Forney 2001.
Clinical features and settings |
Presenting signs and symptoms: Fever over 38 °C or headache or history of fever in the previous 72 hrs Previous treatment for malaria: Patients who were currently taking antimalarial therapy or who had been treated with antimalarial drugs within the previous two weeks were excluded Clinical setting: Outpatient malaria clinics Country: Iquitos, Peru (28% of participants); Mae Sod, Thailand (72% of participants) Malaria endemicity: Seasonal Malaria endemic species:P. falciparum and P.vivax |
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Participants |
Sample size: 3006 enrolled, 2993 had blood collected, 2988 included (2162 Thailand, 838 Peru) Age: 15 years or over (Thailand, 72% of participants); one year or over (Peru, 28% of participants) Sex: Both males and females eligible. Actual proportions of males and females in the participant population not stated. 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: 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 film Person(s) performing microscopy: Trained, certified microscopist Microscopy setting: Malaria testing station Number of high power fields examined before declaring negative: 200 Number of observer or repeats: Two independent observers Resolution of discrepancies between observers: A third senior microscopist examined both microscopist A's and microscopist B's slides, and gave the final judgement |
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Index and comparator tests |
Commerical name of RDT: ParaSight‐F (Beckton Dickinson, Franklin Lakes, NJ, US) 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: Trained investigator and technician, with quality control checks by the principal investigator RDT setting: Malaria testing station |
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Follow‐up | Not applicable | |
Notes | Source of funding: Main funding source not stated. RDT kits provided by the manufacturer. | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Participants were a consecutive series of people attending malaria clinics with fever over 38 °C or headache or history of fever in the previous 72 hrs |
Acceptable reference standard? All tests | Yes | Two independent trained microscopists viewed at least 200 high powered fields before declaring 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 | In all cases, the results of the ParaSight‐F test were determined prior to diagnostic microscopy, with strict blinding between the rapid test results and technicians performing the microscopy |
Index test results blinded? All tests | Yes | In all cases, the results of the ParaSight‐F test were determined prior to diagnostic microscopy, with strict blinding between the rapid test results and technicians performing the microscopy |
Uninterpretable results reported? All tests | Yes | Tests whose results were reported as uninterpretable after the initial procedure were repeated in an attempt to resolve the discrepant event. Repeatedly uninterpretable results were reported as such and were incorporated into calculation of sensitivity and specificity as 'false' results. There were a total of seven uninterpretable results; all were negative for P. falciparum by blood slide. |
Withdrawals explained? All tests | Yes | There were five withdrawals after collection of blood samples; reasons were documented in all cases. |