Strengthening Laboratory

Systems for MDRTB

Strengthening Laboratory

Systems for MDRTBJohn Ridderhof, DrPH

Chair, Subgroup on Laboratory Capacity Strengthening

Associate Director for Laboratory Science

National Center for Prevention, Detection and Control of Infectious Diseases

CCID/CDC

John Ridderhof, DrPH

Chair, Subgroup on Laboratory Capacity Strengthening

Associate Director for Laboratory Science

National Center for Prevention, Detection and Control of Infectious Diseases

CCID/CDC

2

Current challenges/MDRCurrent challenges/MDR

• 5-10%% MDR cases diagnosed

• Difficulties in implementing culture and DST

• Quality of culture and DST is often questionable

• Second line drug (SLD) testing primarily

restricted to SRLs

• 5-10%% MDR cases diagnosed

• Difficulties in implementing culture and DST

• Quality of culture and DST is often questionable

• Second line drug (SLD) testing primarily

restricted to SRLs

3

Key MessagesKey Messages

• Strengthen microscopy and culture and implement new methods

• Better test performance in laboratories where quality systems are required

• Scale up of laboratory capacity will require initiatives to integrate services

• The laboratory is a system and new diagnostics will require strong systems

• Strengthen microscopy and culture and implement new methods

• Better test performance in laboratories where quality systems are required

• Scale up of laboratory capacity will require initiatives to integrate services

• The laboratory is a system and new diagnostics will require strong systems

4

Stop TB Partnership

Workgroups

Stop TB Partnership

Workgroups

• DOTS Expansion WG

� Subgroup on Laboratory Capacity Strengthening (SLCS)

• WG on New TB diagnostics

• TB/HIV WG

• MDRTB WG

• WG on New TB Drugs

• WG on New TB Vaccines

• Advocacy, Communication, and Social Mobilization WG

• DOTS Expansion WG

� Subgroup on Laboratory Capacity Strengthening (SLCS)

• WG on New TB diagnostics

• TB/HIV WG

• MDRTB WG

• WG on New TB Drugs

• WG on New TB Vaccines

• Advocacy, Communication, and Social Mobilization WG

5

Coordinating CentreAntwerp, Belgium

Network of 26 Supranational Laboratories

National/Regional Reference Laboratories

Panel of 30 coded isolates

Panel of 20 coded isolates

Sample of isolates for rechecking

(DRS/DOTS-Plus)

Initial Assessment

Ongoing TA

6

Acceleration of SLCS activitiesAcceleration of SLCS activities

• Formed in 2002, Initial focus on SRLN has evolved to general capacity building

• Development of technical guidance transitioned from volunteer efforts to structured consensus process with partners

• Core group formed, meetings in March and July 2007

• USAID funding for business plan development

• Increase in technical workgroups

• Formed in 2002, Initial focus on SRLN has evolved to general capacity building

• Development of technical guidance transitioned from volunteer efforts to structured consensus process with partners

• Core group formed, meetings in March and July 2007

• USAID funding for business plan development

• Increase in technical workgroups

7

SLCS core groupSLCS core group

• Chair

• WHO Secretariat

• IUATLD

• FIND

• CDC

• Patient Community

• NTP/NRL

• NTP/NRL

• SRL

• SRL

• Observers

• Liaisons with other WG

• Chair

• WHO Secretariat

• IUATLD

• FIND

• CDC

• Patient Community

• NTP/NRL

• NTP/NRL

• SRL

• SRL

• Observers

• Liaisons with other WG

8

Technical Workgroups/ConsultationsTechnical Workgroups/Consultations

• Use of liquid culture methods (March 07)

• Interim policy guidance for second line drug

(SLD) testing (July 07)

• Technical procedures for SLD testing (August

07)

• Use of liquid culture methods (March 07)

• Interim policy guidance for second line drug

(SLD) testing (July 07)

• Technical procedures for SLD testing (August

07)

9

Development of business planDevelopment of business plan

• Consultation with committee of core group

(January 07)

• Review and input of core group/development of

global estimates (March 07)

• Refinement of organizational structure (July 07)

• Consultation with committee of core group

(January 07)

• Review and input of core group/development of

global estimates (March 07)

• Refinement of organizational structure (July 07)

10

Why a Global Network of sharing knowledge,

guidance, and assurance?

Why a Global Network of sharing knowledge,

guidance, and assurance?

