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. 2011 Jul 6;2011(7):CD008122. doi: 10.1002/14651858.CD008122.pub2

Kolaczinski 2004.

Clinical features and settings Presenting signs and symptoms: Suspected malaria/febrile illness
Previous treatment for malaria: No exclusion criteria based on previous use of antimalarials, and no data on previous antimalarial use of the participants was presented
Clinical setting: Basic health units within an Afghan refugee camp
Country: Pakistan (North West Frontier Province)
Malaria endemicity: Not stated
Malaria endemic species: 80% P. vivax, 20%P. falciparum
Participants Sample size: 499
Age: All age groups eligible for inclusion; actual age range of the participants not stated
Sex: Both males and females eligible for inclusion; actual age range of the participants not stated
Co‐morbidities and pregnancy: No exclusions based on co‐morbidities or pregnancy, and no data presented on the frequency of these conditions in the study population
Parasite density of microscopy positive cases: Not presented
Study design Enrollment was consecutive and prospective. One RDT was tested.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick and thin blood films
Person(s) performing microscopy: Microscopists
Microscopy setting: Basic health units within an Afghan refugee camp and HNI's reference laboratory in Peshawar
Number of high power fields examined before declaring negative: 100
Number of observer or repeats: Two, one at the BHU and one at the reference laboratory
Resolution of discrepancies between observers: Not clear, "all of the smears checked by the microscopist at each BHU were cross checked at HNI's reference laboratory at Pashawar"
Index and comparator tests Commerical name of RDT: OptiMAL (DiaMed AG, Cressier, Switzerland)
Parasite(s) designed to detect:P. falciparum or mixed infection, non‐falciparum malaria species only
Designated Type: Type 4
Batch numbers: Not stated
Transport and storage conditions: Not described
Person(s) performing RDT: Microscopists
RDT setting: Basic health units
Follow‐up Not applicable
Notes Source of funding: Not stated
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Participants were a consecutive series of patients attending a basic health unit with suspected malaria
Acceptable reference standard? 
 All tests Yes Two microscopists, one working in a central laboratory, viewed at least 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 No The index test and reference test were undertaken by the same person
Index test results blinded? 
 All tests No The index test and reference test were undertaken by the same person
Uninterpretable results reported? 
 All tests Unclear The number of participants originally enrolled in the study was clearly stated, and corresponded to the number presented in the analysis; therefore there were no exclusions due to invalid test results
Withdrawals explained? 
 All tests Yes The number of participants originally enrolled in the study was clearly stated, and corresponded to the number presented in the analysis; therefore there were no withdrawals