{"title":"免疫球蛋白制剂对抗 HLA 抗体特异性分析的影响。","authors":"Rie Nakagawa, Hideaki Matsuura, Hayato Kojima, Yuko Abe, Ayuna Yamada, Hiroki Doi, Yasuo Miura","doi":"10.1093/labmed/lmae078","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Donor-specific antibodies (DSAs) targeting human leukocyte antigens (HLAs) substantially reduce the longevity of transplanted organs. Desensitization of DSA-positive renal transplant recipients is achieved through intravenous administration of immunoglobulin (IVIg). However, the presence and detectability of anti-HLA antibodies in IVIg preparations following administration are not fully understood. We aimed to assess whether immunoglobulin preparations contain anti-HLA antibodies that can be detected as passive antibodies when administered into the body.</p><p><strong>Methods: </strong>We evaluated 3 immunoglobulin preparations from different pharmaceutical companies, using anti-HLA class I and II antibody specificity tests and immunocomplex capture fluorescence analysis (ICFA).</p><p><strong>Results: </strong>Direct testing for anti-HLA antibodies resulted in high background errors, particularly for Venoglobulin. Diluting Venoglobulin to physiological concentrations revealed the presence of anti-HLA class I antibodies; however, no common alleles were found between the specificity identification test and ICFA.For Glovenin and Venilon, anti-HLA class I and II antibodies were detected; however, variability was observed across different test reagent lots. Moreover, dilution of the globulin formulation revealed a prozone phenomenon.</p><p><strong>Conclusion: </strong>The administration of IVIg complicates the accurate detection of anti-HLA antibodies, underscoring the need for careful interpretation of test results post-IVIg administration.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Impact of immunoglobulin preparations on anti-HLA antibody specificity analysis.\",\"authors\":\"Rie Nakagawa, Hideaki Matsuura, Hayato Kojima, Yuko Abe, Ayuna Yamada, Hiroki Doi, Yasuo Miura\",\"doi\":\"10.1093/labmed/lmae078\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Donor-specific antibodies (DSAs) targeting human leukocyte antigens (HLAs) substantially reduce the longevity of transplanted organs. Desensitization of DSA-positive renal transplant recipients is achieved through intravenous administration of immunoglobulin (IVIg). However, the presence and detectability of anti-HLA antibodies in IVIg preparations following administration are not fully understood. We aimed to assess whether immunoglobulin preparations contain anti-HLA antibodies that can be detected as passive antibodies when administered into the body.</p><p><strong>Methods: </strong>We evaluated 3 immunoglobulin preparations from different pharmaceutical companies, using anti-HLA class I and II antibody specificity tests and immunocomplex capture fluorescence analysis (ICFA).</p><p><strong>Results: </strong>Direct testing for anti-HLA antibodies resulted in high background errors, particularly for Venoglobulin. Diluting Venoglobulin to physiological concentrations revealed the presence of anti-HLA class I antibodies; however, no common alleles were found between the specificity identification test and ICFA.For Glovenin and Venilon, anti-HLA class I and II antibodies were detected; however, variability was observed across different test reagent lots. Moreover, dilution of the globulin formulation revealed a prozone phenomenon.</p><p><strong>Conclusion: </strong>The administration of IVIg complicates the accurate detection of anti-HLA antibodies, underscoring the need for careful interpretation of test results post-IVIg administration.</p>\",\"PeriodicalId\":94124,\"journal\":{\"name\":\"Laboratory medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-09-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Laboratory medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1093/labmed/lmae078\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Laboratory medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/labmed/lmae078","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
背景:针对人类白细胞抗原(HLAs)的捐赠者特异性抗体(DSAs)会大大降低移植器官的寿命。通过静脉注射免疫球蛋白(IVIg)可实现 DSA 阳性肾移植受者的脱敏。然而,人们对给药后 IVIg 制剂中抗 HLA 抗体的存在和可检测性并不完全了解。我们的目的是评估免疫球蛋白制剂是否含有抗 HLA 抗体,这些抗体在进入人体后可作为被动抗体被检测到:我们使用抗 HLA I 类和 II 类抗体特异性测试和免疫复合物捕获荧光分析(ICFA)对来自不同制药公司的 3 种免疫球蛋白制剂进行了评估:结果:直接检测抗-HLA 抗体会产生较高的背景误差,尤其是在检测免疫球蛋白时。将静脉球蛋白稀释到生理浓度后,发现存在抗 HLA I 类抗体;但是,特异性鉴定测试和 ICFA 之间没有发现共同的等位基因。此外,稀释球蛋白制剂还发现了原区现象:结论:IVIg 的使用使抗 HLA 抗体的准确检测变得更加复杂,因此需要在使用 IVIg 后仔细解读检测结果。
Impact of immunoglobulin preparations on anti-HLA antibody specificity analysis.
Background: Donor-specific antibodies (DSAs) targeting human leukocyte antigens (HLAs) substantially reduce the longevity of transplanted organs. Desensitization of DSA-positive renal transplant recipients is achieved through intravenous administration of immunoglobulin (IVIg). However, the presence and detectability of anti-HLA antibodies in IVIg preparations following administration are not fully understood. We aimed to assess whether immunoglobulin preparations contain anti-HLA antibodies that can be detected as passive antibodies when administered into the body.
Methods: We evaluated 3 immunoglobulin preparations from different pharmaceutical companies, using anti-HLA class I and II antibody specificity tests and immunocomplex capture fluorescence analysis (ICFA).
Results: Direct testing for anti-HLA antibodies resulted in high background errors, particularly for Venoglobulin. Diluting Venoglobulin to physiological concentrations revealed the presence of anti-HLA class I antibodies; however, no common alleles were found between the specificity identification test and ICFA.For Glovenin and Venilon, anti-HLA class I and II antibodies were detected; however, variability was observed across different test reagent lots. Moreover, dilution of the globulin formulation revealed a prozone phenomenon.
Conclusion: The administration of IVIg complicates the accurate detection of anti-HLA antibodies, underscoring the need for careful interpretation of test results post-IVIg administration.