U.S. Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, Maryla, United States.
J Biomed Opt. 2021 Oct;27(7). doi: 10.1117/1.JBO.27.7.074705.
Raman spectroscopy has emerged as a promising technique for a variety of biomedical applications. The unique ability to provide molecular specific information offers insight to the underlying biochemical changes that result in disease states such as cancer. However, one of the hurdles to successful clinical translation is a lack of international standards for calibration and performance assessment of modern Raman systems used to interrogate biological tissue.
To facilitate progress in the clinical translation of Raman-based devices and assist the scientific community in reaching a consensus regarding best practices for performance testing.
We reviewed the current literature and available standards documents to identify methods commonly used for bench testing of Raman devices (e.g., relative intensity correction, wavenumber calibration, noise, resolution, and sensitivity). Additionally, a novel 3D-printed turbid phantom was used to assess depth sensitivity. These approaches were implemented on three fiberoptic-probe-based Raman systems with different technical specifications.
While traditional approaches demonstrated fundamental differences due to detectors, spectrometers, and data processing routines, results from the turbid phantom illustrated the impact of illumination-collection geometry on measurement quality.
Specifications alone are necessary but not sufficient to predict in vivo performance, highlighting the need for phantom-based test methods in the standardized evaluation of Raman devices.
拉曼光谱已成为各种生物医学应用的一种很有前途的技术。它具有提供分子特异性信息的独特能力，可深入了解导致疾病状态（如癌症）的潜在生化变化。然而，成功实现临床转化的一个障碍是缺乏用于检测生物组织的现代拉曼系统的校准和性能评估的国际标准。
促进基于拉曼的设备的临床转化，并协助科学界就性能测试的最佳实践达成共识。
我们回顾了当前的文献和可用的标准文件，以确定用于拉曼设备的台式测试的常用方法（例如相对强度校正、波数校准、噪声、分辨率和灵敏度）。此外，还使用了新颖的 3D 打印混浊体模来评估深度灵敏度。这些方法在具有不同技术规格的三个光纤探头式拉曼系统上进行了实施。
虽然传统方法由于探测器、光谱仪和数据处理程序的原因显示出了根本差异，但混浊体模的结果说明了照明-收集几何形状对测量质量的影响。
仅规格是必要的，但不足以预测体内性能，突出了在拉曼设备的标准化评估中需要基于体模的测试方法。
