Nicastri 2009b.
Clinical features and settings |
Presenting signs and symptoms: Fever over 38 °C for less than 10 days Previous treatment for malaria: Participants with previous antimalarial treatment (timescale not stated) were excluded Clinical setting: Outpatient clinics at two peripheral hospitals Country: Tanzania (Pemba Island and Iringa) Malaria endemicity: Not stated Malaria endemic species:P. falciparum |
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Participants |
Sample size: 336 Age: Inclusion criteria: adults and children aged over 12 months Sex: Not reported, no mention of sex as inclusion or exclusion criteria Co‐morbidities and pregnancy: Excluded patients with signs of severe malaria, or with diagnoses of mental illness, measles, chickenpox, otitis, infected wounds or pneumonia Parasite density of microscopy positive cases: Not clear |
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Study design | Enrollment was prospective. The sampling method was not described. One RDT was tested. | |
Target condition and reference standard(s) |
Target condition: Malaria parasitaemia Reference standard: PCR |
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Index and comparator tests |
Commerical name of RDT: ParaHIT‐f (Span Diagnostics Ltd, Surat, India) Parasite(s) designed to detect:P. falciparum Designated Type: Type 1 Batch numbers: Not stated Transport and storage conditions: Not described Person(s) performing RDT: Laboratory technician RDT setting: Hospital laboratory |
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Follow‐up | Not applicable | |
Notes | Source of funding: Part of the activities carried out by the Programme Aid 8282 in Tanzania, funded by the Italian Cooperation and Ministry of Foreign Affairs of Italy. The American Society of Tropical Medicine and Hygiene assisted with the publication expenses | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Unclear | All participants were attending an outpatient department with fever, but the sampling method was not described |
Acceptable reference standard? All tests | Yes | Reference standard was PCR |
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 | There do not appear to be any uninterpretable results, as the number of participants recruited into the study is clearly presented and corresponds with the number presented in the analysis |
Withdrawals explained? All tests | Yes | There do not appear to be any withdrawals, as the number of participants recruited into the study is clearly presented and corresponds with the number presented in the analysis |