update on the global roll -out of xpert mtb/rif 2/van gemert...country implementation of xpert...
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Update on the global rollUpdate on the global roll
1 |
Wayne van Gemert, Fuad Mirzayev, Jean Iragena, Chris Gilpin, Karin Weyer
Laboratories, Diagnostics and Drug Resistance Unit
WHO Stop TB Department
Xpert MTB/RIF Early Implementers Meeting: 18-19 April
Update on the global roll-out of Xpert MTB/RIFUpdate on the global roll-out of Xpert MTB/RIF
Wayne van Gemert, Fuad Mirzayev, Jean Iragena, Chris Gilpin, Karin Weyer
Laboratories, Diagnostics and Drug Resistance Unit
WHO Stop TB Department
April 2012
Contents of this presentationContents of this presentation
� Xpert MTB/RIF global landscape today
� WHO activities to facilitate the global roll
� Actions needed for facilitating larger scale
2 | Xpert MTB/RIF Early Implementers Meeting: 18-19 April
� Expected outcomes of this meeting
Contents of this presentationContents of this presentation
Xpert MTB/RIF global landscape today
WHO activities to facilitate the global roll-out
Actions needed for facilitating larger scale-up
April 2012
Expected outcomes of this meeting
Xpert MTB/RIF global landscape todayXpert MTB/RIF global landscape today
� 47 countries have procured at lea
(public sector in eligible countries)
3 | Xpert MTB/RIF Early Implementers Meeting: 18-19 April
� 460 machines (2401 modules) procured
Xpert MTB/RIF global landscape todayXpert MTB/RIF global landscape today
t least one GeneXpert, as of Dec 2011
(public sector in eligible countries)
April 2012
modules) procuredData: FIND
Xpert MTB/RIF global landscape todayXpert MTB/RIF global landscape today
� 591,450 Xpert MTB/RIF cartridges procured, as of Dec
(public sector in eligible countries)
330,540: South Africa
4 | Xpert MTB/RIF Early Implementers Meeting: 18-19 April
330,540: South Africa
21,440: Pakistan
20,140: Kenya
17,440: Philippines
16,660: Swaziland
14,140: Tanzania
13,970: Zimbabwe
12,280: Kyrgyzstan
10,590: Mozambique
Xpert MTB/RIF global landscape todayXpert MTB/RIF global landscape today
Xpert MTB/RIF cartridges procured, as of Dec 2011
(public sector in eligible countries)
April 2012
Data: FIND
191
300,000
400,000
500,000
600,000
Xpert MTB/RIF global landscape todayXpert MTB/RIF global landscape today
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166 524
40,790
86,320
191
0
100,000
200,000
Q4 2010 Q1 2011 Q2 2011
Modules
Xpert MTB/RIF Early Implementers Meeting: 18-19 April
191,900
329,350
591,450
1500
2000
2500
3000
Xpert MTB/RIF global landscape todayXpert MTB/RIF global landscape today
681 1,441 2,401
191,900
0
500
1000
2 2011 Q3 2011 Q4 2011
Cartridges
Data: FIND
April 2012
(public sector in eligible countries)
WHO activities to facilitate the global rollWHO activities to facilitate the global roll
� December 2010:
– WHO endorsement of Xpert MTB/RIF, following a
Global Consultation (recommended by
an Expert Group Meeting and
endorsed by STAG)
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endorsed by STAG)
– Issuance of the Roadmap for
rolling out Xpert MTB/RIF
Xpert MTB/RIF Early Implementers Meeting: 18-19 April
WHO activities to facilitate the global roll-outWHO activities to facilitate the global roll-out
WHO endorsement of Xpert MTB/RIF, following a
Global Consultation (recommended by
an Expert Group Meeting and
Roadmap for
April 2012
WHO activities to facilitate the global rollWHO activities to facilitate the global roll
� March 2011:
– Issuance of the WHO Rapid Implementation of
Xpert MTB/RIF diagnostic test
• Positioning of the test and site selection
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• Positioning of the test and site selection
• Selection of individuals to test and
patient management
• Key data elements to collect
• Operational considerations
Xpert MTB/RIF Early Implementers Meeting: 18-19 April
WHO activities to facilitate the global roll-outWHO activities to facilitate the global roll-out
WHO Rapid Implementation of
Xpert MTB/RIF diagnostic test
Positioning of the test and site selectionPositioning of the test and site selection
Selection of individuals to test and
Key data elements to collect
Operational considerations
April 2012
WHO activities to facilitate the global rollWHO activities to facilitate the global roll
� April 2011:
– Training workshop for Xpert MTB/RIF Early Implementers
• Focus on the practical application of the
Implementation document within country
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Implementation document within country
context
• Mapping of country and
for roll-out in order to maximize resources and avoid
duplication and overlap
• Understanding of the add
Xpert MTB/RIF Early Implementers Meeting: 18-19 April
WHO activities to facilitate the global roll-outWHO activities to facilitate the global roll-out
Training workshop for Xpert MTB/RIF Early Implementers
Focus on the practical application of the Rapid
document within country-specific document within country-specific
and technical partner / donor plans
