Avaluació de l’especificitat analítica en assajos diagnòstics in vitro

Abstract

In vitro diagnostics is a cornerstone of modern medicine, providing essential information for early

detection, monitoring, and management of a wide range of diseases. A significant proportion of

clinical decisions rely on the results of these analytical tests, making the reliability and specificity

of diagnostic methods crucial.

This project was conducted in the laboratories of Linear Chemicals; a company specialized in in

vitro diagnostic products. The main objective was to evaluate the analytical specificity of clinical

chemistry assays (cholesterol, glucose, creatinine, uric acid, urea, and triglycerides) as part of the

validation process for CE marking.

The assays were performed using control serum samples (normal and pathological),

supplemented with interfering compounds selected based on scientific literature. A deviation

equal to or greater than ±10% compared to the non-supplemented control was considered a

significant interference.

The results show that most of the tested methods demonstrate good analytical specificity.

However, relevant interferences were observed, such as ascorbic acid in glucose determination.

In these cases, dose-response curves were performed to characterize the effect according to the

concentration of the interferent.

This study provides experimental validation of the analytical specificity of these methods and

supports non-interference claims in the technical documentation required for CE certification