Preliminary enquiry into the availability, price and quality of

malaria rapid diagnostic tests in the private health sector of six

malaria-endemic countries
A. Albertini
1
, D. Djalle
2
, B. Faye
3
, D. Gamboa
4,5
, J. Luchavez
6
, M. L. Mationg
6
, G. Mwangoka
7
, W. Oyibo
8
,
J. Bennett
1
, S. Incardona
1
and E. Lee
1
1 FIND (Foundation for Innovative New Diagnostics), Geneva, Switzerland
2 Institut Pasteur Bangui, Bangui, Central African Republic
3 Universite Cheikh Anta Diop, Dakar, Senegal
4 Departamento de Ciencias Celulares y Moleculares, Facultad de Ciencias y Filosoa, Universidad Peruana Cayetano Heredia, Lima, Peru
5 Instituto de Medicina Tropical Alexander Von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru
6 Research Institute for Tropical Medicine (RITM), Muntinlupa City, Philippines
7 Ifakara Health Institute, Tanzania
8 University of Lagos, Lagos, Nigeria
Abstract objectives This enquiry aimed to provide a snap-shot of availability, price and quality of malaria
rapid diagnostic tests (RDTs) in private health facilities at selected sites in six malaria-endemic countries
in Africa, South East Asia and South America.
methods In each study site, data collectors surveyed private healthcare facilities which were selected
based on accessibility from their home institution. Using a questionnaire, information was recorded
about the facility itself and the malaria RDT(s) available. Where possible, a small number of RDTs were
procured and quality control tested using a standardized procedure.
results Of the 324 private healthcare facilities visited, 35 outlets (mainly private clinics and hospitals)
were found to supply 10 different types of RDTs products. RDT prices across the six countries ranged
from US$1.00 to $16.81. Five of the 14 malaria RDTs collected failed quality control testing.
conclusions In the private outlets sampled, the availability of RDTs was limited. Some of the RDTs
whose quality we tested demonstrated inadequate sensitivity. This presents a number of risks. Given the
more widespread distribution of antimalarials currently planned for private sector facilities, parasite-
based diagnosis in this sector will be essential to adhere to the WHO guidelines for effective case
management of malaria. Considerable regulation and quality control are also necessary to assure the
availability of accurate and reliable RDTs, as well as adequate case management and provider adherence
to RDT results. Public sector engagement is likely to be essential in this process.
keywords: malaria, diagnostic, rapid diagnostic tests, private health sector
Introduction
At present, parasite-based diagnosis for malaria is rapidly
being scaled up and implemented in many malaria-endemic
countries (WHO 2010b), in keeping with current WHO
recommendations on malaria case management (WHO
2010a). This is resulting in large-scale procurement of
rapid diagnostic tests (RDTs), through the support of
national governments and their partners (Roll Back
Malaria Procurement and Supply Chain Working Group
and Medicines for Malaria Venture 2009). Most of this
procurement is targeting the public healthcare sector and
driven by Ministries of Health (WHO 2010b). However, a
signicant proportion of the population accesses health
care for malaria-like fever through privately owned health
facilities, for reasons that may include convenience, access
to care at desired times, location, etc. (Mwenesi 1994;
Ndyomugyenyi et al. 1998). A recent study conducted in
Uganda reported that 62.7% of febrile patients who sought
care outside their home had rst gone to drug shops and
private clinics (Rutebemberwa et al. 2009). On the Kenyan
coast, private health facilities were used rst, or solely, in
69% of childhood fevers treated (Molyneux et al. 1999). In
Togo, 83% of febrile children under 5 years of age were
treated at home with an antimalarial obtained from a street
or market vendor (Deming et al. 1989).
