusted relative risk (RR) and 95% confidence intervals for unfavorable TB treatment outcomes. Results Most sites (63%) had access to Xpert, either in the clinic (13%), in the same facility (20%) or offsite (30%). Among 2722 HIV/TB patients included, median age was 35.4 years and 41% were female; BMI and CD4 count were low. Overall, most patients (76%) received at least one TB test; 45% were positive. Only 4% of all patients were tested using Xpert: 64% were Xpert-positive, 13% showed rifampicin (RIF) resistance and 30% were extrapulmonary (EPTB) or both pulmonary-EPTB. Treatment outcomes were mostly favorable (77%) and we found little association between Xpert use and an unfavorable TB treatment outcome (RR 1.25, 95%CI: 0.83, 1.90). Conclusions In this cohort, Xpert utilization was low even though the majority of sites had access to the test. Our findings show the need for expanded implementation and further research exploring barriers to use in low-resource settings.

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Author and article information

Contributors

Danielle Cazabon: Role: Data CurationRole: Formal AnalysisRole: InvestigationRole: ValidationRole: VisualizationRole: Writing – Original Draft Preparation

Tripti Pande: Role: Data CurationRole: Formal AnalysisRole: MethodologyRole: ValidationRole: Writing – Original Draft Preparation

Sandra Kik: Role: MethodologyRole: SupervisionRole: Writing – Review & Editing

Wayne Van Gemert: Role: MethodologyRole: SupervisionRole: Writing – Review & Editing

Hojoon Sohn: Role: MethodologyRole: SupervisionRole: Writing – Review & Editing

Claudia Denkinger: Role: Data CurationRole: SupervisionRole: Writing – Review & Editing

Zhi Zhen Qin: Role: ConceptualizationRole: Writing – Review & Editing

Brenda Waning: Role: SupervisionRole: Writing – Review & Editing

Madhukar Pai: Role: ConceptualizationRole: Funding AcquisitionRole: MethodologyRole: Project AdministrationRole: SupervisionRole: Writing – Review & Editing

ORCID: https://orcid.org/0000-0003-3667-4536

Journal

Journal ID (nlm-ta): Gates Open Res

Journal ID (iso-abbrev): Gates Open Res

Journal ID (pmc): Gates Open Res

Title: Gates Open Research

Publisher: F1000 Research Limited (London, UK )

ISSN (Electronic): 2572-4754

Publication date (Electronic): 25 July 2018

Volume: 2

Electronic Location Identifier: 35

Affiliations

[1 ]McGill International TB Centre, McGill University, Montreal, QC, Canada

[2 ]Foundation for Innovative New Diagnostics, FIND, Geneva, Switzerland

[3 ]Stop TB Partnership, Geneva, Switzerland

[4 ]Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA

[5 ]Epidemiology & Biostatistics, McGill University, Montreal, QC, Canada

[1 ]Department of Global Health, University of Washington, Seattle, WA, USA

[2 ]Halteres Associates, Emeryville, CA, USA

[1 ]School of Medicine Alberto Hurtado, Institute of Tropical Medicine Alexander von Humboldt, Cayetano Heredia University (UPCH), Lima, Peru

[1 ]Treatment Action Group (TAG), New York City, NY, USA

[1 ]Southern Africa Medical Unit, Medecins Sans Frontieres (MSF), Cape Town, South Africa

Author notes

[a ] madhukar.pai@ 123456mcgill.ca

*Both authors contributed equally to this manuscript.

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.

Competing interests: No competing interests were disclosed.

Competing interests: I have a non-financial competing interest (I collaborate with MP and HS). Also, I'm co-investigator in a TB research project funded by FIND (not related with this study).

Competing interests: I have a non-financial competing interest in that I collaborate with co-authors Wayne van Gemert and Brenda Waning on various projects. I am Vice Chair of the TB Procurement & Market-Shaping Work Group that Waning chairs and GDF hosts. My organization TAG receives funding (<$200K / year) from the Stop TB Partnership/Global Drug Facility to work on Demand Generation as Part of a Coordinated, Market-Shaping Approach to Procurement of TB Commodities.

Competing interests: No competing interests were disclosed.

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Madhukar Pai https://orcid.org/0000-0003-3667-4536

Article

DOI: 10.12688/gatesopenres.12842.1

PMC ID: 6139378

PubMed ID: 30234198

SO-VID: 4104e1f9-6f92-46a7-9519-5e53952355a8

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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.

History

Date accepted : 19 July 2018

Funding

Funded by: FIND, Geneva

Funded by: Bill and Melinda Gates Foundation

Award ID: OPP1061487

Funded by: Global Drug Facility, Stop TB Partnership

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.

Market penetration of Xpert MTB/RIF in high tuberculosis burden countries: A trend analysis from 2014 - 2016

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Most cited references 8

Multidisease testing for HIV and TB using the GeneXpert platform: A feasibility study in rural Zimbabwe

Implementation of Xpert MTB/RIF in 22 high tuberculosis burden countries: are we making progress?

Low implementation of Xpert MTB/RIF among HIV/TB co-infected adults in the International epidemiologic Databases to Evaluate AIDS (IeDEA) program

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