Narrowing the gap: Expanding access to new diagnostics … · Narrowing the gap: Expanding access to new diagnostics for patients at risk of MDR-TB ... J ha rk ha n d W e s t

Narrowing the gap:

Expanding access to new diagnostics

for patients at risk of MDR-TB

Daniel Orozco Senior Project Manager – Leader EXPAND-TB Project, FIND

5th GLI Annual Meeting, Annecy, 15 April 2013

MDR-TB

Building diagnostic

capacity for

500,000 new MDR-TB cases

60,000 cases were notified

only

Early detection

Rapid

identificat on

Ensure ACCESS to new diagnostic technologies in countries

Increased MARKET SIZE and PRICE reductions

Implementation in

QUALITY-ASSURED laboratories

2009

1810 cases detected in 4 laboratories

in 3 countries

2 to 3 months needed

for case detection and DST

2012

Roll-out of new technologies and reduced time to diagnosis:

• MGIT: 3-4 weeks • LPA: 3 days

• GeneXpert: 2 hours

36,965 cases detected in 65 laboratories

in 24 countries

2012

end 2014

Project

extension until

2014

115,213 cases detected in 99 laboratories

in 27 countries

• Monitoring and

evaluation

• Impact assessment

• Market dynamics

ROUTINE TESTING

AND MONITORING

Up to year 6

Project phases

• Equipment and

supplies

• Procurement

• Training

• Quality assurance

• Laboratory validation

TECHNOLOGY

TRANSFER

6-12 months

• Laboratory assessment

• Memorandum of

Understanding

• Infrastructure upgrade

• Creation of Standard

Operating Procedures

• Policy reform

LABORATORY

PREPAREDNESS

18-24 months

EXPAND-TB countries

25 countries

1 country

1 country

27 countries

65 operational labs by 2012

175,000 tests in 2012

83,464

MGIT culture

LPA

91,038

Annual and cumulative targets exceeded

37,000

MDR-TB cases detected by end 2012

What is essential

to the eye.” is invisible

Annual and cumulative targets exceeded 2009-2012

Political commitment

54 MoUs signed


Technical

assessment

Over

100 laboratories

assessed


Technology

transfer

562 shipments

for $ 11 million

in 2012


Capacity building

+140 healthcare

workers trained

in 2012


Routine testing

Market Dynamics

Product

Average market price in developed countries (US/UE)

Starting price for UNITAID project Negotiated price with FIND partners

Estimated price based on increased volumes through UNITAID project Volume-based price

Liquid culture tubes USD$ 8-10 USD$ 2.20 USD$ 1.90

LFIA- rapid speciation for TB culture

USD$ 26 USD$ 1.40 USD$ 0.90

Line Probe assay reagent set

EUR€ 13 (~USD$ 20) EUR€ 3.30 (~USD$ 5) EUR€ 3 (~USD$ 4.50)

Xpert MTB/RIF assay USD$ 70-80 USD$ 9.98 EUR€ 6.60 (~USD$ 9.90)

