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. 2014 Dec 18;2014(12):CD011431. doi: 10.1002/14651858.CD011431

Chanie 2011.

Clinical features and settings Presenting signs and symptoms: Suspected malaria: clinical symptoms of malaria, fever
Previous treatments for malaria: 12.5% of the subjects had anti‐malaria treatment in the preceding month
Clinical setting: Outpatient departments of 3 health facilities
Country: Ethiopia
Malaria endemicity: High endemicity
Malaria endemic species:P. falciparum and P. vivax
Participants Sample size: 1092
Age: Mean 22.3 (SD 12.8); range 3 months to 78 years of age
Sex: 48.57% female, 51.43% male
Co‐morbidities or pregnancy: Co‐morbidities and pregnancy not stated
Study design Participants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s) Type(s) of malaria parasite tested for:P. falciparum and P. vivax
Reference standard test(s) used: Microscopy thick and thin smears
Who performed the reference standard tests, and where? Experienced malaria technicians performed the microscopic test. Location not reported (presumably at each of the participating health centres)
If microscopy was used, how many high power fields were looked at? A minimum of 100 high power fields examined on a thick smear
How many observers or repeats were used? Not stated
How were discrepancies between observers resolved? 20% of the positive and 10% of the negative slides and discordant results between RDT and microscopic tests were examined by another well experienced technician
Index and comparator tests Commercial name of the test: CareStart Malaria Pf/Pv Combo (Access Bio Inc, New Jersey, USA)
Parasite species the test is designed to detect:P. falciparum and P. vivax
Designated type: Type Other (HRP‐2 antigen for P. falciparum and pLDH antigen for P. vivax)
Batch numbers: Lot No H38 IV and Lot No H28 IV
Transport and storage conditions: Lot No H38 IV and Lot No H28 IV
Who performed the index test, and where? Experienced malaria technicians performed the index test
Follow‐up Not applicable
Notes Source of funding: Addis Ababa University, The Federal Ministry of Health of Ethiopia. RDT kits were donated by Acces Bio Inc.
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes All participants were attending primary health centres with fever and symptoms of malaria, sampling was consecutive.
Acceptable reference standard? 
 All tests Yes "...discordant results between RDT and microscopic tests were examined by another well experienced technician". Experienced malaria technicians viewed 200 white blood cells or 100 fields.
Partial verification avoided? 
 All tests Yes Characteristics of participants are well described and the only exclusion criterion was refusal to participate in the study.
Differential verification avoided? 
 All tests Yes The same reference standard was used.
Incorporation avoided? 
 All tests Yes The reference standard was microscopy.
Reference standard results blinded? 
 All tests Unclear Blinding procedures not stated. However, microscopic evaluation and RDT were performed independently. Results were recorded in separate sheets.
Index test results blinded? 
 All tests Unclear Blinding procedures not stated. However, microscopic evaluation and RDT were performed independently. Results were recorded in separate sheets.
Uninterpretable results reported? 
 All tests Unclear Number enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained? 
 All tests Yes The number recruited into the study was clearly stated, and corresponded with the number included in the analysis, therefore there were no withdrawals.