Analytical Performance

To demonstrate that the product is safe and performs as intended by the manufacturer, IVD products must undergo performance studies. Analytical performance is one such requirement as described in EU MDR 2017/746, which demonstrates the ability of your device to correctly detect or measure a particular analyte.

Analytical performance studies serve as the foundation for demonstrating the analytical performance of any IVD(s), and the results are recorded in the form of an analytical performance report (APR). Due to its inclusion in the Performance Valuation Report (PER), which serves as a conformity assessment as well, the APR is a vital component in the regulatory approval process for in vitro diagnostic medical devices. A detailed account of the testing and assessment of the In Vitro Diagnostic medical device’s performance may be found in the analytical performance report.

Analytical performance is strictly a technical performance as no correlation with the targeted pathology is required. These studies are often conducted in a laboratory setting and involve testing the diagnostic test using known samples with varying concentrations of the biomarker or parameter.

Samples used: Analytical data can be generated using a mixture of sample types.

• well-characterized clinical samples with a documented history of their collection, handling, and storage;
• Well-documented panels of artificially contrived samples or spiked samples; External Quality Assurance (QA) panels or reference materials.
• Analytical data is necessary to support each proposed sample type. The gathering of whole blood, plasma, and serum datasets is part of this.

The analytical performance data should be summarized as part of the clinical evidence report.

Analytical performance indicators are typically considered similar or even identical across IVDs. These indicators may depend on the assay technology i.e., qualitative, quantitative, or semi-quantitative, and the intended use environment. However, all omissions should be clearly outlined and justified.

Analytical performance, which refers to technical test performance, may include data to demonstrate accuracy (derived from trueness and precision), analytical sensitivity (e.g. limit of detection, limit of quantitation), analytical specificity, linearity, cut-off, measuring interval (range), carry-over, as well as determination of appropriate specimen collection and handling, and endogenous and exogenous interference on assay results.

Clinical and Laboratory Standards Institute (CLSI) guidelines are used to demonstrate analytical performance. Studies must address all the applicable parameters in point (a) of Section 9.1 of Annex I of the IVDR. The relevant performance characteristics, as part of the GSPRs and linked to the analytical features of the IVD should be supported by existing evidence or by generating new evidence.

For performance data generated on earlier versions of the device, include a justification for why the changes do not impact the validity of the data collected and how the data is considered to meet state-of-the-art requirements. To review clinical evidence for the IVD medical device in question, an assessment needs to be made whether the analytical performance data in conjunction with the scientific validity is sufficient to declare conformity with relevant EPs.

For an established and standardized test, information about analytical performance in conjunction with scientific validity information meets the clinical evidence requirements and is sufficient to demonstrate conformity with relevant EPs. For an established and non-standardized test, information about analytical performance in conjunction with scientific validity information alone may not meet the clinical evidence requirements and may not be sufficient to demonstrate conformity with relevant EPs. For a novel test, information about analytical performance in conjunction with scientific validity information alone most likely will not meet the clinical evidence requirements and most likely will not be sufficient to demonstrate conformity with relevant Eps.

Consultants interpret the results, assess the analytical performance characteristics of the IVD device (such as sensitivity, specificity, accuracy, precision, and linearity), and compare them against predefined acceptance criteria and regulatory standards.