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

Kumar 2004.

Clinical features and settings Presenting signs and symptoms: Fever
Previous treatment for malaria: No mention of previous treatment for malaria, either as an exclusion criteria or a characteristic of included participants
Clinical setting: Primary health centres
Country: India (Karnataka state)
Malaria endemicity: Not stated
Malaria endemic species: Mainly P. falciparum, some P. vivax
Participants Sample size: 2891
Age: Not mentioned either as an exclusion criteria or a characteristic of included participants
Sex: Not mentioned either as an exclusion criteria or a characteristic of included participants
Co‐morbidities and pregnancy: Not mentioned either as an exclusion criteria or a characteristic of included participants
Parasite density of microscopy positive cases: Not presented
Study design Enrollment was prospective. The sampling method was not described. One RDTs was evaluated.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick and thin blood film
Person(s) performing microscopy: Laboratory technicians
Microscopy setting: Initially undertaken at the primary health centres and later cross‐checked at the Central Malaria Laboratory
Number of high power fields examined before declaring negative: Not stated
Number of observer or repeats: Two
Resolution of discrepancies between observers: Not described
Index and comparator tests Commerical name of RDT: Paracheck‐Pf (Orchid Biomedical Systems, Goa, India)
Parasite(s) designed to detect:P. falciparum
Designated Type: Type 1
Batch numbers: Not stated
Transport and storage conditions: Stored at 4 °C and brought to room temperature before performing the test
Person(s) performing RDT: Not stated
RDT setting: Not stated
Follow‐up Not applicable
Notes Source of funding: Not stated
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Unclear All participants were attending health centres with fever, but the sampling methods were not described
Acceptable reference standard? 
 All tests Unclear Two independent microscopists read the slides; however the number of high power fields viewed before declaring a slide negative was not stated
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 Blinding not described
Index test results blinded? 
 All tests Unclear Blinding not described
Uninterpretable results reported? 
 All tests Unclear The numbers of participants originally enrolled in the study was not clearly stated; therefore it is unclear whether there were any exclusions due to invalid test results
Withdrawals explained? 
 All tests Unclear The numbers of participants originally enrolled in the study was not clearly stated; therefore it is unclear whether there were any withdrawals