Skip to main content
. 2014 Dec 18;2014(12):CD011431. doi: 10.1002/14651858.CD011431

Dev 2004.

Clinical features and settings Presenting signs and symptoms: Fever
Previous treatment for malaria: No information presented on previous treatment; no suggestion of any exclusions based on previous treatment
Clinical setting: Malaria clinics
Country: India (Assam)
Malaria endemicity: Mesoendemic
Malaria endemic species:P. falciparum and P. vivax
Participants Sample size: 336; but varied by RDT evaluated (10 to 139)
Age: Infants under 12 months excluded; actual age range 1 to 60 years
Sex: Both males and females eligible. Actual proportions of males and females in the participant population not stated
Co‐morbidities and pregnancy: No exclusions criteria based on co‐morbidities or pregnancy were stated, and no details of the frequency of these conditions in the participant population is presented.
Parasite density of microscopy positive cases: Range 300 to 350,000 parasites per µL, mean 59,842, standard deviation (SD) 78,780
Study design Enrolment was prospective. The sampling method was not described. 7 RDTs were evaluated; it is unclear how each RDT was allocated, as no participant received all the tests.
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick and thin blood smears
Who performed the reference standard tests, and where? Technician; all positive slides and 20% of negative slides were also examined by the senior technician for confirmation of result. Setting was the laboratory at the malaria clinics
If microscopy was used, how many high power fields were looked at? 100
How many observers or repeats were used? 1 in the case of most smears judged negative by the technician. 2 in the case of 20% of those initially judged negative, and all those judged positive.
How were discrepancies between observers resolved? The judgement of the senior technician was used
Index and comparator tests Commerical name of RDT:
  • Paracheck Pf (Orchid Biomedical Systems, Goa, India)

  • ParaSight‐F (Beckton Dickinson, Franklin Lakes, NJ)

  • ParaHIT‐F (Span diagnostics Ltd, Surat, India)

  • ICT Malaria Pf (ICT Diagnostics, Sydney, Australia)

  • New Pf‐1 mini (Monozyme India Ltd, Secundrabad, India)

  • SD Malaria Pf/Pv (SD Diagnostics Inc, Korea)

  • Diamed OptiMAL (Flow Inc. Portlad, OR)


Parasite(s) designed to detect:
  • Paracheck Pf ‐ P. falciparum

  • ParaSight‐F ‐ P. falciparum

  • ParaHIT‐F ‐ P. falciparum

  • ICT Malaria Pf ‐ P. falciparum

  • New Pf‐1 mini ‐ P. falciparum

  • SD Malaria Pf/Pv ‐ P. falciparum or mixed infection, non‐falciparum malaria species only

  • Diamed OptiMAL ‐ P. falciparum or mixed infection, non‐falciparum malaria species only


Designated type:
  • Paracheck Pf ‐ Type I

  • ParaSight‐F ‐ Type I

  • ParaHIT‐F ‐ Type I

  • ICT Malaria Pf ‐ Type I

  • New Pf‐1 mini ‐ Type I

  • SD Malaria Pf/Pv ‐ Type 3

  • Diamed OptiMAL ‐ Type 4


Batch numbers: Not stated
Transport and storage conditions: Not described
Person(s) performing RDT: The laboratory attendant performed the test and recorded his or her interpretation. The test kit result was then re‐read for verification by the senior technician.
RDT setting: Malaria clinic laboratory
Follow‐up Not applicable
Notes Source of funding: Mian source of funding not stated. Test kits supplied by the Government of Assam.
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Unclear All participants were attending malaria clinics with fever; however, during the study period, 6663 blood smears were examined but only 336 were evaluated with RDT kits, and the sampling method for RDT evaluation was unclear.
Acceptable reference standard? 
 All tests Unclear 2 observers were used in the vast majority of cases; however, it is unclear whether the observers worked independently.
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 and RDT results were compared by an independent observer.
Index test results blinded? 
 All tests Yes Microscopy and RDT results were compared by an independent observer.
Uninterpretable results reported? 
 All tests No No information presented on numbers initially allocated each RDT, so not possible to judge this.
Withdrawals explained? 
 All tests Unclear No information presented on numbers initially allocated each RDT, so not possible to judge this.