A smartphone-based bioassay for determining relative potency estimated from sigmoidal-response curves and respective measurement uncertainty

摘要

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.