title: Evaluation of the RealArt Malaria LC real-time PCR assay for malaria diagnosis.
abstract: PCR-based methods have advantages over traditional microscopic methods for the diagnosis of malaria, especially in cases of low parasitemia and mixed infections. However, current PCR-based assays are often labor-intensive and not readily quantifiable and have the potential for contamination due to a requirement for postamplification sample handling. Real-time PCR can address these limitations. This study evaluated the performance characteristics of a commercial malaria real-time PCR assay (RealArt Malaria LC Assay; Artus GmbH, Hamburg, Germany) on the LightCycler platform for the detection of malaria parasites in 259 febrile returned travelers. Compared to nested PCR as the reference standard, the real-time assay had a sensitivity of 99.5%, specificity of 100%, positive predictive value of 100%, and negative predictive value of 99.6% for the detection of malaria. Our results indicate that the RealArt assay is a rapid (<45 min), sensitive, and specific method for the detection of malaria in returned travelers.
authors.affiliation: Institute of Medical Science, Department of Medicine, McLaughlin Center for Molecular Medicine, University of Toronto, Ontario, Canada.
authors.forename: Gabriella A
authors.initials: GA
authors.lastname: Farcas
authors.forename: Kathleen J Y
authors.initials: KJ
authors.lastname: Zhong
authors.forename: Tony
authors.initials: T
authors.lastname: Mazzulli
authors.forename: Kevin C
authors.initials: KC
authors.lastname: Kain
mesh_terms: D000818:Animals; D016054:DNA, Protozoan / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D008288:Malaria / Q000175:diagnosis*; D016778:Malaria, Falciparum / Q000175:diagnosis*; D016780:Malaria, Vivax / Q000175:diagnosis*; D010963:Plasmodium falciparum / Q000235:genetics* / Q000302:isolation & purification; D010965:Plasmodium malariae / Q000235:genetics / Q000302:isolation & purification; D041122:Plasmodium ovale / Q000235:genetics / Q000302:isolation & purification; D010966:Plasmodium vivax / Q000235:genetics* / Q000302:isolation & purification; D016133:Polymerase Chain Reaction / Q000379:methods
chemical_list: D016054:DNA, Protozoan