It is not just a device that delivers results, but a set of interconnected components that, working together, allow for accurate, reliable, reproducible, and clinically relevant data. This system is built on three essential pillars: the reagent, the analyser, and the reference material.

Reagents are chemical substances designed to react with specific components present in the patient's sample (e.g. glucose, urea, liver enzymes, etc.). These reactions generate a measurable change — such as a change in color or turbidity — that the analyser detects and translates into a numerical result. The quality and stability of the reagent are critical to ensure the sensitivity and specificity of the analysis.

The analyser is the instrument that automates and executes the biochemical process. It controls parameters such as sample and reagent volume, reaction temperature, reaction time, and reading wavelength. The electromechanical and optical precision of the analyser is essential, but so is its compatibility with the reagents, since not all systems are optimized to work with every reagent on the market.

The third pillar is the reference material, i.e. calibrators and controls, that contain known concentrations of the analytes to be measured. Calibrators allow the concentration of the measurand to be obtained, and controls ensure that the system is functioning correctly. These are used to verify the accuracy and consistency of the system over time. Without them, there's no reliable way to ensure that the results truly reflect the patient’s biological reality.

Many companies in the sector specialize in only one of these three components: they offer analysers, reagents, or reference materials separately. However, this fragmented approach carries risks: incompatibilities, non-comparable results, or challenges in quality control.

In contrast, offering an integrated solution combining all three elements in a single validated system provides clear added value. By designing reagents specifically for a particular analyser and testing both with proprietary reference materials, maximum consistency and performance are ensured. This leads to maximum accuracy, increased robustness, reduced variability, and total control of the analytical process, which directly impact on the reliability of diagnoses.

Additionally, this integrated approach facilitates traceability, simplifies laboratory management, and reduces the risk of human error, especially in high-throughput environments or when staff are in training.