Novel image-based titration method for potency testing of diphtheria toxoid in Vero cell assay.

IF 1.1 4区 医学 Q4 INFECTIOUS DISEASES
Miyuki Kimura, Masaaki Iwaki, Tsuyoshi Kenri, Mitsutoshi Senoh
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引用次数: 0

Abstract

The potency of diphtheria toxoid is determined by titrating neutralizing antibody levels in immunized mice using the Vero cell assay. The WHO manual recommends titration by determining the cytotoxic endpoint through measuring cell metabolism and observing cell morphology under a microscope, which has been conducted in our laboratory; however, the former is time-consuming and the latter subjective. To address these limitations, we have developed a novel endpoint determination method based on cell image analysis. We assessed the feasibility of this image analysis and compared it with microscopic observation and cell metabolism measurement. Consequently, image analysis proved effective for endpoint determination, yielding potency values comparable to existing methods in measuring potencies of commercial vaccines. These findings suggest that image analysis, being objective and convenient, can serve as a reliable alternative method for potency testing of diphtheria vaccines.

基于图像的白喉类毒素Vero细胞效价检测新方法。
白喉类毒素的效力是通过在免疫小鼠中使用Vero细胞测定滴定中和抗体水平来确定的。世卫组织手册建议在显微镜下通过测量细胞代谢和观察细胞形态来确定细胞毒性终点,并在我们实验室进行了滴定;然而,前者是费时的,后者是主观的。为了解决这些限制,我们开发了一种基于细胞图像分析的新型端点确定方法。我们评估了这种图像分析的可行性,并将其与显微镜观察和细胞代谢测量进行了比较。因此,图像分析被证明对终点测定是有效的,产生的效力值与现有的测量商业疫苗效力的方法相当。结果表明,图像分析具有客观、方便的特点,可作为白喉疫苗效价检测的可靠替代方法。
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来源期刊
CiteScore
4.50
自引率
4.50%
发文量
172
审稿时长
2 months
期刊介绍: Japanese Journal of Infectious Diseases (JJID), an official bimonthly publication of National Institute of Infectious Diseases, Japan, publishes papers dealing with basic research on infectious diseases relevant to humans in the fields of bacteriology, virology, mycology, parasitology, medical entomology, vaccinology, and toxinology. Pathology, immunology, biochemistry, and blood safety related to microbial pathogens are among the fields covered. Sections include: original papers, short communications, epidemiological reports, methods, laboratory and epidemiology communications, letters to the editor, and reviews.
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