Annals of Laboratory Medicine

Korean Society for Laboratory Medicine (대한진단검사의학회)
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Performance Evaluation of Real-Q Enterovirus Quantification Kit for Enterovirus by Real-time PCR

  • Song, Dual (Department of Laboratory Medicine, Pusan National University School of Medicine) ;
  • Kim, Shine-Young (Department of Laboratory Medicine, Pusan National University School of Medicine) ;
  • Jo, Son-A (Department of Laboratory Medicine, Pusan National University School of Medicine) ;
  • Hahm, Hyung-Il (Department of Medicine, Pusan National University School of Medicine) ;
  • Hwang, Sang-Hyun (Department of Laboratory Medicine, Pusan National University School of Medicine) ;
  • Lim, Young-Tak (Department of Pediatrics, Pusan National University School of Medicine) ;
  • Kim, Hyung-Hoi (Department of Laboratory Medicine, Pusan National University School of Medicine) ;
  • Chang, Chul-Hun L. (Department of Laboratory Medicine, Pusan National University School of Medicine) ;
  • Lee, Eun-Yup (Department of Laboratory Medicine, Pusan National University School of Medicine)
  • Received : 2010.04.22
  • 심사 : 2010.11.01
  • 발행 : 2010.12.01
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초록

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 $3{\times}10^2$ to $3{\times}10^{10}$ copies/mL, and the detection limit of the kit was 83 copies/mL. The withinrun, 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.

배경 : 무균성 수막염 환자를 분자진단법으로 조기에 진단하는 것은 불필요한 치료 및 의료비용 감소에 중요한 역할을 하는 것으로 알려져 있다. 이에 저자들은 최근 국내에서 개발된 Real-Q Enterovirus Quantification kit (BioSewoom Inc., Korea)의 성능 평가를 시행하였다. 방법 : Real-Q Enterovirus Quantification kit의 검출한계, 정밀도, 직선성, 교차반응 및 전통적인 역전사중합효소연쇄 반응법과의 비교평가를 시행하였다. 2009년 3월부터 9월까지 소아청소년과에서 무균성 수막염이 의심되는 환아 및 1세 미만 영아에서 패혈증이 의심되는 환아 91명, 그리고 열성경련이 의심되어 감별진단을 위해 장바이러스 검사가 의뢰된 환아 48명의 뇌척수액을 대상으로 키트의 성능을 평가하였다. 결과 : Real-Q Enterovirus Quantification kit는 $3{\times}10^2-3{\times}10^{10}$ copies/mL 범위에서 직선성을 보였으며(r=0.997), 검출한계는 83 copies/mL이었다. 정밀도는 검사차례내 정밀도변이계수(CV) 5.3-7.6%, 검사차례간 정밀도 변이계수 9.5-12.3%, 검사일간 정밀도 변이계수는 11.4-13.4%이었다. HBV DNA performance panels 등의 virus 및 다른 세균주와의 교차반응은 없었다. 무균성 수막염이 의심되는 뇌척수액 64예 중 25예(39.1%)에서 양성이었고, 1세 미만 영아에서 패혈증이 의심되어 의뢰된 검체 27예 중 12예(44.4%), 열성경련의 감별진단으로 의뢰된 48예 중에서는 4예(8.3%)에서 양성이었다. 또한 전통적인 역전사중합효소연쇄반응법과 높은 일치율을 보였다(73/74). 결론 : Real-Q Enterovirus Quantification kit는 검출한계, 정밀도, 직선성, 교차반응 등의 성능에 있어 우수하며, 기존 검사법과의 높은 일치율을 보이고, 임상 검체에서도 높은 장바이러스 검출률을 보여, 무균성 수막염의 진단뿐만 아니라 발열을 보이는 1세 미만 영아에서 장바이러스 감염의 진단에도 유용할 것으로 판단된다.

키워드

과제정보

연구 과제 주관 기관 : Pusan National University

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