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

Verle 1996.

Clinical features and settings Presenting signs and symptoms: Fever or history of fever in previous days
Previous treatment for malaria: No exclusion criteria based on prior antimalarial drug use. Data collected and reported only for participants who were found to be false positive or true negative (5 out of 6 false positives, 11 out of 65 true negatives)
Clinical setting: Community health centre. Villagers who felt ill during a malaria epidemic were invited to attend.
Country: Vietnam (Ha Giang Province Northern Vietnam)
Malaria endemicity: Mostly hypoendemic, but there is contact with focal areas endemic for malaria, and the study was undertaken during an epidemic
Malaria endemic species:P. vivax and P. falciparum
Participants Sample size: 93
Age: All ages eligible. Actual numbers of children and adults not stated.
Sex: Both males and females eligible. Actual numbers of males and females not stated.
Co‐morbidities and pregnancy: No exclusion criteria based on co‐morbidities. No details of the frequency of these conditions in the participant population is presented.
Parasite density of microscopy positive cases:P. falciparum geometric mean 6457 parasites per μl, range 2240 to 33,160
Study design Enrollment was consecutive and prospective. One RDT was tested.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick blood smears
Person(s) performing microscopy: An experienced technician
Microscopy setting: Not stated
Number of high power fields examined before declaring negative: 100
Number of observer or repeats: One
Resolution of discrepancies between observers: Not applicable
Index and comparator tests Commerical name of RDT: ParaSight‐F (Beckton Dickinson, Franklin Lakes, NJ, SA)
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: Community health centre
Follow‐up Not applicable
Notes Source of funding: Belgian Agency for Development Co‐operation and the Compagnie Maritime Belge
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Participants were a consecutive series of patients attending a health centre with fever during a malaria epidemic
Acceptable reference standard? 
 All tests No The microscopist was experienced and viewed at least 100 high power fields, however their findings were not verified by a second independent reader
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 Report states that microscopy was undertaken by a technician unaware of the results of the RDT
Index test results blinded? 
 All tests Yes The RDT was undertaken straight away at the health centre, before microscopy results became available
Uninterpretable results reported? 
 All tests Unclear The number of participants originally enrolled in the study was not explicitly stated; therefore it was not possible to assess whether there were any exclusions due to uninterpretable test results
Withdrawals explained? 
 All tests Unclear The number of participants originally enrolled in the study was not explicitly stated; therefore it was not possible to assess whether there were any withdrawals