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

Singh 2003a.

Clinical features and settings Presenting signs and symptoms: Fever or history of fever
Previous treatment for malaria: No explicit exclusions based on previous treatment, and no data reported
Clinical setting: Hospital malaria clinic
Country: India, Jabalpur
Malaria endemicity: Not stated
Malaria endemic species:P. falciparum and P. vivax in roughly equal proportions
Participants Sample size: 80
Age: All age groups eligible. Adults and children included; mean age 27.7 (SD 16.42) for males and 29 (SD 12.8) for females
Sex: Both males and females eligible; included 28 males and 18 females
Co‐morbidities and pregnancy: No explicit 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: Range 40 to 370,574 parasites per μl for P. falciparum and 318 to 9970 for P. vivax
Study design Enrollment was prospective. The sampling method was not described. Only one RDT was evaluated.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick blood films
Person(s) performing microscopy: Not stated
Microscopy setting: Hospital laboratory
Number of high power fields examined before declaring negative: Not stated
Number of observer or repeats: If the results of the OptiMAL conflicted with that of microscopy for any sample, the blood smear was re‐examined by a different technician
Resolution of discrepancies between observers: If the re‐examination of discordant results gave a different result to the first examination, the second result was confirmed by yet another technician
Index and comparator tests Commerical name of RDT: OptiMAL
Parasite(s) designed to detect:P. falciparum or mixed infection, non‐falciparum species only
Designated type: Type 4
Batch numbers: Not stated
Transport and storage conditions: Not described
Person(s) performing RDT: A technician
RDT setting: Hospital clinic or laboratory
Follow‐up Not applicable
Notes Source of funding: Not stated.
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Unclear Participants were all attending a clinic with fever or history of fever, but the sampling method was not described
Acceptable reference standard? 
 All tests Unclear Discordant results between RDT and microscopy were re‐examined; however the number of high power fields viewed before declaring a sample negative was not stated
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 Yes Technicans were blinded to the results of the blood smear examination
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