out in order to maximize resources and avoid
duplication and overlap
additional needs of implementers
April 2012
WHO activities to facilitate the global rollWHO activities to facilitate the global roll
� May 2011:
– Issuance of WHO Policy statement
and refined Rapid Implementation
document
9 | Xpert MTB/RIF Early Implementers Meeting: 18-19 April
– Impact of Xpert MTB/RIF and
other rapid diagnostics on definitions
of cases and treatment outcomes
for MDR-TB and non MDR-TB:
Consultation
WHO activities to facilitate the global roll-outWHO activities to facilitate the global roll-out
Issuance of WHO Policy statement
Rapid Implementation
April 2012
Impact of Xpert MTB/RIF and
other rapid diagnostics on definitions
cases and treatment outcomes
TB:
WHO activities to facilitate the global rollWHO activities to facilitate the global roll
� June 2011:
– Issuance of the Checklist: Prerequisites to
country implementation of Xpert MTB/RIF
and key action points at country level
10 | Xpert MTB/RIF Early Implementers Meeting: 18-19 April
WHO activities to facilitate the global roll-outWHO activities to facilitate the global roll-out
Checklist: Prerequisites to
country implementation of Xpert MTB/RIF
and key action points at country level
April 2012
WHO activities to facilitate the global rollWHO activities to facilitate the global roll
� July 2011 onwards:
– WHO website monitoring the
Xpert MTB/RIF rollout
• Numbers of procured
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GeneXperts and Xpert MTB/RIF
cartridges, by country
• Sites of GeneXperts in countries
• Plans of countries and partners for procurements
• Reported operational problems
Xpert MTB/RIF Early Implementers Meeting: 18-19 April
WHO activities to facilitate the global roll-outWHO activities to facilitate the global roll-out
WHO website monitoring the
and Xpert MTB/RIF
in countries
Plans of countries and partners for procurements
Reported operational problems
April 2012
WHO activities to facilitate the global rollWHO activities to facilitate the global roll
� July 2011 onwards:
– WHO website monitoring the
Xpert MTB/RIF rollout
• Numbers of procured
Some reported problems:� Signal loss errors (5011)
12 |
GeneXperts and Xpert MTB/RIF
cartridges, by country
• Sites of GeneXperts within countries
• Plans of countries and partners for procurements
• Reported operational problems
Xpert MTB/RIF Early Implementers Meeting: 18-19 April
� Broken thermo-sensor
� Module out-of-order
� Recurrent breakage of plastic on lid
� Syringe errors (2005)
WHO activities to facilitate the global roll-outWHO activities to facilitate the global roll-out
WHO website monitoring the
and Xpert MTB/RIF
within countries
Plans of countries and partners for procurements
Reported operational problems
April 2012
breakage of plastic on lid
WHO activities to facilitate the global rollWHO activities to facilitate the global roll
� September, December 2011
– Submission of Letter of Intent (
UNITAID for procurement of
MTB/RIF cartridges
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• Consortium: WHO, Stop TB Partnership, FIND,
Global Laboratory Initiative (GLI), TB REACH,
African Society for Laboratory Medicine
(ASLM), Interactive Research and Development
(IRD)
• Allow for a drop in cartridge price to
Xpert MTB/RIF Early Implementers Meeting: 18-19 April
WHO activities to facilitate the global roll-outWHO activities to facilitate the global roll-out
2011:
Submission of Letter of Intent (LoI) and proposal to
UNITAID for procurement of GeneXperts and Xpert
Consortium: WHO, Stop TB Partnership, FIND,
Global Laboratory Initiative (GLI), TB REACH,
African Society for Laboratory Medicine
(ASLM), Interactive Research and Development
Allow for a drop in cartridge price to 9.98USD
April 2012
WHO activities to facilitate the global rollWHO activities to facilitate the global roll
� December 2011 onwards:
– GLI validation panels for Xpert MTB/RIF
• 5 tubes containing heat
artificial sputum
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artificial sputum
• Results are reported to GLI secretariat and
compared with expected results (MTB RIF
MTB RIF+, not MTB)
• Intended to be used with new machines and with
recalibrated modules
• Requests for panels: [email protected]
Xpert MTB/RIF Early Implementers Meeting: 18-19 April
WHO activities to facilitate the global roll-outWHO activities to facilitate the global roll-out
GLI validation panels for Xpert MTB/RIF
tubes containing heat-killed bacilli in
Results are reported to GLI secretariat and
compared with expected results (MTB RIF-,
Intended to be used with new machines and with
Requests for panels: [email protected]
April 2012
WHO activities to facilitate the global rollWHO activities to facilitate the global roll
� December 2011 onwards:
– GLI validation panels for Xpert MTB/RIF
• 5 tubes containing heat
artificial sputum
Findings of pilot validation panel schemeFindings of pilot validation panel scheme
� Panels sent to 8 countries, 38 sites funded by TB REACH
� 30 sites: all results as expected (103
