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

Sayang 2009.

Clinical features and settings Presenting signs and symptoms: Fever or history of fever in the previous 24 h, and nurse's suspicion of malaria
Previous treatment for malaria: Patients who reported taking antimalarial drugs in the previous two weeks were excluded
Clinical setting: Primary health centre
Country: Yoaunde, Cameroon
Malaria endemicity: Reported to be high
Malaria endemic species:P. falciparum
Participants Sample size: 153
Age: Both adults and children were included; there is no indication of the proportion of adults and children in the sample
Sex: Not mentioned either as an exclusion criteria or a characteristic of included participants
Co‐morbidities and pregnancy: Not mentioned either as an exclusion criteria or a characteristic of included participants
Parasite density of microscopy positive cases: Range 40 to 125,000 parasites per μl. Geometric mean: age 0‐2 = 2869; age 3‐5 = 6440; age 6‐10 = 1580; age over 11 = 1535
Study design Enrollment was prospective. The sampling method was initially consecutive, from which a random sample of patients assigned to RDTs. One RDTs was evaluated.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy
Person(s) performing microscopy: Not stated
Microscopy setting: Laboratory not further described
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: Diaspot cassette device (Acumen Diagnostics Inc, USA)
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: Nurses trained in the use of the device
RDT setting: Primary Health Centre
Follow‐up Not applicable
Notes Source of funding: Supported by the Service de Cooperation et d'Action Culturelle of the French Embassy in Yaounde, European Union (READ‐UP project, STREP, contract no. 018602) and the Centre de Formation et Recherche en Medicine et Sante Tropicale, Marseille, France
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Participants were all attending health centre, had fever and a nurse suspected that they might have malaria. Enrolment into the main study was consecutive, and allocation to RDT study was random.
Acceptable reference standard? 
 All tests Unclear No details given of number of high power fields viewed before declaring negative, or number of observers or repeats
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 Microscopy undertaken at a different site to RDTs
Index test results blinded? 
 All tests Yes RDTs undertaken before microscopy, and at a different site
Uninterpretable results reported? 
 All tests Unclear The number of participants originally enrolled in the study was not clearly stated, therefore it is unclear whether there were any exclusions due to invalid test results
Withdrawals explained? 
 All tests Unclear The number of participants originally enrolled in the study was not clearly stated, therefore it is unclear whether there were any withdrawals