Chayani 2004.
Clinical features and settings |
Presenting signs and symptoms: Specific symptoms: rigor, chills, rise of high temperature and profuse sweating; or irregular fever, joint pain and jaundice Previous treatment for malaria: No explicit exclusions based on previous treatment and no information presented on previous treatment. Clinical setting: Diagnostic and research centre (takes referrals from physicians for the diagnosis of malaria) Country: Orissa, India Malaria endemicity: Not stated Malaria endemic species: In sample, 78.6% P. falciparum, 21.4% P. vivax |
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Participants |
Sample size: 232 Age: Not mentioned, either as inclusion criteria or characteristic of participants Sex: Not mentioned, either as inclusion criteria or characteristic of participants Co‐morbidities and pregnancy: Not mentioned, either as inclusion criteria or characteristic of participants Parasite density of microscopy positive cases: Not presented |
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Study design | Enrollment was prospective. The sampling method was unclear. One RDT was evaluated. | |
Target condition and reference standard(s) |
Target condition: Malaria parasitaemia Reference standard: Microscopy thick and thin blood smear Person(s) performing microscopy: Microscopists Microscopy setting: Diagnostic and research centre Number of high power fields examined before declaring negative: 200 Number of observer or repeats: Two independent observers Resolution of discrepancies between observers: A third microscopist's opinion was taken into account |
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Index and comparator tests |
Commerical name of RDT: OptiMAL (DiaMed AG, Cressier, Switzerland) Parasite(s) designed to detect:P. falciparum or mixed infection, non‐falciparum malaria species only Designated Type: Type 4 Batch numbers: Not stated Transport and storage conditions: Not described Person(s) performing RDT: Not stated RDT setting: Not stated |
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Follow‐up | Not applicable | |
Notes | Source of funding: Not stated | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Unclear | All participants were attending an ambulatory clinic with rigor, chills, rise of high temperature and profuse sweating; or irregular fever, joint pain and jaundice. However the sampling method was not described. |
Acceptable reference standard? All tests | Yes | Two independent microscopists viewed 200 high powered fields 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 | 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 not explicitly stated; therefore it is not possible to judge whether any were excluded from the analysis due to invalid test results |
Withdrawals explained? All tests | Unclear | The number of participants originally enrolled in the study was not explicitly stated; therefore it is not possible to judge whether there were any withdrawals |