Ratsimbasoa 2008.

Clinical features and settings	Presenting signs and symptoms: Fever or fever in the previous 24 h with typical malaria symptoms Previous treatment for malaria: Participants with recent antimalarial use were not excluded from the study; 13% of participants declared antimalarial use Clinical setting: Primary Health Centre Country: Madagascar (Ampasimpotsy, Central Highlands) Malaria endemicity: Transmission is low and predominantly seasonal. This study was carried out in the low season. Malaria endemic species:P. falciparum (approximately 75%) andP. vivax
Participants	Sample size: 200 Age: Eligible age range not stated; actual age range of the included participants was 6 months to 73 years (40% under 5 years, 26.5% 5 to 15 years) Sex: Male:female 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 16 to 285,00 parasites per μl, mean 16,757, Standard Deviation 42,631
Study design	Enrolment was prospective. The sampling method was not described. 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: SD Bioline Malaria Ag Pf (Standard Diagnostics Inc., Suwon City, South Korea) (excluded as required data could not be extracted) SD Bioline Malaria Ag Pf/Pan (Standard Diagnostics Inc., Suwon City, South Korea) Parasite(s) designed to detect: SD Bioline Malaria Ag Pf ‐ P. falciparum SD Bioline Malaria Ag Pf/Pan ‐ P. falciparum or mixed infection, non‐falciparum species only Designated Type: SD Bioline Malaria Ag Pf ‐ Type 1 SD Bioline Malaria Ag Pf/Pan ‐ Type 3 Batch numbers: SD Bioline Malaria Ag Pf ‐ 05FK50 SD Bioline Malaria Ag Pf/Pan ‐ 05FK60 Transport and storage conditions: All tests were kept at room temperature and opened just before use to avoid humidity damage. Person(s) performing RDT: Not stated RDT setting: Not stated
Follow‐up	Not applicable
Notes	Source of funding: Kozone, representing Standard Diagnostics Inc in Madagascar
Table of Methodological Quality
Item	Authors' judgement	Description
Representative spectrum? All tests	Unclear	Participants were all attending a health centre with fever and typical symptoms of malaria, but the sampling method was not described,
Acceptable reference standard? All tests	Yes	The 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	PCR was carried out by technicians blind to the results of RDT testing
Index test results blinded? All tests	Yes	RDTs were undertaken before the results of PCR were known
Uninterpretable results reported? All tests	Yes	Uninterpretable results are reported and excluded from the analysis. There were 2 invalid results for Bioline Pf and 1 for Bioline Pf/Pan
Withdrawals explained? All tests	No	There was one participant missing from the analysis for Bioline Pf/Pan, with no explanation