The concentration-based method is used to show that the matrix effect is not analyte concentration dependent. In this method, the matrix effect is measured with the signal-based method but for a range of analyte concentrations. It doesn’t necessarily provide any indication of other analyte concentrations. This method is useful when only this concentration is relevant. When it is above a hundred, it causes enhancement of the result. If the percentage is below a hundred, the matrix effect results in a suppression of the result. The analyte signal in the matrix is then divided by the analyte signal in the solvent and multiplied by a hundred, resulting in the percentage of matrix effect. This method allows for quantifying the matrix effect for one specific concentration.Īt this concentration, the analyte is measured in the matrix and subsequently measured in a solvent known not to induce any effect.

However, this article will focus on a few quantitative methods often used for bioanalytical techniques. Methods to Evaluate and EliminateĪ few quick, qualitative options exist to determine whether a matrix effect is present, such as the dilution-based method. Each assay is developed to allow monitoring of the matrix effect and, if possible, eliminate it. During the assay development and validation, the impact of the sample matrix is investigated. Therefore, showing that generated analytical data is accurate and no matrix effect is involved is necessary. Based on the obtained data, a decision is made to approve or reject the product batch. To release final product for use in patients, the product undergoes different quantitative or quantitative analytical procedures. So, how important is evaluating the matrix effects when analyzing bioprocess samples? What are the best approaches to evaluate the effect? And in what situations is the matrix effect acceptable? The Importance of Matrix Effect Evaluation Also, these extra evaluation steps bring additional costs. However, their evaluation for each assay and each sample matrix can be very time-consuming. These effects have long been associated with bioanalytical techniques. Matrix effects are observed either as a loss in response, resulting in an underestimation of the amount of analyte or an increase in response, producing an overestimated result. The matrix effect is the effect on an analytical assay caused by all other sample components except the specific compound (analyte) to be analyzed.

Matrix spike definition