• The laboratory systems must address quality and productivity to make an effective and efficient increase in capacity

• The sheer number of laboratory personnel on the global level (200-400,000) calls for new and novel ways of disseminating knowledge

• The laboratory system and donors require far stronger coordination and guidance and assurance on what constitutes appropriate laboratory practice

• More and better focused advocacy for the cause of laboratory strengthening

• The laboratory systems must address quality and productivity to make an effective and efficient increase in capacity

• The sheer number of laboratory personnel on the global level (200-400,000) calls for new and novel ways of disseminating knowledge

• The laboratory system and donors require far stronger coordination and guidance and assurance on what constitutes appropriate laboratory practice

• More and better focused advocacy for the cause of laboratory strengthening

11

Training MaterialsTraining Materials

GuidelinesGuidelines Programs/ReportsPrograms/Reports

Workshops/ConferencesWorkshops/Conferences

The US initiative in the 90The US initiative in the 90’’s to meet the challenge of MDRs to meet the challenge of MDR--TBTB““The Laboratory Makes a DifferenceThe Laboratory Makes a Difference””

12

Required expansion of testing and fundingRequired expansion of testing and funding

2010 2012 2015

Required e

xpansion of

Culture capacity: fro

m 10 to 60

mln pa

# of tests required (mln) $ of funding

required (mln)

2500

2000

1500

1000

500

Required

expansi

on of Smear c

apacity

: from

80 to 20

0 mln p

a

To reach MDG targets, a global capacity gap of 120 mln smear and 50 mln culture tests must be addressed – in accordance to country-specific conditions and priorities. This requires $2,500 mln for investment funding, of which $900 mln is needed for urgent immediate requirements.

2008

Urg

en

t M

DG

Targ

et

200

150

100

50

13

Strengthening the Global TB Laboratory NetworkStrengthening the Global TB Laboratory Network

Network will be an active facilitator of communication and provide various global infrastructure services including guidance, assurance and interface connection activities – all synchronized to be a coherent network service.

Network will be an active facilitator of communication and provide various global infrastructure services including guidance, assurance and interface connection activities – all synchronized to be a coherent network service.

~100.000 smear lab centers200.000-300.000 personnel

~8.000 advanced diagnostic centers40.000 – 50.000 personnel

150 National Reference Labs

70 SLCS Members

WHO Network Office

Knowledge Sharing:

- Coordination of provision of TA and training

- organizing meetings- Advanced communication technologies

- TB-Wiki; Knowledge Resource Network online

Interface Connection:

- Matchmaking of projects between countries and implementing partners

- manage stakeholders- Advocacy for lab funding- Other TB communities- Other disease networks

Assurance activities:

- coordination of EQA- specifications for equipment and machines

- Global accreditation system- Monitoring/evaluation

Guidance Activities:- lab manuals- 2nd line DST- Creation of training materials

- Recommendations for funding strategy

- National Roadmap advice

Exemplary activities of the Network

14

Priority Activities at Global LevelPriority Activities at Global Level

• International training for 100 “implementation”consultants

• New strategies for knowledge sharing

• Drug resistance surveillance funding gap

• Equipment and material specifications

• Training materials for culture and DST

• Guidance for second line drug (SLD) testing

• Update laboratory manuals (WHO/IUATLD/CDC)

• Develop Accreditation for TB laboratories

• National “roadmaps” for countries/technical partner

• Office for coordination of Laboratory Technical Assistance

• International training for 100 “implementation”consultants

• New strategies for knowledge sharing

• Drug resistance surveillance funding gap

• Equipment and material specifications

• Training materials for culture and DST

• Guidance for second line drug (SLD) testing

• Update laboratory manuals (WHO/IUATLD/CDC)

• Develop Accreditation for TB laboratories

• National “roadmaps” for countries/technical partner

• Office for coordination of Laboratory Technical Assistance

15

Key points from planning processKey points from planning process

• Scale up of technical assistance (TA) through multiple partners requires greater coordination, different models of support, and increased tool development

• Network core will be housed in WHO with project management involving partners

• Increase senior and midlevel laboratory consultants

• Scale up of technical assistance (TA) through multiple partners requires greater coordination, different models of support, and increased tool development

• Network core will be housed in WHO with project management involving partners

• Increase senior and midlevel laboratory consultants

16

Next Steps/PrioritiesNext Steps/Priorities

• Refine business plan based on input from key StopTB stakeholders at Capetown

• Meet with multiple donors to seek sustained funding support

• Promote advocacy for laboratory programs/capacity building

• Promote partner participation/contributions through increased SLCS communications and coordination

• Refine business plan based on input from key StopTB stakeholders at Capetown

• Meet with multiple donors to seek sustained funding support

• Promote advocacy for laboratory programs/capacity building

• Promote partner participation/contributions through increased SLCS communications and coordination

17

AcknowledgementsAcknowledgements

• Armand Van Deun

• Karin Weyer

• Rick O'Brien

• Chris Gilpin

• Abigail Wright

• Mohamed Aziz

• Armand Van Deun

• Karin Weyer

• Rick O'Brien

• Chris Gilpin

• Abigail Wright

• Mohamed Aziz

• Moses Joloba

• Kai Man Kam

• Francis Drobniewski

• Lucia Barrera

• Tom Shinnick

• Case Gordon

• Peer Ederer

• Moses Joloba

• Kai Man Kam

• Francis Drobniewski

• Lucia Barrera

• Tom Shinnick

• Case Gordon

• Peer Ederer