Transcript Supply of quality ACTs and RDTs

of
Supply and quality of antimalarial
medicines and diagnostics:
introduction of issues
Dr Andrea Bosman
Global Malaria Programme
RBM Case Management Working Group (CMWG)
Geneva, 9 July 2009
Quality requirements of artemisinin-based
antimalarial medicines
The built-in chemical instability of artemisinin and
its derivatives, necessary for their biological action,
causes pharmaceutical problems both in the
manufacturing process and in the co-formulation
with other compounds. The problems of instability
are accelerated under tropical conditions.
The requirement for observing stringent quality
manufacturing standards are particularly important for these compounds, for which
manufacturers and national regulatory authorities have limited experience.
Differences in product quality selection criteria create opportunities for sub-standard
artemisinin-based antimalarial medicines to access international funds for
procurement, and discourage compliance with more stringent quality standards.
2 |
9 July 2009
GLOBAL
MALARIA PROGRAMME
Inter-agency harmonized criteria for the selection
of artemisinin-based antimalarials
GFATM
QAP
criteria
UNICEF/WHO
tender
criteria
1.
2.
3.
4.
3
WHO Treatment Guidelines
• Inclusion only
PQ approved or SRA-registered
in National
Dossier accepted by PQ or SRA
Treatment
• Restricted
GMP compliance after inspection
Guidelines
annual joint
by WHO PQ or SRA
tender
• Dossier
Review of
submission
efficacy
•
Evaluation of IPPQ:
only to
and
safety
- registration information,
SRA
- regulatory (licensing) situation,
- finished product specifications and compliance
with International Pharmacopoeia standards,
- stability data (in Zone IV),
- labeling information,
GLOBAL
API
characteristics
and
certification.
|
9 July 2009
MALARIA PROGRAMME
New GFATM QA policy and
selection of finished pharmaceutical products
For ARVs, antimalarial and anti-TB FPPs
If 2 or more FPPs
WHO prequalified
or SRA authorized
Number of FPPs
WHO prequalified
or SRA authorized
If 1 or 0 FPPs WHO
prequalified or SRA
authorized
PR has to
procure one
of these FPPs
If product not
available°
PRs may
procure a FPP
recommended
by the ERP
° Inability to supply sufficient quantity of product within 90 days from date of order
Courtesy of Dr Sophie Logez, The Global Fund
4 |
9 July 2009
GLOBAL
MALARIA PROGRAMME
International Non-Proprietary
Name (INN) of product
Strength
Dosage form
Supplier
Presentation
Packaging
Artemether / lumefantrine
20mg/120mg
Fixed dose tablets
Ajanta, India
6x1
6x2
6x3
6x4
6x1
6x2
6x3
6x4
6x1
6x2
6x3
6x4
30 blisters / box
Cipla, India
Ipca, India
Artemisinin-based
antimalarial Medicines
on WHO/UNICEF
procurement lists
(updated: 6.06.2009)
Novartis,
30 blisters / box
Single blisters
6x1
30 blisters / box
China/USA
Artesunate + amodiaquine
25mg+67.5mg
Fixed dose tablets Sanofi Aventis
50mg+135mg
100mg+270mg
100mg+270mg
50mg + 150mg (base) Co-blistered tablets Guilin, China
50mg + 153mg (base) Co-blistered tablets
Cipla, India
Ipca, India
Prequalified
Strides, India
Artesunate + mefloquine
200mg + 250mg
Co-blistered tablets
Mepha,
Switzerland
50mg + 500/25mg
Co-blistered tablets
Cipla, India
6x2
6x3
6x4
3
6
3+3
6+6
12+12
3+3
6+6
12+12
3+3
6+6
12+12
3+3
6+6
12+12
3+6
3+1
25 blisters / box
25 blisters / box
25 blisters / box
10 or 100 treatments / box
10 or 100 treatments / box
10 or 100 treatments / box
10 treatments / box
Single blisters
Single blisters
Artesunate +
6+2
sulfadoxine /
pyrimethamine
12+3
Artemether
5 |
9 July 2009
GLOBAL
Dafra, Belgium
MALARIA
PROGRAMME
80mg/ml
20mg/ml
Injection
3
10
5
3 Ampoules / pack
10 Ampoules / pack
5 Ampoules / pack
Antimalarials recommended by ERP
(with effect on 1.7.2009)
Artemether/Lumefantrine
Artemether/Lumefantrine
Artesunate+
Sulphadoxine/ Pyramethine
6 |
9 July 2009
20mg/120mg
40mg/240mg
50mg + (500
mg+25mg)
TAB
Ipca Laboratories Ltd,
Plot No. 255/1,
Village Athal, Dadra
and Nagar
Haveli(U.T), Silvassa
396 230, India.
