Rakotonirina 2008.

Clinical features and settings	Presenting signs and symptoms: Fever over 37.5 °C or history of fever in the previous 24 h Previous treatment for malaria: Participants with recent antimalarial use were not excluded from the study; 34% of participants declared antimalarial use Clinical setting: Two primary health centres Country: Madagascar (Tsiroanomandidy on the west foothill areas of the Highlands) Malaria endemicity: Low and predominantly seasonal Malaria endemic species:P. falciparum (80%) andP. vivax
Participants	Sample size: 313 Age: All age groups were eligible for inclusion; the actual age range of the included participants was 6 months to 79 years (median age 10 years) Sex: Male: Famale ratio was 1.2:1 Co‐morbidities and pregnancy: Pregnant women were excluded, as were people with signs of severe or complicated malaria Parasite density of microscopy positive cases: Range 32 to 52,750 parasites per μl, mean 4104, Standard Deviation 7894
Study design	Enrolment was consecutive and prospective. Two RDTs were evaluated; all participants received both RDTs.
Target condition and reference standard(s)	Target condition: Malaria parasitaemia Reference standard: PCR
Index and comparator tests	Commerical name of RDT: OptiMAL‐IT (DiaMed AG, Cressier, Switzerland) PALUTOP Parasite(s) designed to detect: OptiMAL‐IT ‐ P. falciparum or mixed infection, non‐falciparum species only PALUTOP ‐ P. falciparum, P.vivax and other malaria types Designated Type: OptiMAL‐IT ‐ Type 4 PALUTOP ‐ Type 6 Batch numbers: OptiMAL‐IT ‐ 46110.85.01 PALUTOP ‐ 91014 Transport and storage conditions: Transported and maintained at the study sites (primary health centres) at room temperature and opened just before use to avoid humidity damage Person(s) performing RDT: Trained technician RDT setting: Primary health centres
Follow‐up	Not applicable
Notes	Source of funding: Global Fund Project for Madagascar, Round 3
Table of Methodological Quality
Item	Authors' judgement	Description
Representative spectrum? All tests	Yes	Participants were a consecutive sample of patients attending primary health centres with fever or history of fever in the previous 24 h
Acceptable reference standard? All tests	Yes	Reference standard was PCR
Partial verification avoided? All tests	Yes	All participants who received the index test also received the reference test
Differential verification avoided? All tests	Yes	The same reference test was used regardless of the index test results
Incorporation avoided? All tests	Yes	The index test does not form part of the reference standard
Reference standard results blinded? All tests	Yes	Stated that the PCR operator was blind to the results of the other tests performed
Index test results blinded? All tests	Yes	Stated that the test readers were blind to the results of the other tests performed
Uninterpretable results reported? All tests	Yes	There were no test failures with either RDT
Withdrawals explained? All tests	Yes	The number of participants enrolled in the study is clearly stated and corresponds to the number presented in the analysis