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. 2011 Jul 6;2011(7):CD008122. doi: 10.1002/14651858.CD008122.pub2

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
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
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
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
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