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

Singh 2000 (c).

Clinical features and settings Presenting signs and symptoms: Fever suspected to be malaria
Previous treatment for malaria: There were no exclusions based on previous treatment, and no information presented; this was an outbreak in a rural area
Clinical setting: Mobile field laboratory
Country: India (forest villages in Chhindwara, central India)
Malaria endemicity: Outbreak situation
Malaria endemic species:P. falciparum and P. vivax
Participants Sample size: 344
Age: All age groups eligible. Actual age range 6 months to 65 years.
Sex: Both males and females eligible. Actual proportions of males and females in the participant population not stated.
Co‐morbidities and pregnancy: No exclusion 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 consecutive and prospective. One RDT was evaluated.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick blood film
Person(s) performing microscopy: Experienced microscopist for all slides; expert microscopist for re‐examined slides
Microscopy setting: Mobile field laboratory for all slides; Malaria Research Centre at Jabalur for re‐examined slides
Number of high power fields examined before declaring negative: Not stated. However, 200 WBCs were counted as an alternative indicator; or 500 WBCs for slides that were re‐examined.
Number of observer or repeats: One, but negative blood smears were re‐examined if the patient was having severe symptoms, the corresponding RDT result was positive, or if P. vivax was diagnosed
Resolution of discrepancies between observers: Not described, most likely accepted the findings of second microscopist
Index and comparator tests Commerical name of RDT: ICT Malaria Pf/Pv (AMRAD, Australia)
Parasite(s) designed to detect:P. falciparum or mixed infection, non‐falciparum species only
Designated type: Type 2
Batch numbers: Not stated
Transport and storage conditions: Not described
Person(s) performing RDT: Field laboratory assistants
RDT setting: Mobile field laboratory
Follow‐up Not applicable
Notes Source of funding: Becton Dickinson provided financial support and supplied the RDTs free of charge
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes All participants were attending an ambulatory setting with fever suspected to be malaria, and enrolment was consecutive
Acceptable reference standard? 
 All tests No Microscopy was undertaken by one microscopist only; and the number of high power fields viewed was unclear (200 WBCs)
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 "Blood films were examined...without reference to the results of ICT"
Index test results blinded? 
 All tests Yes "All specimens were tested...who were blinded to the results of the blood smear tests"
Uninterpretable results reported? 
 All tests Unclear The number of participants originally enrolled in the study was clearly stated and the number presented in the analysis corresponded; therefore there were no exclusions due to uninterpretable test results
Withdrawals explained? 
 All tests Yes The number of participants originally enrolled in the study was clearly stated and the number presented in the analysis corresponded; therefore there were no withdrawals