New Assay System Elecsys Anti-p53 to Detect Serum Anti-p53 Antibodies in Esophageal Cancer Patients and Colorectal Cancer Patients: Multi-institutional Study
New Assay System Elecsys Anti-p53 to Detect Serum Anti-p53 Antibodies in Esophageal Cancer Patients and Colorectal Cancer Patients: Multi-institutional Study
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DOI：
10.1245/s10434-020-09342-4
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发表时间：
2020-11-18
影响因子：
3.7
通讯作者：
Shimada, Hideaki
中科院分区：
文献类型：
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作者：
Yajima, Satoshi;Suzuki, Takashi;Shimada, Hideaki
背景 最近的几项研究表明，血清抗 p53 抗体 (s-p53-Abs) 可以与其他标记物结合来检测食管癌和结直肠癌。在本研究中，我们评估了新型电化学发光免疫分析（ECLIA；Elecsys 抗 p53）的 s-p53-Abs 检测的灵敏度和特异性。方法采用Elecsys抗p53测定法分析食管癌或结直肠癌患者治疗前血清中s-p53抗体的水平。健康志愿者、良性疾病患者和自身免疫性疾病患者的对照血清作为参考。此外，还评估了食管癌患者的鳞状细胞癌抗原（SCC-Ag）和细胞角蛋白19片段（CYFRA21-1），评估了结直肠癌患者的癌胚抗原（CEA）和碳水化合物抗原（CA）19-9。结果 该研究纳入了 281 名食管癌患者、232 名结直肠癌患者和 532 名对照者的样本。对照样品中s-p53-Abs的中值<0.02μg/mL（范围<0.02-29.2μg/mL）。假设特异性为 98%，则截止值确定为 0.05 μg/mL。 20% (57/281) 的食管癌患者和 18% (42/232) 的结直肠癌患者检测到 s-p53-Ab。 s-p53-Abs 分别与 SCC-Ag 和 CEA 结合，检测出 51% (144/281) 的食管癌患者和 53% (124/232) 的结直肠癌患者。结论 新的 s-p53-Abs 检测 Elecsys anti-p53 可用于高特异性检测食管癌和结直肠癌。将 s-p53-Ab 添加到传统标记中显着提高了总体检出率。
Background Several recent studies suggest that serum anti-p53 antibodies (s-p53-Abs) may be combined with other markers to detect esophageal and colorectal cancer. In this study, we assessed the sensitivity and specificity of s-p53-Abs detection of a new electrochemiluminescence immunoassay (ECLIA; Elecsys anti-p53). Methods Elecsys anti-p53 assay was used to analyze the level of s-p53-Abs in blood sera from patients with esophageal or colorectal cancer taken before treatment. Control blood sera from healthy volunteers, patients with benign diseases, and patients with autoimmune diseases served as a reference. In addition, squamous cell carcinoma antigen (SCC-Ag) and cytokeratin 19 fragments (CYFRA21-1) were assessed in patients with esophageal cancer, and carcinoembryonic antigen (CEA) and carbohydrate antigen (CA) 19-9 were assessed in patients with colorectal cancer. Results Samples from 281 patients with esophageal cancer, 232 patients with colorectal cancer, and 532 controls were included in the study. The median value of s-p53-Abs in control samples was < 0.02 mu g/mL (range < 0.02-29.2 mu g/mL). Assuming 98% specificity, the cut-off value was determined as 0.05 mu g/mL. s-p53-Abs were detected in 20% (57/281) of patients with esophageal cancer and 18% (42/232) of patients with colorectal cancer. In combination with SCC-Ag and CEA, respectively, s-p53-Abs detected 51% (144/281) of patients with esophageal and 53% (124/232) of patients with colorectal cancer. Conclusions The new s-p53-Abs assay Elecsys anti-p53 was useful in detecting esophageal and colorectal cancers with high specificity. Adding s-p53-Abs to conventional markers significantly improved the overall detection rates.