Overall exponential

growth

Annual and cumulative targets exceeded 2009






0

20000

40000

60000

80000

100000

120000

2009 2010 2011 2012 2013 2014

1,810 4,196

12,095

36,965

74,949

115,213

MDR-TB cases detected cumulative targets

0

20000

40000

60000

80000

100000

120000

140000

160000

180000

200000

MDR-TB cases detected Tests performed

2012

24,870

174,205

Cases detected and tests performed in 2012


EXPAND-TB country experiences

Kyrgyzstan

Mozambique

Cameroon India



Kyrgyzstan

India

Mozambique

Cameroon C. N. Paramasivan

Head of TB Programme

India & SE Asia

Annual and cumulative targets exceeded Estimated TB burden

Population: 1.2 billion

Prevalence: 3.1 million

249/100,000

Incidence: 2.2 million

181/100,000

Mortality: 300,000

24/100,000 Source: Global Tuberculosis Report 2012, TB India 2012

Annual and cumulative targets exceeded MDR-TB burden

Among new TB cases: 2.1%

Among previously treated TB cases: 15%

Estimated number of cases emerging annually: 99,000

Estimated number of cases out of notified pulmonary TB cases: 300,000

Source: Global Tuberculosis Report 2012, TB India 2012

CTD - EXPAND-TB MoU

8th March 2010


Entire Country Under PMDT Coverage - 24 March

2013

Source: Laboratory Management

Training, Presentation on Nikshay

Mumbai – 8th - 12th April 2013

PMDT introduced in Aug

2007

100% Nationwide

Coverage of PMDT

services has been achieved

across 692 reporting

districts in all 35 states/UTs

in India As on 24th March

2013

78 DR-TB Centers

Rajasthan

Gujarat

Maharashtra

Orissa

Madhya Pradesh

Bihar

Uttar Pradesh

Karnataka

Andhra Pradesh

Jammu & Kashmir

Assam

Chhatisgarh

Tamil Nadu

Punjab

JharkhandWest Bengal

Kerala

Haryana

Uttaranchal

Arunachal Pradesh

HimachalPradesh

Manipur

Mizoram

Nagaland

Sikkim

A&N Islands

D&N Haveli

Lakshadweep

#Delhi

#

Meghalaya

#

Tripura

1% - 25%26% - 50%51% - 75%76% - 99%100

DR TB Centres

% Population with access to PMDT Services


Culture & DST labs network

(24 March 2013)

Source: PMDT Updates RNTCP Regional PMDT

Review Meeting of Northern States,

Lucknow – 28th Feb – 1st Mar 2013

Med Col / NGO / Private Labs (Certified)

IRL (Certified )

IRL (Under Process)

Med Col / NGO / Private Labs (Under Process)

National Reference Labs

Xpert Sites

A&N Islands

Arunachal Pradesh

Chandigarh

D&N Haveli

Daman & Diu

Goa

Karnataka

Lakshadweep

Meghalaya

Mizoram

Nagaland

Pondicherry

Sikkim

Tripura

Haryana

Delhi

Gujarat

Andhra Pradesh

Assam

Manipur

Punjab

Kerala

West Bengal

Jammu & Kashmir

Himachal Pradesh

Rajasthan

Maharashtra

Tamil Nadu

Orissa

Madhya Pradesh

Chhatisgarh

Uttar Pradesh

Uttaranchal

Jharkhand

Bihar

TRC

HARYANANDTC

AIIMS-2 LRS

NTI

JALMA

Gurgaon


DST coverage at various districts (Dec. 2012)

Source: PMDT Updates RNTCP Regional PMDT

Review Meeting of Northern States,

Lucknow – 28th Feb – 1st Mar 2013

LPA 510

DST technology at districts (n = 625)

