Richter A W
Int Arch Allergy Appl Immunol. 1980;61(4):457-66. doi: 10.1159/000232474.
A simple immunochemical procedure, based on reversed single radial immunodiffusion (RSRI) was developed to detect commonly occurring traces of antigenic contaminants in clinical dextran. High-titred antisera against non-dextran components of Leuconostoc mesenteroides NRRL B512 were produced and served as analytical reagents. Dextran samples were incorporated into a gel layer. Presence of contaminants is revealed by precipitate formation following application of antiserum to a well cut into the gel. Antigenic contaminants can be detected in concentrations exceeding 10 ppm by the Leuconostoc-RSRI test. Screen results on 119 clinical dextran samples from manufactures in different countries disclosed presence of antigen traces in 82% of preparations. Introduction of the new test and improved purification measures at Pharmacia AB resulted in purer clinical dextran with negative RSRI test scores in 99% of batches produced. Only batches passing this test are released for clinical use. Although no direct correlation was found between contaminant levels and incidence of dextran reactions, antigenic contaminants may play a contributory role in elicitation of mild reactions.
开发了一种基于反向单向免疫扩散（RSRI）的简单免疫化学方法，用于检测临床用右旋糖酐中常见的痕量抗原性污染物。制备了针对肠系膜明串珠菌NRRL B512非右旋糖酐成分的高效价抗血清，并用作分析试剂。将右旋糖酐样品掺入凝胶层中。将抗血清加入凝胶中切出的孔中后，通过沉淀形成来揭示污染物的存在。通过明串珠菌-RSRI试验可以检测到浓度超过10 ppm的抗原性污染物。对来自不同国家制造商的119份临床右旋糖酐样品的筛查结果显示，82%的制剂中存在抗原痕迹。在Pharmacia AB公司引入新的检测方法和改进的纯化措施后，生产的临床右旋糖酐纯度更高，99%的批次RSRI检测结果为阴性。只有通过该检测的批次才能放行用于临床。虽然未发现污染物水平与右旋糖酐反应发生率之间存在直接相关性，但抗原性污染物可能在引发轻度反应中起促成作用。
