Update on the global roll -out of Xpert MTB/RIF 2/van Gemert...country implementation of Xpert...

Update on the global rollUpdate on the global roll

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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)


� 460 machines (2401 modules) procured


t least one GeneXpert, as of Dec 2011


April 2012

modules) procuredData: FIND


� 591,450 Xpert MTB/RIF cartridges procured, as of Dec


330,540: South Africa


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 cartridges procured, as of Dec 2011


April 2012

Data: FIND

191

300,000

400,000

500,000

600,000


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166 524

40,790

86,320

191

0

100,000

200,000

Q4 2010 Q1 2011 Q2 2011

Modules


191,900

329,350

591,450

1500

2000

2500

3000


681 1,441 2,401

191,900

0

500

1000

2 2011 Q3 2011 Q4 2011

Cartridges

Data: FIND

April 2012


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


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


� 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



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


� 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



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


� May 2011:

– Issuance of WHO Policy statement

and refined Rapid Implementation

document


– Impact of Xpert MTB/RIF and

other rapid diagnostics on definitions

of cases and treatment outcomes

for MDR-TB and non MDR-TB:

Consultation


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:


� June 2011:

– Issuance of the Checklist: Prerequisites to

country implementation of Xpert MTB/RIF

and key action points at country level



Checklist: Prerequisites to

country implementation of Xpert MTB/RIF

and key action points at country level

April 2012


� 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



WHO website monitoring the

and Xpert MTB/RIF

in countries

Plans of countries and partners for procurements

Reported operational problems

April 2012


� 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


� Broken thermo-sensor

� Module out-of-order

� Recurrent breakage of plastic on lid

� Syringe errors (2005)


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


� 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



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


� 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]



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


� 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]


– 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


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


� February 2012 onwards:

– Launch of website to collect evidence for scale

described in Rapid Implementation

document


– Facilities invited to provide data on:

• Laboratory workload

• Numbers of tests being

performed and results

• Main logistical and operational

problems being encountered


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


� 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


http://www.who.int/tb/laboratory/mtbrifrollout


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


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


� 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


� Greater understanding of the needs of Xpert MTB/RIF

implementers

Thank you

[email protected]

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

[email protected]

Update on the global roll -out of Xpert MTB/RIF 2/van Gemert...country implementation of Xpert...

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