Tagbo 2007.
Clinical features and settings |
Presenting signs and symptoms: History of fever and body temperature 37.5 °C or higher Previous treatment for malaria: No exclusions based on previous antimalarial use, and no data presented on the numbers that previously used antimalarials Clinical setting: Outpatient department of all small private hospital for children Country: Nigeria Malaria endemicity: Holoendemic Malaria endemic species:P. falciparum |
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Participants |
Sample size: 89 Age: Children only, mean age 3.6 years, range 2 weeks to 14 years Sex: 50 males and 39 females Co‐morbidities and pregnancy: No exclusion criteria based on co‐morbidities or pregnancy; 83 of the 89 included participants had a clinical diagnosis of malaria, the remaining 6 had other infections diagnosed clinically. Of the 83 with diagnosed malaria, 29 had acute respiratory infection, 4 had gastroenteritis and 4 had otitis media. Parasite density of microscopy positive cases: Mean 9058 parasites per μl |
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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: Certified medical laboratory scientists Microscopy setting: Nigeria Institute for Medical Research at Lagos Number of high power fields examined before declaring negative: at least 100 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: 32037E Transport and storage conditions: Stored at room temperatures within the range of 4 °C and 30 °C recommended by the manufacturers Person(s) performing RDT: The study authors RDT setting: Outpatient clinic |
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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 with fever attending an outpatients clinic |
Acceptable reference standard? All tests | No | Certified microscopists viewed at least 100 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 | Reports that the laboratory was blinded to the results of the RDT |
Index test results blinded? All tests | Yes | RDT was undertaken before the microscopy reference standard |
Uninterpretable results reported? All tests | Unclear | The number of participants originally enrolled in the study was clearly stated and the number presented in the analysis corresponded; therefore there were no exclusions due to uninterpretable test results |
Withdrawals explained? All tests | Yes | The number of participants originally enrolled in the study was clearly stated and the number presented in the analysis corresponded; therefore there were no withdrawals |