Korean Journal of Clinical Laboratory Science (대한임상검사과학회지)

Korean Society for Clinical Laboratory Science (대한임상검사과학회)
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Clinical Evaluation of a Rapid Diagnostic Test Kit for Canine Parvovirus and Coronavirus

개 파보바이러스와 코로나바이러스 진단을 위한 신속진단키트의 임상적 유용성

  • Chaeyeong MIN (Department of Clinical Laboratory Science, Dong-eui University) ;
  • Won-Shik KIM (Department of Clinical Laboratory Science, Daejeon Health Institute of Technology) ;
  • Chom-Kyu CHONG (GenBody Inc) ;
  • Yong LIM (Department of Clinical Laboratory Science, Dong-eui University)
  • 민채영 (동의대학교 임상병리학과) ;
  • 김원식 (대전보건대학교 임상병리과) ;
  • 정점규 (젠바디) ;
  • 임용 (동의대학교 임상병리학과)
  • Received : 2022.12.20
  • Accepted : 2023.03.08
  • Published : 2023.03.31
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Abstract

Canine parvovirus type 2 (CPV-2) and canine coronavirus (CCoV) are major pathogens that can induce gastroenteritis in dogs. They are highly contagious and have a high morbidity rate. There are no specific treatments available for them to date. Therefore, rapid and accurate diagnosis becomes essential. The rapid diagnostic test (RDT) for animals can be used widely in the field because it is fast and easy to use for diagnosis. Thus, this study aimed to clinically evaluate and confirm the clinical utility of CPV-2/CCoV RDT. The parameters evaluated included the limit of detection (LoD), cross-reactivity, interference, sensitivity, specificity, negative likelihood ratio (NLR), and kappa value. The results revealed that the LoD values for CPV-2 and CCoV were 9.7×10 50% tissue culture infectious dose (TCID50)/mL and 2.5×102 TCID50/mL, respectively. There was no cross-reactivity with nine pathogens or interference by interfering materials. The RDT showed a sensitivity of 90.0%, a specificity of 100.0%, NLR of 0.1, and a kappa value of 0.90 for diagnosing both viruses. In conclusion, CPV-2/CCoV RDT is useful as a screening test because of its high sensitivity, specificity, kappa value, and low NLR.

개 파보바이러스(canine parvovirus type 2, CPV-2)와 코로나바이러스(canine coronavirus, CCoV)는 개에서 위장관염을 일으키는 주요 병원체이다. 두 바이러스는 전염성과 이환율이 높고 특정한 치료법이 없어 신속 정확한 진단이 필요하다. 동물용 신속진단키트 (rapid diagnostic test, RDT)는 빠르고, 간편하여 진료현장에서 널리 활용되고 있다. 이에 본 연구에서는 성능평가를 통해 CPV-2/CCoV RDT의 임상적 유용성을 확인하고자 하였다. 성능평가 항목으로 최소검출한계(limit of detection, LoD), 교차반응, 간섭, 민감도, 특이도, 음성우도비(negative likelihood ratio, NLR), 카파통계량(kappa value, κ) 등을 확인하였다. 성능평가 결과, LoD는 CPV-2 9.7×10 50% tissue culture infections dose (TCID50)/mL, CCoV 2.5×102 TCID50/mL로 나타났다. 병원체 9종에 의한 교차반응과 간섭물질에 대한 간섭은 관찰되지 않았다. RDT는 두 바이러스의 검출에 있어 민감도 90.0%, 특이도 100.0%, NLR=0.1, κ=0.90으로 나타났다. 결론적으로 CPV-2/CCoV RDT는 높은 민감도, 특이도, κ와 낮은 NLR을 보여 선별검사로써 유용할 것으로 생각된다.

Keywords

Acknowledgement

This article is a revision of the first author's master's thesis.

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