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 |
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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 |
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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 |
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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 |
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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 |