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

Guthmann 2002.

Clinical features and settings Presenting signs and symptoms: Clinical suspicion of malaria, diagnosed by the clinical officer
Previous treatment for malaria: No exclusion criteria based on antimalarial use and no data collected on this
Clinical setting: Outpatient department of a reference hospital
Country: Mbarara, Uganda
Malaria endemicity: Not stated
Malaria endemic species:P. falciparum
Participants Sample size: 742
Age: All age groups eligible; 315 were aged less than 5 years
Sex: Both males and females eligible. 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 pregnancy or co‐morbidities
Parasite density of microscopy positive cases: Not presented
Study design Enrollment was consecutive and prospective. Five RDTs were tested, and most participants received all the tests.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick and thin blood films
Person(s) performing microscopy: Trained malaria technician
Microscopy setting: Not stated
Number of high power fields examined before declaring negative: 200
Number of observer or repeats: One, except in the case of discordant results between microscopy and RDTs
Resolution of discrepancies between observers: All discordant results, all slides where only gametocytes were detected and a random sample of 20% of the remaining slides were checked blind by an independent trained laboratory technician
Index and comparator tests Commerical name of RDTs:
Paracheck Pf dipstick (Orchid Biomedical Systems, Goa, India)
Paracheck Pf device (Orchid Biomedical Systems, Goa, India) (data not included in review as duplicates Paracheck Pf dipstick)
ParaHIT‐f (Span diagnostics Ltd, Surat, India) (excluded as required data could not be extracted)
BIO P.F (excluded as required data could not be extracted)
Malaria Rapid (excluded as required data could not be extracted)
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: Two independent readers (persons unspecified)
RDT setting: The research clinic
Follow‐up Not applicable
Notes Source of funding: Medicins sans Frontieres, French section. Laboratories provided the tests kits free of charge.
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Participants were a consecutive series of people suspected to have malaria and attending an outpatient clinic
Acceptable reference standard? 
 All tests No Microscopy was undertaken by trained microscopists viewing 200 high powered fields before declaring negative, but their findings were not confirmed by a second independent observer
Partial verification avoided? 
 All tests Yes All participants who received the index tests 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 the results were blind
Index test results blinded? 
 All tests Yes Readers were kept blinded to the results of the microscopy examination
Uninterpretable results reported? 
 All tests Yes A small number of test results (one each for Paracheck dipstick and cassette, four for paraHIT, three for BIO PF and 21 for Malaria Rapid) were invalid, and these are presented as participants missing from the analysis
Withdrawals explained? 
 All tests Yes Of the 742 participants who received microscopy, 741 received Paracheck Pf, 738 received ParaHIT Pf, 739 received BIO PF and 721 received Malaria Rapid. All withdrawals after tests were given represent invalid RDTresults