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

Hopkins 2007.

Clinical features and settings Presenting signs and symptoms: Fever
Previous treatment for malaria: No exclusion criteria based on antimalarial use and no data collected on this
Clinical setting: Clinic specially set up as part of a longitudinal study, based within a main public hospital
Country: Uganda (Kampala)
Malaria endemicity: Not stated
Malaria endemic species:P. falciparum
Participants Sample size: 918
Age: Children aged 1.5 to 11.5 years
Sex: Both males and females eligible. Actual proportions of males and females in the participant population not stated.
Co‐morbidities: No exclusions were made, and there was no information presented on co‐morbidities
Parasite density of microscopy positive cases: Not presented
Study design Enrollment was consecutive and prospective. Two RDTs were tested, and all participants received both tests.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick and thin blood films
Person(s) performing microscopy: Experienced laboratory technologists
Microscopy setting: Hospital laboratory
Number of high power fields examined before declaring negative: 100
Number of observer or repeats: Two; all smears were read a second time by study laboratory staff to confirm results
Resolution of discrepancies between observers: Discrepant readings were resolved by a third reader
Index and comparator tests Commerical name of RDTs:
Paracheck Pf (Orchid Biomedical Systems, Goa, India)
Parabank (Zephyr Biomedicals, Goa, India)
Parasite(s) designed to detect:
Paracheck Pf (Orchid Biomedical Systems, Goa, India) ‐ P. falciparum
Parabank (Zephyr Biomedicals, Goa, India) ‐ P. falciparum or mixed infection, non‐falciparum malaria species only
Designated Type:
Paracheck: Type 1
Parabank: Type 4
Batch numbers: Not stated
Transport and storage conditions: Obtained directly from the manufacturer and stored in their original packaging at room temperature in the clinic. The temperature ranged from 19 °C to 29 °C over the course of the study.
Person(s) performing RDT: Laboratory technicians.
RDT setting: The research clinic
Follow‐up Not applicable
Notes Source of funding: US National Institute of Health, with additional support from the Doris Duke Charitable Foundation
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Participants were a consecutive series of children attending a clinic with fever in a malaria endemic area
Acceptable reference standard? 
 All tests Yes Two independent experienced microscopists viewed 100 high powered fields before declaring 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 Microscopy was undertaken at a different location to the RDTs
Index test results blinded? 
 All tests Yes Readers were unaware of the microscopy results at the time they undertook the study
Uninterpretable results reported? 
 All tests Unclear The number of participants who received the tests was explicitly stated and corresponded to the number included in the analysis; therefore there were no exclusions due to invalid results
Withdrawals explained? 
 All tests Yes RDTs were not performed in 15 episodes: nine at the discretion of the physician during follow‐up for non‐febrile illness, and six because of protocol errors