Al/PVC/PVDC
blister(pack of
1x6's, 2x6's, 3x6's,
4x6's and 3x8's)
TAB
Cipla Limited,
MIDC, Patalinga,
Al/Al blister(pack of 3's,
Plot A-33, -42 MIDC,
6's and 12's)
Dist Raigad,
Maharashtra, India
TAB
Cipla Limited,
MIDC, Patalinga,
Plot A-33, -42 MIDC,
Dist Raigad,
Maharashtra, India
GLOBAL
MALARIA PROGRAMME
CO BLISTERPVC/PE/PVDC film
blister with (12
Art+ 3 SP tabs), (6
Art+ 2 SP tabs),(3
Art+ 1SP tab)
Quality Control of Pharmaceutical Products
Quality Control Test
Multi
Source
Single and limited
source products
complying with
option A or B
Single and limited
source products
complying with option
C
Responsibility
PR or sub recipient
GF Secretariat
Condition (s)
In accordance with the Good
Procurement Practice
Notification submission
by PR to GF
No Objection by GF
When
After receipt of drugs at country
level
Before any shipment of
drugs to the country
Frequency
At random, to be determined by
the PR
Mandatory for all
Purchase Order
Laboratory
To be selected by PR, laboratory
recognized by NDRA, WHO
prequalified lab when possible
SGS laboratory ,
contracted by GF
Procedures and Assays
To be defined by the PR and
selected laboratory
Listed in SGS/GF
Contract
All details in FAQ:
http://www.theglobalfund.org/pdf/guidelines/QCTestingPharmaceuticalProducts.pdf
ACT Prices for procurement by WHO
(last updated 15.01.2009)
AL
AS+AQ
A
L
A
ja
nt
A
a
L
C
ip
A la
A L Ip
L
ca
N
ov
A
SA ar
tis
Q
A
S+ San
A
of
Q
i
G
A
ui
S+
lin
A
Q
C
A
S+ ip
la
A
A
S+ Q
Ip
A
ca
Q
St
A
S+ rid
SP es
C
ip
la
1.8
1.6
1.4
1.2
1
0.8
0.6
0.4
0.2
0
8 |
9 July 2009
GLOBAL
MALARIA PROGRAMME
4
3
2
1
Age-groups
Price per unit
treatment (USD)
Fixed-Dose Combinations Co-blistered Combinations
6-24 months from adoption to implementation
180
90
160
160
80
140
70
130
120
60
97
100
50
82.7
80
40
60
30
40
20
31.3
20
0.5
0.6
2.1
10
5
0
0
2001
2002
ACT procured
9 |
Forecast
9 July 2009
2003
2004
2005
2006
No countries: ACT 1st line
2007
2008
2009
No countries deploying
GLOBAL
MALARIA PROGRAMME
Cumulative number of countries
Millions of ACT treatment courses
Adoption, deployment, past procurement
and 2009 forecast of ACTs
Price reduction of artesunate + amodiaquine
over 6 UNICEF/WHO joint tenders
Price per adult treatment course (USD)
2
1.5
1
0.5
0
10 |
Not co-blistered
2.5
2003
14-38%
4-28%
5-10%
2004
2005
2006
10%
2007
0- 12%
2008
Company A+X
Company A
Company B
Company C
Company D
Company E
9 July 2009
GLOBAL
MALARIA PROGRAMME
Price reduction of Coartem®
(artemether-lumefantrine): 2003 - 2008
Price per adult treatment course (USD)
2.5
25 %
22 %
2
1.5
1
0.5
0
2003
2004
6 x 1 tab
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9 July 2009
2005
6 x 2 tabs
2006
2007
6 x 3 tabs
GLOBAL
MALARIA PROGRAMME
2008
6 x 4 tabs
Price variations relating to
production and demand of artemisinin
Global shortage
USD
1200
1000
Relative over-supply
800
Spot prices of
artemisinin
USD/kg
600
400
Cost of
production
200
0
2003
12 |
9 July 2009
2004
2005
2006
2007
2008
GLOBAL
MALARIA PROGRAMME
Complex SCM of ACTs: example of AL
Extractors
Extraction
(1 month)
Seedling, nursery, plantation, growth and harvest (7 months)
Growers
Derivatisation
API (2 months)
suppliers
Co-formulation, tabletting,
