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1
TB Diagnostics*
Vinand M Nantulya
*Presentation at TAC/TAG First Africa Region TB/HIV Advocacy, 19-21 June 2006, Cape Town, South Africa
2
Fundamental diagnostic: 1882
Fundamental diagnostic: 2006
Market uptake
Lack of progress in TB diagnostics
Discovery Science
Product Development
Targets & Reagents
Companies & Platforms
Performance testing
Evaluation & Approval
Need & Access
3
Annual Cost of TB Diagnostic Testing
> 1.2 billion Total :
$35,119,542* NAAT
$580,955.889Mantoux
$509,406,090Xray
$376,258,898*Culture
$324,906,257Microscopy
*Manufacturers cost applied. Reimbursement cost may be higher.
Current global direct expenditures on TB diagnostic tests
The diagnostic yield of this expenditure is limited, with only 19% of all TB cases detected and reported as smear-positive.*
4
Availability of diagnostic servicesAvailability of diagnostic services
Pop
ulat
ion
(mill
ions
)
Gro
ss N
atio
nal I
ndex
DS
T la
bs/1
00k
popu
latio
n
DS
T la
bs/1
00k
TB
su
spec
ts
Cu
ltu
re la
bs/1
00k
popu
latio
n
Cu
ltu
re la
bs/1
00k
TB
su
spec
ts
Mic
rosc
op
y la
bs/1
00k
popu
latio
n
Mic
rosc
op
y la
bs/1
00k
TB
sus
pect
s
Hea
lth
po
sts
/100
k po
pula
tion
Hea
lth
po
sts
/100
k T
B
susp
ects
North America 328 37,610 0.10 64.2 0.35 226.4 0.88 570 1.46 951Europe 459 22,850 0.16 34.0 0.44 95.3 0.49 106 3.89 851Japan 127 34,510Other High Income 30 18,000 0.11 15.7 0.35 49.4 0.96 135 4.33 608Total from 22 HBC 3,892 869 0.02 1.0 0.06 3.6 1.16 67 8.06 466Rest of World 1,383 0.06 1.8 0.08 2.5 1.37 41 8.87 263Total 6,219 5,500 0.04 2.2 0.11 5.8 1.12 59 7.40 388
Among 22 high burden countries there is an average of 1.12 microscopy centers per 100,000 population BUT 50% do not work due to logistical problems (missing or broken materials, strikes, lack of trained personnel) making access to microscopy difficult
5
• In Lima, 22% of 259 TB patients first sought health care from pharmacists. But only 56% of TB patients were requested to submit sputum specimens and did so.
• In Chennai, 13% of 1000 patients being evaluated for symptomatic respiratory disease did not complete the diagnostic process, and 11% of patients in whom TB was detected were not notified of the diagnosis.
• In Lusaka, on the other hand, due primarily to the necessity for patients to purchase the sputum collection container, only 0.5% of patients completed the diagnostic process and only 6 of 600 patients even submitted a single sample.
6
Private health expenditure in countries with high TB burdens
0
20
40
60
80
100
pri
vate
as
% o
f to
tal
exp
end
iture
Uplekar 2001
7
• Although DOTS provides free diagnosis and treatment, repeated visits to health facilities are required. The cost of transportation and food, coupled with low income because of time away from work, may be more than poor TB patients or families can afford.
• A study from Malawi estimated that on average, TB patients spent US$ 13 and lost 22 days from work at the diagnosis stage alone.
• Patients presenting for diagnosis in a study in Ho Chi Minh City contacted 1.3 different health providers with an average of 2.5 visits per health care provider. Moving from one provider to the next delays treatment and involves considerable cost to the patient.
Economic barriers
8
Delays to diagnosis within the health
system varied widely, but were in many
cases substantial, and could be limited by
introducing technologies that could be
used more peripherally, where patients first
seek care.
