14651858.cd008122

Cochrane Database of Systematic Reviews
Immunochromatography-based rapid diagnostic tests for

diagnosing uncomplicated malaria in endemic countries
(Protocol)
Naing CM, Abba K, Garner P, Win DK, Maung M, Deeks JJ, Olliaro P
Naing CM, Abba K, Garner P, Win DK, Maung M, Deeks JJ, Olliaro P.
Immunochromatography-based rapid diagnostic tests for diagnosing uncomplicated malaria in endemic countries.
Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD008122.
DOI: 10.1002/14651858.CD008122.
www.cochranelibrary.com
Immunochromatography-based rapid diagnostic tests for diagnosing uncomplicated malaria in endemic countries (Protocol)
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Immunochromatography-based rapid diagnostic tests for diagnosing uncomplicated malaria in endemic countries (Protocol) i
[Diagnostic Test Accuracy Protocol]
Immunochromatography-based rapid diagnostic tests for

diagnosing uncomplicated malaria in endemic countries
Cho-Min Naing1 , Katharine Abba2 , Paul Garner2 , Daw-Khin Win3 , Mala Maung4 , Jonathan J Deeks5 , Piero Olliaro6
1 Divisionof Community Medicine, International Medical University, Kuala Lumpur, Malaysia. 2 International Health Group, Liver-
pool School of Tropical Medicine, Liverpool, UK. 3 Biology, International Medical University, Kuala Lumpur, Malaysia. 4 Pathology,
International Medical University, Kuala Lumpur, Malaysia. 5 Public Health, Epidemiology and Biostatistics, University of Birmingham,
Birmingham, UK. 6 Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva,
Switzerland
Contact address: Cho-Min Naing, Division of Community Medicine, International Medical University, No.126 Jalan 19/155B, Bukit
Jalil, Kuala Lumpur, 57000, Malaysia. [email protected].
Editorial group: Cochrane Infectious Diseases Group.