� Of the remaining 8 sites (36 tests):
– 3 tests: false RIF susceptibility
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artificial sputum
• Results are reported to GLI secretariat and
compared with expected results (MTB RIF
MTB RIF+, not MTB)
• Intended to be used with new machines and with
recalibrated modules
• Requests for panels: [email protected]
Xpert MTB/RIF Early Implementers Meeting: 18-19 April
– 3 tests: false RIF susceptibility
– 2 tests: false RIF resistance
– 2 tests: false MTB detection
– 3 occurrences of errors, plus 1
were invalid
� There is a need to include the panels with shipments of
instruments/modules
WHO activities to facilitate the global roll-outWHO activities to facilitate the global roll-out
GLI validation panels for Xpert MTB/RIF
tubes containing heat-killed bacilli in
Findings of pilot validation panel schemeFindings of pilot validation panel scheme
sites funded by TB REACH
103/103 tests)
tests):
tests: false RIF susceptibilityResults are reported to GLI secretariat and
compared with expected results (MTB RIF-,
Intended to be used with new machines and with
Requests for panels: [email protected]
April 2012
tests: false RIF susceptibility
1 site in which all 4 tests
There is a need to include the panels with shipments of
WHO activities to facilitate the global rollWHO activities to facilitate the global roll
� February 2012 onwards:
– Launch of website to collect evidence for scale
described in Rapid Implementation
document
16 | Xpert MTB/RIF Early Implementers Meeting: 18-19 April
– Facilities invited to provide data on:
• Laboratory workload
• Numbers of tests being
performed and results
• Main logistical and operational
problems being encountered
WHO activities to facilitate the global roll-outWHO activities to facilitate the global roll-out
Launch of website to collect evidence for scale-up, as
Rapid Implementation
April 2012
Facilities invited to provide data on:
Main logistical and operational
problems being encountered
WHO activities to facilitate the global rollWHO activities to facilitate the global roll
� Other ongoing activities:
– Quarterly updates on the Xpert MTB/RIF roll
our mailing list
– Online list of published literature on Xpert MTB/RIF,
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– Online list of published literature on Xpert MTB/RIF,
updated monthly
Xpert MTB/RIF Early Implementers Meeting: 18-19 April
http://www.who.int/tb/laboratory/mtbrifrollout
WHO activities to facilitate the global roll-outWHO activities to facilitate the global roll-out
Quarterly updates on the Xpert MTB/RIF roll-out, sent to
Online list of published literature on Xpert MTB/RIF, Online list of published literature on Xpert MTB/RIF,
April 2012
www.who.int/tb/laboratory/mtbrifrollout
Actions needed for facilitating larger scaleActions needed for facilitating larger scale
� Price drop!
– Ongoing negotiations with UNITAID, FIND, other donors and
buyers, with the manufacturer
� Refining of WHO guidance, bas
18 | Xpert MTB/RIF Early Implementers Meeting: 18-19 April
data from early implementers
– Collection of evidence (key labo
and partners, including TB REACH, TB CARE sites
– Findings from operational research
Actions needed for facilitating larger scale-upActions needed for facilitating larger scale-up
Ongoing negotiations with UNITAID, FIND, other donors and
buyers, with the manufacturer
, based on the experiences and
April 2012
data from early implementers
laboratory and patient data) by WHO
and partners, including TB REACH, TB CARE sites
Findings from operational research
Actions needed for facilitating larger scaleActions needed for facilitating larger scale
� Adoption of the technology by the private sector
� Technological innovations to fa
globally
� Review of accuracy data on detection of
19 | Xpert MTB/RIF Early Implementers Meeting: 18-19 April
� Review of accuracy data on detection of
and paediatric TB for possible endorsement
Actions needed for facilitating larger scale-upActions needed for facilitating larger scale-up
Adoption of the technology by the private sector
to facilitate use in peripheral sites
Review of accuracy data on detection of extrapulmonary TB
April 2012
Review of accuracy data on detection of extrapulmonary TB
and paediatric TB for possible endorsement
Expected outcomes of this meetingExpected outcomes of this meeting
� Sharing of up-to-date information and country experiences on
use of Xpert MTB/RIF and best practices
� Sharing of country, partner and donor activities and plans for
improved coordination
� Greater understanding of the needs of Xpert MTB/RIF
20 | Xpert MTB/RIF Early Implementers Meeting: 18-19 April
� Greater understanding of the needs of Xpert MTB/RIF
implementers
Thank you
Expected outcomes of this meetingExpected outcomes of this meeting
date information and country experiences on
use of Xpert MTB/RIF and best practices
Sharing of country, partner and donor activities and plans for
Greater understanding of the needs of Xpert MTB/RIF
April 2012
Greater understanding of the needs of Xpert MTB/RIF
Thank you