Earticle

초록

영어

When one makes a decision based on a quantified value, one must know the precision
of the value, the LOD and the ROQ. According to the guideline for the validation of the
ICH, the precision of an analytical value by ELISA can be described from the standard
deviation or related standard deviation (RSD) by repeated experiments at various
concentrations of the analyte. We developed a mathematical model for predicting
precision without performing repeated experiments using ELISA. When the model is
applied to ELISA, the RSD of measurements is expressed as the error parameters and
the calibration curve. The optimum conditions for ELISA, such as the reaction time, the
concentration of the antibodies, and the concentration of the enzyme-conjugated antigen
(antibody) have been determined by trial and error. In this study, to reduce the number
of optimization experiments, the initial screening of the candidate antibodies and the
determination of the optimal reaction conditions has often been carried out on the basis
of the kinetic properties against the antigen of interest. The LOD and ROQ were
determined from a model describing the calibration curve and precision profile of the
ELISA.

저자

• Dong Hwan Choi [ BioNanotechnology Research Center, Korea Research Institute of Bioscience and Biotechnology ]
• Yoshio Katakura [ Department of Biotechnology, Graduate School of Engineering, Osaka University ]
• Rieko Matsuda [ National Institute of Health Science, Tokyo, Japan ]
• Yuzuru Hayashi [ National Institute of Health Science, Tokyo, Japan ]
• Seok Ki Lee [ BioNanotechnology Research Center, Korea Research Institute of Bioscience and Biotechnology ]
• Junhyoung Ahn [ BioNanotechnology Research Center, Korea Research Institute of Bioscience and Biotechnology ]
• Joo Young Byun [ BioNanotechnology Research Center, Korea Research Institute of Bioscience and Biotechnology ]
• Hwa Young Sung [ BioNanotechnology Research Center, Korea Research Institute of Bioscience and Biotechnology ]
• Nae-Rym Lee [ BioNanotechnology Research Center, Korea Research Institute of Bioscience and Biotechnology ]
• Min-Gon Kim [ BioNanotechnology Research Center, Korea Research Institute of Bioscience and Biotechnology ]
• Suteaki Shioya [ Department of Biotechnology, Graduate School of Engineering, Osaka University ]

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국생물공학회 학술대회

• 간기

  반년간

• 수록기간

  1985~2013

• 십진분류

  KDC 476 DDC 576