Publication status and date: New, published in Issue 1, 2010.
Citation: Naing CM, Abba K, Garner P, Win DK, Maung M, Deeks JJ, Olliaro P. Immunochromatography-based rapid diagnostic
tests for diagnosing uncomplicated malaria in endemic countries. Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.:
CD008122. DOI: 10.1002/14651858.CD008122.
ABSTRACT
This is a protocol for a Cochrane Review (Diagnostic test accuracy). The objectives are as follows:
To assess the diagnostic accuracy of RDTs for detecting malaria parasitaemia and different types of malaria parasite in persons living in
malaria endemic areas with symptoms of malaria.
BACKGROUND and 85% were children under the age of five years (World Health
Organization 2008a). Malaria may be uncomplicated or severe.
Most cases are uncomplicated, commonly presenting with fever,
and sometimes other non-specific symptoms including headache,
and aches and pains elsewhere in the body (Gilles 1991; World
Target condition being diagnosed
Health Organization 2003). Severe malaria presents with confu-
Malaria is a life-threatening illness caused by the parasitic proto- sion or drowsiness with extreme weakness, and may lead to coma
zoan Plasmodium, which is transmitted by many species of anophe- and other life-threatening complications involving many organs.
line mosquitoes. In 2006, an estimated 3.3 billion people, almost The two most common species of malaria parasites are Plasmod-
half the world’s population, were living in malaria endemic ar- ium falciparum and Plasmodium vivax. Falciparum malaria is the
eas, and there were between 189 and 327 million cases of malaria most common cause of severe malaria and malaria deaths and can
(World Health Organization 2008a). Around 87% of cases were also cause other complications such as anaemia and, in pregnancy,
in Africa, 9% in South East Asia, 2% in the Middle East and 1% in low birth weight babies. Vivax malaria is a relapsing form, which is
South America (World Health Organization 2008a). In the same rarely fatal but can cause serious anaemia in children. Malaria is a
year, nearly a million people died from malaria; 91% were in Africa
Immunochromatography-based rapid diagnostic tests for diagnosing uncomplicated malaria in endemic countries (Protocol) 1
curable disease, and therefore malaria related morbidity and mor- • Type V: pLDL (P. falciparum-specific) and pLDH (P. vivax-
tality can be reduced. Early, prompt and accurate diagnosis fol- specific). Possible results: no malaria, Pf, Pv, Pf and Pv, invalid
lowed by appropriate treatment is the key to effective disease man- • Type VI: HRP-2 (P. falciparum-specific), pLDH (pan-
agement (World Health Organization 2003) and is a basic tenet of specific) and pLDH (P. vivax-specific). Possible results: no
current malaria control policy (World Health Organization 2005; malaria, Pf and Pv +/- Po and/or Pm, Pf +/- Po and/or Pm, Pv +/
Bell 2006). - Po and/or Pm, Po and/or Pm, invalid
People who are exposed repeatedly to malaria infection develop • Type VII: Aldolase. Possible results: no malaria, Pf, Pv, Po
a partial and incomplete immunity. This means that in highly and/or Pm, invalid
endemic areas those most at risk are children under the age of five,
HRP-2 can stay in the blood for 28 days after initiating the anti-
who have not yet had the chance to develop immunity. In less
malarial therapy (Kakkilaya 2003). Because of this ’persistent anti-
endemic areas, or areas of seasonal or epidemic transmission, older
genaemia’, it is not possible to use these tests in assessing parasite
children and adults are also at risk due to less developed immunity.
clearance following treatment, and false positive results may be
Travellers from non-endemic to endemic countries are at highest
found in patients who have recently been treated for malaria. In
risk because they have no immunity at all.
contrast, pLDH is rapidly cleared from the blood following para-
site death; in fact it may clear more rapidly than the dead parasites
(World Health Organization 2009).
Index test(s)
Rapid diagnostic tests (RDTs)(World Health Organization 2003)
detect parasite-specific antigens in a drop of fresh blood through Alternative test(s)
lateral flow immunochromatography (World Health Organization
Microscopic examination of Giemsa-stained thick and thin blood
2006). The World Health Organization currently lists 96 commer-
films remain the conventional laboratory method and are still re-
cially available test kits meeting ISO131485 manufacturing stan-
garded as the ‘gold standard’. Microscopic examination provides
dards (World Health Organization 2009). RDTs do not require a
a good sensitivity and specificity (although very low parasitaemias
laboratory or any special equipment (World Health Organization
may not be detected), and it allows species and stage differentia-
2006), are simple to use and can give results as a simple posi-
