A high serum HER-2 extracellular domain (sHER-2 ECD) level has a reverse association with tumor behaviors. In this study, a portable platform for the disease biomarker sHER-2 ECD detection has been established using a pressure-based bioassay. The pressure bioassay consists of a monoclonal antibody immobilized on an eight-well strip, the analyte HER-2, and another monoclonal antibody labeled with the Pt nanoparticles (PtNPs), which have the catalytic ability to decompose H₂O₂ into H₂O and O₂(g). The increased pressure due to O₂(g) generation is measured by a hand-held pressure meter. A total of 34 serum samples were collected to validate the performance of the pressure bioassay. The results showed that the pressure bioassay platform of HER-2 had a dynamic range from 2 to 50 ng/mL with a limit of detection (LOD) of 2 ng/mL, which was consistent with the ELISA result. In the real serum samples, there was a significant correlation between sHER-2 ECD level and several clinicopathological parameters, especially tissue HER-2 status. Furthermore, the sHER-2 ECD level was found to decrease after targeted therapy in a patient with tHER-2 positive. Overall, this bioassay can facilitate breast cancer diagnosis and prognosis in clinical scenarios and resource-limited areas.

中文翻译：

---

基于压力的平台可便携式检测乳腺癌中的血清HER-2

高血清HER-2细胞外结构域（sHER-2 ECD）水平与肿瘤行为呈反向关联。在这项研究中，已经使用基于压力的生物测定法建立了用于疾病生物标记sHER-2 ECD检测的便携式平台。压力生物测定包括固定在一个八孔条的单克隆抗体，分析物HER-2，并标有的Pt纳米颗粒（PtNPs），其具有分解小时催化能力的另一种单克隆抗体的₂ ö ₂成H ₂ ö和O ₂（g）。由于O ₂而增加的压力（g）产生是通过手持压力计测量的。总共收集了34个血清样品以验证压力生物测定的性能。结果表明，HER-2压力生物测定平台的动态范围为2至50 ng / mL，检测限（LOD）为2 ng / mL，与ELISA结果一致。在真实的血清样本中，sHER-2 ECD水平与一些临床病理参数（尤其是组织HER-2状态）之间存在显着相关性。此外，发现在靶向治疗后，tHER-2阳性患者的sHER-2 ECD水平降低。总的来说，这种生物测定可以在临床情况和资源有限的地区促进乳腺癌的诊断和预后。