Cerba Research is your trusted partner for your analytical performance study needs
The interest of analytical performance
Based on Article 2 of the European Regulation IVDR 2017/746, analytical performance is defined as follows: “the ability of a device to correctly detect or measure a particular analyte.”
The analytical performance focuses on the gathering of evidence that the IVD reliably, accurately, and consistently detects (qualitative output) and/or measures (quantitative output) the analyte. The manufacturer must also verify that all different specimen types and specimen sampling conditions that are indicated in the intended use are assessed and demonstrated. If different specimen types are taken in consideration (e.g. blood, saliva, etc.), the analytical performance shall be demonstrated for all these specimen types. Specimen collection, storage and transport conditions shall be considered part of the analytical performance study.
The concept of analytical performance includes different parameters that have to be taken into consideration in the context to ensure quality, safety and efficacy of an IVD device. According to IVDR Annex I Section 9.1a, the determination of the following parameters is considered analytical performance:
- Analytical sensitivity,
- Analytical specificity,
- Trueness (bias),
- Precision (repeatability and reproducibility),
- Accuracy (resulting from trueness and precision),
- Limits of detection and quantitation,
- Measuring range,
- Cut-off, including determination of appropriate criteria for specimen collection and handling and control of known relevant endogenous and exogenous interference
- Sample stability
How Cerba Research support you in your Analytical Performance Studies?
Analytical performance should always be demonstrated based on analytical performance studies.
Cerba Research is committed to designing protocols for analytical performance evaluation for CE marking /FDA approval in agreement with international guidelines, finding sites and documentation as well as human and material resources to perform the services in both a costly and timely manner.
Cerba Research is able to organize performance studies to verify the analytical performance of your In Vitro Diagnostics Medical Device (analytical sensitivity and specificity, precision, accuracy) by:
- Writing the protocols and the analytical performance report to be directly integrated into your technical documentation.
- Providing and testing the appropriate biospecimens (link to Testing capacities section) as claimed in the intended use.
- Performing the assays in compliance with international standards and in a routine lab environment (EN ISO 15189:2012).
- Analyzing data.
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