title: Field evaluation of a malaria rapid diagnostic test (ICT Pf).
abstract: BACKGROUND
  Malaria rapid diagnostic tests (MRDTs) are quick and easy to perform and useful for diagnosing malaria in primary health care settings. In South Africa most malaria infections are due to Plasmodium falciparurrm, and HRPII-based MRDTs have been used since 2001. Previous studies in Africa showed variability in sensitivity and specificity of HRPII-based MRDTs; hence, we conducted a field evaluation in Limpopo province to determine the accuracy of the MRDT currently used in public sector clinics and hospitals.
  
  
  METHODS
  A cross-sectional observational study was conducted to determine the sensitivity and specificity of an ICT Pf MRDT. We tested 405 patients with fever with ICT Pf MRDT and compared the results with blood film microscopy (the gold standard). RESULTS. The overall sensitivity of the ICT Pf MRDT was 99.48% (95% confidence interval (CI) 96.17-100%), while specificity was 96.26% (95% CI 94.7-100%). The positive predictive value of the test was 98.48 (99% CI 98.41-100%), and the negative predictive value was 99.52% (95% CI 96.47-100%).
  
  
  CONCLUSIONS
  The ICT Pf MRDT is an appropriate test to use in the field in South Africa where laboratory facilities are not available. It has a high degree of sensitivity and acceptable level of specificity in accordance with the World Health Organization criteria. However, sensitivity of MRDT at low levels of parasitaemia (<100 parasites/microl of blood) in field conditions must still be established.
authors.affiliation: London School of Hygiene and Tropical Medicine, Keppel Street, London, UK. moonad@health.gov.za
authors.forename: Devanand
authors.initials: D
authors.lastname: Moonasar
authors.forename: Ameena E
authors.initials: AE
authors.lastname: Goga
authors.forename: Philip S
authors.initials: PS
authors.lastname: Kruger
authors.forename: Christine
authors.initials: C
authors.lastname: La Cock
authors.forename: Rajendra
authors.initials: R
authors.lastname: Maharaj
authors.forename: John
authors.initials: J
authors.lastname: Frean
authors.forename: Daniel
authors.initials: D
authors.lastname: Chandramohan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000953:Antigens, Protozoan / Q000032:analysis*; D002648:Child; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D016778:Malaria, Falciparum / Q000175:diagnosis* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D015800:Protozoan Proteins / Q000032:analysis*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D012737:Sex Factors; D013019:South Africa / Q000453:epidemiology; D055815:Young Adult
chemical_list: D000953:Antigens, Protozoan; C514457:HRP-2 antigen, Plasmodium falciparum; D015800:Protozoan Proteins; D011933:Reagent Kits, Diagnostic