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

Bharti 2008.

Clinical features and settings Presenting signs and symptoms: Fever or history of fever, and suspicion of malaria
Previous treatment for malaria: No exclusions based on previous treatment; it was undertaken in a remote area with no medical facilities
Clinical setting: Mobile field clinics in 10 villages
Country: India (Remote forested region of Jabalpur during the peak monsoon season)
Malaria endemicity: Low endemic areas with higher transmission during the monsoon
Malaria endemic species:P. falciparum andP. vivax
Participants Sample size: 291
Age: All age groups eligible. Actual age range of participants 1 to 60 years.
Sex: Both males and females eligible. Male: female ratio 1:1.15.
Co‐morbidities and pregnancy: No criteria based on co‐morbidities or pregnancy. No details of the frequency of these conditions in the participant population presented.
Parasite density of microscopy positive cases: Range 80 to 111,920 parasites per cul, mean 8011, Standard Deviation 21,595
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 films
Person(s) performing microscopy: Experienced microscopist
Microscopy setting: Laboratory of NIMR
Number of high power fields examined before declaring negative: 100
Number of observer or repeats: One for all samples, two independent readers for samples discordant between microscopy and RDT
Resolution of discrepancies between observers: Where the second reading gave a different result from the first, the results of the second reading were confirmed by a third examination by another technician
Index and comparator tests Commerical name of RDT: First Response Combo Malaria Ag card test (Premier Medical Corporation Ltd, Mumbai, India)
Parasite(s) designed to detect:P. falciparum or mixed infection, non‐falciparum malaria species only
Designated Type: Type 3
Batch numbers: 61F0107
Transport and storage conditions: RDTs were stored properly, at temperature of 4 °C to 30 °C, and used within their shelf life
Person(s) performing RDT: Field laboratory assistants. Independent staff re‐read the saved tests after two months and matched them with the originally recorded results
RDT setting: Field laboratory
Follow‐up Not applicable
Notes Source of funding: Indian Council of Medical Research, Delhi. Test kits provided by Premier Medical Corporation Ltd.
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Participants were a consecutive sample of people attending mobile field clinics with fever or history of fever, and suspicion of malaria
Acceptable reference standard? 
 All tests Yes An experienced microscopist viewed at least 100 high power fields before declaring a slide negative, and results discordant with RDT were independently re‐examined by a second microscopist, and a third if necessary
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 Microscopy was undertaken "without reference to the RDT"
Index test results blinded? 
 All tests Yes RDTs were undertaken on site, and the results recorded before the microscopy results became available
Uninterpretable results reported? 
 All tests Yes The paper reported that there were no invalid results
Withdrawals explained? 
 All tests Yes The number of participants enrolled in the study was clearly stated, and corresponded to the number presented in the analysis; therefore there were no withdrawals