Standardization of an ELISA for the Relative Potency Assay of Inactivated Rabies Vaccines for Animal Use
スポンサーリンク
概要
- 論文の詳細を見る
The use of ELISA for the standardization of relative potency assay method of inactivated rabies vaccines for animal use was evaluated. The vaccine tested in this study was a candidate for the national reference vaccine, which induces enough protective immune response and constantly passes the challenge protection test using guinea-pigs that is adopted as the potency test in Japan. The international unit of this vaccine by NIH potency test was 3.5 I.U.<BR>The vaccine was gelfiltrated before ELISA. The ELISA was based on the sandwich ELISA descrived by M. Lafon. Dose response values were showed by logarithmic conversion of the optical density [y=log<SUB>10</SUB> (OD×1000) ] . The effective numbers of wells in a microplate were two. The gelfiltrated sample kept at 4°C was available within the limits of a whole day and night. The most suitable doses were D1=2<SUP>-2</SUP>, 2<SUP>-1</SUP>, 2<SUP>0</SUP> (dose metameter x=log<SUB>10</SUB>D<SUB>1</SUB>) .<BR>The relative potency assay method was defined as two parallel line assay with three doses by use of a reference vaccine. From the results of three or five replications by six examiners, error variance (δ<SUP>2</SUP>=s<SUP>2</SUP>), regression coefficient b and index of precision λ (=s/b) were 0.0066 (σ=s=0.081), 0.7860, and 0.1030 respec-tively. In addition, we defined error of the first kind or producer's risk as p=0.05 and error of the second kind or consumer's risk as p=0.1.<BR>Three tentative methods, A (number of replications r=2), B (r=3) and C (r=5), which settled desirable acceptance relative potency, m<SUB>0</SUB> and desirable rejected relative potency, m<SUB>1</SUB>, were drafted. Validity tests of linearity, quadratic, non parallelism of linearity and non parallelism of quadratic were performed by the sum of products calculated from dose response value. Next, acceptance or rejection of relative potency P (=antilog<SUB>10</SUB> m) was judge by acceptance value P (A method≥0.683, B method≥0.718, C method≥0.756) . Operating characteristic (OC) curve indicated that the efficiency of the assay was A>B>C and overall accurancy was A<B<C.
- 獣医疫学会の論文
獣医疫学会 | 論文
- 関節炎罹患豚由来アクリフラビン耐性豚丹毒菌の病原性と遺伝学的性状
- 健康牛における Erysipelothrix 属菌の保菌状況
- 我が国に飛来する水鳥における Vibrio 属菌の保有状況
- 繁殖育成豚および繁殖母豚の脚弱に関する実態調査
- 一養豚場における肥育豚の硝酸塩中毒の発生例