LJ 28

CBNAAT 87


Country achievements under EXPAND-TB 2011-2013

CBNAAT

tests reported

till 1Q13

MDR-TB suspects tested: Actual till 1Q13

LPA Tests

conducted till 1Q13

885 1 062 1 683

3 047

8 518

17 417

22 808 22 614

24 380

- - - - - -

1 707

3 674 4 411

0

5 000

10 000

15 000

20 000

25 000

30 000

Q1 2011-Actual

Q2 2011-Actual

Q3 2011-Actual

Q4 2011-Actual

Q1 2012-Actual

Q2 2012-Actual

Q3 2012-Actual

Q4 2012-Actual

Q1 2013-Actual

LPA Tests conducted till 1Q13 CBNAAT tests reported till 1Q13

2 Moy. mobile sur pér. (LPA Tests conducted till 1Q13) 2 Moy. mobile sur pér. (CBNAAT tests reported till 1Q13)


Country achievements under EXPAND-TB 2011-2013

CBNAAT

MDRTB case

detection

reported till 1Q13

MDR-TB cases detected: Actual till 1Q13

LPA MDRTB

case detection

reported

till 1Q13

349 329 538

994

2 300

4 122

4 710

4 095 4 310

- - - - - -

299 502

663

0

500

1 000

1 500

2 000

2 500

3 000

3 500

4 000

4 500

5 000

Q1 2011-Actual

Q2 2011-Actual

Q3 2011-Actual

Q4 2011-Actual

Q1 2012-Actual

Q2 2012-Actual

Q3 2012-Actual

Q4 2012-Actual

Q1 2013-Actual

LPA MDRTB case detection reported till 1Q13

CBNAAT MDRTB case detection reported till 1Q13

2 Moy. mobile sur pér. (LPA MDRTB case detection reported till 1Q13)

2 Moy. mobile sur pér. (CBNAAT MDRTB case detection reported till 1Q13)


Graph summarizing EXPAND-TB target / cumulative cases till end of March 2013

12 926

5,735

18,661

16 028

4 973

21 001

2012 1Q2013 Cumulative

Target Detected


Main challenges for project implementation

Challenges

No identified agency for

installation and maintenance

of Hain equipment

Strategy / Actions adapted

Sustainability of establishments

beyond 2014

Difficulties being faced by

sites for AMC of equipment

supplied under EXPAND-TB

beyond warranty period

Quality of Xpert modules

and cartridges

FIND-India Technical

Consultants/Bio Medical

Engineers fulfilled these tasks

Central TB Division/GoI being

requested to develop strategy

Vendors for CMC being

identified, funding support

being explored (e.g. WHO)

Observations brought into the

notice of technical team of Cepheid

Annual and cumulative targets exceeded Milestones and acceleration plan

Achievement

Labs upgraded: 1Q 2013 – LPA: 35/40 – LC: 16/32 – Xpert: 12/13

Acceleration Plan (2013)

In 2012: MDR-TB cases detected: 16,028

Target set: 12,926

Labs to be upgraded – LPA: All 40

– LC: All 32 – Xpert: All 13

MDR-TB cases estimated

to be detected:

30,473 against the target of 22,941

Annual and cumulative targets exceeded Plans ahead

3Q 2013: Establish service delivery

of remaining 5 LPA & 16 LC labs

National training at ICELT:

2 LPA & 6 LC

On site trainings: 5 LPA & 16 LC

Collaborating with PATH:

– Infrastructure upgrades

of 2 LPA & one LC labs

– Laboratory Management Workshop

Support CTD for conducting

regional PMDT review meetings

Annual and cumulative targets exceeded Acknowledgements

• UNITAID

• GFATM

• WHO

• Partners – PATH, USAID, CDC

• BMGF

• Central TB Division, MOH,

Government of India

• National Reference Laboratories

• National Laboratory Committee

• Respective States, STDCs and

other institutions including participating

NGOs and Private Providers

• Others



Kyrgyzstan

Mozambique

Cameroon

Gulmira Kalmambetova, MD

Head of the NRL, the Kyrgyz Republic

India


Country population 1.01.2011 5,447,960 million

New cases 26%

Estimated TB burden

Retreatment cases 52%

MoU with MoH KR

May 28th 2010


EXPAND-TB has

started in 2010

Included in the project:

– NRL Bishkek

– Inter-Regional Reference Lab Osh

EXPAND-TB activities


EXPAND-TB laboratory location


Country achievements under EXPAND-TB

Target MDR-TB cases 2012 600

Actually detected MDR-TB cases 2012 941

EXPAND-TB Target 3000

Cumulative MDR-TB cases detected by 2012 1766

% of EXPAND-TB Target achieved 59


Graph summarizing EXPAND-TB target / cumulative cases to date (March 2013)

0

500

1000

1500

2000

2500

3000

3500

�2011 �2012 �Cumulative/Overall

Target

Targets Cases Detected

AZERBAIJAN AZERBAIJAN

825


3000

1766

941

annual target

(600) exceeded



Challenges

Disruption in working process while transferring NRL at the new premises;

Laboratory stock out

March/April 2013: Assembling modules of new NRL building (financial support from KfW, technical assistance: GITEC, SRL Munich-Gauting)

Preparatory work and applied technical support in collaboration with SRL to assure smooth transition;

Timely preparation of the next laboratory order (process was started February 2012 within the reporting quarter)

Actions addressing challenges

Annual and cumulative targets exceeded Annual action plan

Annual and cumulative targets exceeded TB National Reference Lab


Commissioning the new laboratory premises of the NRL

Six weeks intensive staff training during

commissioning period by experts from SRL partner

Later-on, continuous on-site trainings of

NRL staff for up to three years by FIND/SRL

Munich-Gauting and other partners

Development of National Laboratory Strategy


Development and introduction of SOPs under

coordination of SRL partner

Preparation of new laboratory orders adjusted

to current needs and possibilities

Continuation of close collaboration

with SRL Munich-Gauting, ICRC,

and other partners


• MoH Kyrgyzstan

• GSIN (penal sector)

