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 |
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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 |
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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 |
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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 |
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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 |