基于唾液的基质金属蛋白酶-1 快速条带检测用于口腔癌检测的临床验证。
Clinical validation of a saliva-based matrix metalloproteinase-1 rapid strip test for detection of oral cavity cancer.
机构信息
Molecular Medicine Research Center, Chang Gung University, Taoyuan, Taiwan; Graduate Institute of Biomedical Sciences, Chang Gung University, Taoyuan, Taiwan; Department of Otolaryngology-Head and Neck Surgery, Chang Gung Memorial Hospital, Linkou, Taiwan.
S & T Biomed Co., Ltd, Hsinchu, Taiwan.
出版信息
Biomed J. 2024 Feb;47(1):100594. doi: 10.1016/j.bj.2023.04.002. Epub 2023 Apr 10.
BACKGROUND
We previously identified matrix metalloproteinase-1 (MMP-1) as one of the most promising salivary biomarkers for oral squamous cell carcinoma (OSCC) and developed a sensitive ELISA for MMP-1 with good performance in detection of OSCC using a cohort of 1160 saliva samples.
METHODS
A time-saving rapid strip test (RST) for MMP-1 was developed in this study and its diagnostic performance compared with ELISA using saliva samples from a new cohort of 603 subjects (171 healthy controls, 236 patients with oral potentially malignant disorders, and 196 OSCC patients).
RESULTS
Salivary MMP-1 levels measured using RST and ELISA were highly comparable and both assays could effectively distinguish between OSCC and non-cancerous groups. Similar to ELISA, receiver operating characteristic curve analysis of the MMP-1 RST was effective in identifying patients with OSCC at different oral cavity sites and stages.
CONCLUSIONS
Salivary MMP-1 can be sensitively detected using both RST and ELISA methods. Our newly developed point-of-care MMP-1 RST is a promising in vitro diagnostic device (IVD) that may serve as a novel auxiliary tool in the routine clinical detection and monitoring of OSCC.
背景
我们之前确定基质金属蛋白酶-1（MMP-1）是唾液中最有前途的口腔鳞状细胞癌（OSCC）生物标志物之一，并开发了一种灵敏的 ELISA 方法，使用包含 1160 份唾液样本的队列检测 OSCC，该方法具有良好的性能。
方法
本研究中开发了一种省时的快速条带检测（RST）方法用于 MMP-1，并使用来自 603 名受试者（171 名健康对照者、236 名口腔潜在恶性疾病患者和 196 名 OSCC 患者）的新队列唾液样本对其诊断性能与 ELISA 进行比较。
结果
使用 RST 和 ELISA 测量的唾液 MMP-1 水平高度可比，两种检测方法均能有效区分 OSCC 和非癌性组。与 ELISA 相似，MMP-1 RST 的受试者工作特征曲线分析可有效识别不同口腔部位和阶段的 OSCC 患者。
结论
RST 和 ELISA 方法均可灵敏地检测唾液 MMP-1。我们新开发的即时 MMP-1 RST 是一种很有前途的体外诊断设备（IVD），可作为 OSCC 常规临床检测和监测的新型辅助工具。
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