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

Mens 2007b.

Clinical features and settings Presenting signs and symptoms: Suspected uncomplicated malaria, fever or history of fever in the previous 24 h
Previous treatment for malaria: No exclusions based on previous treatment, and no data presented on previous use of antimalarials
Clinical setting: Hospital outpatients
Country: Kenya
Malaria endemicity: Mesoendemic
Malaria endemic species:P. falciparum
Participants Sample size: 184
Age: 6 months to 12 years
Sex: Both males and females eligible; male: female ratio 1:1
Co‐morbidities and pregnancy: No exclusions based on co‐morbidities. No details of the frequency of these conditions in the participant population presented.
Parasite density of microscopy positive cases: Range 400 to 828,800 parasites per μl, mean 18,680
Study design Enrollment was consecutive and prospective. Three RDTs were tested. All individuals received all three tests.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick and thin blood films
Person(s) performing microscopy: Experienced microscopists
Microscopy setting: Not stated
Number of high power fields examined before declaring negative: Not stated. Parasite density was counted against 200 leukocytes.
Number of observer or repeats: Two
Resolution of discrepancies between observers: Report stated that there were no discordant results between the two microscopists
Index and comparator tests Commerical name of RDT:
Paracheck Pf (Orchid Biomedical Systems, Goa, India)
OptiMAL (Diamed AG, Switzerland)
Parascreen (Zephyr Biomedical, Verna, Goa, India)
Parasite(s) designed to detect:
Paracheck Pf ‐ P. falciparum
OptiMAL ‐ P. falciparum or mixed infection, non‐falciparum species only
Parascreen ‐ P. falciparum or mixed infection, non‐falciparum species only
Designated Type:
Paracheck Pf ‐ Type 1
OptiMAL ‐ Type 4
Parascreen ‐ Type 3
Batch numbers: Not stated
Transport and storage conditions: Not described
Person(s) performing RDT: Two independent readers
RDT setting: Not mentioned
Follow‐up Not applicable
Notes Source of funding: The Hubrecht‐Janssen Fund, KIT, Amsterdam, Netherlands
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Participants were a consecutive sample of children with fever or history of fever in the past 24 h
Acceptable reference standard? 
 All tests Unclear Two independent microscopists examined the slides. Unclear how many high power fields were examined before declaring a slide negative.
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 microscopists were blinded to the results of the other tests performed
Index test results blinded? 
 All tests Yes Report states that readers were blinded to the results of the other tests performed
Uninterpretable results reported? 
 All tests Yes Paracheck: 4 failures; OptiMAL: 5 failures; Parascreen: 1 failure
Withdrawals explained? 
 All tests No Unclear whether test failures were repeated, or whether they were included or excluded in the analysis