tions and quantification of parasites, all of which are important in
tive/ negative result, at thresholds pre-set by the manufacturers,
assessing the disease severity and prescribing appropriate therapy.
within 15 minutes (Talman 2007). RDTs are therefore, in gen-
Intensive examination is more likely to reveal parasitaemia, so the
eral, suitable for remote areas with limited facilities and relatively
test is carried out with a fixed number of fields being examined.
untrained staff. However, they have a limited shelf life and need
Polymerase chain reaction (PCR) which is molecular method
to be kept dry and away from extremes of temperature. They may
based on DNA amplification is the most accurate method of de-
also fail to detect malaria where there are low levels of parasites
tecting parasites in the blood. This technique is currently not
in the blood, for example in young children with low immunity,
widely available due to logistic constraints and the need of specially
and false positives are possible due to cross reactions or gametocy-
trained technicians and a well equipped laboratory. It is usually
taemia (Kakkilaya 2003).
used only for research purposes.
These assays detect one or several antigens, the most common are
histidine-rich protein-2 (HRP-2), aldolase and lactate dehydro-
genase (pLDH) (Talman 2007). Detection of HRP-2 is a marker
for P. falciparum while pLDH may be specific for P. falciparum, P.
Rationale
vivax or may detect all species (including P. ovale and P. gambiae). A diagnostic test which is simple to perform, rapid and accurate
Aldolase is pan-specific, detecting all types of malaria but not dif- is important in many situations to ensure prompt specific treat-
ferentiating between them. There are seven types of commercially ment, reduce misdiagnosis of non-malarial illness as malaria, limit
available test, using different antigen combinations (Bell 2006): the development of drug resistance (Talman 2007) and reduce
• Type I: HRP-2 (P. falciparum-specific). Possible results: no drug wastage. The World Health Organization lists some of the
Pf, Pf, invalid situations where RDTs can be particularly useful as remote areas
• Type II: HRP-2 (P. falciparum specific) and aldolase (pan- without access to expert microscopy, complex emergencies, and se-
specific). Possible results: no malaria, Pf or mixed, Pv, Po and/or vere malaria, where rapid diagnosis is essential to save lives (World
Pm, invalid Health Organization 2000).
• Type III: HRP-2 (P. falciparum-specific) and pLDH (pan- The World Health Organization now recommends artemisinin-
specific). Possible results: no malaria, Pf or mixed, Pv, Po and/or based combination therapy (ACT) for the treatment of malaria
Pm, invalid (World Health Organization 2006a). This is more effective and
• Type IV: pLDH (P. falciparum-specific) and pLDH (pan- also more expensive than previously used antimalarial drugs
specific). Possible results: no malaria, Pf or mixed, invalid. (Sinclair 2009; Omari 2006). Since the introduction of ACTs,
World Health Organization policy for highly malaria endemic ar- range of RDTs for diagnosing malaria in people with symptoms
eas has changed from treating all people with fever, to recom- in endemic areas.
mending only treating following diagnostic confirmation by mi-
croscopy or RDTs, with the exception of children under the age of
five. However, local practice is often very different, some studies
indicating that, even where diagnostic tests are used, treatment for
malaria is often still given to all patients with fever (Hamer 2007). OBJECTIVES
The relative costs of microscopy and RDTs vary according to con- To assess the diagnostic accuracy of RDTs for detecting malaria
text. Where there is a relatively high prevalence of malaria and an parasitaemia and different types of malaria parasite in persons liv-
established microscopy service, microscopy would usually be less ing in malaria endemic areas with symptoms of malaria.
expensive than RDTs, because most of the costs associated with
microscopy are fixed costs, and microscopy can also be used to
diagnose other diseases. In areas where malaria is less prevalent, or
very rural areas where access to good quality microscopy services Investigation of sources of heterogeneity
is limited, RDTs may be less expensive than microscopy (World We will investigate heterogeneity in relation to the test and test
Health Organization 2008.). The costs of RDTs also depends on conditions (index and reference), as well as patients’ characteristics
the type of test used, which will depend on the types of malaria and endemicity.
parasite endemic in the area; World Health Organization describes
three zones (World Health Organization 2005a):
• Zone 1- P. falciparum only or other species almost always as
a mixed infection (most of Sub-saharan Africa, lowland Papua
New Guinea). Tests using HRP-2 to detect P. falciparum only are METHODS
appropriate.