Tropical Medicine and International Health doi:10.1111/j.1365-3156.2011.02904.x
volume 17 no 2 pp 147152 february 2012
2011 Blackwell Publishing Ltd 147
Private sector facilities can be classied as either formal
or informal and demonstrate a wide range of products
and services as well as skills and quality of care provided
(Forsberg et al. 2011; Montagu et al. 2011). Those gener-
ally considered to be part of the formal private sector
include licensed pharmacies (Part One pharmacies), small
private clinics, private healthcare practitioners and private
hospitals that typically cater to a wealthier clientele. In
some countries, the formal private sector may also include
licensed drug outlets, such as duka la dawa baridi in
Tanzania (Tanzania Food and Drugs Authority http://
www.tfda.or.tz/). The informal private sector often con-
sists of small outlets, manned by personnel with little to no
formal healthcare training (Oshiname & Brieger 1992;
Rajakaruna et al. 2006). Illegal stocks of antimalarials and
other drugs have been found in some drug stores (Good-
man et al. 2004). These may include chemical sellers
(Ghana), unlicensed patent medicine vendors (Nigeria) or
unlicensed duka la dawa (Tanzania).
There are very few published data on the availability and
use of parasite-based diagnosis in the private healthcare
sector of developing countries. However, a recent study in
Nigeria showed that malaria is often diagnosed solely on
the basis of symptoms (52%), microscopy was performed
in relatively few cases (34.5%), and no RDTs (0%) were
performed in the non-hospital facilities investigated (On-
wujekwe et al. 2009). This exploratory study of RDT
availability, quality and prices in private sector outlets was
carried out to encourage and inform more in-depth studies
that focus on implementation of private sector malaria
diagnosis.
Methods
Data collection
The study surveyed private health facilities in six
malaria-endemic countries in Asia, Africa and South
America. In each country, data collection was carried out
in major urban areas (such as the capital city) where
malaria is endemic, including: Metro Manila and Puerto
Princesa (The Philippines), Bangui (Central African
Republic), Lagos (Nigeria), Dakar (Senegal), Dar Es
Salam (Tanzania) and Iquitos (Peru). All sites chosen
have local malaria transmission, except Metro Manila,
where patients none-the-less seek care for malaria-like
fevers, often on their return from malaria-endemic areas
nearby. All data collectors were under the direct super-
vision of local collaborating institutions. Private health
facilities were selected based on the availability and
accessibility: data were collected from at least ve easily
accessible sites in each country, within a 2 h drive of the
collaborating institution. Private health facilities were
dened as those that were not part of the government-
managed healthcare sector and included both formal and
informal private sector facilities. To simplify data anal-
ysis, several categories of private health facilities used in
an ongoing project (ACTwatch 2008) were adapted to
suit the needs of this study. Outlets were classied
according to the following three categories: private
clinical care providers, Part One pharmacies and private
diagnostic laboratories.
Data were compiled based on a questionnaire already in
use for collecting data on essential medicines, modied to
determine RDT availability and pricing. After adequate
training by the respective institutions, the data collectors
recorded information about the facility itself (type of
outlet, level of care) and the malaria RDT(s) available
(product name, type, manufacturer, lot number and expiry
date). Data collectors also collected information on the
price that the patient paid to be tested with an RDT,
which may include a service fee or laboratory fee for
performing the assay, but did not include a consultation
fee. Where possible, data collectors were instructed to buy
three RDTs of each product type available (to test one low
positive malaria sample, one high positive malaria sample
and one negative malaria sample) with the accompanying
buffer. The RDTs were selected by the outlet vendors,
simulating a routine patient purchase. Quality control
testing was performed by the participating institution at
each study site, using a standardized protocol (WHO, TDR
& FIND 2008).
Rapid diagnostic test quality control
All quality control (QC) testing of malaria RDT samples
was carried out by the laboratories of participating
institutions using existing QC panels which had been
established during the WHO TDR FIND CDC project
to create a global malaria specimen bank. QC panels
consist of a series of patient samples of parasite-positive
(diluted to specied parasite equivalent concentrations)
and parasite-negative blood that are collected from the
eld in malaria-endemic zones. The methods were
adapted from the Methods Manual for Laboratory
Quality Control Testing of Malaria Rapid Diagnostic
Tests, version 5 (WHO, TDR & FIND 2008). Using the
QC panels, three RDTs from each purchase were tested:
two were tested against samples containing Plasmodium
falciparum taken from naturally infected humans, and,
where appropriate, Plasmodium vivax, at dilutions of
2000 and 200 parasites per microlitre, respectively; and
one RDT was tested against a parasite-negative blood
sample.
