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

Fernando 2004.

Clinical features and settings Presenting signs and symptoms: Fever or history of fever
Previous treatment for malaria: No exclusions because of prior antimalarial use, and no data presented on the frequency of recent antimalarial use in the participants
Clinical setting: A malaria research station and a malaria clinic
Country: Sri Lanka
Malaria endemicity: Not stated
Malaria endemic species:P. vivax (70%) and P. falciparum
Participants Sample size: 328
Age: All ages above five years eligible; mean age 28.3 years (range 5 to 72 years)
Sex: Both males and females eligible; 64% of the participants were males
Co‐morbidities and pregnancy: No exclusion criteria based on co‐morbidities or pregnancy. No details of the frequency of these conditions in the participant population is presented.
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 think blood films
Person(s) performing microscopy: Trained microscopists
Microscopy setting: At the clinics and in a laboratory
Number of high power fields examined before declaring negative: 400
Number of observer or repeats: Two independent readers; one at the clinics and another in a laboratory
Resolution of discrepancies between observers: There were no discrepancies between the two microscopists
Index and comparator tests Commerical name of RDT: ICT Malaria Pf/Pv (Amrad‐ICT, Sydney, Australia)
Parasite(s) designed to detect:P. falciparum or mixed infection, non‐falciparum malaria species only
Designated Type: Type 2
Batch numbers: Not stated
Transport and storage conditions: Stored and used at room temperature, which often exceeds 30 °C
Person(s) performing RDT: The researchers
RDT setting: At the clinics
Follow‐up Not applicable
Notes Source of funding: National Science Foundation, Sri Lanka
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Participants were a consecutive sample of people attending clinics with fever or history of fever
Acceptable reference standard? 
 All tests Yes Twp independent trained microscopists viewed 400 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 Unclear The number of participants enrolled was clearly stated, and the number included in the analysis corresponds to this number, indicating no withdrawals
Withdrawals explained? 
 All tests Yes The number of participants enrolled was clearly stated, and the number included in the analysis corresponds to this number, indicating no withdrawals