Korean J Lab Med.  2010 Dec;30(6):624-630. 10.3343/kjlm.2010.30.6.624.

Performance Evaluation of Real-Q Enterovirus Quantification Kit for Enterovirus by Real-time PCR

• Song D
• Kim SY
• Jo SA
• Hahm HI
• Hwang SH
• Lim YT
• Kim HH
• Chang CL
• Lee EY

• KMID: 1781669
• DOI: http://doi.org/10.3343/kjlm.2010.30.6.624

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.

Keyword

Human enteroviruses; Aseptic meningitis; Real time PCR; Performance evaluation; Cerebrospinal fluid

MeSH Terms

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

Figure

• 

  Fig. 1. Linearity range of Real-Q Enterovirus Quantification kit (BioSewoom Inc., Korea).

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