Gerstl 2009.
| Clinical features and settings |
Presenting signs and symptoms: Fever (axillary temperature >37.5 °C) or history of fever in the previous 72 h and no signs of severe disease Previous treatment for malaria: Not mentioned, either as an inclusion criteria or characteristic of included participants Clinical setting: MSF community health centre Country: Sierra Leone (Bo District, Eastern Sierra Leone) Malaria endemicity: Hyperendemic Malaria endemic species:P. falciparum |
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| Participants |
Sample size: 345 Age: Inclusion criteria 2 to 59 months Sex: Both males and females eligible Co‐morbidities: No exclusions based on co‐morbidities; no information presented about the frequency of co‐morbid conditions in the study sample Parasite density of microscopy positive cases: Not presented |
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| Study design | Enrollment was consecutive and prospective. One test was evaluated. | |
| Target condition and reference standard(s) |
Target condition: Malaria parasitaemia Reference standard: Microscopy Person(s) performing microscopy: Not stated Microscopy setting: Not stated Number of high power fields examined before declaring negative: Not stated Number of observer or repeats: Not stated 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) Carestart Pf/Pan Parasite(s) designed to detect: ParaCheck‐Pf ‐ P. falciparum Carestart Pf/Pan ‐ P. falciparum or mixed infection, non‐falciparum malaria species only Designated Type: ParaCheck‐Pf ‐ Type 1 Carestart 3 line ‐ Type 4 Batch numbers: Not stated Transport and storage conditions: Not described Person(s) performing RDT: Not stated RDT setting: Not stated |
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| Follow‐up | Not applicable | |
| Notes | Source of funding: Not stated | |
| Table of Methodological Quality | ||
| Item | Authors' judgement | Description |
| Representative spectrum? All tests | Yes | Participants were a consecutive sample of children presenting to a community health centre with fever |
| Acceptable reference standard? All tests | Unclear | No information was provided about the microscopy process |
| Partial verification avoided? All tests | Unclear | Not enough information presented to assess this |
| Differential verification avoided? All tests | Unclear | 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 | Not enough information presented to enable assessment of this |
| Withdrawals explained? All tests | Unclear | Not enough information presented to enable assessment of this |