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 |
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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 |
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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 |
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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 |
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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 |