Hopkins 2007.
Clinical features and settings |
Presenting signs and symptoms: Fever Previous treatment for malaria: No exclusion criteria based on antimalarial use and no data collected on this Clinical setting: Clinic specially set up as part of a longitudinal study, based within a main public hospital Country: Uganda (Kampala) Malaria endemicity: Not stated Malaria endemic species:P. falciparum |
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Participants |
Sample size: 918 Age: Children aged 1.5 to 11.5 years Sex: Both males and females eligible. Actual proportions of males and females in the participant population not stated. Co‐morbidities: No exclusions were made, and there was no information presented on co‐morbidities Parasite density of microscopy positive cases: Not presented |
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Study design | Enrollment was consecutive and prospective. Two RDTs were tested, and all participants received both tests. | |
Target condition and reference standard(s) |
Target condition: Malaria parasitaemia Reference standard: Microscopy thick and thin blood films Person(s) performing microscopy: Experienced laboratory technologists Microscopy setting: Hospital laboratory Number of high power fields examined before declaring negative: 100 Number of observer or repeats: Two; all smears were read a second time by study laboratory staff to confirm results Resolution of discrepancies between observers: Discrepant readings were resolved by a third reader |
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Index and comparator tests |
Commerical name of RDTs: Paracheck Pf (Orchid Biomedical Systems, Goa, India) Parabank (Zephyr Biomedicals, Goa, India) Parasite(s) designed to detect: Paracheck Pf (Orchid Biomedical Systems, Goa, India) ‐ P. falciparum Parabank (Zephyr Biomedicals, Goa, India) ‐ P. falciparum or mixed infection, non‐falciparum malaria species only Designated Type: Paracheck: Type 1 Parabank: Type 4 Batch numbers: Not stated Transport and storage conditions: Obtained directly from the manufacturer and stored in their original packaging at room temperature in the clinic. The temperature ranged from 19 °C to 29 °C over the course of the study. Person(s) performing RDT: Laboratory technicians. RDT setting: The research clinic |
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Follow‐up | Not applicable | |
Notes | Source of funding: US National Institute of Health, with additional support from the Doris Duke Charitable Foundation | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Participants were a consecutive series of children attending a clinic with fever in a malaria endemic area |
Acceptable reference standard? All tests | Yes | Two independent experienced microscopists viewed 100 high powered fields before declaring 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 | Yes | Microscopy was undertaken at a different location to the RDTs |
Index test results blinded? All tests | Yes | Readers were unaware of the microscopy results at the time they undertook the study |
Uninterpretable results reported? All tests | Unclear | The number of participants who received the tests was explicitly stated and corresponded to the number included in the analysis; therefore there were no exclusions due to invalid results |
Withdrawals explained? All tests | Yes | RDTs were not performed in 15 episodes: nine at the discretion of the physician during follow‐up for non‐febrile illness, and six because of protocol errors |