• FIND

• SRL Munich-Gauting

• ICRC

• KNCV

• MSF-Switzerland

• Project HOPE



Mozambique

Cameroon

Kyrgyzstan

Sara EYANGOH, PhD

Head of Mycobacteriology Unit

Centre Pasteur Cameroon

NRL of NTP Cameroon

India


Cameroon’s population: >19 million

25,000 reported TB cases/year

Estimated TB burden

500 MDR-TB cases (WHO estimation)

Country MoU signed 8th October 2010 to cover 3 labs

(NRL in Yaoundé et 2 regional Lab in Bamenda and Douala)

Annual and cumulative targets exceeded EXPAND-TB activities

Diagnotic activity (oct 2011)

free for MDR-TB suspected patients

Material reception and MGIT installation (May 2011)

Training on Biosecurity and Liquid culture (13-23 June)

3 months LC and DST validation (July-September)


Labs supported by EXPAND-TB and technologies operating

-Liquid culture

-Line Probe Assay -Solid culture -MPT64 antigen test

-Ongoing

construction

- Liquid culture and DST

- Line Probe Assay - Solid culture - MPT64 antigen test

- GeneXpert



Plan Achievement

2 Laboratories are fully functional

with both LPA and LC and

DST capacity

Training on Biosecurity and

liquid culture

Significant increase in the

number of reported cases but

target has not yet been met

Algorithm of diagnosis revised

Standardization of request

and results form

Introduce

new technologies

Training

Increase in number

of reported cases

Algorithm

Facilitate management

of patients



Challenges Action put in place

GIZ is monitoring the

construction of this third

laboratory

referral system functionning

in one region and implementation

in the other region based

on same model

Ex-TB Cam LIS has been

established to report and

centralise data

Solid culture

in North region (Garoua)

Construction

of the Douala site

Reach the

expected target

Reporting

of data

Expand culture network

for better country coverage



0

100

200

300

400

500

600

700

800

900

2011 2012 Cumulative/Overall

Target

Targets Cases DetectedAZERBAIJAN AZERBAIJAN

250


810

217

10

207


Liquid culture and DST

ongoing in 2 labs under WHO DST EQA

Additional funds from OFID

(OPEC Fund for International Development)

– One GeneXpert for the NRL and free catridges

– HR (1 technician)

– Training on LPA and GeneXpert: workshop with 9 NRL

(Benin, Burkina Faso, CAR, Côte d’ivoire, Guinea Bissau,

Niger, Togo, Mali) in February 2012 with SRL


Finalization of the construction of the 3rd laboratory

3 GeneXpert analyzers will be

procured with support from EXPAND-TB

Involve prisons inmates and

HIV patients in diagnosis

Strengthen the laboratory

network and sample referral system

Other partners to sustain the project

-Liquid culture


-Xpert

-Liquid culture


-Xpert


Prospective / envisaged network

- Solid culture

- LPA or - Xpert

- Liquid culture and DST

- Line Probe Assay - Solid culture - MPT64 antigen test

- GeneXpert


• MOH

• GIZ: for The 3rd lab construction and

development of samples referral system

• WHO: facilitate customs clearance and

support of LIS

• INIP and UNION: for OFID fund



Mozambique

Sofia Omar Viegas Coordinator of TB Reference Lab

Kyrgyzstan

Cameroon India

Annual and cumulative targets exceeded Estimated TB burden

Population – 24 million

TB was decreed a National Emergency in 2011

TB incidence – 548 per 100,000 population

TB prevalence – 490 per

100,000 population

MDR-TB prevalence in new cases – 3.5%

MDR-TB prevalence in retreatment cases – 12%

EXPAND-TB MoUs signed on 30th May 2012, first orders placed in August 2012


Activities TB

Reference labs: MDR TB diagnosis,

training, research, EQA,

MDR surveillance

Two labs

supported; currently assessing

possibility of third location

Laboratories supported under EXPAND-TB

• Liquid and solid culture

• Rapid speciation

• DST

• Liquid and solid culture

• Rapid speciation

• DST

• LPA



Lab assessment

13-17/02/12

MoU signature

30/05/2012

Emergency order

8/2012

Normal order

02/2013

Translation of GLI-

endorsed training

material into Portuguese

01/2013

Liquid culture and LPA training

02/2013

In-country consultant placed in

Beira

02/2013

67 MDR cases

diagnosed as of

31/03/2013

Initiation of reporting



29 38 67 0

200

400

600

800

1000

1200

1400

2012 2013 2014 Cummulative/overalltarget

Target Cases detected

58

650

750

1458



Challenges

Delays in customs clearance

Mitigation

Lack of training materials

in Portuguese

Sample referral system

Reporting of results

to peripheral sites

Equipment maintenance

Lack of awareness amongst

clinicians on diagnostic algorithm

Broken equipment (MGIT)

