Analytical Performance Report (APR)

What is an Analytical Performance Report?

The Analytical Performance Report (APR) is used to describe the ability of a device to correctly detect or measure a particular analyte/biomarker. How good a device is at detecting a specific analyte/biomarker is typically based on the manufacturer’s own non-clinical studies. Such studies may provide documentation of the device’s analytical specificity, sensitivity, trueness/bias, precision, accuracy, limits of detection (LOD) & quantitation (LOQ), measuring range, and cut-off/thresholds, etc.

The APR will follow the requirements as defined in the European In-Vitro Diagnostic Regulation 2017/746 (IVDR), Annex XIII, Part A, Section 1.2.2.

AML Christensen’s service

At AML Christensen, we can present your study data in a way that establishes the analytical performance of your device in compliance with the IVDR and relevant guidelines. As such, we are happy to create the first APR for your device and ensure that the APR is regularly updated throughout the device’s lifetime.

At AML Christensen, we have a proven APR template, which has been developed to ensure that the requirements of the IVDR are met. Your APR may be based on the AML template, or we can use your own template, if so preferred.

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Analytical Performance Report (APR)

What is an Analytical Performance Report?

AML Christensen’s service

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