packaging and shipping
1. Drying of leaves
2. Extraction
Artemisia annua
H
O
H 3C
O
O
H
H
3. Purrification
O
Yield: 0.3 - 0.5%
O
Artemisinin
H
H
O
(4 months)
Manufacturers
of finished pharmaceutical products
13 |
9 July 2009
GLOBAL
MALARIA PROGRAMME
O
O
O
H
O
H 3C
O
H
O
OCH 3
Artemether DS
H
H
O
OH
Di-hydro-Artemisinin
ACT demand and artemisinin supply
Forecast of ACTs
(in millions)
2009
2010
ACTs for public sector
140
190
Artemisinin supply
(in tonnes)
ACTs for private sector
through AMFm
10
45
Secured for ACT
production
ACT in private sector
10
5
Requirements to meet
ACT demand
80
120
total ACTs
160
240
Artemisinin stocks
available/gap
0-10
-30
-40
80
120
Artemisinin forecast
(in tonnes)°
°2m treatments = 1 ton of artemisinin
14 |
9 July 2009
GLOBAL
MALARIA PROGRAMME
2008
2009
2010
80-90 80-90
Revolving fund to artemisinin extractors
Development Bank
Triodos
Witholding of amount Y
for repayment + interest
(1) Loan
(4) Payments
amounts X minus Y
Producer /
exporter
Artemisinin extractors
15 |
9 July 2009
(3) Payments amount X
Buyer /
importer
(2) delivery of
products
API suppliers/ACT manucatures
GLOBAL
MALARIA PROGRAMME
Malaria Rapid Diagnostic Tests (RDTs)
[email protected]
Malaria RDTs in context of overall Round 8 portfolio
100%
80
$1,164M
RDTs account for
est. $45M or 3% of
R8 Malaria portfolio
$1,568M
ESTIMATES
$327M
Other Budget Categories $502M
Other Health Products $3M
Other Budget Categories $757M
PSM Costs $133M
60
Microscopy $8M
Other
Budget
Categories
$210M
IRS $36M
Rapid Diagnostic Test $45M
Test equipment (non-RDT:
CD4, PCR, ELISA, etc.) $36M
40
Reagents $33M
Condoms, lubricant $23M
LLIN $749M
X-Ray
equipment,
film,
consumables
$20M
20
ARV2 $31M
ARV1 $134M
HIV
PSM
Costs
$13M
Other
general
lab
equipment,
supplies
$17M
PSM Costs $39M
0
Total =
$3,059M
ACT $86M
Medicines for PEP $7M
Medicines for OI $24M
Source: TRP Report on recommended proposals, sampling of
detailed budgets for largest HIV and malaria grants, and
procurement reported planned in proposal Attachment B’s.
Note Diagnostics
that applicantsJune
were inconsistent
Malaria
23 2009 in where freight, insurance, distribution, etc. costs were allocated. In
most cases, it appears that these costs were included under “PSM Costs” but requires further review.
Malaria
TB
Other Anti-malarial
Medicines $7M
Second
Line
Anti-TB
$22M
First
Line
Anti-TB
$19M
Courtesy of Dr Joelle Daviaud, GFATM
Malaria RDTs in approved proposals for Rounds 6-8
Estimated Proposed RDT Procurement as Percentage of Total
Malaria Budget in Approved Proposals by Round
Estimated Proposed Malaria RDT Procurement included in
Approved Proposals (Years 1-2) by Round
$50M
$45M
25%
$40M
20%
$30M
15%
$20M
$20M
ESTIMATES
10%
$12M
6%
$10M
5%
$0M
0%
6
7
Round
8
4%
3%
6
7
8
Round
• Significant increase in value of procurement proposed for malaria RDTs over Rounds 6-8
• As percentage of total malaria proposal budgets, RDTs have accounted for 3-6% over last three
rounds
Source: Sampling and analysis of proposal documents for R6-8.
Malaria Diagnostics June 23 2009
Courtesy of Dr Joelle Daviaud, GFATM
Access Bio
ACON (Inverness)
Alldiag
Ameritek
Amgenix
AZOG
Bhat biotec
Binax (Inverness)
BioMed Industries
Bio-Quant Inc.
