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

Tjitra 1999.

Clinical features and settings Presenting signs and symptoms: Symptomatic with a presumptive clinical diagnosis of malaria: fever or history of fever in the last 24 h and no other obvious cause of fever
Previous treatment for malaria: Prior use of antimalarials was not an exclusion criteria. Approximately half of the participants reported use of antimalarials within the previous 4 weeks.
Clinical setting: Primary health centre
Country: Indonesia (Laratama sub district, West Sumba, East Nusa Tenggara Province, Eastern Indonesia)
Malaria endemicity: Infection rate in children 0 to 9 years of 5.1%
Malaria endemic species:P. falciparum and P. vivax
Participants Sample size: 560
Age: All ages eligible. Actual age range of the participants 0 to 80 years.
Sex: Males and females eligible; 289 males and 271 females included
Co‐morbidities: Not mentioned either as an exclusion criteria or a characteristic of the included participants
Parasite density of microscopy positive cases:P. vivax mean 7157 parasites per μl
Study design Enrollment was prospective. The sampling method was not described. One RDT was tested.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick and thin blood smears
Person(s) performing microscopy: Expert microscopists with over 20 years experience each
Microscopy setting: One local (exact setting not stated); cross‐checking was done in Darwin, Australia
Number of high power fields examined before declaring negative: At least 100 for all slides, at least 200 for those cross‐checked
Number of observer or repeats: One observer for the majority of slides; discordant results between microscopy and RDT and 20% of slides with concordant results were cross‐checked by a second microscopist, blind to the results of first microscopy and RDT
Resolution of discrepancies between observers: Not described
Index and comparator tests Commerical name of RDT: ICT Malaria Pf/Pv
Parasite(s) designed to detect:P. falciparum or mixed infection, non‐falciparum species only
Designated Type: Type 2
Batch numbers: 100088 for the first 393 tests, and 041388 for the remaining 167 tests
Transport and storage conditions: Not described
Person(s) performing RDT: Performed by trained health workers and read by a study physician blinded to the microscopy results
RDT setting: Primary health centre
Follow‐up Not applicable
Notes Source of funding: Financial assistance received from the Northern Territory Government 50th Anniversary of Indonesian Independence Malaria‐Tuberculosis Research Fellowships. ICT Pf/Pv kits and some logistical costs were supported by AMRAD‐ICT Sydney, New South Wales, Australia.
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Unclear Participants were all attending a primary health care centre with fever and symptoms of malaria, but the sampling method was not described
Acceptable reference standard? 
 All tests Yes All slides were read by an experienced microscopist viewing at least 100 high power fields, and results discordant with RDT were re‐examined by another, independent microscopist
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 "The microscopist was unaware of the immunochromatographic test result"
Index test results blinded? 
 All tests Yes "The results were read by a study physician who was blinded to the microscopy results"
Uninterpretable results reported? 
 All tests Unclear The number of participants enrolled in the study was clearly stated and corresponded to the number presented in the analysis; therefore there were no exclusions due to uninterpretable test results
Withdrawals explained? 
 All tests Yes The number of participants enrolled in the study was clearly stated and corresponded to the number included in the analysis; therefore there were no withdrawals