• Zone 2 - both P. falciparum and P. vivax, most commonly as
a single species (Asian and the Americas, Ethiopian highlands).
Criteria for considering studies for this review
Combination RDTs are needed, which detect all species and
distinguish between P. falciparum and P. vivax.
• Zone 3 - non-falciparum only (vivax only areas of East Asia
and Central Asia, some highland areas elsewhere). Pan-specific or Types of studies
vivax-specific RDTs are appropriate. Studies using a consecutive series of patients, or a randomly se-
RDTs may be used to confirm diagnosis before commencing treat- lected series of patients.
ment in people with symptoms of malaria where confirmation by
microscopy is currently unavailable or unused, thereby increas-
ing the specificity of diagnosis, which would otherwise be made Participants
on symptoms only. Alternatively, RDTs may be used to replace People living in malaria endemic areas attending ambulatory
microscopy for confirmatory diagnosis, where logistic factors and healthcare settings with symptoms of uncomplicated malaria at
relative costs indicate that this may be beneficial. The usefulness the time of the study.
of RDTs in these roles will depend to a large extent on their ac- We will exclude studies if participants:
curacy, which will be explored in this review. The sensitivity and i. are non-immune persons returning from endemic countries or
specificity thresholds that decide whether a test is useful in prac- are mainly migrant or displaced populations from non-endemic
tice will depend upon the situation; as malaria endemicity varies areas
enormously by geographic area, and positive and negative predic- ii. have been treated for malaria and the test is performed to assess
tive values will vary considerably with endemicity. In addition, treatment outcome
microscopy is not a perfect reference standard in itself, and the iii. have symptoms of severe malaria
relative accuracy of RDTs and microscopy will depend to a large iv. do not have symptoms of malaria
extent on the performance of the laboratory facilities and person- In studies where only a subgroup of participants is eligible for
nel available for microscopy. inclusion in the review, the study will be included provided that
Previously published systematic reviews have focused on the ac- it is possible to extract relevant data specific to that subgroup.
curacy of RDTs for diagnosing malaria in travellers returning to If studies include some patients with severe malaria, and data spe-
non-endemic countries from endemic countries (Marx 2005) or cific to a subgroup of participant with uncomplicated malaria can-
on one particular test only (Cruciani 2004). As far as we know this not be extracted, the study will be included if 90% or more of the
will be the first systematic review to assess the accuracy of the full participants have uncomplicated malaria.
Index tests Immumochromatography, antigen detection, antigen test, Combo
All types of immunochromatography-based rapid diagnostic tests card.
(RDTs) We will not limit the search by language or publication status. We
will restrict the searches to human studies.
Comparator tests
Searching other resources
Studies may or may not assess more than one type of RDT against
the same reference standard We will handsearch reference lists of included articles, and any
relevant review articles identified through the search, for possible
eligible articles. We will contact test manufacturers to identify any
Target conditions unpublished studies. We will also handsearch conference proceed-
Symptomatic uncomplicated malaria, before treatment is com- ings and reports of the World Health Organization to identify ad-
menced, including fever or a recent history of fever ditional studies. We will contact researchers, authors of included
trials, and other experts in the field of malaria diagnostics for in-
formation on ongoing or unpublished studies.
Reference standards
1. Conventional microscopy of thick blood smears, thin blood
smears or both. Presence of asexual parasites of any density is Data collection and analysis
regarded as a positive smear.
2. Polymerase chain reaction (PCR).
There may be some studies using more than one reference test. Selection of studies
If this is a case, we will present data relating to comparisons with
One author will assess the titles and abstracts identified by the
each reference standard.
search strategy.
The reference standard should be performed using blood samples
All potentially relevant articles will be retrieved in full and two
drawn at the same time as those for the index tests.
authors (Cho-Min Naing and Katharine Abba) will independently
examine for inclusion in the present review, using a proforma as a
guide. Any discrepancy will be resolved by discussion. If agreement
Search methods for identification of studies cannot be reached, the opinion of a third author will be sought.
Electronic searches Data extraction and management

