Department of Pathology, University of California San Diego, La Jolla, California, USA.
Aurora Health Care, Milwaukee, Wisconsin, USA.
J Clin Pathol. 2024 Mar 20;77(4):284-290. doi: 10.1136/jcp-2022-208371.
Several modes of assay interference common to immunoassays affect solid-phase single-antigen bead-based immunoassays (SAB) used to detect antibodies against human leucocyte antigens (HLA). Best practice recommendations include methods to address assay interference, though the clinical impact and optimal approaches are undefined. We sought to evaluate assay interference in HLA SAB to identify an efficient approach for avoiding erroneous results.
Retrospective analysis of 14 059 patient samples tested for anti-HLA antibodies was performed. This included 4685 samples tested prior to implementation of serum pretreatment with EDTA and 4982 samples tested with routine EDTA treatment using the same testing algorithm. An algorithm for efficiently identifying and processing samples with suspected interference was evaluated in a separate cohort of 4392 EDTA-treated samples.
EDTA serum pretreatment reduced assay interference, but did not eliminate all modes of interference. A protocol for identification and testing of samples with suspected interference facilitated efficient detection of interference while reducing the amount of additional testing required.
Our data indicate that a single-method approach is insufficient to address all sources of interference in HLA SAB. A multimodal approach with a proactive screening is a more effective way to minimise risk of erroneous results.
几种常见于免疫测定的检测干扰模式会影响用于检测针对人类白细胞抗原（HLA）的抗体的固相单抗原珠免疫测定（SAB）。最佳实践建议包括解决检测干扰的方法，尽管其临床影响和最佳方法尚不清楚。我们试图评估 HLA SAB 中的检测干扰，以确定避免错误结果的有效方法。
对 14059 例接受抗 HLA 抗体检测的患者样本进行回顾性分析。这包括在实施 EDTA 血清预处理之前检测的 4685 例样本和使用相同检测算法检测的 4982 例常规 EDTA 处理样本。在另一个 4392 例 EDTA 处理样本的队列中评估了一种用于有效识别和处理疑似干扰样本的算法。
EDTA 血清预处理减少了检测干扰，但并未消除所有干扰模式。一个用于识别和测试疑似干扰样本的方案促进了干扰的有效检测，同时减少了所需的额外测试量。
我们的数据表明，单一方法不足以解决 HLA SAB 中所有来源的干扰。具有主动筛查的多模式方法是降低错误结果风险的更有效方法。