Tropical Medicine and International Health volume 17 no 2 pp 147152 february 2012
A. Albertini et al. Malaria RDTs in the private health sector
148 2011 Blackwell Publishing Ltd
Results
Rapid diagnostic test distribution
Data were collected from 324 private health facilities
across the six countries. The outlets visited fell into three
different categories: 180 private clinical care providers
(including clinics, hospitals, medical ofces, non-govern-
mental organizations [NGOs] and religious missions), 119
Part One pharmacies (selling prescription medicine at a
commercial rate and staffed by pharmacists or qualied
health practitioners) and 25 private diagnostic laboratories
(all in Lagos, Nigeria).
The majority of RDTs (86%) were found in facilities
operated by private clinical care providers. Of the diag-
nostic laboratories visited (all in Lagos), only one had
RDTs available. Only four of the Part One pharmacies
assessed supplied RDTs (two in Senegal and two in
Tanzania).
Availability of RDTs in facilities visited in each country
was as follows:
Iquitos (Peru): no RDTs in any of the 24 private
health facilities visited (23 Part One pharmacies and
one clinic).
Metro Manila and Palawan province (The Philip-
pines): data were collected from 83 outlets, including
25 private clinics, 41 private hospitals and 17 Part
One pharmacies. Of these, 18 private hospitals
provided malaria RDTs, of which there were six
different types available.
Dakar (Senegal): 17 private clinical care providers and
53 Part One pharmacies were sampled. Of these, two
Part One pharmacies had a stock of malaria RDTs.
Lagos (Nigeria): data were collected from 85 private
clinics, 25 private diagnostic laboratories and 10 Part
One pharmacies. Five private outlets (four private
clinics and one diagnostic laboratory) supplied
malaria RDTs, of which four different brands were
available. Five RDT samples were purchased for
assessment at two private facilities in Lagos, Nigeria.
One of these had neither packaging instructions nor
the manufacturers contact details.
Bangui (Central African Republic): 25 outlets were
surveyed, including eight NGOs, three religious mis-
sions and 14 Part One pharmacies. Nine private
facilities had malaria RDTs, including all eight
NGOs. These outlets were unwilling to sell RDTs to
the data collectors, so no quality control was possible.
Dar es Salam (Tanzania): two outlets were surveyed,
both Part One pharmacies. RDT samples were
purchased in each facility.
Pricing
Information on pricing was obtained for 24 different
samples of RDTs from 22 private outlets in four of the
countries involved in this study (Table 1). Overall, RDT
prices across the four countries ranged from US$1.00 (at a
Part One pharmacy in Dar Es Salam, Tanzania) to $16.81
(at a private hospital in Lagos, Nigeria). Mean and median
RDT prices were US$ 7.51 and $7.38, respectively. No
further statistic analysis was performed because the sample
size was too small to produce any meaningful results.
Quality control
As detailed in Table 1, a total of 14 RDTs that were
available for purchase were collected and quality control
tested. Nine RDTs passed the quality control testing at
Table 1 Malaria RDTs stock availability, prices and quality in sampled private outlets of the six study countries
Country no
Private facilities
visited no
Private facilities
with RDTs in
stock no
RDT price per test
(USD) (Median)
RDT products
type collected no
% RDT samples that
passed quality
control (Total
purchases no)
Central African Republic
(Bangui)
25 9 NA 2 NA
Nigeria (Lagos) 120 4 2.5216.81 (5.88) 4 40 (5)
Senegal (Dakar) 70 2 2.754.00 (3.37) 2 50 (2)
Tanzania (Dar Es Salam) 2 2 12.31 (1.66) 2 50 (2)
Philippines (Metro Manila
and Palawan, Puerto
Princesa)
83 18 3.8012.00 (7.43) 6 100 (5)
Peru (Iquitos) 24 0 NA NA NA
TOTAL 324 35 1.0016.81 (7.38) 10 64 (14)
NA: Not applicable.
Tropical Medicine and International Health volume 17 no 2 pp 147152 february 2012
A. Albertini et al. Malaria RDTs in the private health sector
2011 Blackwell Publishing Ltd 149
both 200 and 2000 Plasmodium falciparum parasites per
microlitre. One RDT (malaria RDT Pf Pan type) failed
quality control testing at both 200 and 2000 P. falciparum
parasites per microlitre, and four RDTs (malaria Pf RDT
types) failed to detect a dilution of 200 P. falciparum
parasites per microlitre.