Biosynex
Biotech Laboratories
Blue cross Bio Medical
Brittney Ltd
Cellabs
Chemoquip
Core Diagnostics
Cortez
CTK
Dialab
Diamed AG
Fortress Diagnostics
Genix technologies/Innovatek
Guangzhou Wondfo Biotech
GlobaleMed
Hepatika
Human Gmbh
IND
Intec
International Immunodiagnostics
J Mitra
KAT Medical
Makro Medical
Merlin Labs
Omega Diagnostics
Orchid Biomedical Systems
Pacific Biotec
Premier Medical Corporation
PT INneec
R&R Marketing
Sallamander Concepts Pvt
Span Diagnostics
Standard Diagnostics
Syntillent
Unimed
Vision Biotech
Zephyr Biomedical Systems
Bio-Rad
Bio Merieux SA
Biotech Training partners
Cumberland Diagnostics
(Trinity Biotech PLC)
Diazyme
Genelabs Diagnotics Pvt Ltd
Product lists and manufacturing quality
Submission to Product Testing 2008
ALL
~ 60+ million tests procured in 2008
60+ Manufacturers
~200 products
Access Bio
ACON (Inverness)
Alldiag
Ameritek
Amgenix
AZOG
Bhat Biotec
Binax ((nverness)
Biosynex
Biotech Laboratories
Cellabs
Chemoquip
Core Diagnostics
Cortez
Dialab
Diamed AG
Fortress Diagnostics
Genix Technologies/Innovatek
Guonzhou Wondfo Biotech
Human Gmbh
IND
Intec
Innovatek
J Mitra
Merlin
Omega Diagnostics
Orchid Biomedical Systems
Premier Medical Corporation
PT INdec
R&R Marketing
Span Diagnostics
Standard Diagnostics
Unimed
Vision Biotech
Zephyr Biomedical Systems
ISO13485:2003
35 Manufacturers
112 products
Access Bio, Inc.
ACON Laboratories, Inc.
Amgenix International, Inc.
AZOG, Inc.
Biosynex
Diagnostics Automation Inc.
DiaMed
Human GmbH
IND Diagnostic Inc.
Innovatek Medical Inc.
Intec Products Inc.
Inverness Medical Innovations
J. Mitra Company Pvt Ltd
Orchid Biomedical Systems
Premier Medical Corporation Ltd.
ICT Diagnostics
Span Diagnostics
Standard Diagnostics, Inc.
Unimed International, Inc.
Vision Biotech
Guangzhou Wondfo Biotech Co., Ltd
Zephyr Biomedicals
Evaluated 2008
21 Manufacturers
41 products
New Developments in 2007-2009:
International QA systems in place
 The WHO Malaria RDT Evaluation Programme, jointly coordinated by
WPRO, TDR, FIND and US CDC, completed Round 1 product testing in
2009 and publication of results allows comparative assessment of RDTs
in relation to parasite detection thresholds, stability, false positivity rate,
invalid test results and ease of use.
 Product testing, together with pre/post-shipment lot-testing, allows informed
decisions for procurement agencies to take place.
 New WHO guidelines for Quality Assurance of Malaria Microscopy have
been published and provide new and practical approaches for QA in
malaria microscopy, including methods for accreditation of national expert
microscopists, and routine validation of slide examination.
20 |
9 July 2009
GLOBAL
MALARIA PROGRAMME
International Quality Assurance Systems
for Malaria Rapid Diagnostic Tests
Lot testing
2007
Product testing
Dossier review and
manufacturer
inspections
2008
2009
Pre-qualification
2010
9 July 2009
QC Lot-testing of Malaria RDTs
Country programme
Procurement
125 RDTs
Report in 5
wk days
Lot-testing lab
200 para/ul x2
2000 para/uL x1
x12
Negative
x10
Requirements:
125 Pf RDTs
175 Pf-pan RDTs
Release to field
Incubate
Report every
3 months
End of shelf life
9 July 2009
200 para/ul x2
2000 para/uL x1
x6
Negative
x2
Failures:
Follow re-testing algorithm
Confirm at second lab
Courtesy of Dr Jennifer Juchavez, RITM
Summary of RDT lot testing performed
at RITM (2003-07)
- 134 lots, from 27 manufacturers, >400 reports, 2-4 lots/month
QC Testing Result
TOTAL
Pass
(%)
Deferred/Failed
Pf
(%)
Non-Pf
(%)
2003*
6
2
(33.3)
4
(66.7)
0
(0.0)
2004
25
18
(72.0)
4
(16.0)
3
(12.0)
2005
29
19
(65.5)
3
(10.3)
7
(24.1)
2006
26
24
(92.3)
1
(3.8)
1
(3.8)
2007
48
44
(91.7)
1
(2.1)
3
(6.3)
TOTAL
134
107
(79.9)
13
(9.7)
14
(10.4)
* Initial development of SOPs for QC lot testing.
