Innovative Optical System for Hemagglutination Assays

用于血凝测定的创新光学系统

• 批准号: 9301443
• 负责人: KATHY L ROWLEN
• 金额: $ 99.48万
• 依托单位: INDEVR, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-05-01 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9301443
• 关键词: Address; Agglutination; Agreement; Algorithmic Analysis; Algorithms; Antibodies; Bacteria; Biological Assay; Biological Neural Networks; Caliber; Cavia; Centers for Disease Control and Prevention (U.S.); Clinical; Databases; Diagnostic; Disadvantaged; Ebola virus; Effectiveness; Ensure; Equipment; Erythrocytes; Exhibits; Feedback; Generations; Gold; HIV; Hemagglutination; Hematology; Hour; Human; Image; Image Analysis; Immune response; Influenza; Intuition; Laboratories; Link; Manuals; Measures; Meleagris gallopavo; Methods; Multivariate Analysis; Names; Optics; Performance; Phase; Process; Quality Control; Reader; Reading; Records; Reproducibility; Robotics; Sampling; Scanning; Shapes; Signal Transduction; Silver; Site; Spottings; System; Techniques; Testing; Vaccine Antigen; Vaccine Production; Vaccines; Virus; Walking; World Health Organization; digital imaging; high throughput analysis; improved; innovation; instrument; operation; prototype; seasonal influenza; success; tool

PROJECT SUMMARY The Hemagglutination assay (HA) and Hemagglutination Inhibition (HI) assay are widely used methods for characterizing viruses, bacteria, and antibodies. The World Health Organization recently recommended that HI remain the gold standard method for influenza seroepidemiology. Although the HA and HI assays are applied worldwide, they have the disadvantages of manual plate reading, non- specific inhibition, and other operational limitations causing poor reproducibility and inconsistent results between laboratories. This proposal primarily addresses the manual reading challenge by developing an instrument to record and analyze digital images of HA and HI assay plates. In Phase I, InDevR developed and launched a first generation instrument with an intuitive user interface and excellent HA and HI titer agreement with expert human readers. The Specific Aims for Phase II are to: 1) develop an advanced image analysis algorithm for challenging (seroepidemiology) samples, 2) enhance the Cypher HA/HI reader to create a walk-away high throughput system integrated with commercial automated plate handling equipment and sample tracking, and 3) validate reader performance at 3-5 facilities to demonstrate agreement with human experts and overall operational effectiveness. The advanced image analysis algorithm will analyze and compare specific features of control wells with sample wells. Preliminary results have shown greater than 95% agreement with expert human readers, including to ability to overcome non-specific inhibition and its effects on image interpretation. The new system will also support improved results transfer and LIMS integration. The high throughput system will be most valuable to laboratories like the FDA CBER`s group as well as WHO Collaborating Centers that select seasonal influenza vaccine antigens during peak periods using thousands of HA and HI assays.

项目摘要 血凝试验（HA）和血凝抑制试验（HI）是目前广泛使用的方法 用于鉴定病毒细菌和抗体世界卫生组织日前 建议HI仍然是流感血清流行病学的金标准方法。虽然 HA和HI测定在世界范围内得到应用，它们具有手动读板阅读、非实时性、不稳定性和不稳定性等缺点。 特异性抑制和其他操作限制，导致重现性差和结果不一致 实验室之间。该提案主要通过开发一个 仪器记录和分析HA和HI测定板的数字图像。在第一阶段，InDevR开发了 并推出了第一代仪器，具有直观的用户界面和出色的HA和HI滴度 与人类专家的协议。第二阶段的具体目标是：1）开发先进的 用于挑战（血清流行病学）样本的图像分析算法，2）增强Cypher HA/HI 阅读器创建与商业自动化板集成的步行式高通量系统 处理设备和样本跟踪，以及3）在3-5个机构验证读取器性能， 证明与人类专家的一致性和整体操作效率。先进形象 分析算法将分析和比较对照威尔斯井与样本威尔斯井的具体特征。 初步结果显示，与专家人类读者的一致性超过95%，包括 克服非特异性抑制及其对图像解释的影响的能力。新系统将 还支持改进成果转移和LIMS集成。高通量系统将是最 对于FDA CBER小组以及世卫组织合作中心这样的实验室来说， 使用数千种HA和HI检测，在高峰期检测季节性流感疫苗抗原。