Verle 1996.
Clinical features and settings |
Presenting signs and symptoms: Fever or history of fever in previous days Previous treatment for malaria: No exclusion criteria based on prior antimalarial drug use. Data collected and reported only for participants who were found to be false positive or true negative (5 out of 6 false positives, 11 out of 65 true negatives) Clinical setting: Community health centre. Villagers who felt ill during a malaria epidemic were invited to attend. Country: Vietnam (Ha Giang Province Northern Vietnam) Malaria endemicity: Mostly hypoendemic, but there is contact with focal areas endemic for malaria, and the study was undertaken during an epidemic Malaria endemic species:P. vivax and P. falciparum |
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Participants |
Sample size: 93 Age: All ages eligible. Actual numbers of children and adults not stated. Sex: Both males and females eligible. Actual numbers of males and females not stated. Co‐morbidities and pregnancy: No exclusion criteria based on co‐morbidities. No details of the frequency of these conditions in the participant population is presented. Parasite density of microscopy positive cases:P. falciparum geometric mean 6457 parasites per μl, range 2240 to 33,160 |
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Study design | Enrollment was consecutive and prospective. One RDT was tested. | |
Target condition and reference standard(s) |
Target condition: Malaria parasitaemia Reference standard: Microscopy thick blood smears Person(s) performing microscopy: An experienced technician Microscopy setting: Not stated Number of high power fields examined before declaring negative: 100 Number of observer or repeats: One Resolution of discrepancies between observers: Not applicable |
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Index and comparator tests |
Commerical name of RDT: ParaSight‐F (Beckton Dickinson, Franklin Lakes, NJ, SA) 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: Not stated RDT setting: Community health centre |
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Follow‐up | Not applicable | |
Notes | Source of funding: Belgian Agency for Development Co‐operation and the Compagnie Maritime Belge | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Participants were a consecutive series of patients attending a health centre with fever during a malaria epidemic |
Acceptable reference standard? All tests | No | The microscopist was experienced and viewed at least 100 high power fields, however their findings were not verified by a second independent reader |
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 | Report states that microscopy was undertaken by a technician unaware of the results of the RDT |
Index test results blinded? All tests | Yes | The RDT was undertaken straight away at the health centre, before microscopy results became available |
Uninterpretable results reported? All tests | Unclear | The number of participants originally enrolled in the study was not explicitly stated; therefore it was not possible to assess whether there were any exclusions due to uninterpretable test results |
Withdrawals explained? All tests | Unclear | The number of participants originally enrolled in the study was not explicitly stated; therefore it was not possible to assess whether there were any withdrawals |