9 July 2009
Courtesy of Dr Jennifer Juchavez, RITM
First Response Malaria Ag Combo (PLDH/HRP2)
First Response Malaria Ag HRP2
CareStart Malaria HRP2 (Pf)
Advantage P.f. Malaria Card
CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO
SD BIOLINE Malaria Ag Pf
SD BIOLINE Malaria Ag Pf/Pan
Immunoquick Malaria +4
CareStart Malaria pLDH (PAN)
Malaria Plasmodium falciparum Rapid test Device (Whole blood)
Binax Now Malaria
Immunoquick Malaria Falciparum
Malaria Rapid Combo
ICT Malaria Combo Cassette Test (ML02)
ICT Malaria Pf Cassette Test (ML01)
Parahit-f DIPSTICK FOR FALCIPARUM MALARIA
AZOG Malaria pf (HRP-II) /pv (pLDH) Antigen Detection Test Device
Malaria Rapid Dual
Paracheck Pf Rapid test for P.falciparum Malaria ( Dipstick)
Malaria P.F/Vivax
Advantage Pan Malaria Card
Malaria Rapid Pf
ADVANCED QUALITY TM One Step Malaria (p.f.) Test (whole blood)
Malascan Rapid Test for Malaria Pf/Pan (Device)
Advantage Mal Card
Wondfo One Step Malaria Pf/Pan Whole Blood Test
OnSight – ParaQuick (Pan
ADVANCED QUALITY TM MALARIA (p.f) POCT
Paracheck Pf Rapid test for P. falciparum Malaria ( Device)
Parascreen Rapid Test for Malaria Pan/Pf (Device)
FirstSign – ParaView-2 (Pv + Pf) Card Test
Hexagon Malaria Combi
Hexagon Malaria
Parahit-f TEST DEVICE FOR FALCIPARUM MALARIA
OptiMAL-IT
Parahit-Total Device Rapid test for P. falciparum and Pan malarial species.
FirstSign – Malaria Pf Card Test
SD BIOLINE Malaria Ag
One Step Malaria Antigen Strip
Parabank Rapid Test for Malaria Pan (Device)
Quickstick Malaria Antigen Test
Detection rate (%)
Phase 2 Detection Rate for P. falciparum samples
100
75
50
200 (HRP2)
25
200 (pLDH)
2000 (HRP2)
2000 (pLDH)
0
Advantage Mal Card
Advantage Pan Malaria Card
CareStart Malaria pLDH (PAN)
OptiMAL-IT
CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO
First Response Malaria Ag Combo (PLDH/HRP2)
OnSight – ParaQuick (Pan Pf) Test
SD BIOLINE Malaria Ag
SD BIOLINE Malaria Ag Pf/Pan
AZOG Malaria pf (HRP-II) /pv (pLDH) Antigen Detection Test Device
Immunoquick Malaria +4
Parabank Rapid Test for Malaria Pan (Device)
Wondfo One Step Malaria Pf/Pan Whole Blood Test
Parascreen Rapid Test for Malaria Pan/Pf (Device)
Binax Now Malaria
Malaria Rapid Combo
Malaria Rapid Dual
FirstSign – ParaView-2 (Pv + Pf) Card Test
Hexagon Malaria Combi
ICT Malaria Combo Cassette Test (ML02)
Malaria P.F/Vivax
Malascan Rapid Test for Malaria Pf/Pan (Device)
One Step Malaria Antigen Strip
Parahit-Total Device Rapid test for P. falciparum and Pan malarial species.
