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Kampala, 22 Oct 2012
Ajay Thirumala
MDR TB Diagnostics
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.
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
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
Pipeline for New Diagnostics for TB and MDR-TB, July 2012
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
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
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
Civil works - Ward 5&6-Mulago Hospital, NTRL, Kampala, UGANDA
Main entrance
Ramp
Equipment installation
The Republic of Uganda
MINISTRY OF HEALTH
Lab showing air-extraction ducts
The Republic of Uganda
MINISTRY OF HEALTH
Tuberculosis Rapid Diagnostics Lab at Mulago
Entry door for containment roomAnteroom entry to containment room
View of containment room from anteroom
Containment room
The Republic of Uganda
MINISTRY OF HEALTH
Heating block for DNA extraction
Pre-amp room view
Microfuge-DNA extraction
Hands on trainings for LPA
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
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
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?
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
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)
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
Thank You
23
National TB & Leprosy Program
MOH, Uganda
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
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