title: [Performance evaluation of Real-Q Enterovirus Quantification kit for enterovirus by real-time PCR].
abstract: BACKGROUND
  Molecular methods have enabled rapid diagnosis of aseptic meningitis and have reduced both unnecessary therapeutic interventions and medical costs. In this study, we evaluated the analytical performance of the recently developed Real-Q Enterovirus Quantification kit (BioSewoom Inc., Korea).
  
  
  METHODS
  We evaluated the detection limit, precision, linearity, and cross-reactivity of the Real-Q Enterovirus Quantification kit and compared it with the conventional PCR method. From March to September 2009, we tested 91 CSF specimens from patients who visited the pediatrics department of the university hospital with symptoms of aseptic meningitis or infantile sepsis, and we also tested 48 CSF specimens from patients with febrile convulsion for differential diagnosis.
  
  
  RESULTS
  The Real-Q Enterovirus Quantification kit showed good linearity (r=0.997) within a range from 3 × 10(2) to 3 × 10(10) copies/mL, and the detection limit of the kit was 83 copies/mL. The within-run, between-run, and between-day CVs were 5.3-7.6%, 9.5-12.3%, and 11.4-13.4%, respectively. There was no cross reactivity between enteroviruses and various microorganisms. Positive results were obtained for 39.1% (25/64) of the patients suspected of aseptic meningitis and 44.4% (12/27) of the patients suspected of infantile sepsis. However, among the 48 children with febrile conversion, only 4 were positive for enterovirus. Further, the concordance with conventional PCR was high (73/74).
  
  
  CONCLUSIONS
  The Real-Q Enterovirus Quantification kit showed excellent linearity and high reliability with a broad reportable range. It showed good detection rate when used with clinical specimens and also showed a high concordance with the conventional method. Therefore, this assay would be clinically useful not only in diagnosis of aseptic meningitis but also in differential diagnosis of infantile sepsis.
authors.affiliation: Department of Laboratory Medicine, Pusan National University School of Medicine, Busan, Korea.
authors.forename: Dual
authors.initials: D
authors.lastname: Song
authors.forename: Shine Young
authors.initials: SY
authors.lastname: Kim
authors.forename: Son A
authors.initials: SA
authors.lastname: Jo
authors.forename: Hyung-Il
authors.initials: HI
authors.lastname: Hahm
authors.forename: Sang-Hyun
authors.initials: SH
authors.lastname: Hwang
authors.forename: Young Tak
authors.initials: YT
authors.lastname: Lim
authors.forename: Hyung Hoi
authors.initials: HH
authors.lastname: Kim
authors.forename: Chulhun L
authors.initials: CL
authors.lastname: Chang
authors.forename: Eun Yup
authors.initials: EY
authors.lastname: Lee
mesh_terms: D002648:Child; D002675:Child, Preschool; D003429:Cross Reactions; D004279:DNA, Viral / Q000032:analysis*; D004770:Enterovirus / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D007223:Infant; D008582:Meningitis, Aseptic / Q000175:diagnosis / Q000821:virology; D016133:Polymerase Chain Reaction / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic