title: Comparison of CareStart™ HRP2/pLDH COMBO rapid malaria test with light microscopy in north-west Ethiopia.
abstract: BACKGROUND
  In Ethiopia, light microscopy is the gold standard for malaria diagnosis although it is not available in most peripheral health facilities. It is time consuming, requires trained personnel and needs careful preparation and application of reagents to ensure quality results. This study was aimed at testing the diagnostic performance of CareStart™ malaria rapid diagnostic test (RDT) with reference to light microscopy for the diagnosis of falciparum and vivax malaria in Ethiopia.
  
  
  METHODS
  Blood samples were collected from 254 patients suspected to have malaria at Kola Diba Health Center in the late malaria transmission peak season from November 2011 to December 2011. The samples were examined immediately by light microscopy and the RDT (CareStart™ Malaria HRP2/pLDH COMBO Test kit). Statistical analysis was performed using SPSS version 16 and the JavaStat two-way contingency table analysis.
  
  
  RESULTS
  The overall sensitivity and specificity of CareStartTM RDT was found to be 95% (90-97.9%, 95% CI) and 94.2% (90.9-96%, 95% CI), respectively. The sensitivity of the CareStartTM RDT for Plasmodium falciparum or mixed infection was calculated to be 92.9% (82.5-98%, 95%CI) while a sensitivity of 90.9% (74.1-98.4%, 95%CI) was found for non-falciparum species. The specificity for P. falciparum or mixed infections was found to be 95.4% (92.5-96.8%, 95%CI) while it was 97.3% (94.8-98.4%, 95%CI) for non-falciparum species. There was an excellent agreement between the two tests with a kappa value of 0.918.
  
  
  CONCLUSIONS
  The CareStartTM RDT test showed good sensitivity and specificity with an excellent agreement to the reference light microscopy. The RDT could therefore be used in place of light microscopy, which in poor set-ups cannot be used routinely.
authors: Department of Immunology and Molecular Biology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, 196, Gondar, Ethiopia. beyemoges@gmail.com
authors: Beyene
authors: B
authors: Moges
authors: Bemnet
authors: B
authors: Amare
authors: Yeshambel
authors: Y
authors: Belyhun
authors: Zinaye
authors: Z
authors: Tekeste
authors: Muchiye
authors: M
authors: Gizachew
authors: Meseret
authors: M
authors: Workineh
authors: Amare
authors: A
authors: Gebrehiwot
authors: Desalegn
authors: D
authors: Woldeyohannes
authors: Andargachew
authors: A
authors: Mulu
authors: Afework
authors: A
authors: Kassu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001769:Blood / Q000469:parasitology; D002648:Child; D002675:Child, Preschool; D019411:Clinical Laboratory Techniques / Q000379:methods*; D003430:Cross-Sectional Studies; D005002:Ethiopia; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007223:Infant; D016778:Malaria, Falciparum / Q000175:diagnosis*; D008297:Male; D008853:Microscopy / Q000379:methods*; D008875:Middle Aged; D010274:Parasitology / Q000379:methods*; D010963:Plasmodium falciparum / Q000166:cytology / Q000235:genetics / Q000302:isolation & purification*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D011933:Reagent Kits, Diagnostic