Devi 2002.
Clinical features and settings |
Presenting signs and symptoms: Fever and referred for malaria diagnosis by physicians Previous treatment for malaria: No exclusions based on previous treatment and no information presented on previous treatment Clinical setting: Exact setting unclear, but based at M.S. Ramaiah Medical Teaching Hospital, Bangalore Country: India, Bangalore Malaria endemicity: Not stated Malaria endemic species: mainly P. falciparum some P. vivax |
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Participants |
Sample size: 100 Age: All age groups eligible. Actual age structure of the study sample not described. Sex: Both males and females eligible. Actual proportions of males and females in the participant population not stated. Co‐morbidities and pregnancy: No exclusions 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 random and prospective. One RDT was evaluated. | |
Target condition and reference standard(s) |
Target condition: Malaria parasitaemia Reference standard: Microscopy thick and thin blood smears Person(s) performing microscopy: Not stated Microscopy setting: Large teaching hospital, in a malaria endemic area Number of high power fields examined before declaring negative: Not stated Number of observer or repeats: Not stated Resolution of discrepancies between observers: Not applicable |
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Index and comparator tests |
Commerical name of RDT: ParaHIT‐f (Span Diagnostics, India) Parasite(s) designed to detect:P. falciparum Designated Type: Type I Batch numbers: Not stated Transport and storage conditions: Not described Person(s) performing RDT: Not stated RDT setting: Large teaching hospital, in a malaria endemic area |
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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 | All participants had a fever and were referred to the study site for diagnosis of malaria; however it is unclear how participants were selected for referral |
Acceptable reference standard? All tests | Unclear | No details given of the microscopy process |
Partial verification avoided? All tests | Yes | All participants received both the index and the reference tests |
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 | Unclear | Blinding not described |
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 |