To identify all relevant studies, we will search the following A standard set of data will be extracted from each study, using
databases using the search terms and strategy identified in Table 1 a tailored data extraction form. Two authors will independently
Cochrane Infectious Diseases Group Specialized Register; MED- extract data, and any discrepancies will be resolved by discussion,
LINE; EMBASE; MEDION; Science Citation Index; Web of and if necessary by consultation with a third author. In cases of
Knowledge; African Index Medicus; LILACS; IndMED studies where only a subgroup of participants is included in the
We will base the search on the following MeSH, full text and key- review, data will only be extracted and presented for that particular
word terms: Malaria, Plasmodium, reagent kits, diagnosis, diag- subgroup.
nostics, RDT, dipstick, MRDD, OptiMal, Binax Now, Parasight, For each study, data will be extracted on:
Study ID First author, year of publication
Clinical features and settings Presenting signs and symptoms, previous treatments for malaria, clinical setting
Participants Sample size, age, sex, comorbidities or pregnancy, country, malaria endemicity, malaria species
Study design Were consecutive patients enrolled retrospectively or prospectively?
Whether the sample is consecutive or random
(Continued)
If the study evaluated more than one RDT, how were tests allocated to individuals, or did each
individual receive all the tests?
Target condition Type(s) of malaria parasite tested for? (e.g. P. falciparum alone, P. vivax alone, any type of malaria
parasite?)
Reference standard The reference standard test(s) used
Who performed the reference standard test(s), and where?
If microscopy was used, how many high power fields were looked at?
How many observers or repeats were used?
How were discrepancies between observers resolved?
Index tests The parasite species the test is designed to detect, the antigens used, and the commercial name. Batch
numbers if provided. Transport and storage conditions. Details of the test operators, including any
special training provided
Notes Source of funding, anything else of relevance.
For each comparison of index test with reference test, data will be
extracted for the index test on the number of true positives, true Assessment of methodological quality
negatives, false positives and false negatives. Results of RDTs are
Two independent authors will assess the quality of each individ-
always binary (either negative or positive). Microscopy results will
ual study using the check list adapted from the QUADAS tool
be deemed positive at any level of parasitaemia, while PCR results
(Whiting 2003). Each question on the checklist will be answered
will use the cut-off points presented by the study authors. Any
with a yes/no response, or noted as unclear if insufficient informa-
additional data provided in cases of discordant results between
tion is reported to enable a judgement to be made, and the reasons
index and reference tests will also be recorded.
for the judgement made will be documented.
Quality Indicator Notes
Was the spectrum of patients representative of the spectrum of ’Yes’ if the characteristics of the participants are well described and
patients who will receive the test in practice? probably typical of an ambulatory health care setting
’No’ if the sample is unrepresentative of people with uncompli-
cated malaria in general. (For example, patients with some other
presenting health problem, such as pneumonia.)
’Unclear’ if the source or characteristics of participants is not ad-
equately described
Is the reference standard likely to correctly identify the target con- ’Yes’ if microscopy undertaken by expert microscopist(s) with ad-
dition? equate laboratory facilities. Slides are viewed by at least two in-
dependent observers, either for all slides or for those where there
are discordant results between the index and the reference test. At
least 100 microscopic fields before declaring negative
(Continued)
’Yes’ if reference standard is PCR

