实验室开发的使用克隆 E1L3N 检测非小细胞肺癌 PD-L1 表达状态的检测方法的临床评估。
Clinical evaluation of a laboratory-developed test using clone E1L3N for the detection of PD-L1 expression status in non-small cell lung cancer.
机构信息
The Key Laboratory of Interventional Pulmonology of Zhejiang Province, Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Department of Pathology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
出版信息
J Clin Lab Anal. 2021 Mar;35(3):e23696. doi: 10.1002/jcla.23696. Epub 2021 Jan 12.
BACKGROUND
Programmed death ligand 1 (PD-L1) has been used as a diagnostic marker to identify patients that will benefit from immune checkpoint inhibitors in non-small cell lung cancer (NSCLC). Immunohistochemistry with E1L3N clone is one of the most widely used and inexpensive laboratory-developed tests for PD-L1, but still need to be compared and validated with standard methods for clinical application.
METHODS
We investigated the performance of E1L3N clone for PD-L1 testing in 299 tumor tissues of NSCLC patients and its comparability with FDA-approved 22C3 clone.
RESULTS
The results show that the negative coincidence rate, weak positive coincidence rate, and positive coincidence rate were 97.4%, 92.2%, and 97.6% using the E1L3N assay relative to the 22C3 assay, respectively. An overall agreement of 96.3% was achieved between these two assays. We also found that the overall concordances were 97.8% and 93.9% for PD-L1 detection in large and small specimens, respectively, and no significant difference was obtained between these two assays (p = 0.076). In addition, the expression of PD-L1 was not detected in tumor tissues of benign lung disease using both the E1L3N and 22C3 assays.
CONCLUSION
E1L3N can be used as a reliable alternative antibody clone to evaluate PD-L1 expression status for NSCLC patients.
背景
程序性死亡配体 1（PD-L1）已被用作一种诊断标志物，以确定非小细胞肺癌（NSCLC）患者是否受益于免疫检查点抑制剂。E1L3N 克隆的免疫组织化学是最广泛使用和廉价的实验室开发的 PD-L1 检测方法之一，但仍需要与标准方法进行比较和验证，以用于临床应用。
方法
我们研究了 E1L3N 克隆在 299 例 NSCLC 患者肿瘤组织中用于 PD-L1 检测的性能，并与 FDA 批准的 22C3 克隆进行了比较。
结果
结果显示，E1L3N 检测相对于 22C3 检测的阴性符合率、弱阳性符合率和阳性符合率分别为 97.4%、92.2%和 97.6%。两种检测方法之间的总体一致性达到 96.3%。我们还发现，在大标本和小标本中，PD-L1 检测的总体一致性分别为 97.8%和 93.9%，两种检测方法之间没有显著差异（p=0.076）。此外，两种检测方法均未在良性肺部疾病的肿瘤组织中检测到 PD-L1 的表达。
结论
E1L3N 可作为一种可靠的替代抗体克隆，用于评估 NSCLC 患者的 PD-L1 表达状态。
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