Abingdon Analytical Performance Evaluation Brochure

Analytical and clinical performance studies for IVDs and medical devices, run in Abingdon Analytical’s UKAS-accredited ISO/IEC 17025 laboratory and planned around your target submission, including FDA and IVDR, for the USA, EU and UK.

The brochure covers the analytical performance studies we run: analytical sensitivity (LOD), analytical specificity (interference and cross-reactivity), precision (repeatability and reproducibility), matrix equivalence, measuring range and hook effect, flex and robustness, and shelf life, shipping and in-use stability. It also explains how our team works to CLSI, ICH and ISO guidance.