’No’ if microscopy is undertaken by insufficiently trained indi-
viduals, by one individual only, or in a situation with inadequate
equipment. Viewed less than 100 microscopic fields before declar-
ing negative
’Unclear’ if insufficient information is provided
Is partial verification avoided? ’Yes’ if all participants who received the index text also underwent
the reference test
’No’ if not all the participants who received the index test also
underwent the reference test
If not all participants received the reference tests, how many did
not (of the total)?
Is differential verification avoided? ’Yes’ if the same reference test was used regardless of the index test
results
’No’ if different reference tests are used depending on the results
of the index test
If any participants received a different reference test, what were the
reasons stated for this, and how many participants were involved?
Is incorporation avoided? (the index test does not form part of the Should be ‘Yes’ for all studies, as the reference standard is defined
reference standard) in the inclusion criteria as microscopy or PCR
Are the reference standard test results blinded? ’Yes’ if the report stated that the person undertaking the reference
test did not know the results of the index tests, or if the two tests
were carried out in different places
’No’ if the report stated that the same person performed both tests,
or that the results of the index tests were known to the person
undertaking the reference tests
’Unclear’ if insufficient information provided.
Are the index test results blinded? ’Yes’ if the report stated that the person undertaking the index test
did not know the results of the reference tests, or if the two tests
were carried out in different places
’No’ if the report stated that the same person performed both tests,
or that the results of the index tests were known to the person
undertaking the reference tests
’Unclear’ if insufficient information provided
Were uninterpretable results reported? ’Yes’ if the number of participants in the two-by-two table matches
the number of participants recruited into the study, or if sufficient
explanation is provided for any discrepancy
’No’ if the number of participants in the two-by-two table does
not match the number of participants recruited into the study,
and insufficient explanation is provided for any discrepancy
“Unclear” if insufficient information is given to permit judgement
(Continued)
Report how many results were uninterpretable (of the total)
Were any withdrawals explained? ’Yes’ if there are no participants excluded from the analysis, or if
exclusions are adequately described
’No’ if there are participants excluded from the analysis and there
is no explanation given
’Unclear’ if not enough information is given to assess whether any
participants were excluded from the analysis
Report how many participants were excluded from the analysis,
for reasons other than uninterpretable results
Investigations of heterogeneity
Statistical analysis and data synthesis
We will initially use visual inspection of the forest plot and sum-
mary ROC plots to check for heterogeneity between study results,
and to investigate further using formal meta-analytical methods.
In the description of studies we will assess the number of uninter- If sufficient studies are available, we will conduct meta-regression
pretable or invalid test results. We will examine this by type of test by adding the following variables to the meta-analysis models: age
in a subsidiary analysis. (adult or child), pregnancy; level of parasitaemia (< 500 parasites/
The numbers of true positives, false positives, true negative and µl, 500 to 2000 parasites/ µl, >2000 parasites/ µl), malaria en-
false negatives will be extracted for each study (Smidt 2008), based demicity; and continent (Africa, Asia, South America).
only on the types of malaria the test is designed to detect. For each
test, estimates of the observed sensitivities and specificities will
be plotted in forest plots in the receiver-operating characteristic Sensitivity analyses
(ROC) space. These plots will demonstrate the variation in ac- If sufficient trials are available, we will assess the robustness of
curacy between studies. Where adequate data are available, meta- the meta-analyses by conducting sensitivity analyses using com-
analyses will be undertaken to estimate and compare the perfor- ponents of the quality assessment, particularly those relating to
mance of the tests. The initial analyses will estimate and compare the quality of the reference standard and the proportion of par-
summary ROC curves through regression modelling using hier- ticipants not included in the analysis for any reason, including
archical summary ROC random-effects models. Covariates will uninterpretable results
be included for test type, and analyses will be undertaken of all
studies, and of the groups of studies that make direct comparisons
between tests. Assessment of reporting bias
We will present the results in groups according to the following We will not attempt to assess reporting bias.
hierarchy:
1. Type of malaria parasite tested for (P. falciparum, P. vivax,
all species)
2. Antigen targeted by the test
ACKNOWLEDGEMENTS
3. Commercial test name (if sufficient studies available)
Commerical tests no longer available will be included in the anal- We are grateful to our Affiliated Institutions and Organizations,
ysis because they may use the same antigens, and very similar tech- and to the Department of International Development, UK for
nology, to tests which are currently available or may become avail- research grants. We thankfully acknowledge the referees for their
able in the future. comments.
REFERENCES
Additional references Malaria Journal October 2007;6:140. DOI: 10.1186/

