Performance Evaluation of Real-Q Enterovirus Quantification Kit for Enterovirus by Real-time PCR.
10.3343/kjlm.2010.30.6.624
- Author:
Dual SONG
1
;
Shine Young KIM
;
Son A JO
;
Hyung Il HAHM
;
Sang Hyun HWANG
;
Young Tak LIM
;
Hyung Hoi KIM
;
Chulhun L CHANG
;
Eun Yup LEE
Author Information
1. Department of Laboratory Medicine, Pusan National University School of Medicine, Busan, Korea. mindcatch@hanmail.net
- Publication Type:Original Article ; English Abstract ; Evaluation Studies ; Research Support, Non-U.S. Gov't
- Keywords:
Human enteroviruses;
Aseptic meningitis;
Real time PCR;
Performance evaluation;
Cerebrospinal fluid
- MeSH:
Child;
Child, Preschool;
Cross Reactions;
DNA, Viral/*analysis;
Enterovirus/genetics/*isolation & purification;
Humans;
Infant;
Meningitis, Aseptic/diagnosis/virology;
Polymerase Chain Reaction/*methods;
Reagent Kits, Diagnostic;
Sensitivity and Specificity
- From:The Korean Journal of Laboratory Medicine
2010;30(6):624-630
- CountryRepublic of Korea
- Language:Korean
-
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 3x10(2) to 3x10(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.
