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

Endeshaw 2012f.

Clinical features and settings Presenting signs and symptoms: Clinically presumptive malaria: an axillary temperature greater than or equal to 37.5°C or history of fever in the previous 48 hours
Previous treatments for malaria: Not stated
Clinical setting: Ten health centres
Country: Ethiopia
Malaria endemicity: The study was conducted in an area with range of transmission intensities, during the peak transmission period of malaria infection
Malaria endemic species: Not stated
Participants Sample size: 1997. 4 RDTs were not done (reason not reported)
Age: Range: 8 months to 85 years. Mean 20.7 (SD not stated)
Sex: 56.2 male, 43.8 female
Co‐morbidities or pregnancy: patients with other known causes of non malarial febrile illnesses or serious illness were excluded. Pregnancy status 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? Microscopy assessment was performed by experienced medical laboratory technicians
If microscopy was used, how many high power fields were looked at? Not stated
How many observers or repeats were used? Slides were also sent for expert microscopy at The Carter Center in Addis Ababa
How were discrepancies between observers resolved? Not stated
Index and comparator tests Commercial name of the test: ParaScreen Pan/Pf (Zephyr Biomedical systems, Verna, Goa,India)
Parasite species the test is designed to detect:P. falciparum or mixed infection, non‐falciparum malaria species only
Designated type: Type 3
Batch numbers: Not stated
Transport and storage conditions: Not stated
Who performed the index test, and where? The ten experienced laboratory technicians involved in this study were trained on the RDT sampling and evaluation procedures
Follow‐up Not applicable
Notes Source of funding: Not stated.
"Out of 2000 recruited patients, 1997 febrile cases were examined for malaria parasites by blood slide microscopy."
"Of the 1997 persons tested by slide, 1993 samples were also examined by ParaScreen RDT at the health centers."
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes In each health centre the first 200 self‐presenting patients of any age and either sex who qualified as clinically presumptive malaria were recruited.
Acceptable reference standard? 
 All tests Unclear Slides were evaluated by trained technicians at each site and were also sent to a central lab for expert microscopy. However, number of microscopic field have not been stated.
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 Microscopy was used as reference standard.
Reference standard results blinded? 
 All tests Yes Although blind procedures for local technicians are not reported, slides were also sent for expert microscopy at a central lab where they were examined in blinded fashion.
Index test results blinded? 
 All tests Yes Microscopy and ParaScreen Pan/PfH RDT were done immediately by health centre technicians.
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 Number enrolled in the study was explicitly stated as 2000, 1993 were presented in the analysis; therefore there were 7 withdrawals. These were explained as 3 who declined to participate and 4 who did not have RDT because the technicians had too much work.