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 |
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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 |
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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? 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 |
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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 |
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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. |