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 |
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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. |
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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 |
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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 |
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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." |
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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. |