title: [Field evaluation for diagnostic accuracy of the rapid test SD Bioline Malaria Antigen Pf/Pv® in Colombia].
abstract: BACKGROUND
  Rapid diagnostic tests (RDT) have been postulated as a way to ensure access to malaria diagnosis in remote areas. Despite its widespread use, there are no field studies to evaluate the accuracy of the SD Bioline Malaria Antigen Pf/Pv in Colombia RDT.
  
  
  OBJECTIVE
  To evaluate the diagnostic accuracy of the SD Bioline Malaria Antigen Pf/Pv® RDT in two departments endemic for malaria, comparing diagnosis with thick film corrected with PCR.
  
  
  METHODS
  A retrospective study was carried out to evaluate sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), concordance and sensitivity limits according to parasitemia ranges for the SD Bioline Malaria Antigen Pf/Pv ® test in Cordoba and Choco. The results were compared with microscopy corrected by PCR.
  
  
  RESULTS
  A total of 383 samples processed, 121 were positive (75 for P. vivax , 42 for P. falciparum and 4 for mixed infection) and 262 negative samples. P. vivax: sensitivity 92.0% (95% CI: 83.6-96.3), specificity 98.7% ( 95% CI: 96.7-99.5), PPV 94.5% (95% CI: 86.7-97.9), NPV 98.1% (95% CI: 95.8-99.1), Cohen's kappa coefficient was 0.90 (0.80-1.00). P. falciparum: sensitivity 88.1% (95% CI: 75.0-94.8), specificity 97.9% (95% CI: 95.8-99.0), PPV 84.1% (95% CI: 70.6-92.1), NPV 98.5% (95% IC: 96.6-99.4), Cohen's kappa coefficient 0.80 (95% CI: 0.70-0.90).
  
  
  CONCLUSIONS
  The test performed well, being better for P. vivax as compared to P. falciparum. There are still difficulties of RDT to detect low parasitemias. The non amplification of Pfhrp2 and Pfhrp3 genes in two samples diagnosed as mixed infection, suggest a possible deletion of these two genes together.
authors.affiliation: Grupo de Parasitología, Instituto Nacional de Salud, Bogotá, D.C, Colombia.
authors.forename: Nohora Marcela
authors.initials: NM
authors.lastname: Mendoza
authors.affiliation: Grupo de Parasitología, Instituto Nacional de Salud, Bogotá, D.C, Colombia.
authors.forename: Zulma Milena
authors.initials: ZM
authors.lastname: Cucunubá
authors.affiliation: Grupo de Bioquímica, Instituto Nacional de Salud, Bogotá, D.C, Colombia.
authors.forename: Samanda
authors.initials: S
authors.lastname: Aponte
authors.affiliation: Grupo de Parasitología, Instituto Nacional de Salud, Bogotá, D.C, Colombia.
authors.forename: Nohora Elizabeth
authors.initials: NE
authors.lastname: González
authors.affiliation: Grupo de Bioquímica, Instituto Nacional de Salud, Bogotá, D.C, Colombia.
authors.forename: Sindy Durley
authors.initials: SD
authors.lastname: Bernal
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000953:Antigens, Protozoan / Q000097:blood*; D002648:Child; D003105:Colombia; D005260:Female; D006801:Humans; D016778:Malaria, Falciparum / Q000139:chemically induced*; D016780:Malaria, Vivax / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D010963:Plasmodium falciparum / Q000276:immunology*; D010966:Plasmodium vivax / Q000276:immunology*; D016133:Polymerase Chain Reaction; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D013997:Time Factors; D055815:Young Adult
chemical_list: D000953:Antigens, Protozoan