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. 2011 Jul 6;2011(7):CD008122. doi: 10.1002/14651858.CD008122.pub2

Kyabayinze 2008.

Clinical features and settings Presenting signs and symptoms: History of fever in the previous 24 h or axillary temperature 37.5 °C or over; no evidence of concomitant febrile illness; no danger signs or evidence of severe malaria
Previous treatment for malaria: No exclusion criteria based on antimalarial use; data collected on prior antimalarial use but not presented for the study sample
Clinical setting: Regional referral hospital outpatient department
Country: Uganda
Malaria endemicity: Hyperendemic
Malaria endemic species: Mainly P. falciparum
Participants Sample size: 357
Age: Inclusion criteria over the age of six months; 46% were under the age of five; median age 11 years (range 1 to 28 years)
Sex: Both males and females eligible; 60% were female and 40% male
Co‐morbidities and pregnancy: People with evidence of concomitant febrile illness were excluded from the study
Parasite density of microscopy positive cases: Not presented
Study design Enrollment was consecutive and prospective. One RDT was evaluated.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick and thin blood smears
Person(s) performing microscopy: Hospital microscopists
Microscopy setting: Hospital laboratory
Number of high power fields examined before declaring negative: 100
Number of observer or repeats: Two in most cases. A third microscopist read a random 10% of slides for quality control.
Resolution of discrepancies between observers: A third external microscopist, unaware of the first two results, resolved any discordant results
Index and comparator tests Commerical name of RDTs: ICT Malaria‐Pf (ICT Diagnostics, Brookvale, NSW, Australia)
Parasite(s) designed to detect:P. falciparum
Designated Type: Type 1
Batch numbers: Not stated
Transport and storage conditions: Storage temperature ranged from 22 °C to 29 °C, and a single spike temperature of 38 °C was recorded during transportation
Person(s) performing RDT: Two independent readings by trained staff
RDT setting: Hospital laboratory
Follow‐up Not applicable
Notes Source of funding: UK DFID through the COMDIS research programme consortium
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Participants were a consecutive series of people with fever attending outpatient clinics
Acceptable reference standard? 
 All tests Yes Two microscopists working in a central laboratory viewed at least 100 high power fields before declaring a slide negative
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 Unclear Blinding not described
Index test results blinded? 
 All tests Unclear Blinding not described
Uninterpretable results reported? 
 All tests Yes 7 enrolled participants were excluded due to uninterpretable blood smears
Withdrawals explained? 
 All tests Yes 7 enrolled participants were excluded due to uninterpretable blood smears; otherwise there were no withdrawals