Availing import documents in advance

Local translation of materials into

Portuguese

Lobbying with partners

SMS printer

Lobbying with partners;

inclusion into funding applications

Training pack available

Immediate repair and provision of UPS

Annual and cumulative targets exceeded TB National Reference Lab

Annual and cumulative targets exceeded TB Reference Lab Nampula


Estimated EXPAND-TB timelines Mozambique timelines

Strengthening culture and DST testing in Beira

Tapping into Xpert referral cases to reference labs

Laboratory Preparedness

Technology transfer

Routine testing and monitoring

3 months Q4 2012 –

Q4 2014 5 months

Actions to target

Active case finding of MDR contacts

Possible inclusion of LPA in Beira

Possible inclusion of Nampula as third site

• Monitoring and evaluation

• Impact assessment • Market dynamics

ROUTINE TESTING AND MONITORING

Up to year 6

• Equipment and supplies

• Procurement • Training • Quality assurance • Laboratory

validation

TECHNOLOGY TRANSFER

6-12 months

• Laboratory assessment • Memorandum of

Understanding • Infrastructure upgrade • Creation of Standard

Operating Procedures • Policy reform

LABORATORY PREPAREDNESS

18-24 months


On site mentoring to continue

Introduction of LPA in Beira

Referral of Rif-resistance cases to reference labs

Possible cooperation

with CDC on Nampula


Implementation of 2nd line DST

Train clinicians and lab techs in new testing guidelines

and algorithms

Expand SMS

printer reporting System

ISO 15189 Accreditation

by 2014 for Maputo lab

Annual and cumulative targets exceeded Partners and their contribution

Partners supporting TB Reference Laboratories in Mozambique

Activities supported Expand

-TB

CDC/A

PHL

CDC/A

SM

CDC/F

UJB

CDC/AS

CLM

CDC

Grant FHI CHAI MSF HAI

INCO-

TB WHO SNRL

Reagents, consumables X X

GeneXpert X X X X X X

Technical assistance X X X X X X

Training X X X X

EQA X

Second line testing X

Laboratory Information System X

Implementing Quality X X X X X X X X X X X

Infrastructure upgrade X

SMS printer to send TB results X

Distributing reports X

Equipament maintenence X X

Important activities currently unsupported

Equipment maintenance

Improvement of Sample Referal

System

Training new algorithms and

guidelines



Lack of/Poor SPECIMEN referral

Import permits

and CUSTOM process

LIMS Equipment

MAINTENANCE

Gaps in

TREATMENT initiation

Challenges

Annual and cumulative targets exceeded Way forward

MoU amendment

with 26 countries until end 2014

GeneXpert Roll out

in 10 EXPAND TB countries

(overlap with TB Project

(25/27 countries)

Work towards

milestones

(Acceleration plans)

99 operational labs on

phase III/2013

Annual and cumulative targets exceeded Transitioning strategy

Ensuring smooth project

TRANSITION to local Ministries of Health or partners

PILOT STRATEGY on a few sites and develop model for all 27 countries


• UNITAID

Robert Matiru

Yamuna Mundade

• GLI / WHO

Wayne Van Gemert Christopher Gilpin

Jean Iragena

Fuad Mirzayev

Karin Weyer

• GDF

John Loeber Thomas Verges

• Country counterparts (MoH/NTP)

• SRLs

• Other partners

• FIND

Eric Adam Catharina Boehme

Knut Feldmann

Cristina Gutierrez

Sandy Haldimann

Kekeletso Kao

Alexei Korobitsyn

Evan Lee

C.N. Paramasivan

Akos Somoskovi

Alessandra Varga

Balasangameshwara Vollepore

Jesse Wambugu

• FIND India team

• FIND Uganda team

• FIND/GLI consultant network

Documents

Narrowing the gap: Expanding access to new diagnostics … · Narrowing the gap: Expanding access to new diagnostics for patients at risk of MDR-TB ... J ha rk ha n d W e s t