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首页> 外文期刊>Biologicals: Journal of the International Association of Biological Standardization >Validation of ELISA for the determination of anti-ricin immunoglobulin G concentration in mouse sera.
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Validation of ELISA for the determination of anti-ricin immunoglobulin G concentration in mouse sera.

机译：ELISA在确定小鼠血清中抗蓖麻毒素免疫球蛋白G浓度中的有效性。

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摘要

An enzyme-linked immunosorbent assay (ELISA) for the determination of anti-ricin immunoglobulin G (IgG) concentration in mouse sera was systematically validated. The results obtained throughout the validation process strongly demonstrated that the ELISA was reliable, reproducible, and suitable for its intended use. The assay had a high level of precision within and between runs, was specific for the anti-ricin IgG, and showed no interference with a number of different serum matrices. The assay exhibited excellent accuracy, linearity, and stability. The mean recovery of four test samples with different known concentrations was 100.9+/-11.3%, 102.7+/-10.8%, 99.0+/-7.2%, and 95.9+/-11.3%, respectively (n=10). The mean recovery of the observed anti-ricin IgG concentration of three quality control samples run on 73 plates to their nominal concentrations was 100.1+/-7.3%, 100.2+/-5.8%, and 103.7+/-8.1%; and the coefficient of variation (CV) was 7.3%, 5.8%, and 7.8%, respectively. The back-calculated anti-ricin IgG concentration, %CV, and relative error of seven standards from the calibration curves run in the entire validation study were analyzed (n=7 x 73). The results indicated that the four-parameter logistic (4PL) equation, y=(a-d)/(1+(x/c)b)+d, provided an accurate representation of a sigmoidal relationship between the measured response and the logarithm of observed concentration of anti-ricin IgG in mouse sera for this ELISA. The lower limit of quantification and upper limit of quantification of the calibration curve were 3.3 ng/ml and 82.8 ng/ml, respectively. The measurable range of the assay would cover all possible anti-ricin IgG concentrations in mouse sera stimulated with a ricin vaccine candidate, when the test sera are measured at a 1:800 starting dilution followed by four additional fourfold serial dilutions.
机译：系统验证了用于测定小鼠血清中抗蓖麻毒素免疫球蛋白G（IgG）浓度的酶联免疫吸附测定（ELISA）。在整个验证过程中获得的结果有力地证明了ELISA的可靠性，可重复性和适用性。该试验在运行中和运行之间具有很高的精确度，对抗蓖麻毒素IgG具有特异性，并且对多种不同的血清基质均无干扰。该测定法显示出极好的准确性，线性和稳定性。具有不同已知浓度的四个测试样品的平均回收率分别为100.9 +/- 11.3％，102.7 +/- 10.8％，99.0 +/- 7.2％和95.9 +/- 11.3％（n = 10）。在73个平板上运行的三个质量控制样品中观察到的抗蓖麻毒素IgG浓度的平均回收率分别为100.1 +/- 7.3％，100.2 +/- 5.8％和103.7 +/- 8.1％;变异系数（CV）分别为7.3％，5.8％和7.8％。在整个验证研究中，对反算的抗蓖麻毒素IgG浓度，％CV和七个标准品相对于校准曲线的相对误差进行了分析（n = 7 x 73）。结果表明，四参数对数（4PL）方程y =（ad）/（1+（x / c）b）+ d可以准确表示测量的响应与实测对数之间的S形关系。 ELISA检测小鼠血清中抗蓖麻毒素IgG的浓度。校准曲线的定量下限和定量上限分别为3.3 ng / ml和82.8 ng / ml。当以1：800的起始稀释度和随后的四倍的四倍系列稀释度测量测试血清时，该测定的可测量范围将涵盖用蓖麻毒素疫苗候选物刺激的小鼠血清中所有可能的抗蓖麻毒素IgG浓度。

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