Hopkins 2008a.
Clinical features and settings |
Presenting signs and symptoms: Outpatients who had been referred to the laboratory for malaria blood smears in accordance with the usual standard of are. Previous treatment for malaria: No exclusion criteria based on antimalarial use and no data collected on this Clinical setting: Health centres Country: Uganda Malaria endemicity: 7 different sites of varying endemicity. Results not presented separately. Malaria endemic species:P. falciparum |
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Participants |
Sample size: 7000 Age: All ages included. 3161 participants were under the age of 5 years. No separate analysis available by age. Sex: Both males and females eligibles. Actual proportions of males and females in the participant population not stated. Co‐morbidities and pregnancy: No exclusions were made, and there was no information presented on co‐morbidities or pregnancy 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: Health centre laboratory staff and expert microscopists at a central laboratory Microscopy setting: Health centre staff and central hospital laboratory Number of high power fields examined before declaring negative: 100 Number of observer or repeats: Two; all smears were read by both the health centre laboratory staff and expert microscopists at the central laboratory Resolution of discrepancies between observers: Discrepant readings between the health centre and expert central laboratory microscopists were resolved by a second expert microscopist |
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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 ‐ P. falciparum Parabank ‐ 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 31 °C over the course of the study, and relative humidity from 39% to 87%. Person(s) performing RDT: Study staff RDT setting: Health centres |
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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 | All participants were referred for microscopy for suspected malaria under usual care protocols |
Acceptable reference standard? All tests | Yes | Two microscopists, including one expert microscopist at a central laboratory, read each smear. They examined 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 | Unclear | Blinding not described |
Index test results blinded? All tests | Unclear | Blinding not described |
Uninterpretable results reported? All tests | Unclear | The number of participants originally enrolled in the study was clearly stated, and corresponds with the number presented in the analysis; therefore there were no exclusions due to invalid results |
Withdrawals explained? All tests | Yes | The number of participants originally enrolled in the study was clearly stated, and corresponds with the number presented in the analysis; therefore there were no withdrawals due to invalid results |