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. 2011 Jul 6;2011(7):CD008122. doi: 10.1002/14651858.CD008122.pub2

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
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
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
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
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