Key Laboratory of Clinical Laboratory Diagnostics (Ministry of Education), 12550 College of Laboratory Medicine, Chongqing Medical University , Chongqing, China.
Department of Laboratory Medicine, 12550 The First Affiliated Hospital of Chongqing Medical University , Chongqing, China.
Clin Chem Lab Med. 2024 Jul 30;63(1):193-207. doi: 10.1515/cclm-2024-0724. Print 2025 Jan 29.
It has been reported that serum Clara cell secreted protein 16 (CC16) is a potential biomarker for lung injury diseases, but currently, there is no other method that is faster, more accurate, or more sensitive being applied in clinical practice apart from ELISA. The current study was designed to established a magnetic nanoparticles chemiluminescence immunoassay (MNPs-CLIA) for highly sensitive automated detection of serum Clara cell secretory protein 16 (CC16), and validated its diagnostic performance for lung disease.
The study included the expression of CC16 recombinant protein, the preparation and screening of its monoclonal antibody (MAb), as well as the construction, optimization and analytical evaluation of the MNPs-CLIA method. The clinical application value of this method was investigated by detecting CC16 level in 296 serum samples.
The linear range of the MNPs-CLIA assay system was 0.2-50 ng/mL, and the limit of detection was 0.037 ng/mL. Performance parameters such as specificity, recovery rate, and precision can meet the industry standards of diagnostic reagents. The established method reveals consistent results with ELISA (R=0.9962) currently used clinically, and it also exhibits satisfactory diagnostic efficacy of silicosis, chronic obstructive pulmonary disease (COPD), and pulmonary sarcoidosis, with areas under the curve (AUC) of 0.9748, 0.8428 and 0.9128, respectively.
Our established MNPs-CLIA method has the advantages of automation, high throughput, rapidity, and simplicity, and can be promoted for widely popularized in clinical applications. MNPs-CLIA detection of serum CC16 has efficient diagnostic potentiality for predicting and diagnosing lung diseases.
据报道，血清克拉拉细胞分泌蛋白 16（CC16）是一种潜在的肺损伤疾病生物标志物，但目前除 ELISA 外，尚无其他更快、更准确或更敏感的方法应用于临床实践。本研究旨在建立一种磁性纳米粒子化学发光免疫分析（MNPs-CLIA）方法，用于高度敏感地自动检测血清克拉拉细胞分泌蛋白 16（CC16），并验证其对肺部疾病的诊断性能。
本研究包括 CC16 重组蛋白的表达、单克隆抗体（MAb）的制备和筛选，以及 MNPs-CLIA 方法的构建、优化和分析评价。通过检测 296 份血清样本中的 CC16 水平，研究了该方法的临床应用价值。
MNPs-CLIA 检测系统的线性范围为 0.2-50ng/ml，检测限为 0.037ng/ml。特异性、回收率和精密度等性能参数均符合诊断试剂的行业标准。与目前临床应用的 ELISA（R=0.9962）相比，该方法具有一致性，且对矽肺、慢性阻塞性肺疾病（COPD）和肺结节病的诊断效果也令人满意，曲线下面积（AUC）分别为 0.9748、0.8428 和 0.9128。
我们建立的 MNPs-CLIA 方法具有自动化、高通量、快速和简单的优点，可推广应用于临床。MNPs-CLIA 检测血清 CC16 对预测和诊断肺部疾病具有高效的诊断潜力。
