Bharti 2008.
Clinical features and settings |
Presenting signs and symptoms: Fever or history of fever, and suspicion of malaria Previous treatment for malaria: No exclusions based on previous treatment; it was undertaken in a remote area with no medical facilities Clinical setting: Mobile field clinics in 10 villages Country: India (Remote forested region of Jabalpur during the peak monsoon season) Malaria endemicity: Low endemic areas with higher transmission during the monsoon Malaria endemic species:P. falciparum andP. vivax |
|
Participants |
Sample size: 291 Age: All age groups eligible. Actual age range of participants 1 to 60 years. Sex: Both males and females eligible. Male: female ratio 1:1.15. Co‐morbidities and pregnancy: No criteria based on co‐morbidities or pregnancy. No details of the frequency of these conditions in the participant population presented. Parasite density of microscopy positive cases: Range 80 to 111,920 parasites per cul, mean 8011, Standard Deviation 21,595 |
|
Study design | Enrollment was consecutive and prospective. One RDT was evaluated. | |
Target condition and reference standard(s) |
Target condition: Malaria parasitaemia Reference standard: Microscopy thick blood films Person(s) performing microscopy: Experienced microscopist Microscopy setting: Laboratory of NIMR Number of high power fields examined before declaring negative: 100 Number of observer or repeats: One for all samples, two independent readers for samples discordant between microscopy and RDT Resolution of discrepancies between observers: Where the second reading gave a different result from the first, the results of the second reading were confirmed by a third examination by another technician |
|
Index and comparator tests |
Commerical name of RDT: First Response Combo Malaria Ag card test (Premier Medical Corporation Ltd, Mumbai, India) Parasite(s) designed to detect:P. falciparum or mixed infection, non‐falciparum malaria species only Designated Type: Type 3 Batch numbers: 61F0107 Transport and storage conditions: RDTs were stored properly, at temperature of 4 °C to 30 °C, and used within their shelf life Person(s) performing RDT: Field laboratory assistants. Independent staff re‐read the saved tests after two months and matched them with the originally recorded results RDT setting: Field laboratory |
|
Follow‐up | Not applicable | |
Notes | Source of funding: Indian Council of Medical Research, Delhi. Test kits provided by Premier Medical Corporation Ltd. | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Participants were a consecutive sample of people attending mobile field clinics with fever or history of fever, and suspicion of malaria |
Acceptable reference standard? All tests | Yes | An experienced microscopist viewed at least 100 high power fields before declaring a slide negative, and results discordant with RDT were independently re‐examined by a second microscopist, and a third if necessary |
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 | Yes | Microscopy was undertaken "without reference to the RDT" |
Index test results blinded? All tests | Yes | RDTs were undertaken on site, and the results recorded before the microscopy results became available |
Uninterpretable results reported? All tests | Yes | The paper reported that there were no invalid results |
Withdrawals explained? All tests | Yes | The number of participants enrolled in the study was clearly stated, and corresponded to the number presented in the analysis; therefore there were no withdrawals |