1. MDR TB Diagnostics
Kampala, 22 Oct 2012
Ajay Thirumala

2. Our strategy
Accelerate diagnostic innovation along a value chain: ISO certification for project management and clinical trials. (Focus: TB, Malaria and HAT)
Leverage investment against preferential prices for low and middle income countries. (Affordable)
Strengthen Local Laboratory facilities to ensure new technologies are Accessible to everyone (Focus: Public Health Facilities).
Produce Development Partnership: Build and sustain effective partnerships- currently 200 active partners in 61 countries.

3. The impact of diagnostics
Tuberculosis
The slow path to diagnosis for patients with cough:
Grzybowski, et al. Bull Int Un Tuberc 1975;50:90
Reduced disease transmission
Effective disease control, including DRTB
Decreased morbidity/mortality
Credible health system
More and more slow path: Drug resistant TB detection and treatment

4. Key advancements in the diagnostics - FIND’s role
2007
2008
2009
2010
2011
Liquid culture;
rapid speciation
Line probe assay
LED-based fluorescence microscopy
Automated NAAT (Xpert MTB/RIF) TB
Implementation of WHO endorsed tests and capacity building
Round 2
Round 1
Round 3
RDT product testing
Blood transfer device
Malaria
Implementation support (training, job-aids, SMS reporting)
LED-based fluorescence microscopy
Rapid screening test prototype developed
HAT / OND
mAECT production in DRC

5. Pipeline for New Diagnostics for TB and MDR-TB, July 2012

6. Drug resistant TB MDR-TB*: Uganda Multidrug resistance- MDR TB
Isoniazid and Rifampicin
Extensively drug-resistance- XDR
MDR + fluoroquinolones and at least one of injectables: amikacin, capreomycin or kanamycin
MDR-TB*: Uganda

7. Expandx TB Project
Overall grant (GLI, GDF, FIND): 90.5 Mio (incl. 2 Mio for Xp)
Funding for FIND: 21.2 Mio (including 1.5 Mio OGAC)
Duration: Dec Dec 2013
Project goal: Expand access to MDR-TB dx in 27 countries
Key deliverables: Identify 129,000 MDR cases; Impact market dynamics (price, # suppliers)
Progress:
MOUs with 22/27 countries
Initial assessments for 24/27 countries
>10,000 MDR-TB patients diagnosed by end 2011

9. Expandx TB Uganda 2010- July: MOU with Min. of Health, Uganda
2010- July: 1st Lab Assessment – GLI-FIND combined
2010- Sep/Oct: Civil work initiated at Mulago Referral Hospital for point-of-care MDR-TB lab
2011- May: New diagnostic equipment installation at the Lab
2011 July-Sep- Standardization of technology, trainings and orientations to staff
2011 Nov- Lab started testing for patients; and is provided 5 start SLAMTA accreditation as part of NTRL

10. Civil works - Ward 5&6-Mulago Hospital, NTRL, Kampala, UGANDA
Main entrance
Ramp

11. Equipment installation
The Republic of Uganda
MINISTRY OF HEALTH
Equipment installation

12. Tuberculosis Rapid Diagnostics Lab at Mulago
The Republic of Uganda
MINISTRY OF HEALTH
Tuberculosis Rapid Diagnostics Lab at Mulago
Lab showing air-extraction ducts

13. Entry door for containment room
Anteroom entry to containment room
Entry door for containment room
View of containment room from anteroom

14. The Republic of Uganda
MINISTRY OF HEALTH
Containment room

15. Pre-amp room view Heating block for DNA extraction
Microfuge-DNA extraction
Pre-amp room view

16. Hands on trainings for LPA

18. Year MDR* All Susceptible Total** 2010 37 228 312 2011 49 489 655 2012
Line Probe Assay (LPA) for detection of MDR-TB NTRL, Uganda (15th Mar th Oct 2012)
 Year
MDR*
All Susceptible
Total**
2010 37
228
312
2011 49
489
655
2012 83
360
551
Total
169
1077
1518
*- MDR- Patients showing resistance to both Isoniazid and Rifampicin
**- Includes other than MDR drug resistant patients

19. GeneXpert (Xpert MTB/RIF) for Diagnosis of TB and rifampicin resistant TB
- Two hours cartridge based test.
Automated
Possible at district level.
Peripheral Lab and clinical staff can run it
Can detect Smear negative TB- problem of HIV patients
Challenge in POC facilities-Electricity?

20. Local innovations: GeneXpert works with Solar power- Luwero HC IV
Capacity:
3 Gx-4 runs/ day
Expected sun-hours:
/year
Started in:
April 2011
Approx Cost:
3600 USD
Early Evidence for scale up
Grant: Dutch Government
FIND March-2011
Details of Mfg:
Solar Panels: Dulas Solar (
Solar Charge Controller: Tarom, Steca GmbH (
Inverter: Local Kampala market- Chinese make
Solar batteries: Local Kampala market- Luminous India make
Technician: Local Kampala school pass-out

21. Grant: TB reach Wv2, STOP TB Partnership (0.6 million USD)
Early scale-up of Xpert for TB in HIV positive patients at six sites under NTLP

22. Results of Xpert roll-out in Uganda (Nov 2011 -June 2012)
Xpert site
TB Negative
MTB positive very Low
MTB positive Low
MTB positive Medium
MTB positive High
TOTAL
TASO, Entebbe
527 42 24 14 4
631
Fort Portal RRH
585 56 46 7
770
Jinja RRH
339 19 13 2
421
Lira RRH
547 62 27 3
738
Masaka RRH
392 34 16
539
Soroti RRH
509 60 23
703
2899
273
180
117 26
3802
*3 rifampicin resistance cases out 596 TB cases: two confirmed at NTRL, and one died

23. National TB & Leprosy Program
Thank You
National TB & Leprosy Program
MOH, Uganda 23

25. Bunyaazi Island Around 30 nautical miles south of Entebbe
Client visit : beneficiary of FIND-TBR Wv 2 project –Xpert MTB/RIF test
Visit 20-June-2012
(FIND, NTRL (MoH), TASO)
Bunyaazi Island Around 30 nautical miles south of Entebbe
UGANDA
Entebbe
Lake Victoria
Bunyaazi