Journal of the Korea Institute of Military Science and Technology (한국군사과학기술학회지)

The Korea Institute of Military Science and Technology (한국군사과학기술학회)
권호 표지

ELISA Validation for anti-PA Antibody Titer Measurements

항-보호항원 항체의 역가 측정을 위한 효소면역측정법 밸리데이션

  • Received : 2010.03.19
  • Accepted : 2010.05.20
  • Published : 2010.05.05
Download PDF
⟨ Previous Next ⟩

Abstract

The vaccine is biological pretreatment that improves immunity to a particular disease. We can get immunity from producing antibody with injection antigen which has ability to defense against the disease. The ELISA is the most widely used method to measure antibody titer. We have developed and performed validation of ELISA according to the guideline of KFDA and ICH. In this paper, we have verified ELISA method is an excellent method to measure the titer of anti-PA antibody. We have constructed recombinant protective antigen among anthrax toxins and used as antigen of ELISA. In this validation, we have evaluated precision (repeatability, interlaboratory precision), specificity, linearity(range) and LOD, which are validation articles suggested by guideline. Inter-person precision was replaced with inter-laboratory precision. From the results, we have confirmed high precision in all experiments with CV under 20%.

Keywords

References

  1. "의약품등 분석법의 밸리데이션에 대한 가이드라인", 식품의약품안전청 의약품평가부, 2004.
  2. ICH Guidance for Inductry; Validation of Analytical Procedures: Methodology. Nov., 1996.
  3. Hering, D., Thompson, W., Hewetson, J., Little, S., Norris, S. and Pace-Tempeton, J. "Validation of the Anthrax Lethal Toxin Neutralization Assay", Biologicals., Vol. 32, pp. 17-27, 2004. https://doi.org/10.1016/j.biologicals.2003.09.003
  4. Pombo, M., Berthold, I., Gingrich, E., Jaramillo, M., Leef, M., Sirota., L, Hsu, H. and Arciniega, J. "Validation of an anti-PA ELISA for the Potency Testing of Anthrax Vaccine in Mice", Biologicals, Vol. 32, pp. 157-163, 2001.
  5. 경천수, "Method Validation Methodology and Case Study for Biologics", 생물산업기술실용화센터 보고서, 한국생산기술연구원 생물산업기술실용화센터, 2005.