Trouvay 2013.
Clinical features and settings |
Presenting signs and symptoms: Febrile patients who consulted for suspected malaria Previous treatment for malaria: Not reported on, but there were no exclusion criteria based on antimalarial use Clinical setting: Not clear Country: French Guiana Malaria endemicity: At a low number of focal points on the coast, associated with gold mining Malaria endemic species: 31% P. falciparum and 68.5% P. vivax. P. malariae cases are occasional. |
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Participants |
Sample size: 960 Age: All ages eligible. Actual age range of the participants 1 to 92 years (median age 25.8 years) Sex: Males and females eligible; ratio of male to female was 1.2:1 Co‐morbidities: Not mentioned either as an exclusion criteria or a characteristic of the included participants Parasite density of microscopy positive cases:P. vivax mean 0.11% |
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Study design | Enrolment was prospective, with all eligible participants were included. 1 RDT was tested. | |
Target condition and reference standard(s) |
Target condition: Malaria parasitaemia Reference standard: Microscopy thick and thin blood smears Who performed the reference standard tests, and where? An expert microscopist at Cayenne Hospital laboratory If microscopy was used, how many high power fields were looked at? 200 fields in the thin film How many observers or repeats were used? 1 observer. How were discrepancies between observers resolved? Not applicable. However, PCR was conducted on samples where microscopy and RDT gave different results |
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Index and comparator tests |
Commerical name of RDT: SD malaria Ag Pf/Pan Parasite(s) designed to detect:P. falciparum or mixed infection, non‐falciparum species only Designated type: Type 3 Batch numbers: not stated Transport and storage conditions: Tests were guaranteed to have been stored at the correct temperature (24 to 28C) and were used within their recommended shelf life. Person(s) performing RDT: Technician RDT setting: Cayenne Hospital |
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Follow‐up | Not applicable | |
Notes | Source of funding: French Ministry of Health | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | All febrile patients who consulted with suspected malaria during a prospective study were initially included. P. malariae cases were subsequently excluded, however, only 3 of 960 enrolled participants were excluded for this reason. |
Acceptable reference standard? All tests | No | Only 1 microscopist was used. In case of discordant results between RDT and microscopy, PCR was used to determine infections and species. However, the PCR results were not used to adjust the microscopy results. |
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 | The microscopic examination was carried out simultaneously. |
Index test results blinded? All tests | Yes | Interpretation of the test was carried out independently of the microscopic examination. |
Uninterpretable results reported? All tests | Yes | No invalid RDTs were observed. |
Withdrawals explained? All tests | Yes | There were 3 exclusions post‐enrolment, due to P. malariae infection. |