Chitkara 2004.
Clinical features and settings |
Presenting signs and symptoms: Fever Previous treatment for malaria: No exclusions based on previous treatment and no information presented on previous treatment, although this data was collected as part of the study Clinical setting: Temporary fever treatment camp Country: India (Assam and Arunachal Pradesh) Malaria endemicity: Varied Malaria endemic species: mainly P. falciparum, someP. vivax |
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Participants |
Sample size: 673 Age: All age groups eligible; actual age range not reported Sex: Both males and females eligible; actual proportions in the sample not reported Co‐morbidities and pregnancy: No exclusions based on co‐morbidities or pregnancy; actual frequency of these conditions in the same not reported 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 and thin blood smear Person(s) performing microscopy: Chief microscopist of the District Malaria Office and two pathologists of Assam Medical College Microscopy setting: District Malaria Office and Assam Medical College Number of high power fields examined before declaring negative: Not stated Number of observer or repeats: All positive slides and 20% of negative slides were independently read by the pathologists from Assam Medical College Resolution of discrepancies between observers: Not described |
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Index and comparator tests |
Commerical name of RDT: ParaHIT‐F (Span diagnostics Ltd, Surat, India) Parasite(s) designed to detect:P .falciparum Designated Type: Type I Batch numbers: Not stated Transport and storage conditions: Not stated Person(s) performing RDT: Laboratory technicians RDT setting: Temporary fever treatment camp |
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Follow‐up | Not applicable | |
Notes | Source of funding: Span Diagnostics provided the RDT test kits free of charge | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Participants were a consecutive sample attending a temporary treatment camp with fever |
Acceptable reference standard? All tests | Unclear | Unclear, as the numbers of high power fields viewed before declaring negative was not stated. However, the microscopy was undertaken by expert microscopists in a central malaria laboratory. |
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 | Two different technicians did the microscopic examination and the ParaHIT‐f test and the results of their observations were compared later. |
Index test results blinded? All tests | Yes | Two different technicians did the microscopic examination and the ParaHIT‐f test and the results of their observations were compared later. |
Uninterpretable results reported? All tests | Unclear | The number of participants originally enrolled in the study was not explicitly stated; therefore it is not possible to judge whether any were excluded from the analysis due to invalid test results |
Withdrawals explained? All tests | Unclear | The number of participants originally enrolled in the study was not explicitly stated; therefore it is not possible to judge whether there were any withdrawals |