9
• FIND was established in 2003 by World Health Assembly resolution
• A public / private partnership • Based in Geneva as a Swiss tax-exempt
foundation• Current portfolio includes TB, Malaria and sleeping
sickness, each run as an independent business unit
• Currently funded by Bill and Melinda Gates Foundation, but there is need for funds from public sector donors
A brief background about FIND
10
FIND is pursuing a two-pronged strategy
• Develop and evaluate better diagnostic tools• Explore creative, sustainable ways to
strengthen overall quality of diagnostic services in both public and private health sector, using new tools as catalyst
11
Purpose
Case Detection
Drug susceptibility testing
Latent TB Infection
Test Indications
• Detect pulmonary TB with high bacterial load (SS+)
• Detect pulmonary TB with low bacterial load (SS -, Cx +)
• Detect extra-pulmonary and pediatric TB
• Detect MDR-TB for treatment
• Detect LTBI for treatment
Priority
# 1
# 2
# 3
# 4
# 5
Priority setting
12
Levels of health system
FIND’s strategy is driven by customer requirements and the different levels of health system
Few hours
Less than 1 hour
NAAT
Cultures
MicroscopyOnly 19 % (1.7 million) of new cases detected by microscopy (smear +)
5 days
15 days
1 day
2 M undetected unreported
smear + patients
45 days
5 days
13
FeasibilityContract
phase Development
phaseEvaluation
phaseDemonstration
phaseGlobal Policy
2 3 654 71
Cu
stom
er R
equ
iremen
ts
Sp
ecification
s
Tactic: Milestones for Process and Outputs
PHASES
Milestones 8
National Practice
Impact
Cu
stom
er sup
po
rt d
ocu
men
t
WH
O g
uid
elines
Effectiven
ess
Efficacy
Pro
du
ct in b
ox
Effe
ctivene
ss &
Access
Registration
FINDPARTNER
Output
Access
Customer support document
14
Development EvaluationFeasibility
DistrictDistrictLabLab
PeripheralPeripheralLabLab
TB Product pipeline – Status 2006
ClinicClinicHealth postHealth post
Demonstration
MGIT- MTB
SPECIATIONMGIT-DST
PHAGE RIF RESIST
REAL TIME PCRTK-MEDIA
E-NOSEFLUOR MICROSCOPEURINE LAM ELISALAMP ISOTHERMAL NATURINARY DNA DETECTION
AG DISCOVERY PROJECTS
RAPID ANTIBODY TESTFLURESCENCE STRIP METER FOR AB DETECTION
ANTIGEN LAT FLOWURINE LAM LAT FLOW
AccessAccess
FEASIBILITY DEVELOPMENT EVALUATION DEMONSTRATION POLICY
15
FEASIBILITY
Bottlenecks to success
Bottleneck
Inadequate proven principles
Action
More investments in product driven discovery research
Civil society
DEVELOPMENT EVALUATION DEMONSTRATION POLICY NATIONAL PRACTICE
Bottleneck?
Reluctance or slow process
Action Strategic communication& finance activities & civil society
Bottleneck:
• Training
• Maintenance
• Trouble shooting, QC/QA
• Access for underprivileged
Action
• Involve industry, partners & civil society
• Creative solutions
Bottleneck?
Clinical, management & infrastructure capacity
Action
Continuous partner involvement including civil society
16
Project sites and demonstration goals
Study sites MGIT in established
labMGIT in new lab (district level)
Impact on clinical outcome
Cost-effectiveness
ZAMSTAR: Lusaka, Cape Town
NRL in Lusaka, TB lab at Stellenbosch
Impact of MGIT for AFB- TB on care
Overall cost of MGIT for AFB- TB cases
THIBELO: gold mines in 3 regions in South Africa
NHLS laboratory in Johannesburg
Relative diagnostic yield in AFB- TB cases
Expected value of clinical information
THRio: HIV care clinics in Rio de Janeiro
TB lab in national research center
Relative diagnostic yield in AFB- TB cases
QUALYs gained by MGIT vs no culture
Tanzania: Dar es Salaam and Iringa Region
National TB Reference lab in Dar
New TB lab in Iringa TBD TBD
Eldoret: HIV care program
New TB lab in AMPATH program
TBD TBD
Cambodia: two to four provinces with TB/HIV activities
New TB labs TBD TBD
17
Mbeya Medical Research Programme, TanzaniaMbeya Medical Research Programme, Tanzania