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 |
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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 |
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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 |
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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 |
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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 |