Introduction: Four different programmed death ligand 1 immunohistochemical assays are approved or in development as companion or complementary diagnostics to different immunotherapeutic agents in lung carcinoma. We sought to determine whether these assays are technically equivalent and whether one antibody can be used on an alternate staining platform. Methods: Serial sections of tissue microarrays constructed from 368 cases of resected lung cancer were stained for 22C3 and 28‐8 on the Dako Link 48 platform (Dako, Carpinteria, Ca) and for SP142 and SP263 on the Ventana Benchmark Ultra platform (Ventana Medical Systems, Tucson, AZ) strictly as per product insert. A protocol was developed to use the 22C3 antibody on the Ventana Benchmark Ultra platform. Results: Differences in mean tumor cell and immune cell staining were observed between the four assays (p < 0.001). Differences between 22C3 and 28‐8 were not statistically significant. Concordance of tumor cell scores was good (intraclass correlation coefficient [ICC] = 0.674), particularly when SP142 was excluded as an outlier (ICC = 0.755). The highest concordance was seen between 22C3 and 28‐8 (ICC = 0.812). Concordance was poor for immune cell staining (ICC = 0.212). When dichotomized according to clinically relevant cutoffs, pairwise comparisons showed poor to moderate concordance (&kgr; = 0.196–0.578), with positive percent agreement ranging from 15.1% to 90.0%. The 22C3 antibody performed comparably on the Dako Link 48 platform and the alternate Ventana Benchmark Ultra platform (ICC = 0.921, &kgr; = 0.897). Conclusions: Concordance between the four programmed death ligand 1 immunohistochemical assays when performed and scored as intended show that apart from 28‐8 and 22C3, they cannot be used interchangeably in clinical practice. A protocol was successfully developed to use 22C3 on an alternate platform, which may help to overcome some barriers to implementation.

中文翻译：

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肺癌中四种 PD-L1 免疫组化检测的比较

简介：四种不同的程序性死亡配体 1 免疫组织化学分析已被批准或正在开发中，作为肺癌不同免疫治疗药物的伴随或补充诊断方法。我们试图确定这些检测在技术上是否等效，以及是否可以在替代染色平台上使用一种抗体。方法：从 368 例切除的肺癌患者构建的组织微阵列的连续切片在 Dako Link 48 平台（Dako，Carpinteria，Ca）上染色 22C3 和 28-8，在 Ventana Benchmark Ultra 平台（Ventana Medical）上染色 SP142 和 SP263 Systems, Tucson, AZ) 严格按照产品说明书。开发了在 Ventana Benchmark Ultra 平台上使用 22C3 抗体的协议。结果：在四种测定之间观察到平均肿瘤细胞和免疫细胞染色的差异（p < 0.001）。22C3 和 28-8 之间的差异无统计学意义。肿瘤细胞评分的一致性很好（类内相关系数 [ICC] = 0.674），特别是当 SP142 作为异常值被排除时（ICC = 0.755）。最高的一致性出现在 22C3 和 28-8 之间（ICC = 0.812）。免疫细胞染色的一致性较差（ICC = 0.212）。当根据临床相关临界值进行二分时，成对比较显示出差到中等的一致性（&kgr; = 0.196–0.578），阳性百分比一致性范围为 15.1% 到 90.0%。22C3 抗体在 Dako Link 48 平台和替代的 Ventana Benchmark Ultra 平台上的表现相当（ICC = 0.921，&kgr; = 0.897）。结论：按预期进行和评分时，四种程序性死亡配体 1 免疫组织化学测定之间的一致性表明，除了 28-8 和 22C3，它们在临床实践中不能互换使用。成功开发了一个协议，在替代平台上使用 22C3，这可能有助于克服一些实施障碍。