ABSTRACT The use of smartphones in colorimetric bioassay applications is an alternative to spectrophotometric measurements. However, the development of bioassays requires the optimization of several critical analytical parameters. The aim of this work was to develop and optimize a smartphone-based colorimetric bioassay for determining relative potency of antibiotics and the respective measurement uncertainty. Analytical development was performed using an analytical quality by design (AQbD) approach. Critical analytical parameters were identified using risk assessment and optimized using a factorial design. The bioassay was accurate, precise, and robust. Relative potency values obtained from smartphone-based colorimetric measurements and spectrophotometric measurements were found to be comparable. The correlation of quantities due to shared analytical conditions significantly reduced the uncertainty multiplicative factor associated with the relative potency. AQbD approach was found to be a useful tool in developing and optimizing bioassays. In addition, the measurement uncertainty associated with the relative potency estimated from sigmoidal-response curves was successfully evaluated.

中文翻译：

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基于智能手机的生物测定，用于确定从 S 形响应曲线和相应测量不确定度估计的相对效力

摘要 在比色生物测定应用中使用智能手机是分光光度测量的替代方法。然而，生物测定的发展需要优化几个关键的分析参数。这项工作的目的是开发和优化基于智能手机的比色生物测定，用于确定抗生素的相对效力和相应的测量不确定度。使用分析质量源于设计 (AQbD) 方法进行分析开发。使用风险评估确定关键分析参数并使用因子设计进行优化。生物测定准确、精确且稳健。发现从基于智能手机的比色测量和分光光度测量获得的相对效力值具有可比性。由于共享分析条件而导致的数量相关性显着降低了与相对效力相关的不确定性乘数因子。发现 AQbD 方法是开发和优化生物测定的有用工具。此外，成功评估了与从 S 形响应曲线估计的相对效力相关的测量不确定性。