title: Evaluation of a rapid diagnostic test specific for Plasmodium vivax.
abstract: Plasmodium vivax is the only human malaria indigenous to the Republic of Korea (ROK). A rapid and sensitive diagnostic test (RDT) that detects P. vivax is appropriate for evaluating suspected malaria patients with no travel history abroad. The RDTs, SD Malaria Antigen P.v (SD diagnostic, Kyonggi, ROK) specific for P. vivax and the well documented OptiMAL (DiaMed, Cressier, Switzerland) were compared among 282 volunteers for specificity and sensitivity of P. vivax and Plasmodium falciparum malaria infections against Giemsa-stained blood smears read by an experienced microscopist. A total of 137 volunteers were diagnosed with P. vivax, 45 cases (returned travellers from overseas) were diagnosed with P. falciparum and 100 healthy volunteers were diagnosed as negative for malaria. Correspondingly, the SD Malaria Antigen P.v test identified P. vivax infections in 128/137 malaria patients (93.4%) and 0/100 (0%) healthy volunteers. Three patients identified with P. falciparum also were interpreted as P. vivax by the SD Malaria Antigen P.v test; however, these patients were later confirmed as mixed infections of P. vivax and P. falciparum by polymerase chain reaction. OptiMAL interpreted the three mixed infections only as P. falciparum and detected 130/137 (94.9%) patients with P. vivax. The sensitivity of the SD Malaria Antigen P.v test decreased from 100% (>5000 parasite/microl) to 81.3% (1-100 parasites/microl) as parasitaemia levels declined. For the regions where P. vivax is the primary malaria parasite, the SD P. vivax-specific rapid diagnostic test may be useful for screening suspected malaria patients when sufficient material and human resources (e.g. trained microscopists) are unavailable for malaria diagnosis.
authors.affiliation: Department of Laboratory Medicine, College of Medicine, Korea University, Seoul, Korea.
authors.forename: Sun Hyung
authors.initials: SH
authors.lastname: Kim
authors.forename: Myung-Hyun
authors.initials: MH
authors.lastname: Nam
authors.forename: Kyoung Ho
authors.initials: KH
authors.lastname: Roh
authors.forename: Hae Chul
authors.initials: HC
authors.lastname: Park
authors.forename: Deok Hwa
authors.initials: DH
authors.lastname: Nam
authors.forename: Gli Hong
authors.initials: GH
authors.lastname: Park
authors.forename: Eun Taek
authors.initials: ET
authors.lastname: Han
authors.forename: Terry A
authors.initials: TA
authors.lastname: Klein
authors.forename: Chae Seung
authors.initials: CS
authors.lastname: Lim
mesh_terms: D000818:Animals; D000953:Antigens, Protozoan / Q000032:analysis*; D016022:Case-Control Studies; D016009:Chi-Square Distribution; D005260:Female; D006801:Humans; D007723:Korea; D007770:L-Lactate Dehydrogenase / Q000032:analysis*; D016780:Malaria, Vivax / Q000175:diagnosis* / Q000276:immunology; D008297:Male; D018512:Parasitemia / Q000175:diagnosis; D010963:Plasmodium falciparum / Q000276:immunology; D010966:Plasmodium vivax / Q000276:immunology*; D016133:Polymerase Chain Reaction / Q000379:methods; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D000953:Antigens, Protozoan; D011933:Reagent Kits, Diagnostic; D007770:L-Lactate Dehydrogenase