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

Devi 2002.

Clinical features and settings Presenting signs and symptoms: Fever and referred for malaria diagnosis by physicians
Previous treatment for malaria: No exclusions based on previous treatment and no information presented on previous treatment
Clinical setting: Exact setting unclear, but based at M.S. Ramaiah Medical Teaching Hospital, Bangalore
Country: India, Bangalore
Malaria endemicity: Not stated
Malaria endemic species: mainly P. falciparum some P. vivax
Participants Sample size: 100
Age: All age groups eligible. Actual age structure of the study sample not described.
Sex: Both males and females eligible. Actual proportions of males and females in the participant population not stated.
Co‐morbidities and pregnancy: No exclusions criteria based on co‐morbidities or pregnancy. No details of the frequency of these conditions in the participant population is presented.
Parasite density of microscopy positive cases: Not presented
Study design Enrollment was random and prospective. One RDT was evaluated.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick and thin blood smears
Person(s) performing microscopy: Not stated
Microscopy setting: Large teaching hospital, in a malaria endemic area
Number of high power fields examined before declaring negative: Not stated
Number of observer or repeats: Not stated
Resolution of discrepancies between observers: Not applicable
Index and comparator tests Commerical name of RDT: ParaHIT‐f (Span Diagnostics, India)
Parasite(s) designed to detect:P. falciparum
Designated Type: Type I
Batch numbers: Not stated
Transport and storage conditions: Not described
Person(s) performing RDT: Not stated
RDT setting: Large teaching hospital, in a malaria endemic area
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 had a fever and were referred to the study site for diagnosis of malaria; however it is unclear how participants were selected for referral
Acceptable reference standard? 
 All tests Unclear No details given of the microscopy process
Partial verification avoided? 
 All tests Yes All participants received both the index and the reference tests
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