Sharew 2009.
| Clinical features and settings |
Presenting signs and symptoms: Febrile patients, clinically suspected for malaria Previous treatment for malaria: No exclusions based on previous treatment. Information on previous treatment collected, but actual data not provided. Clinical setting: Outpatient departments of two health centres Country: Ethiopia (Southern ‐ Wondo Genet) Malaria endemicity: Takes place throughout the year Malaria endemic species:P. falciparum and P. vivax |
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| Participants |
Sample size: 668 Age: All age groups eligible. Actual age range 6 months to 75 years. Sex: 361 (54%) males, 307 (46%) females Co‐morbidities and pregnancy: No exclusion criteria based on co‐morbidities or pregnancy. No details of the frequency of these conditions in the participant population is presented. Parasite density of microscopy positive cases: Not presented |
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| Study design | Enrollment was consecutive and prospective. Two different RDTs were evaluated, and each participant received both tests. | |
| Target condition and reference standard(s) |
Target condition: Malaria parasitaemia Reference standard: Microscopy thick and thin blood films Person(s) performing microscopy: Experienced malaria technicians Microscopy setting: Not stated, but in the Wondo Genet area Number of high power fields examined before declaring negative: 100 Number of observer or repeats: Two independent technicians, also checked by the team leader Resolution of discrepancies between observers: All discordant results between microscopy and RDTs were repeated |
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| Index and comparator tests |
Commerical name of RDT: Paracheck Pf (Orchid Biomedical Systems, Goa, India) CareStart Malaria Pf/Pv Combo test (Access Bio Inc., New Jersey, USA) Parasite(s) designed to detect:P. falciparum Paracheck Pf ‐ P. falciparum CareStart Malaria Pf/Pv Combo test ‐ P. falciparum, P. vivax or mixed infection Designated Type: Paracheck Pf ‐ Type 1 CareStart Malaria Pf/Pv Combo test ‐ Type 5 Batch numbers: Not stated Transport and storage conditions: As per the instructions of the manufacturer Person(s) performing RDT: Not stated RDT setting: Two health centres |
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| Follow‐up | Not applicable | |
| Notes | Source of funding: School of Graduate Studies of the Addis Adaba University through the Graduate Programme in Tropical and Infectious Diseases, Aklilu Lemma Institute of Pathobiology and from the Federal Ministry of Health of Ethiopia. Federal Ministry of Health of Ethiopia and Access Bio Inc. donated the test kits. | |
| Table of Methodological Quality | ||
| Item | Authors' judgement | Description |
| Representative spectrum? All tests | Yes | Participants were a consecutive sample of febrile patients attending health centres with suspected malaria |
| Acceptable reference standard? All tests | Yes | Two experienced microscopists independently viewed 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 | Unclear | Not described |
| Index test results blinded? All tests | Yes | Strict blinding with the results available before microscopy reported |
| Uninterpretable results reported? All tests | Yes | If a test was uninterpretable then it was repeated |
| Withdrawals explained? All tests | Yes | The number of participants enrolled in the study was clearly stated and corresponds to the number included in the analysis; therefore there were no withdrawals |