Dionne Sara O, Akana Hillary C S R, Real Michael, Elliott Kimberly A, O'Neale Brenden R
Eurofins Donor & Product Testing, LLC, Centennial, CO, USA.
MTF Biologics, Edison, NJ, USA.
Cell Tissue Bank. 2025 Sep 8;26(3):40. doi: 10.1007/s10561-025-10193-0.
In the United States, the use of Food & Drug Administration (FDA)-licensed, approved, or cleared tests is required for infectious disease screening and determining the eligibility of deceased donors for all Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). With the discontinuation of two manual enzyme-linked immunoassay (EIA) tests, automated Chemiluminescent Microparticle Immunoassay (CMIA) technology was introduced as the primary alternative. This study compares serologic reactivity rates between manual EIA and automated CMIA methods. Serology testing was performed on blood specimens from deceased tissue and cornea donors using either manual EIA assays or automated CMIA platforms. A retrospective analysis of over 160,000 donors was conducted to evaluate assay-specific reactive rates. Concordance between serology and Nucleic Acid Testing (NAT) results was also assessed. Reactive rates for HBsAg, HIV-1/2 antibodies, and HTLV-I/II antibodies increased following the transition to CMIA-based testing compared to manual EIA methods. However, these increases were not associated with a corresponding rise in NAT reactive results, indicating a potential increase in false-positive or non-viremic results. Automated testing offers improved quality control and reduces variability associated with manual techniques. However, the shift to CMIA assays resulted in a higher number of reactive serology results, leading to increased donor ineligibility despite negative NAT results. The data presented here highlights the potential impact on donor deferral rates for tissue and cornea donors due to assay platform changes.
在美国，进行传染病筛查以及确定所有人类细胞、组织和基于细胞与组织的产品（HCT/Ps）的已故捐赠者资格时，需要使用获得美国食品药品监督管理局（FDA）许可、批准或核准的检测方法。随着两种手动酶联免疫吸附测定（EIA）检测方法的停用，自动化化学发光微粒子免疫测定（CMIA）技术作为主要替代方法被引入。本研究比较了手动EIA和自动化CMIA方法之间的血清学反应率。使用手动EIA检测或自动化CMIA平台对已故组织和角膜捐赠者的血液标本进行血清学检测。对超过160,000名捐赠者进行了回顾性分析，以评估特定检测方法的反应率。还评估了血清学与核酸检测（NAT）结果之间的一致性。与手动EIA方法相比，向基于CMIA的检测方法转变后，乙肝表面抗原（HBsAg）、人类免疫缺陷病毒1/2型（HIV-1/2）抗体和人类嗜T淋巴细胞病毒I/II型（HTLV-I/II）抗体的反应率有所增加。然而，这些增加与NAT反应性结果的相应上升无关，表明假阳性或非病毒血症结果可能增加。自动化检测提供了更好的质量控制，并减少了与手动技术相关的变异性。然而，转向CMIA检测导致反应性血清学结果数量增加，尽管NAT结果为阴性，但仍导致捐赠者不合格率上升。此处呈现的数据突出了检测平台变化对组织和角膜捐赠者的捐赠延期率的潜在影响。
