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. 2014 Dec 18;2014(12):CD011431. doi: 10.1002/14651858.CD011431

Trouvay 2013.

Clinical features and settings Presenting signs and symptoms: Febrile patients who consulted for suspected malaria
Previous treatment for malaria: Not reported on, but there were no exclusion criteria based on antimalarial use
Clinical setting: Not clear
Country: French Guiana
Malaria endemicity: At a low number of focal points on the coast, associated with gold mining
Malaria endemic species: 31% P. falciparum and 68.5% P. vivax. P. malariae cases are occasional.
Participants Sample size: 960
Age: All ages eligible. Actual age range of the participants 1 to 92 years (median age 25.8 years)
Sex: Males and females eligible; ratio of male to female was 1.2:1
Co‐morbidities: Not mentioned either as an exclusion criteria or a characteristic of the included participants
Parasite density of microscopy positive cases:P. vivax mean 0.11%
Study design Enrolment was prospective, with all eligible participants were included. 1 RDT was tested.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick and thin blood smears
Who performed the reference standard tests, and where? An expert microscopist at Cayenne Hospital laboratory
If microscopy was used, how many high power fields were looked at? 200 fields in the thin film
How many observers or repeats were used? 1 observer.
How were discrepancies between observers resolved? Not applicable. However, PCR was conducted on samples where microscopy and RDT gave different results
Index and comparator tests Commerical name of RDT: SD malaria Ag Pf/Pan
Parasite(s) designed to detect:P. falciparum or mixed infection, non‐falciparum species only
Designated type: Type 3
Batch numbers: not stated
Transport and storage conditions: Tests were guaranteed to have been stored at the correct temperature (24 to 28C) and were used within their recommended shelf life.
Person(s) performing RDT: Technician
RDT setting: Cayenne Hospital
Follow‐up Not applicable
Notes Source of funding: French Ministry of Health
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes All febrile patients who consulted with suspected malaria during a prospective study were initially included. P. malariae cases were subsequently excluded, however, only 3 of 960 enrolled participants were excluded for this reason.
Acceptable reference standard? 
 All tests No Only 1 microscopist was used. In case of discordant results between RDT and microscopy, PCR was used to determine infections and species. However, the PCR results were not used to adjust the microscopy results.
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 The microscopic examination was carried out simultaneously.
Index test results blinded? 
 All tests Yes Interpretation of the test was carried out independently of the microscopic examination.
Uninterpretable results reported? 
 All tests Yes No invalid RDTs were observed.
Withdrawals explained? 
 All tests Yes There were 3 exclusions post‐enrolment, due to P. malariae infection.