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. 2011 Jul 6;2011(7):CD008122. doi: 10.1002/14651858.CD008122.pub2

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
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.
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.
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
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