Eibach 2013.
Clinical features and settings |
Presenting signs and symptoms: Suspected malaria with a temperature > 37.5°C Previous treatments for malaria: More than 90% of the patients reported receiving traditional or registered drugs, including antipyretics, antimalarials and antibiotics previously. However, the quality of drugs, the dosage and the duration of treatment remained unknown. Clinical setting: General health centre Country: Mali Malaria endemicity: Hyperendemic in the peripheral villages, mesoendemic in the periurban area and hypoendemic in the city. Malaria endemic species: 95% P. falciparum |
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Participants |
Sample size: 727 Age: Mean 23.5 (SD 14.9) median = 21, range 1 to 60) Sex: Not reported Co‐morbidities or pregnancy: Not reported |
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Study design | Participants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 2 RDTs. | |
Target condition and reference standard(s) |
Type(s) of malaria parasite tested for:P. falciparum, PAN malaria Reference standard test(s) used: Microscopy thick and thin smears Who performed the reference standard tests, and where? Local investigators If microscopy was used, how many high power fields were looked at? 100 How many observers or repeats were used? Thick and thin smears were assessed by 2 local investigators, and by an expert at the Parasitology Department of the Lyon University Hospital, as a quality control How were discrepancies between observers resolved? Local investigators resolved all discrepancies between themselves by consensus. All discordant results between microscopy and the 2 RDTs were resolved by PCR and test characteristics were recalculated according to the PCR‐corrected results. |
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Index and comparator tests |
Commercial name of the test: VIKIA Malaria Ag Pf/Pan (IMAccess, Lyon, France), CareStart Malaria (AccessBio, USA) Parasite species the test is designed to detect: VIKIA Malaria Ag Pf/Pan: P. falciparum or mixed infection, non‐falciparum malaria species only CareStart Malaria: P. falciparum or mixed infection, non‐falciparum malaria species only Designated type: VIKIA Malaria Ag Pf/Pan: Type 2 CareStart Malaria: Type 3 Batch numbers: VIKIA Malaria Ag Pf/Pan: RD_MA2_110527 CareStart Malaria: G21MR Transport and storage conditions: Not reported Who performed the index test, and where? Local community health workers trained to use both tests . |
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Follow‐up | Not applicable | |
Notes |
Source of funding: The study was supported by IMACCESS. Data from the Lyon part of the study was not included as it did not match inclusion criteria. The VIKIA Malaria Ag Pf/Pan™ test was read at different time points (15, 20, 30, 60 minutes), while the CareStart Malaria™ test was read after 20 minutes as recommended. 2 drops of blood were spotted onto filter paper, individually stored in a plastic bag and sent to the Parasitology Department of the Lyon University Hospital for PCR correction. |
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Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Consecutive sample of people attending a clinic with symptoms of malaria. |
Acceptable reference standard? All tests | Yes | Microscopy was undertaken by 2 trained local health workers and corrected by PCR at the Parasitology Department of the Lyon University Hospital. |
Partial verification avoided? All tests | Yes | All participants who received the index test also received the reference tests. |
Differential verification avoided? All tests | Yes | The same reference test was used. |
Incorporation avoided? All tests | Yes | Standard microscopy and PCR. |
Reference standard results blinded? All tests | Yes | All microscopists were blinded to the results of the RDTs. |
Index test results blinded? All tests | Yes | RDTs were performed immediately after sampling. |
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 of participants enrolled was clearly stated, and the number included in the analysis corresponds to this number, indicating no withdrawals. |