Moonasar 2009.
Clinical features and settings |
Presenting signs and symptoms: Fever or headache or chills Previous treatment for malaria: Patients who had recent malaria or had recently been on malaria treatment were excluded Clinical setting: Clinics Country: South Africa (Vhembe district, Limpopo province) Malaria endemicity: Not stated. The study was conducted during the high‐transmission season in an area chosen because it had the highest incidence of malaria in the province for the previous nine years. Malaria endemic species: Mainly P. falciparum |
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Participants |
Sample size: 405 Age: All ages eligible for inclusion; actual age range was 1 to 81 years, median 24.5 years Sex: Both males and females eligible for inclusion; 56% of included participants were male Co‐morbidities and pregnancy: Severely ill patients needing referral; patients with an obvious non‐malarial fever and pregnant women were excluded Parasite density of microscopy positive cases: Range 440 to >20,000 parasites per μl. Median 25,680. |
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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 and thin blood films Person(s) performing microscopy: Specialised malaria microscopists Microscopy setting: Health Centre Number of high power fields examined before declaring negative: 100 (stated that "standard techniques" were used and gave an appropriate reference) Number of observer or repeats: Two independent readers Resolution of discrepancies between observers: In the case of discordant results between microscopy and RDT, a medical technologist at the Limpopo Department of Health reference centre who was highly skilled in malaria microscopy and blinded to previous results re‐read the slides. This result was taken to be correct. |
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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: Nurses trained in RDT testing RDT setting: Outpatient clinic |
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Follow‐up | Not applicable | |
Notes | Source of funding: Ernest Oppenheimer Trust provided financial assistance in conducting the study | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Participants were a consecutive series of people attending a health centre with fever, headache or chills |
Acceptable reference standard? All tests | Yes | Two experienced microscopists (3 in the case of discordant results between microscopy and RDT) independently viewed at least 100 high power fields 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 | The microscopists were blinded to the RDT results and read the thin and thick films independently |
Index test results blinded? All tests | Yes | RDTs were carried out first and result recorded by the nurse at the clinic |
Uninterpretable results reported? All tests | Unclear | The number enrolled is clearly stated and corresponds to the number included in the analysis; therefore we can assume that there were no exclusions due to invalid results |
Withdrawals explained? All tests | Yes | The number enrolled is clearly stated and corresponds to the number included in the analysis; therefore we can assume that there were no withdrawals |