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 |
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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 |
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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 |
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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 |
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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 |