Dev 2004.

Clinical features and settings	Presenting signs and symptoms: Fever Previous treatment for malaria: No information presented on previous treatment; no suggestion of any exclusions based on previous treatment Clinical setting: Malaria clinics Country: India (Assam) Malaria endemicity: Mesendemic Malaria endemic species:P. falciparum and P. vivax
Participants	Sample size: 336; but varied by RDT evaluated (10 to 139) Age: Infants under 12 months excluded; actual age range 1 to 60 years Sex: Both males and females eligible. Actual proportions of males and females in the participant population not stated. Co‐morbidities and pregnancy: No exclusion criteria based on co‐morbidities or pregnancy were stated, and no details of the frequency of these conditions in the participant population is presented Parasite density of microscopy positive cases: Range 300 to 350,000 parasites per μl, mean 59,842, Standard Deviation 78,780
Study design	Enrollment was prospective. The sampling method was not described. Seven RDTs were evaluated; it is unclear how each RDT was allocated, as no participant received all the tests.
Target condition and reference standard(s)	Target condition: Malaria parasitaemia Reference standard: Microscopy thick and thin blood smears Person(s) performing microscopy: Technician; all positive slides and 20% of negative slides were also examined by the senior technician for confirmation of result. Microscopy setting: Laboratory at the malaria clinics Number of high power fields examined before declaring negative: 100 Number of observer or repeats: One in the case of most smears judged negative by the technician. Two in the case of 20% of those initially judged negative, and all those judged positive. Resolution of discrepancies between observers: The judgement of the senior technician was used
Index and comparator tests	Commerical name of RDT: Paracheck Pf (Orchid Biomedical Systems, Goa, India) ParaSight‐F (Beckton Dickinson, Franklin Lakes, NJ, US) ParaHIT‐F (Span diagnostics Ltd, Surat, India) ICT Malaria Pf (ICT Diagnostics, Sydney, Australia) New Pf‐1 mini (Monozyme India Ltd, Secundrabad, India) SD Malaria Pf/Pv (SD Diagnostics Inc, Korea) Diamed OptiMAL (Flow Inc., Portland, OR, US) Parasite(s) designed to detect: Paracheck Pf ‐ P. falciparum ParaSight‐F ‐ P. falciparum ParaHIT‐F ‐ P. falciparum ICT Malaria Pf ‐ P. falciparum New Pf‐1 mini ‐ P. falciparum SD Malaria Pf/Pv ‐ P. falciparum or mixed infection, non‐falciparum malaria species only Diamed OptiMAL ‐ P. falciparum or mixed infection, non‐falciparum malaria species only Designated Type: Paracheck Pf ‐ Type I ParaSight‐F ‐ Type I ParaHIT‐F ‐ Type I ICT Malaria Pf ‐ Type I New Pf‐1 mini ‐ Type I SD Malaria Pf/Pv ‐ Type 3 Diamed OptiMAL ‐ Type 4 Batch numbers: Not stated Transport and storage conditions: Not described Person(s) performing RDT: The laboratory attendant performed the test and recorded his or her interpretation. The test kit result was then re‐read for verification by the senior technician. RDT setting: Malaria clinic laboratory
Follow‐up	Not applicable
Notes	Source of funding: Main source of funding not stated. Test kits supplied by the Government of Assam.
Table of Methodological Quality
Item	Authors' judgement	Description
Representative spectrum? All tests	Unclear	All participants were attending malaria clinics with fever. However, during the study period, 6663 blood smears were examined, but only 336 were evaluated with RDT kits, and the sampling method for RDT evaluation was unclear.
Acceptable reference standard? All tests	Unclear	Two observers were used in the vast majority of cases; however, it is unclear whether the observers worked independently
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	Microscopy and RDT results were compared by an independent observer
Index test results blinded? All tests	Yes	Microscopy and RDT results were compared by an independent observer
Uninterpretable results reported? All tests	Unclear	No information presented on numbers initially allocated each RDT, so not possible to judge this
Withdrawals explained? All tests	Unclear	No information presented on numbers initially allocated each RDT, so not possible to judge this