title: Genetic variability in Plasmodium vivax aldolase gene in Korean isolates and the sensitivity of the Binax Now malaria test.
abstract: Introduction of rapid malaria diagnostic tests (RDT) initiated numerous field evaluations in various epidemiologic settings. But the efficiency of some RTD kits based on aldolase raised reservations for direct implementation of RDT into clinical settings. We performed Binax Now malaria test in 84 Korean Plasmodium vivax isolates and compared it with the traditional Giemsa stain microscopy test as the reference standard. The sensitivity of Binax Now was 62.0% for P. vivax cases (52/84, 95% CI 51.2-71.6%) with 100.0% specificity (50/50, 95% confidence interval 92.9-100%). After the aldolase gene sequence analysis of 84 isolates, two synonymous mutations in aldolase gene were identified in both Binax Now positive and negative samples. No significant association between the mutations and Binax Now malaria tests was found. Thus, the genetic variability would not explain the poor performance of P. vivax RDTs by detecting aldolase in ROK isolates.
authors.affiliation: Department of Laboratory Medicine, Brain Korea 21 Graduate School of Medicine, College of Medicine, Korea University, Seoul, Korea.
authors.forename: Chi-Hyun
authors.initials: CH
authors.lastname: Cho
authors.forename: Myoung Hyun
authors.initials: MH
authors.lastname: Nam
authors.forename: Jang Su
authors.initials: JS
authors.lastname: Kim
authors.forename: Eun Taek
authors.initials: ET
authors.lastname: Han
authors.forename: Won Ja
authors.initials: WJ
authors.lastname: Lee
authors.forename: Jun Seo
authors.initials: JS
authors.lastname: Oh
authors.forename: Seong Soo A
authors.initials: SS
authors.lastname: An
authors.forename: Chae Seung
authors.initials: CS
authors.lastname: Lim
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D005634:Fructose-Bisphosphate Aldolase / Q000235:genetics*; D014644:Genetic Variation; D006801:Humans; D016780:Malaria, Vivax / Q000175:diagnosis*; D008875:Middle Aged; D010966:Plasmodium vivax / Q000201:enzymology* / Q000235:genetics; D020641:Polymorphism, Single Nucleotide; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D011933:Reagent Kits, Diagnostic; D005634:Fructose-Bisphosphate Aldolase