Department of Biomedical Engineering, Rutgers, The State University of New Jersey, 599 Taylor Road, Piscataway, NJ, 08854, USA.
Ann Biomed Eng. 2014 Jan;42(1):231-40. doi: 10.1007/s10439-013-0918-z. Epub 2013 Oct 5.
One of the key elements in point-of-care (POC) diagnostic test instrumentation is the optical system required for signal detection and/or imaging. Many tests which use fluorescence, absorbance, or colorimetric optical signals are under development for management of infectious diseases in resource limited settings, where the overall size and cost of the device is of critical importance. At present, high-performance lenses are expensive to fabricate and difficult to obtain commercially, presenting barriers for developers of in vitro POC tests or microscopic image-based diagnostics. We recently described a compact "hybrid" objective lens incorporating both glass and plastic optical elements, with a numerical aperture of 1.0 and field-of-view of 250 μm. This design concept may potentially enable mass-production of high-performance, low-cost optical systems which can be easily incorporated in the readout path of existing and emerging POC diagnostic assays. In this paper, we evaluate the biological imaging performance of these lens systems in three broad POC diagnostic application areas; (1) bright field microscopy of histopathology slides, (2) cytologic examination of blood smears, and (3) immunofluorescence imaging. We also break down the fabrication costs and draw comparisons with other miniature optical systems. The hybrid lenses provided images with quality comparable to conventional microscopy, enabling examination of neoplastic pathology and infectious parasites including malaria and cryptosporidium. We describe how these components can be produced at below $10 per unit in full-scale production quantities, making these systems well suited for use within POC diagnostic instrumentation.
在即时诊断（POC）诊断测试仪器中，一个关键元素是用于信号检测和/或成像的光学系统。许多使用荧光、吸光度或比色光学信号的测试正在为资源有限环境中的传染病管理而开发，在这些环境中，设备的整体尺寸和成本至关重要。目前，高性能透镜的制造昂贵且难以从商业上获得，这为体外 POC 测试或基于显微镜图像的诊断的开发人员带来了障碍。我们最近描述了一种紧凑的“混合”物镜，它结合了玻璃和塑料光学元件，数值孔径为 1.0，视场为 250μm。这种设计理念可能能够大规模生产高性能、低成本的光学系统，这些系统可以轻松地集成到现有的和新兴的 POC 诊断分析的读出路径中。在本文中，我们评估了这些透镜系统在三个广泛的 POC 诊断应用领域中的生物成像性能；（1）组织病理学载玻片的明场显微镜检查，（2）血液涂片的细胞学检查，以及（3）免疫荧光成像。我们还分解了制造成本，并与其他微型光学系统进行了比较。这些混合透镜提供的图像质量可与传统显微镜相媲美，能够检查肿瘤病理学和寄生虫感染，包括疟疾和隐孢子虫。我们描述了如何在大规模生产中以每个单元低于 10 美元的价格生产这些组件，这使得这些系统非常适合用于 POC 诊断仪器中。
