title: Evaluation of the Palutop+4 malaria rapid diagnostic test in a non-endemic setting.
abstract: BACKGROUND
  Palutop+4 (All. Diag, Strasbourg, France), a four-band malaria rapid diagnostic test (malaria RDT) targeting the histidine-rich protein 2 (HRP-2), Plasmodium vivax-specific parasite lactate dehydrogenase (Pv-pLDH) and pan Plasmodium-specific pLDH (pan-pLDH) was evaluated in a non-endemic setting on stored whole blood samples from international travellers suspected of malaria.
  
  
  METHODS
  Microscopy corrected by PCR was the reference method. Samples include those infected by Plasmodium falciparum (n = 323), Plasmodium vivax (n = 97), Plasmodium ovale (n = 73) and Plasmodium malariae (n = 25) and 95 malaria negative samples.
  
  
  RESULTS
  The sensitivities for the diagnosis of P. falciparum, P. vivax, P. malariae and P. ovale were 85.1%, 66.0%, 32.0% and 5.5%. Sensitivities increased at higher parasite densities and reached 90.0% for P. falciparum >100/microl and 83.8% for P. vivax > 500/microl. Fourteen P. falciparum samples reacted with the Pv-pLDH line, one P. vivax sample with the HRP-2 line, and respectively two and four P. ovale and P. malariae samples reacted with the HRP-2 line. Two negative samples gave a signal with the HRP-2 line. Faint and weak line intensities were observed for 129/289 (44.6%) HRP-2 lines in P. falciparum samples, for 50/64 (78.1%) Pv-pLDH lines in P. vivax samples and for 9/13 (69.2%) pan-pLDH lines in P. ovale and P. malariae samples combined. Inter-observer reliabilities for positive and negative readings were excellent for the HRP-2 and Pv-pLDH lines (overall agreement > 92.0% and kappa-values for each pair of readers >or= 0.88), and good for the pan-pLDH line (85.5% overall agreement and kappa-values >or= 0.74).
  
  
  CONCLUSIONS
  Palutop+4 performed moderately for the detection of P. falciparum and P. vivax, but sensitivities were lower than those of three-band malaria RDTs.
authors.affiliation: Faculty of Health, Medicine and Life Sciences (FHML), Maastricht, The Netherlands. D.vanDijk@student.maastrichtuniversity.nl
authors.forename: David P J
authors.initials: DP
authors.lastname: van Dijk
authors.forename: Philippe
authors.initials: P
authors.lastname: Gillet
authors.forename: Erika
authors.initials: E
authors.lastname: Vlieghe
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; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D002648:Child; D002675:Child, Preschool; D016001:Confidence Intervals; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005189:False Positive Reactions; D005260:Female; D005602:France; D006801:Humans; D007223:Infant; D007770:L-Lactate Dehydrogenase; D008288:Malaria / Q000175:diagnosis* / Q000453:epidemiology / Q000469:parasitology; D008297:Male; D008853:Microscopy / Q000379:methods; D008875:Middle Aged; D010961:Plasmodium / Q000145:classification / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction / Q000379:methods; D011506:Proteins; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D014195:Travel; D055815:Young Adult; D000099053:Histidine-Rich Glycoprotein
chemical_list: D011506:Proteins; D011933:Reagent Kits, Diagnostic; D000099053:Histidine-Rich Glycoprotein; D007770:L-Lactate Dehydrogenase