Willcox 2009b.
Clinical features and settings |
Presenting signs and symptoms: Symptoms of uncomplicated malaria, primarily fever Previous treatment for malaria: No exclusion criteria based on previous antimalarial use, and no data presented on the numbers that previously used antimalarials Clinical setting: Village health worker Country: Mali Malaria endemicity: Mesoendemic Malaria endemic species: mainly P. falciparum |
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Participants |
Sample size: 143 aged five or over (301 total) Age: All ages included in the study. Refers only to the analysis of participants over the age of five years. Sex: Both males and females eligible. Co‐morbidities and pregnancy: No exclusion criteria based on co‐morbidities. No details of the frequency of these conditions in the participant population is presented. Parasite density of microscopy positive cases: Geometric mean 267 parasites per μl, 95% CI 172 to 413 |
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Study design | Enrollment was consecutive and prospective. 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: Experienced microscopists Microscopy setting: Field laboratory Number of high power fields examined before declaring negative: 100 Number of observer or repeats: Two independent microscopists Resolution of discrepancies between observers: Cross checked until both microscopists agreed. |
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Index and comparator tests |
Commerical name of RDT: Paracheck Pf (Orchid Biomedical Systems, Goa, India) Parasite(s) designed to detect:P. falciparum Designated Type: Type 1 Batch numbers: Not stated Transport and storage conditions: Stored at room temperatures of up to 40°C Person(s) performing RDT: A clinician and a laboratory technician from the research team RDT setting: Field laboratory |
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Follow‐up | Not applicable | |
Notes | Source of funding: Swiss Agency for Development and Co‐operation. Orchid Biomedical Systems supplied the Paracheck Pf tests free of charge. | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Participants were a consecutive series of patients presenting with suspected malaria |
Acceptable reference standard? All tests | Yes | Two experienced microscopists viewed 100 high power fields before declaring a slide 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 | Reported that microscopists were blinded to the results of the RDTs |
Index test results blinded? All tests | Yes | Dipsticks were labelled with random numbers so that the people recording the results did not know which people the tests belonged to |
Uninterpretable results reported? All tests | Yes | There were no uninterpretable test results (the control line was positive in all cases) |
Withdrawals explained? All tests | Yes | The number of participants enrolled was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals |