目前，关于荧光流式细胞仪的计量和溯源方面的资料相对有限。为了研究基于荧光检测的流式细胞仪的技术发展并加快其标准化进程，对国内外文献资料进行整合，并总结了荧光流式细胞仪的类别、应用、相关标准化研究进展和关键参数的详细信息，主要包括仪器分辨率、散射光和荧光灵敏度、荧光线性相关系数、检出限、准确性、可重复性和稳定性等。国内外对广泛使用的几种评价荧光流式细胞仪性能的计量方法具有基本一致的标准。各个研究组织与应用领域对于流式细胞仪的性能具有不同的需求，一套完整可溯源的表征流式细胞术的计量标准及其评价方法能够方便实验室之间进行可重复和可比较的研究交流与讨论。

为了评估眼科光学相干断层成像（OCT）设备的分辨率、视场角、图像匹配度、深度测量准确性等多个关键参数，确保设备输出量值的准确性与有效性，设计并研制了一种模拟真实人眼结构且参数可溯源的模拟眼，包含角膜和晶状体等人眼主要屈光结构。设计并依托3D打印技术加工了用于横向与轴向分辨率检测的三维分辨率板；设计加工了用于视场角检测的阶梯状同心圆环结构；同时设计加工了用于图像匹配度检测的交叉光纤组件和用于深度测量准确性参数检测的平行玻璃板组件，可适配于模拟眼眼底凹槽内。使用共焦拉曼显微镜对三维分辨率板尺寸溯源，横向和轴向最小可检测分辨率分别为9.7 μm和5.7 μm；使用尼康投影仪对同心圆环尺寸及光纤直径溯源，最大可检测视场角109.03°以及最小62.5 μm的图像匹配度检测；使用尼康高度计对平行玻璃板中心厚度溯源，其测量不确定度小于5 μm。经过对商用眼科OCT设备测试表明，结合微纳3D打印技术的计量校准用模拟眼具有精度高、集成度高、适用范围广、稳定性强等优点，适用于眼科OCT设备的计量校准。

Optical coherence tomography (OCT) has been extensively used as noninvasive tool for biological tissues owing to its three-dimensional imaging ability and high axial resolution. OCT quality assurance is vital in these occasions to keep the reliability and accuracy in medical diagnosis. It is necessary to develop a calibration tool for OCT product manufacture, calibration, and quality control. A practical tool is demanded in the OCT quality control and calibration of OCT. So far, there is no such a practical tool that can test all the key parameters of OCT. We design and fabricate a model eye tool, which has this function. The model eye comprises a doublet lens, a single filament, a piece of glass plate and the microsphere-embedded phantom. The doublets lens is bonded by two pieces of planoconvex lenses in the plane position. The first lens focuses parallel light onto the rear surface of the second lens. The rear surface marked with concentric circles serves as retina to measure the angular field of view (FOV). The small flat surface on the peak of the second lens is used to test signal to noise ratio (SNR). The single filament with 125 μm diameter is used to check the co-alignment of preview and OCT scan. The empty chamber between the small plane of the second lens and the first surface of glass plate is used to measure the depth scaling of the OCT. The microspheres of 1 μm diameter distributed uniformly in the phantom, which can test the lateral and the axial resolution of OCT equipment. Experimental results are presented to show the validity of the proposed tool. It is shown that the tool is able to be used in the calibration and quality control of retinal OCT.

Optical coherence tomography (OCT) has been widely applied to the diagnosis of eye diseases during the past two decades. However, valid evaluation methods are still not available for the clinical OCT devices. In order to assess the axial resolution of the OCT system, standard model eyes with micro-scale multilayer structure have been designed and manufactured in this study. Mimicking a natural human eye, proper Titanium dioxide (TiO2) materials of particles with different concentrations were selected by testing the scattering coe±cient of PDMS phantoms. The artificial retinas with multilayer films were fabricated with the thicknesses from 9.5 to 30 micrometers using spin coating technology. Subsequently, standard OCT model eyes were accomplished by embedding the retina phantoms into the artificial frames of eyes. For ease of measurement processing, a series of model eyes were prepared, and each contained films with three kinds of thicknesses. Considering the traceability and accuracy of the key parameters of the standard model eyes, the thicknesses of multilayer structures were verified using Thickness Monitoring System. Through the experiment with three different OCT devices, it demonstrated the model eyes fabricated in this study can provide an effective evaluation method for the axial resolution of an ophthalmic OCT device.

点扩散函数一般用于成像光学系统的分辨率评价，而掺杂微球的模体经常被用于获取光学相干层析成像(OCT)系统的点扩散函数。采用一种简单快速的基于表面硅烷化处理的加工工艺，制作出掺杂直径为1 μm 聚苯乙烯微球的聚二甲基硅氧烷(PDMS)点扩散函数模体，该工艺无需任何打磨与抛光即可得到光洁度优良的模体表面。使用一台谱域OCT系统对该模体进行检测，通过处理OCT图像得到点扩散函数并计算得到OCT系统的轴向与横向分辨率，分别为6.8 μm 和14.3 μm，与理论预测值十分接近，证明了点扩散函数模体评价方法的有效性。

尽管 OCT早已在世界范围内获得临床诊断许可, 但这项技术尚无任何国际标准。如何验证 OCT的成像能力及有效性被认为是该技术标准化进程中的重要一环。本研究研制了一种可用于 OCT三维成像分辨率测试的模拟眼。该模拟眼利用透明树脂材料仿真了人眼的重要光学元件: 角膜与晶状体。采用 3D打印技术在模拟眼眼底制作出了参照 USAF1951靶板设计的三维分辨率测试图案。研究结果表明该模拟眼能够对 OCT设备的三维成像分辨率性能进行初步评估, 通过进一步改进, 未来可用于注册检验或日常质控。