采用免疫放射分析和酶联免疫吸附测定法测定疫苗制剂中的胎牛血清。

Determination of foetal calf serum in vaccine preparations by immunoradiometric assay and enzyme-linked immunosorbent assay.

作者信息

Tresćec A, Valinger Z, Smerdel S, Tomasić J

机构信息

Institute of Immunology, Zagreb, Croatia.

出版信息

Biologicals. 1993 Jun;21(2):163-8. doi: 10.1006/biol.1993.1069.

DOI:10.1006/biol.1993.1069

PMID:8297600

Abstract

A simple and sensitive immunoradiometric assay (IRMA) for detection of foetal calf serum proteins in vaccine preparations has been developed. In this two-site sandwich assay the same preparation of polyclonal anti-FCS immunoglobulin (IgG) was used for coating the solid phase (as a capture antibody) and in a labelled form (I-125 labelled) for detection. The developed assay allows precise and accurate quantification of FCS proteins (down to 10 ng/ml) in vaccine preparations and has been used for screening of FCS residues (a) during production of measles vaccine, and (b) in various different commercial vaccine preparations. An enzyme-linked immunosorbent assay (ELISA) was also developed based on the same assay two-site sandwich principle, where anti-FCS was directly labelled with horse-radish peroxidase. ELISA was comparable in sensitivity and accuracy with IRMA.

摘要

已开发出一种简单灵敏的免疫放射分析（IRMA）方法，用于检测疫苗制剂中的胎牛血清蛋白。在这种双位点夹心分析中，使用相同的多克隆抗胎牛血清免疫球蛋白（IgG）制剂包被固相（作为捕获抗体），并以标记形式（碘-125标记）用于检测。所开发的分析方法能够精确、准确地定量疫苗制剂中的胎牛血清蛋白（低至10 ng/ml），并已用于（a）麻疹疫苗生产过程中以及（b）各种不同商业疫苗制剂中胎牛血清残留的筛查。还基于相同的双位点夹心原理开发了一种酶联免疫吸附测定（ELISA）方法，其中抗胎牛血清直接用辣根过氧化物酶标记。ELISA在灵敏度和准确性方面与IRMA相当。