一种超敏增强型酶促化学发光体系

An ultra-sensitive enzyme-enhanced chemiluminescence immunoassay

目的建立一套高灵敏度，且可广泛应用于临床检测的化学发光免疫检测平台。方法采用碱性磷酸酶标记和一种增强型发光底物配方，极大地提升化学发光免疫检测的灵敏度，并通过典型的应用实例进行可行性研究。结果增强型[3-（2-螺旋金刚烷）-4-甲氧基-4-（3-磷氧酰）-苯基-1，2-二氧环乙烷]底物液配方可提升检测的信噪比。选择要求高灵敏度的促甲状腺激素（TSH）、前列腺特异性抗原（TPSA）、肌钙蛋白（cTnI）和HIVp24抗原项目进行了免疫试剂开发的可行性研究，所选项目都具备与国际主流厂家可比的检测低限及特异性。结论迈瑞自主研发的增强型酶促化学发光增强技术可以保证整个系统的高灵敏度及临床检测结果的一致性，实现多种临床免疫检测项目的功能需求。

Objective To establish an ultra-sensitive chemiluminescence immunoassay system for clin- ical diagnosis. Methods By utilizing alkaline phosphatase as the label and optimized substrate formulation,the sensitivity, of chemiluminescence immunoassay has been greatly enhanced. Feasibility has been demonstrated with several assays of clinical utility. Results The signal-to-noise ratio was significantly increased by optimiza- tion of AMPPD substrate formulation; TSH, TPSA, cTnI, and HIV p24 were selected to demonstrate the feasibili- ty of high specificity and low detection limit. Conclusions The enzyme-enhanced chemil assay technology developed by Mindray guarantees high sensitivity and good correlation in clinical performance evaluation, making it a reality to detect multiple clinical analytes on a single integrated platform.