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

Chitkara 2004.

Clinical features and settings Presenting signs and symptoms: Fever
Previous treatment for malaria: No exclusions based on previous treatment and no information presented on previous treatment, although this data was collected as part of the study
Clinical setting: Temporary fever treatment camp
Country: India (Assam and Arunachal Pradesh)
Malaria endemicity: Varied
Malaria endemic species: mainly P. falciparum, someP. vivax
Participants Sample size: 673
Age: All age groups eligible; actual age range not reported
Sex: Both males and females eligible; actual proportions in the sample not reported
Co‐morbidities and pregnancy: No exclusions based on co‐morbidities or pregnancy; actual frequency of these conditions in the same not reported
Parasite density of microscopy positive cases: Not presented
Study design Enrollment was consecutive and prospective. 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: Chief microscopist of the District Malaria Office and two pathologists of Assam Medical College
Microscopy setting: District Malaria Office and Assam Medical College
Number of high power fields examined before declaring negative: Not stated
Number of observer or repeats: All positive slides and 20% of negative slides were independently read by the pathologists from Assam Medical College
Resolution of discrepancies between observers: Not described
Index and comparator tests Commerical name of RDT: ParaHIT‐F (Span diagnostics Ltd, Surat, India)
Parasite(s) designed to detect:P .falciparum
Designated Type: Type I
Batch numbers: Not stated
Transport and storage conditions: Not stated
Person(s) performing RDT: Laboratory technicians
RDT setting: Temporary fever treatment camp
Follow‐up Not applicable
Notes Source of funding: Span Diagnostics provided the RDT test kits free of charge
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Participants were a consecutive sample attending a temporary treatment camp with fever
Acceptable reference standard? 
 All tests Unclear Unclear, as the numbers of high power fields viewed before declaring negative was not stated. However, the microscopy was undertaken by expert microscopists in a central malaria laboratory.
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 Two different technicians did the microscopic examination and the ParaHIT‐f test and the results of their observations were compared later.
Index test results blinded? 
 All tests Yes Two different technicians did the microscopic examination and the ParaHIT‐f test and the results of their observations were compared later.
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