Sharma 1999.
Clinical features and settings |
Presenting signs and symptoms: Clinical symptoms of malaria Previous treatment for malaria: No exclusions based on previous treatment. Information on previous treatment collected, but actual data not provided except in the case of false positive results. Clinical setting: Malaria Clinics Country: Orissa, India Malaria endemicity: Not stated Malaria endemic species: Mainly P. falciparum, some P. vivax |
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Participants |
Sample size: 125 Age: Not mentioned either as an inclusion criteria or characteristic of the included participants Sex: Not mentioned either as an inclusion criteria or characteristic of the included participants 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: Range 40 to 36,000 parasites per μl |
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Study design | Enrollment was prospective. Random sampling was used, but exact method used to obtain a random sample was not stated. One RDT was evaluated. | |
Target condition and reference standard(s) |
Target condition: Malaria parasitaemia Reference standard: Microscopy thick and thin blood films Person(s) performing microscopy: Not stated Microscopy setting: Not stated Number of high power fields examined before declaring negative: Not stated Number of observer or repeats: Results discordant between microscopy and RDT were re‐examined for confirmation of the results Resolution of discrepancies between observers: Not described |
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Index and comparator tests |
Commerical name of RDT: ICT Malaria Pf (ICT Diagnostics, Sydney, Australia) Parasite(s) designed to detect:P. falciparum Designated Type: Type 1 Batch numbers: Not stated Transport and storage conditions: Not described Person(s) performing RDT: Various clinic staff RDT setting: Malaria clinics |
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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 | Yes | Participants were a random sample of people attending a clinic with clinical symptoms of malaria |
Acceptable reference standard? All tests | Unclear | Discordant results between RDTs and microscopy were re‐examined; however it is unclear how many high power fields were viewed before declaring a slide negative |
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 | "Evaluation was double blind" |
Index test results blinded? All tests | Yes | "Evaluation was double blind" |
Uninterpretable results reported? All tests | Yes | There were five uninterpretable test results; these were excluded from the analysis |
Withdrawals explained? All tests | Yes | The numbers enrolled in the study and the numbers with data presented for them correspond, with the exception of the five excluded from the analysis due to uninterpretable test results |