Bell 2001a.
Clinical features and settings |
Presenting signs and symptoms: History of fever, headache, chills or rigors occurring within the preceding three days; or more distant history of fever or non‐specific signs suggestive of malaria. Previous treatment for malaria: Participants who had recently taken antimalarials were not excluded; 5% of participants reported prior antimalarial use. Clinical setting: Village health workers in five barangaya (districts) Country: Philippines (Agusan del Sur Province in the northeast of the island of Maindano) Malaria endemicity: Generally low perennial transmission, with pockets of high transmission Malaria endemic species:P. falciparum andP. vivax |
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Participants |
Sample size: 350 Age: Eligible age range not stated. Mean age of the participants was 19.5 years. Sex: Both males and females eligible. There were 171 male and 179 female participants. Co‐morbidities and pregnancy: Not mentioned, either an exclusion criteria or characteristic of included participants Parasite density of microscopy positive cases: Not presented |
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Study design | Enrollment was prospective. The sampling method was not described. One RDT was evaluated. | |
Target condition and reference standard(s) |
Target condition: Malaria parasitaemia Reference standard: Microscopy of thick and thin blood smears Person(s) performing microscopy: An experienced local microscopist for all slides; selected slides were also read by an experienced parasitologist Microscopy setting: Local laboratory and hospital laboratory in Australia Number of high power fields examined before declaring negative: 100 Number of observer or repeats: One, except in discordant cases where RDT and microscopy results differed, all cases RDT‐positive for P. vivax and 20% of cases negative by slide and RDT, in which case a second reader was used Resolution of discrepancies between observers: The second, off‐site reading was taken as the correct one |
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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 4 Batch numbers: Not stated Transport and storage conditions: Refrigerated until two weeks before use Person(s) performing RDT: Researchers RDT setting: Study villages |
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Follow‐up | Not applicable | |
Notes | Source of funding: The Australian National Health and Medical Research Council | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Unclear | All participants had approached village health workers with symptoms suggestive of malaria, but the sampling method was not described |
Acceptable reference standard? All tests | Yes | An experienced microscopist viewed at least 100 high powered fields and discordant results were re‐examined |
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 | "Slides were read by a local microscopist who was not aware of the results of the ICT tests" |
Index test results blinded? All tests | Yes | RDTs were performed two to four weeks before microscopy |
Uninterpretable results reported? All tests | Yes | The paper reported that there was one uninterpretable microscopy result |
Withdrawals explained? All tests | Unclear | The number of participants originally enrolled in the study was not stated; therefore it is unclear whether there were any withdrawals |