Improving Protein Assay Methods to More Accurately Assess Medical Device Cleanliness.

Abstract

Protein assays commonly used to evaluate reusable device cleanliness do not always accurately measure the low concentrations of protein that are expected on reusable medical devices after processing. Methods often are adapted to provide an estimation of protein concentration; however, sensitivity issues in the portion of standard curves at the acceptance criteria of 6.4 μg/cm2 protein have been reported. Using analytical validation criteria, method improvements for the micro-bicinchoninic acid assay for protein residuals are demonstrated by incorporating a standard addition method, increasing the well volume, and changing the working reagent ratio. These improvements increased method sensitivity and accuracy in the reliable detection of protein levels for device cleaning validations.