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

Mwanza 2005.

Clinical features and settings Presenting signs and symptoms: Fever
Previous treatment for malaria: Not mentioned, either as an exclusion criteria or characteristic of included participants
Clinical setting: Outpatient clinics
Country: Zambia (copper belt, Ndola and Kitwe)
Malaria endemicity: Not stated
Malaria endemic species: Not stated
Participants Sample size: 119
Age: Inclusion criteria: adults and children aged over 60 months
Sex: Not reported, no mention of sex as inclusion or exclusion criteria
Co‐morbidities and pregnancy: Not reported, no mention of these conditions as inclusion or exclusion criteria
Parasite density of microscopy positive cases: Not presented
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: Microscopy
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: Hexagon Malaria
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 Participants were all attending outpatient clinics with fever, however the sampling method was not described
Acceptable reference standard? 
 All tests Unclear Microscopy process is not described
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 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