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

Gaye 1998.

Clinical features and settings Presenting signs and symptoms: Malaria symptoms
Previous treatment for malaria: No exclusion criteria relating to prior antimalarial drug use. Data collected but only presented in the case of false positives.
Clinical setting: Outpatient clinic
Country: Senegal (Dakar)
Malaria endemicity: Hypoendemic and seasonal
Malaria endemic species: PredominantlyP. falciparum
Participants Sample size: 66
Age: All ages eligible. Actual age range 1 to 65 years
Sex: Both males and females eligible. Actual proportions of males and females in the participant population 35 female, 31 male.
Co‐morbidities and pregnancy: Not mentioned
Parasite density of microscopy positive cases: Range 500 to 86,286 parasites per μl
Study design Enrollment was prospective. The sampling method was not described. Three RDTs were evaluated and all participants received all three tests.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick blood film
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
Index and comparator tests Commerical name of RDT:
ICT Malaria Pf (ICT Diagnostics, Sydney, Australia)
ParaSight‐F (Beckton Dickinson, Franklin Lakes, NJ, US)
Malaria IgG CELISA (CelLabs Sydney, Australia) (excluded as not eligible for inclusion in this review)
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: Not stated
RDT setting: Not stated
Follow‐up Not applicable
Notes Source of funding: Not stated
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Unclear All participants were presenting to an outpatient clinic with malaria symptoms, but the sampling method was not described
Acceptable reference standard? 
 All tests Unclear No details given of the microscopy process
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 The numbers of participants originally enrolled in the study was clearly stated, and corresponds to the number presented in the analysis; therefore there were no exclusions due to invalid test results
Withdrawals explained? 
 All tests Yes The numbers of participants originally enrolled in the study was clearly stated, and corresponds to the number presented in the analysis; therefore there were no withdrawals