Skip to main content
. 2011 Jul 6;2011(7):CD008122. doi: 10.1002/14651858.CD008122.pub2

Hopkins 2008a.

Clinical features and settings Presenting signs and symptoms: Outpatients who had been referred to the laboratory for malaria blood smears in accordance with the usual standard of are.
Previous treatment for malaria: No exclusion criteria based on antimalarial use and no data collected on this
Clinical setting: Health centres
Country: Uganda
Malaria endemicity: 7 different sites of varying endemicity. Results not presented separately.
Malaria endemic species:P. falciparum
Participants Sample size: 7000
Age: All ages included. 3161 participants were under the age of 5 years. No separate analysis available by age.
Sex: Both males and females eligibles. Actual proportions of males and females in the participant population not stated.
Co‐morbidities and pregnancy: No exclusions were made, and there was no information presented on co‐morbidities or pregnancy
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: Health centre laboratory staff and expert microscopists at a central laboratory
Microscopy setting: Health centre staff and central hospital laboratory
Number of high power fields examined before declaring negative: 100
Number of observer or repeats: Two; all smears were read by both the health centre laboratory staff and expert microscopists at the central laboratory
Resolution of discrepancies between observers: Discrepant readings between the health centre and expert central laboratory microscopists were resolved by a second expert microscopist
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 ‐ P. falciparum
Parabank ‐ 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 31 °C over the course of the study, and relative humidity from 39% to 87%.
Person(s) performing RDT: Study staff
RDT setting: Health centres
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 All participants were referred for microscopy for suspected malaria under usual care protocols
Acceptable reference standard? 
 All tests Yes Two microscopists, including one expert microscopist at a central laboratory, read each smear. They examined 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 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 clearly stated, and corresponds with the number presented in the analysis; therefore there were no exclusions due to invalid results
Withdrawals explained? 
 All tests Yes The number of participants originally enrolled in the study was clearly stated, and corresponds with the number presented in the analysis; therefore there were no withdrawals due to invalid results