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Kampala, 22 Oct 2012
Ajay Thirumala
MDR TB Diagnostics
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Our strategy
1. Accelerate diagnostic innovation along a value chain: ISO 13485 certification for project management and clinical trials. (Focus: TB, Malaria and HAT)
2. Leverage investment against preferential prices for low and middle income countries. (Affordable)
3. Strengthen Local Laboratory facilities to ensure new technologies are Accessible to everyone (Focus: Public Health Facilities).
4. Produce Development Partnership: Build and sustain effective partnerships- currently 200 active partners in 61 countries.
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The impact of diagnostics
Reduced disease transmissionEffective disease control, including DRTBDecreased morbidity/mortalityCredible health system
Tuberculosis
The slow path to diagnosis for patients with cough:
Grzybowski, et al. Bull Int Un Tuberc 1975;50:90
More and more slow path: Drug resistant TB detection and treatment
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TB
Malaria
HAT / OND
Liquid culture;
rapid speciation
Line probe assay
LED-based fluorescence microscopy
Automated NAAT (Xpert MTB/RIF)
RDT product testing Blood transfer device
mAECT production in DRC
Rapid screening test prototype developed
Implementation of WHO endorsed tests and capacity building
Round 1Round 2
Round 3
Key advancements in the diagnostics - FIND’s role
Implementation support (training, job-aids, SMS reporting)
LED-based fluorescence microscopy
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Pipeline for New Diagnostics for TB and MDR-TB, July 2012
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Drug resistant TB• 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
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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 2008 - 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
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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
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Civil works - Ward 5&6-Mulago Hospital, NTRL, Kampala, UGANDA
Main entrance
Ramp
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Equipment installation
The Republic of Uganda
MINISTRY OF HEALTH
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Lab showing air-extraction ducts
The Republic of Uganda
MINISTRY OF HEALTH
Tuberculosis Rapid Diagnostics Lab at Mulago
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Entry door for containment roomAnteroom entry to containment room
View of containment room from anteroom
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Containment room
The Republic of Uganda
MINISTRY OF HEALTH
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Heating block for DNA extraction
Pre-amp room view
Microfuge-DNA extraction
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Hands on trainings for LPA
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Algorithm for MDR-TB diagnosis
MDR-TB suspect
Smear microscopy
Positive
LPA (rapid)
MDR (confirm on LJ)
Mono-Rif (confirm on LJ)
Non-MDR
Negative
Culture
Positive
LPA (rapid)
Negative
XpertMTB/Rif
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Line Probe Assay (LPA) for detection of MDR-TB NTRL, Uganda (15th Mar 2010-18th Oct 2012)
Year MDR* All Susceptible Total**2010 37 228 3122011 49 489 6552012 83 360 551Total 169 1077 1518
*- MDR- Patients showing resistance to both Isoniazid and Rifampicin**- Includes other than MDR drug resistant patients
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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?
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Details of Mfg:
Solar Panels: Dulas Solar (http://www.dulas.org.uk/index.cfm)
Solar Charge Controller: Tarom, Steca GmbH (http://www.stecasolar.com/index.php?Steca_Tarom_en)
Inverter: Local Kampala market- Chinese make
Solar batteries: Local Kampala market- Luminous India make
Technician: Local Kampala school pass-out
Capacity:
3 Gx-4 runs/ day
Expected sun-hours:
1800-2000/year
Started in:
April 2011
Approx Cost:
3600 USD
Capacity:
3 Gx-4 runs/ day
Expected sun-hours:
1800-2000/year
Started in:
April 2011
Approx Cost:
3600 USD
Local innovations: GeneXpert works with Solar power- Luwero HC IV
Early Evidence for scale up
Grant: Dutch Government
FIND March-2011
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Early scale-up of Xpert for TB in HIV positive patients at six sites under NTLP
Grant: TB reach Wv2, STOP TB Partnership (0.6 million USD)
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Results of Xpert roll-out in Uganda (Nov 2011 -June 2012)
Xpert siteTB
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 24 7 770
Jinja RRH 339 19 14 13 2 421
Lira RRH 547 62 42 27 3 738
Masaka RRH 392 34 27 16 3 539
Soroti RRH 509 60 27 23 7 703
TOTAL 2899 273 180 117 26 3802
*3 rifampicin resistance cases out 596 TB cases: two confirmed at NTRL, and one died
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Thank You
23
National TB & Leprosy Program
MOH, Uganda
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Two different approaches to Diagnosis of Smear Negative PTB, at a HIV-care setting in Uganda
(for Clients of Lake Victoria Islands)
HIV Positive female (36 years) patient on ARVs (CD4-115
cells/uL)
Lymphadenitis (TB)??? Advised FNA of lymph node but had no access - Smear negative PTB???
PTB, Xpert Positive. Placed on treatment same day
2 yrs& 2 months
6 months
Cured, Xpert- negative after 7 months
of Rx
HIV Positive female (26 years) patient on Septrin-CTX prophylaxis- (CD4-423 cells/uL)
PMTCT-AZT Prophylaxis
Cough-productive for 2 months
PTB, SSN-Xray suggestive-Rx same day
CD 4: 264 cells/uL; -> placed on ARVs
Defaulted for TB drugs (‘REACH” issues)
1 year
6 months
3 months
1 and half month Lack of trust in system
Delays in TB-
Dx
Transmitted TB to 3 ½ year HIV +ve Child
Lab got a Gx at this stage
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Bunyaazi IslandAround 30 nautical miles south of Entebbe
Bunyaazi IslandAround 30 nautical miles south of Entebbe
Entebbe
Bunyaazi
Lake Victoria
Client visit : beneficiary of FIND-TBR Wv 2 project –Xpert MTB/RIF test
Visit 20-June-2012
(FIND, NTRL (MoH), TASO)
UGANDA
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