title: Evaluation of a rapid diagnostic test (CareStart Malaria HRP-2/pLDH (Pf/pan) Combo Test) for the diagnosis of malaria in a reference setting.
abstract: BACKGROUND
  Malaria Rapid Diagnostic Tests (RDTs) are widely used for diagnosing malaria. The present retrospective study evaluated the CareStart Malaria HRP-2/pLDH (Pf/pan) Combo Test targeting the Plasmodium falciparum specific antigen histidine-rich protein (HRP-2) and the pan-Plasmodium antigen lactate dehydrogenase (pLDH) in a reference setting.
  
  
  METHODS
  The CareStart Malaria HRP-2/pLDH (Pf/pan) Combo Test was evaluated on a collection of samples obtained in returned international travellers using microscopy corrected by PCR as the reference method. Included were P. falciparum (n = 320), Plasmodium vivax (n = 76), Plasmodium ovale (n = 76), Plasmodium malariae (n = 23) and Plasmodium negative samples (n = 95).
  
  
  RESULTS
  Overall sensitivity for the detection of P. falciparum was 88.8%, increasing to 94.3% and 99.3% at parasite densities above 100 and 1,000/microl respectively. For P. vivax, P. ovale and P. malariae, overall sensitivities were 77.6%, 18.4% and 30.4% respectively. For P. vivax sensitivity reached 90.2% for parasite densities above 500/microl. Incorrect species identification occurred in 11/495 samples (2.2%), including 8/320 (2.5%) P. falciparum samples which generated only the pan-pLDH line. For P. falciparum samples, 205/284 (72.2%) HRP-2 test lines had strong or medium line intensities, while for all species the pan-pLDH lines were less intense, especially in the case of P. ovale. Agreement between observers was excellent (kappa values > 0.81 for positive and negative readings) and test results were reproducible. The test was easy to perform with good clearing of the background.
  
  
  CONCLUSIONS
  The CareStart Malaria HRP-2/pLDH (Pf/pan) Combo Test performed well for the detection of P. falciparum and P. vivax, but sensitivities for P. ovale and P. malariae were poor.
authors.affiliation: Department of Medical Microbiology, Faculty of Health, Medicine and Life Sciences (FHML), Maastricht, The Netherlands.
authors.forename: Jessica
authors.initials: J
authors.lastname: Maltha
authors.forename: Philippe
authors.initials: P
authors.lastname: Gillet
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Bottieau
authors.forename: Lieselotte
authors.initials: L
authors.lastname: Cnops
authors.forename: Marjan
authors.initials: M
authors.lastname: van Esbroeck
authors.forename: Jan
authors.initials: J
authors.lastname: Jacobs
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D000953:Antigens, Protozoan / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007223:Infant; D007770:L-Lactate Dehydrogenase / Q000276:immunology*; D008288:Malaria / Q000175:diagnosis* / Q000469:parasitology; D008853:Microscopy; D008875:Middle Aged; D010961:Plasmodium / Q000145:classification / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction; D011506:Proteins / Q000032:analysis / Q000276:immunology*; D015800:Protozoan Proteins / Q000276:immunology; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D014195:Travel; D000099053:Histidine-Rich Glycoprotein
chemical_list: D000953:Antigens, Protozoan; C514457:HRP-2 antigen, Plasmodium falciparum; D011506:Proteins; D015800:Protozoan Proteins; D011933:Reagent Kits, Diagnostic; D000099053:Histidine-Rich Glycoprotein; D007770:L-Lactate Dehydrogenase