1475-2875-6-140
Bell 2006
Whiting 2003
Bell D, Wongsrichanalai C, Barnwell JW. Evaluating
Whiting P, Rutjes AWS, Reitsma JB, Bossuyt PMM,
diagnostics: ensuring quality and access for malaria
Kleinjen J. The development of QUADAS: a tool for the
diagnosis: how can it be achieved?. Nature Reviews
quality assessment of studies of diagnostic test accuracy
Microbiology September 2006;4:S7–S20. DOI: 10.1038/
included in systematic reviews. BMC Medical Research
nrmicro1525
Methodology 2003;3(25):http://www.biomedcentral.com/
Cruciani 2004 1471–2288/3/25.
Cruciani M, Nardi S, Malena M, Bosco O, Serpelloni
World Health Organization 2000
G, Mengoli C. Systematic review of the accuracy of the
World Health Organization. New perspectives: malaria
ParaSight-F tests in the diagnosis of Plasmodium falciparum
diagnosis: report of a joint WHO/ USAID informal
malaria. Medical science monitor: international medical
consultation 25-27 October 1999. Geneva: World Health
journal of experimental and clinical research 2004;10(7):
Organization, 2000.
MT81–8.
Gilles 1991 World Health Organization 2003
Gilles HM. Management of severe malaria: a practical World Health Organization. Malaria rapid diagnosis:making
handbook. Second edition. Geneva: World Health it work: World Health Organization meeting report 20-23
Organization, 2000. January Manila. Geneva: World Health Organization,
2003.
Hamer 2007
Hamer DH, Ndhlovu M, Zurovac D, Fox M, Yeboah- World Health Organization 2005
Antwi K, Chanda P, et al. Improved diagnostic testing World Health Organization. Prevention and control of
and malaria treatment practices in Zambia. Journal of the malaria. Strategic orientation paper. Geneva: World Health
American Medical Association 2007;297(20):2227–32. Organization, 2005.
Kakkilaya 2003 World Health Organization 2005a
Kakkilaya BS. Rapid diagnosis of malaria. Laboratory Roll Back Malaria Department, World Health Organization.
Medicine 2003;34:602–08. Interim notes on selection of type of malaria rapid diagnostic
Marx 2005 test in relation to the occurrence of different parasite species:
Marx A, Pewsner D, Egger M, Nuesch R, Heiner C, Bucher Guidance for national malaria control programmes. Geneva:
MD, et al. Meta-analysis: Accuracy of rapid tests for World Health Organization, 2005.
malaria in travellers returning from endemic areas. Annals World Health Organization 2006
of Internal Medicine 2005;142:836–846. World Health Organization. Towards quality testing of
Omari 2006 malaria rapid diagnostic tests: evidence and methods.
Omari AAA, Gamble CL, Garner P. Artemether- Proceedings of the WHO Informal Consultation on
lumefantrine (four-dose regimen) for treating uncomplicated development and methods for testing malaria rapid diagnostic
falciparum malaria. Cochrane Database of Systematic Reviews tests 28 February - 2 March 2006. Geneva: World Health
2006, Issue 2. DOI: 10.1002/14651858.CD005965 Organization, 2006.
Sinclair 2009 World Health Organization 2008
Sinclair D, Zani B, Bukirwa H, Donegan S, Olliaro World Health Organization Western Pacific Region.
O, Garner P. Artemisinin-based combination therapy Determining cost effectiveness of malaria rapid diagnostic
for treating uncomplicated malaria. Cochrane Database tests in rural areas with high prevalence. www.wpro.who.int/
of Systematic Reviews 2009, Issue 3. DOI: 10.1002/ sites/rdt (accessed 17/10/2008).
14651858.CD007483.pub2 World Health Organization 2008a
Smidt 2008 World Health Organization. World Malaria Report 2008.
Smidt N, Deeks J, Moore T. Chapter 4: Guide to the Geneva: World Health Organization, 2008.
contents of a Cochrane review and protocol. The Cochrane World Health Organization 2009
Handbook for Systematic Reviews of Diagnostic Test Accuracy World Health Organization. List of known commercially-
(Version 0.4) [Updated September 2008]. The Cochrane available antigen-detecting malaria RDTs: Information
Collaboration, 2008. for national public health services and UN Agencies
Talman 2007 wishing to procure RDTs. http://www.wpro.who.int/NR/
Talman AM, Duval L, Legrans E, Hubert V, Yen S, rdonlyres/990245C0-F157-417A-90C7-B08A7E1A50BA/
Bell B, et. al. Evaluation of the intra and inter-specific 0/TotallistofISO131485criteria Rev 24MAR09.pdf 2009.
genetic variability of Plasmodium lactate dehydrogenase. ∗
Indicates the major publication for the study
ADDITIONAL TABLES
Table 1. Table Search Strategy
Search set MEDLINE EMBASE
1 Exp Malaria[MeSH] Exp Malaria [Emtree]
2 Exp Plasmodium [MeSH] Exp Plasmodium [Emtree]
3 Malaria ti, ab Malaria ti, ab
4 1 or 2 or 3 1 or 2 or 3
5 Exp Reagent kits, diagnostics [MeSH] Exp Diagnostic procedures [Emtree]
6 rapid diagnos* test* ti, ab rapid diagnos$ test$ ti, ab
7 RDT ti, ab RDT ti, ab
8 Dipstick* ti, ab Dipstick$ ti, ab
9 Rapid diagnos* device* ti, ab Rapid diagnos$ device$ ti, ab
10 MRDD ti, ab MRDD ti, ab
11 OptiMal ti, ab OptiMal ti, ab
12 Binax NOW ti, ab Binax NOW ti, ab
13 ParaSight ti, ab ParaSight ti, ab
14 Immunochromatograph* ti, ab Immunochromatography [Emtree]
15 Antigen detection method* Antigen detection method$
16 Rapid malaria antigen test* Rapid malaria antigen test$
17 Combo card test* ti, ab Combo card test$ ti, ab
18 Immunoassay [MeSH] Immunoassay [Emtree]
19 Chromatography [MeSH] Chromatography [Emtree]
20 Enzyme-linked immunosorbent assay [MeSH] Enzyme-linked immunosorbent assay [Emtree]
21 Rapid test* ti, ab Rapid test$ ti, ab
22 Card test* ti, ab Card test$ ti, ab
Table 1. Table Search Strategy (Continued)
23 Rapid AND (detection* or diagnos*) ti, ab Rapid AND (detection$ or diagnos$) ti, ab
24 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or
16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23
25 4 and 19 4 and 19
26 Limit 20 to Humans Limit 20 to Human
CONTRIBUTIONS OF AUTHORS
Cho Min Naing had the original idea for the review. The protocol was devised mainly by Cho Min Naing and Katharine Abba, with
input on the analysis and statistics from Jon Deeks, and further input on content, methodology and presentation from Paul Garner,
Piero Olliaro, Daw-Khin Win and Mala Maung.
DECLARATIONS OF INTEREST
There are no known conflicts of interest.
SOURCES OF SUPPORT
Internal sources
• International Medical University, Malaysia.
Research grant ID 134/2007
• Liverpool School of Tropical Medicine, UK.
External sources
• Department for International Development, UK.
Research Programme Grant

