化学发光蛋白芯片用于检测肝癌患者血清CA19-9水平的方法研究

目的:探讨一种简单、有效、低成本、低耗时的化学发光蛋白芯片方法用于检测血清中的糖链抗原19-9(Carbohydrate Antigen19-9,CA19-9),以有助于对原发性肝癌的早期辅助诊断。方法:预先在醛基芯片上包被鼠源CA19-9单克隆抗体,建立CA19-9抗体蛋白芯片,共筛选出46份肝癌血清和32份正常健康人血清,然后用蛋白芯片方法进行检测,并以化学发光成像对检测结果进行判定。结果:24份肝癌血清的CA19-9水平高于37 U/m L,22份肝癌血清的CA19-9水平低于37 U/m L;30份正常人血清CA19-9含量低于37 U/m L,2份正常人血清的CA19-9含量为37 U/m L;灵敏度为52.17%,特异性为93.75%,ROC曲线下面积0.688[95%CI:0.566,0.811]。结论:本研究成功的建立了血清CA19-9的化学发光蛋白芯片检测方法。

Detection of Serum CA19-9 Levels in Patients with Primary Hepatic Carcinoma by Using Chemiluminescent Protein Microarray

ABSTRACT Objective: To develop a simple, effective, low-cost, time saving chemiluminescent protein microarray to detect the serum CA19-9 level of patients with primary hepatic carcinoma. Methods: A protein microarray was developed for detecting CA19-9 levels in the serum samples after spotting mouse-derived CA19-9 monoclonal antibody on an aldehyde-based chip. Serum from primary hepatic carcinoma(n=46) and healthy controls(n=32) were tested by using this assay. Results: The results showed that 24 out of 46 patients with primary hepatic carcinoma had serum CA19-9 levels above 37 U/mL, and 22 out of 46 patients with primary hepatic carcinoma had serum CA19-9 levels under 37 U/mL. In healthy control, 30 out of 32 total cases were under 37 U/ml. Only two healthy controls were 37 U/mL. The sensitivity, specificity and AUC of protein microarray were 52.17%, 93.75%, 0.688 [95% CI: 0.566, 0.811]. Conclusion: A chemiluminescent protein microarray method was established for detection of CA19-9 in serum.