肺癌仍然是全球最主要的癌症死亡原因。开发早期检测诊断方法，特别是非侵入性方法，是提高肺癌总体生存率和预后的关键组成部分。本研究的目的是评估一种新型体外细胞免疫反应测试的两个协议，以检测肺癌。该测试专门量化糖代谢途径，它是免疫细胞激活水平的生物标志物。它总结了两项临床试验的结果，每项试验都采用不同协议的版本来检测肺癌。在后一项临床试验中，应用了改进的测试协议。测试平台基于免疫细胞在与肺癌相关的抗原刺激后代谢途径的改变。单位体外分离的外周血单个核细胞与各种肺肿瘤相关抗原和发出pH依赖性吸收移位的荧光探针一起加载在多孔板上。在连续读取3小时后的37°C，通过商业荧光板阅读器设备监测细胞外液中的酸化过程，记录每个孔接收到的荧光信号。在后一次临床试验中，应用改进的测试协议，结果显示测试的准确度提高。在肺癌I期，测试的特异性提高到94.0％，灵敏度提高到97.3％。这种基于新型细胞免疫代谢反应的改进协议检测法，具有高特异性和敏感性，材料成本低，结果快速。© 2023. The Author(s).

Lung cancer remains the leading cause of death from cancer, worldwide. Developing early detection diagnostic methods, especially non-invasive methods, is a critical component to raising the overall survival rate and prognosis for lung cancer. The purpose of this study is to evaluate two protocols of a novel in vitro cellular immune response test to detect lung cancer. The test specifically quantifies the glycolysis metabolism pathway, which is a biomarker for the activation level of immune cells. It summarizes the results of two clinical trials, where each deploys a different protocol's version of this test for the detection of lung cancer. In the later clinical trial, an improved test protocol is applied.The test platform is based on changes in the metabolic pathways of the immune cells following their activation by antigenic stimuli associated with Lung cancer. Peripheral Blood Mononuclear Cells are loaded on a multiwell plate together with various lung tumor associated antigens and a fluorescent probe that exhibits a pH-dependent absorption shift. The acidification process in the extracellular fluid is monitored by a commercial fluorescence plate reader device in continuous reading for 3 h at 37 °C to document the fluorescent signal received from each well.In the later clinical trial, an improved test protocol was applied and resulted in increased test accuracy. Specificity of the test increased to 94.0% and test sensitivity increased to 97.3% in lung cancer stage I, by using the improved protocol.The improved protocol of the novel cellular immune metabolic response based test detects stage I and stage II of lung cancer with high specificity and sensitivity, with low material costs and fast results.© 2023. The Author(s).