Mboera 2006a.
Clinical features and settings |
Presenting signs and symptoms: Fever Previous treatment for malaria: No exclusions based on previous treatment, and no data presented on previous use of antimalarials Clinical setting: Hospitals, health centres and dispensaries Country: Tanzania, Babati Malaria endemicity: Prevalence of infection varying from 1.3% in highlands to 62% in the lowlands Malaria endemic species:P. falciparum |
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Participants |
Sample size: 308 Age: All age groups eligible. Actual age profile of participant population not presented. Sex: Both males and females eligible. Actual proportions of males and females in the participant population not stated. Co‐morbidities and pregnancy: No exclusion criteria based on co‐morbidities or pregnancy. No details of the frequency of these conditions in the participant population is presented. Parasite density of microscopy positive cases: Not presented |
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Study design | Enrollment was consecutive and prospective. One RDT was evaluated. | |
Target condition and reference standard(s) |
Target condition: Malaria parasitaemia Reference standard: Microscopy thick and thin blood films Person(s) performing microscopy: Experienced microscopists Microscopy setting: Not stated Number of high power fields examined before declaring negative: 200 Number of observer or repeats: One Resolution of discrepancies between observers: Not applicable |
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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 4 °C and used within one month of purchase Person(s) performing RDT: Local study team trained in the use of the RDT RDT setting: Not stated |
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Follow‐up | Not applicable | |
Notes | Source of funding: Italian cooperation and international water management institute through the system‐wide initiative in malaria and agriculture. Also the Sir Halley Stewart Trust for one author. | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Participants were a consecutive series who had a fever and were seeking treatment for suspected malaria |
Acceptable reference standard? All tests | No | An experienced microscopist viewed at least 200 high power fields before declaring a slide negative; however their results were not verified by a second, independent reader |
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 blood smears were examined by experienced microscopists who were unaware which samples had been found positive in the RDT and which negative" |
Index test results blinded? All tests | Yes | "Local team member read the results independently and without knowledge of the microscopy results" |
Uninterpretable results reported? All tests | Unclear | The numbers of participants originally enrolled in the study was not clearly stated, therefore it is unclear whether there were any exclusions due to invalid test results |
Withdrawals explained? All tests | Unclear | The numbers of participants originally enrolled in the study was not clearly stated, therefore it is unclear whether there were any withdrawals |