Mens 2007a.
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: Health centre Country: Tanzania Malaria endemicity: Hypoendemic Malaria endemic species:P. falciparum |
|
Participants |
Sample size: 154 Age: 6 months to 12 years Sex: Both males and females eligible; Male:female ratio 1.8:1 Co‐morbidities and pregnancy: No exclusion criteria based on co‐morbidities. No details of the frequency of these conditions in the participant population is presented. Parasite density of microscopy positive cases: 3 cases: 160, 120 and 1000 parasites per μl |
|
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 |
|
Index and comparator tests |
Commerical name of RDT: Paracheck Pf (Orchid Biomedical Systems, Goa, India) OptiMAL (Diamed AG, Switzerland) ‐ P. falciparum or mixed infection, non‐falciparum malaria species only Parasite(s) designed to detect: Paracheck Pf ‐ P. falciparum OptiMAL ‐ P. falciparum or mixed infection, non‐falciparum malaria species only Designated Type: Paracheck Pf ‐ Type 1 OptiMAL ‐ Type 4 Batch numbers: Not stated Transport and storage conditions: Not described Person(s) performing RDT: Two independent readers RDT setting: Not mentioned |
|
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 others 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: 4 failures |
Withdrawals explained? All tests | No | Unclear whether test failures were repeated, or whether they were included or excluded in the analysis |