14651858.cd008122

Uploaded by

Copyright:

Available Formats

14651858.cd008122

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

14651858.cd008122

Uploaded by

Copyright:

Available Formats

Cochrane Database of Systematic Reviews

Immunochromatography-based rapid diagnostic tests for

Immunochromatography-based rapid diagnostic tests for

Editorial group: Cochrane Infectious Diseases Group.

Electronic searches Data extraction and management

Study ID First author, year of publication

Study design Were consecutive patients enrolled retrospectively or prospectively?

Whether the sample is consecutive or random

Reference standard The reference standard test(s) used

Who performed the reference standard test(s), and where?

How many observers or repeats were used?

How were discrepancies between observers resolved?

Notes Source of funding, anything else of relevance.

Quality Indicator Notes

’Yes’ if reference standard is PCR

Report how many results were uninterpretable (of the total)

Additional references Malaria Journal October 2007;6:140. DOI: 10.1186/

Search set MEDLINE EMBASE

1 Exp Malaria[MeSH] Exp Malaria [Emtree]

2 Exp Plasmodium [MeSH] Exp Plasmodium [Emtree]

3 Malaria ti, ab Malaria ti, ab

5 Exp Reagent kits, diagnostics [MeSH] Exp Diagnostic procedures [Emtree]

6 rapid diagnos* test* ti, ab rapid diagnos$ test$ ti, ab

7 RDT ti, ab RDT ti, ab

8 Dipstick* ti, ab Dipstick$ ti, ab

9 Rapid diagnos* device* ti, ab Rapid diagnos$ device$ ti, ab

10 MRDD ti, ab MRDD ti, ab

11 OptiMal ti, ab OptiMal ti, ab

12 Binax NOW ti, ab Binax NOW ti, ab

13 ParaSight ti, ab ParaSight ti, ab

14 Immunochromatograph* ti, ab Immunochromatography [Emtree]

15 Antigen detection method* Antigen detection method$

16 Rapid malaria antigen test* Rapid malaria antigen test$

17 Combo card test* ti, ab Combo card test$ ti, ab

18 Immunoassay [MeSH] Immunoassay [Emtree]

19 Chromatography [MeSH] Chromatography [Emtree]

20 Enzyme-linked immunosorbent assay [MeSH] Enzyme-linked immunosorbent assay [Emtree]

21 Rapid test* ti, ab Rapid test$ ti, ab

22 Card test* ti, ab Card test$ ti, ab

26 Limit 20 to Humans Limit 20 to Human

You might also like