Discussion
In the six endemic countries covered by this study, and
within the designated sampling areas, the availability of
malaria RDTs in the private sector outlets surveyed was
very limited. In Peru, no RDTs were found in any of the
private facilities sampled, despite malaria being endemic to
the Iquitos region. Even a basic awareness of the role and
availability of RDTs seems lacking: in Nigeria, most of the
private facilities visited did not know about RDTs for
malaria diagnosis.
At the time of the survey, the public sectors of ve of the
countries (Senegal, Tanzania, Peru, Central African
Republic and the Philippines) involved in this study were
providing RDTs free of charge, and the sixth (Nigeria) has
since commenced implementation, as shown in Table 2.
This may add to the challenges of implementing RDTs in
the private sector. Furthermore, in the 35 private outlets
that were found to stock RDTs, a variety of different
brands were available. This is not the case in the public
sector, where a single RDT brand is generally selected for
country-wide implementation. Only in one country (Tan-
zania) was there an overlap between the brand of RDT
chosen by the National Malaria Control Programme for
distribution in the public sector and the products available
in the private sector. This will compound the challenges
associated with training and quality control.
The evaluations of RDT quality and performance
indicated that some RDTs found in private outlets had
inadequate sensitivity. Although limited by sample size,
this suggests that the quality of RDTs available in the
private sector should be regulated and monitored more
closely. Reduced RDT sensitivity may be due to poor
manufacture, or inadequate precautions taken during
transportation and storage (Jorgensen et al. 2006), issues
currently being addressed by many National Malaria
Control Programmes but probably not extending beyond
the public sector. The survey also highlights a wide range in
pricing for malaria RDTs, even across a small sample of
private healthcare facilities, and observed deciencies in
packaging and labelling, an issue noted elsewhere (Gillet
et al. 2011).
This preliminary enquiry has a number of limitations,
many of which are inherent its design and methodology.
Most of the data were collected in urban centres. The
Table 2 Malaria RDTs products stocked in sampled private outlets and available in the public sector of the six study countries
Countries
Malaria RDTs available in 2009 (manufacturer)
Public sector Private sector
Central African Re-public Paracheck (Orchid Biomedical) ICT combo (ICT diagnostics)
Hexagon Malaria (Human GMBH)
Nigeria NA (not yet implemented) Diaspot Rapid Test (not indicated)
Binax Now malaria (Inverness)
One step rapid test (Global devices)
Pf Check-1(Lanpharm)
Peru Parascreen (Zephyr Biomedical)*
Optimal IT (Diamed)*
NA
Philippines Paracheck Pf (Orchid Biomedical System)
ICT Malaria Combo Test (ICT Diagnostics)
Panbio (Panbio Diagnostics)
Parascreen (Zephyr Biomedical)
Parabank (Zephyr Biomedical)
Paraview (Unimed Inc.)
SD Ag P.f Pan (Standard Diagnostics)
Dima Malaria P.f Pan (MK Bio GmbH)
Senegal SD Malaria Antigen Pf (Standard Diagnostic) Parahit (Span diagnostics)
Optimal IT (Diamed)
Tanzania ParaHit (Span Diagnostics)
Pilot study in three regions
ICT combo (ICT diagnostics)
Parahit (Span diagnostics)
*These RDTs products were purchased in 2006 and 2007 but were still being distributed in the public sector in 2009. Since then no malaria
RDTs have been procured by the Ministry of Heath in Peru.
NA: Not applicable.
