Oral & Maxillofacial Surgery, School of Dentistry, University of California, Los Angeles, Los Angeles, CA 90095-1668, USA.
Psychoneuroendocrinology. 2011 Feb;36(2):193-9. doi: 10.1016/j.psyneuen.2010.07.008. Epub 2010 Aug 9.
The translation of salivary alpha-amylase (sAA) to the ambulatory assessment of stress hinges on the development of technologies capable of speedy and accurate reporting of sAA levels. Here, we describe the developmental validation and usability testing of a point-of-care, colorimetric, sAA biosensor. A disposable test strip allows for streamlined sample collection and a corresponding hand-held reader with integrated analytic capabilities permits rapid analysis and reporting of sAA levels. Bioanalytical validation utilizing saliva samples from 20 normal subjects indicates that, within the biosensor's linear range (10-230 U/ml), its accuracy (R(2)=0.989), precision (CV<9%), and measurement repeatability (range -3.1% to +3.1%) approach more elaborate laboratory-based, clinical analyzers. The truncated sampling-reporting cycle (<1 min) and the excellent performance characteristics of the biosensor has the potential to take sAA analysis out of the realm of dedicated, centralized laboratories and facilitate future sAA biomarker qualification studies.
唾液α-淀粉酶（sAA）的转化为压力的流动评估取决于能够快速准确报告 sAA 水平的技术的发展。在这里，我们描述了一种即时、比色、sAA 生物传感器的开发验证和可用性测试。一次性测试条允许简化样本采集，而相应的手持式阅读器具有集成的分析功能，可快速分析和报告 sAA 水平。利用来自 20 名正常受试者的唾液样本进行的生物分析验证表明，在生物传感器的线性范围（10-230 U/ml）内，其准确性（R²=0.989）、精密度（CV<9%）和测量重复性（范围为-3.1%至+3.1%）接近更复杂的基于实验室的临床分析仪。缩短的采样-报告周期（<1 分钟）和生物传感器的优异性能特征有可能将 sAA 分析从专用、集中式实验室中分离出来，并促进未来的 sAA 生物标志物资格研究。