Quickstick Malaria Antigen Test
Detection rate (%)
P. vivax Detection Rate
100
Phase 2
75
50
200 (aldolase)
200 (pLDH)
2000 (aldolase)
2000 (pLDH)
25
0
P. vivax
detection
75
50
25
200 (HRP2)
200 (pLDH)
0
Detection rate (%)
100
Phase 2 Detection Rate for P. falciparum samples
Advantage Mal Card
Advantage Pan Malaria Card
CareStart Malaria pLDH (PAN)
OptiMAL-IT
CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO
First Response Malaria Ag Combo (PLDH/HRP2)
OnSight – ParaQuick (Pan Pf) Test
SD BIOLINE Malaria Ag
SD BIOLINE Malaria Ag Pf/Pan
AZOG Malaria pf (HRP-II) /pv (pLDH) Antigen Detection Test Device
Immunoquick Malaria +4
Parabank Rapid Test for Malaria Pan (Device)
Wondfo One Step Malaria Pf/Pan Whole Blood Test
Parascreen Rapid Test for Malaria Pan/Pf (Device)
Binax Now Malaria
Malaria Rapid Combo
Malaria Rapid Dual
FirstSign – ParaView-2 (Pv + Pf) Card Test
Hexagon Malaria Combi
ICT Malaria Combo Cassette Test (ML02)
Malaria P.F/Vivax
Malascan Rapid Test for Malaria Pf/Pan (Device)
One Step Malaria Antigen Strip
Parahit-Total Device Rapid test for P. falciparum and Pan malarial species.
Quickstick Malaria Antigen Test
First Response Malaria Ag Combo (PLDH/HRP2)
First Response Malaria Ag HRP2
CareStart Malaria HRP2 (Pf)
Advantage P.f. Malaria Card
CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO
SD BIOLINE Malaria Ag Pf
SD BIOLINE Malaria Ag Pf/Pan
Immunoquick Malaria +4
CareStart Malaria pLDH (PAN)
Malaria Plasmodium falciparum Rapid test Device (Whole blood)
Binax Now Malaria
Immunoquick Malaria Falciparum
Malaria Rapid Combo
ICT Malaria Combo Cassette Test (ML02)
ICT Malaria Pf Cassette Test (ML01)
Parahit-f DIPSTICK FOR FALCIPARUM MALARIA
AZOG Malaria pf (HRP-II) /pv (pLDH) Antigen Detection Test Device
Malaria Rapid Dual
Paracheck Pf Rapid test for P.falciparum Malaria ( Dipstick)
Malaria P.F/Vivax
Advantage Pan Malaria Card
Malaria Rapid Pf
ADVANCED QUALITY TM One Step Malaria (p.f.) Test (whole blood)
Malascan Rapid Test for Malaria Pf/Pan (Device)
Advantage Mal Card
Wondfo One Step Malaria Pf/Pan Whole Blood Test
OnSight – ParaQuick (Pan
ADVANCED QUALITY TM MALARIA (p.f) POCT
Paracheck Pf Rapid test for P. falciparum Malaria ( Device)
Parascreen Rapid Test for Malaria Pan/Pf (Device)
FirstSign – ParaView-2 (Pv + Pf) Card Test
Hexagon Malaria Combi
Hexagon Malaria
Parahit-f TEST DEVICE FOR FALCIPARUM MALARIA
OptiMAL-IT
Parahit-Total Device Rapid test for P. falciparum and Pan malarial species.
FirstSign – Malaria Pf Card Test
SD BIOLINE Malaria Ag
One Step Malaria Antigen Strip
Parabank Rapid Test for Malaria Pan (Device)
Quickstick Malaria Antigen Test
Detection rate (%)
Combo tests with high detection rate of both
P. falciparum and P. vivax at 200 parasites/µl
100
P. vivax Detection Rate
75
50
200 (aldolase)
200 (pLDH)
2000 (aldolase)
2000 (pLDH)
2000 (HRP2)
25
2000 (pLDH)
0
WHO procurement criteria for malaria RDTs:
evolution over time
Criteria for inclusion:

2006: ISO13485:2003 or ‘sufficient equivalence’ *

2007: ISO13485:2003 or US FDA 21 CFR 820 *

2008: Only Products submitted to WHO Product- Testing
Programme

2009: RDTs with good performance in product testing
* Plus credible heat-stability protocol
 Select RDTs with:
– high detection rate,
– low false positive
rate,
– low invalid rate.
 In populations with
low immunity,
higher detection of
low parasitaemia is
important
28 |
9 July 2009
GLOBAL
MALARIA PROGRAMME
Current WHO/UNICEF prices of
malaria RDTs eligible for RFP 2009-2010
Price per test (USD)
Pan-malaria
n=3
Combo
RDTs eligible
for procurement
by WHO and
UNICEF
n=8
RDTs with
highest detection
at 200 parasites/µl
n=10
Pf-only
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
USD
29 |
9 July 2009
GLOBAL
MALARIA PROGRAMME