Tropical Medicine and International Health volume 17 no 2 pp 147152 february 2012
A. Albertini et al. Malaria RDTs in the private health sector
150 2011 Blackwell Publishing Ltd
availability and range of malaria diagnostics are likely to
be even worse in rural areas. Without adequate baseline
data on the number and location of private sector outlets, a
many of discretion was left to the study coordinators at
participating institutions, and a variable number of outlets
were visited across countries. Future studies should use a
larger sampling frame based on a census of private sector
outlets to obtain statistically robust data, as well as data on
the use and availability of microscopy services. Although
the data collected on RDT price included a laboratory or
service fee for carrying out the assay, they did not include
any consultation fee, which may vary widely between
healthcare providers and between countries. Future studies
should collect disaggregated data on the following: pro-
curement price, retail price, service or laboratory fee,
consultation fee and any other additional charges. These
limitations have a direct impact on the strength of our
conclusions; however, even this small study highlights the
wide variation in availability, price, and quality of RDTs in
the private healthcare sector.
The WHO today recommends that ACTs should be
provided only when malaria is conrmed with parasite-
based diagnosis. Recent initiatives to increase access to
ACTs in the private sector, such as the Affordable
Medicines Facility for Malaria (The Global Fund 2010),
highlight the need to address parasite-based diagnosis in
this sector. Lack of RDT use and the resultant over
prescription of ACTs increase the risk of developing
parasite-resistance to these valuable drugs and can delay
appropriate management of non-malarial fevers, also a
major cause of child mortality (Black et al. 2010).
However, if RDTs are widely used, the lack of quality
control of RDTs in the private sector can also present a
potential risk to patients, through incorrect diagnosis and
inappropriate withholding of antimalarial treatment. Poor
quality RDTs in the private sector may also reduce
condence in public sector programmes thus hindering
the improvements in public sector management of febrile
disease.
The introduction of routine parasite-based diagnosis into
the private sector will be essential to effectively implement
the WHO recommendations on parasite-based diagnosis,
as this sector is vital to ensuring adequate access to ACTs
in many countries (Moon et al. 2009; Sabot et al. 2009).
However, the use of RDTs in the private sector will require
considerable regulation and quality control of these prod-
ucts, together with appropriate management of transport
and storage (WHO-Western Pacic Regional Ofce
(WHO-WPRO), USAID | DELIVER PROJECT, Founda-
tion for Innovative New Diagnostics (FIND), Roll Back
Malaria Partnership & Presidents Malaria Initiative (PMI)
(2009) to ensure adequate performance of RDTs. A further
requirement is training of private healthcare providers in
test preparation, correct interpretation of results and case
management of both positive and negative results. Despite
many challenges, experience with RDT implementation at
the community level shows that this is possible (Rennie
et al. 2007; Harvey et al. 2008). Other measures to ensure
adherence to RDT results and sufcient motivation to
private providers to comply with good practice must also
be addressed (Mbonye et al. 2010).
Strong public sector engagement will be needed
throughout the process to ensure product quality and
adherence to guidelines. Enabling the use of public sector
resources to expand quality control and training to benet
malaria case management in the private sector presents
potential political and legal challenges. A review of
regulatory processes governing private health sector activ-
ities may be required in addition to ensure harmonization
between the two sectors.
In conclusion, this preliminary enquiry provides a snap-
shot of RDTavailability in privately run healthcare facilities
in selected countries. Far more extensive studies are
required to delineate private sector needs, inform public
policy and ensure appropriate malaria diagnosis and treat-
ment in the private sector. The results of such studies are
likely to be very country-specic. Nevertheless, the chal-
lenges associated with establishing the routine use of RDTs
in settings outside of the public sector must be tackled, as
the distribution of RDTs and ACTs must occur hand in
hand to ensure effective case management of febrile disease.
Acknowledgements
We thank the data collection teams in Nigeria, The
Philippines, Senegal, Tanzania, Peru and the Central
African Republic for their participation in this study. We
also thank Iveth Gonzalez for review of the results, Beatrice
Gordis and Heidi Hopkins for comments on the manu-
script. The study was funded by FIND (Foundation for
Innovative New Diagnostics), an independent non-prot
foundation with headquarters in Geneva, Switzerland, and
with eld ofces in Uganda and India, through a grant
from the Bill and Melinda Gates Foundation.
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Corresponding Author Audrey Albertini, FIND, 16 Avenue de Bude, Geneva, Switzerland. Tel.: +41 22 710 93 14;
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Tropical Medicine and International Health volume 17 no 2 pp 147152 february 2012
A. Albertini et al. Malaria RDTs in the private health sector
152 2011 Blackwell Publishing Ltd