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Performance comparison and evaluation of interferon-gamma assay kit for bovine tuberculosis diagnosis

소 결핵 진단을 위한 인터페론감마 검사 키트의 성능 비교 평가

  • Hong, Leegon (College of Veterinary Medicine, Seoul National University) ;
  • Choi, Woojae (College of Veterinary Medicine, Seoul National University) ;
  • Ro, Younghye (College of Veterinary Medicine, Seoul National University) ;
  • Ahn, Sunmin (College of Veterinary Medicine, Seoul National University) ;
  • Kim, Eunkyung (Farm Animal Clinical Training and Research Center, Seoul National University) ;
  • Choe, Eunhee (Farm Animal Clinical Training and Research Center, Seoul National University) ;
  • Kim, Danil (College of Veterinary Medicine, Seoul National University)
  • 홍이곤 (서울대학교 수의과대학) ;
  • 최우재 (서울대학교 수의과대학) ;
  • 노영혜 (서울대학교 수의과대학) ;
  • 안선민 (서울대학교 수의과대학) ;
  • 김은경 (서울대학교 산업동물임상교육연수원) ;
  • 최은희 (서울대학교 산업동물임상교육연수원) ;
  • 김단일 (서울대학교 수의과대학)
  • Received : 2020.08.06
  • Accepted : 2020.12.15
  • Published : 2020.12.30

Abstract

In Korea, bovine tuberculosis (bTB) is a representative zoonotic disease that causes considerable economic loss. In determining the positive bTB, the ELISA method for examining the amount of interferon-gamma (IFN-γ) is included in Korea's diagnostic standard method. Recently, commercially available BIONOTE TB-Feron ELISA Plus (TB-Feron Plus) that detects IFN-γ has been introduced. However, since the scientific basis for the performance is limited, we evaluated performance by comparing it with the results of another IFN-γ ELISA assay kit (BOVIGAM®) certified by Office International des Epizooties. In our research, 42 positive blood samples preliminarily tested with a tuberculin skin test and/or BOVIGAM® and 54 negative blood samples collected from three bTB free farms were subjected to IFN-γ assay using the TB-Feron Plus and the BOVIGAM®, respectively. The result shows that the sensitivity, specificity and accuracy were 81.0% (34/42), 100% (54/54), 91.7% (88/96) in TB-Feron Plus kit and 78.6% (33/42), 100% (54/54), 90.6% (87/96) in BOVIGAM® kit, respectively. Moreover, the overall accordance percentage of the two kits was 99.0% (95/96) and there was almost perfect agreement between two assays (Kappa=0.977, P<0.0001). Furthermore, additional studies confirmed that elevated lymphocyte numbers in blood did not interfere with the results of the TB-Feron Plus kit. And, delayed time from sampling to culture decreased the optical density (OD) value. Therefore, we concluded that the TB-Feron Plus kit was not inferior to BOVIGAM® in performance. High lymphocyte numbers in blood did not impact on TB-Feron Plus results, while delayed time before culture interfered with OD value.

Keywords

References

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