Étude de l’item d’interférence dans un dossier de validation de méthode : cas de la coloration HPS après fixation en formol-zinc et comparaison à la fixation en formol tamponné à 4 %

Abstract

The department of neuropathology of Sainte-Anne Hospital uses zinc-formalin as the fixative agent for its samples. No publication referenced in Pubmed has proven the validity of this fixative agent. In the context of the accreditation of our standard staining (HPS for Hemalun-Phloxin-Saffron), we started a file for the validation of this method in which the fixative agent constitutes an «interfering» substance which can modify the quality of the technique. The aim of this study was to prove that the use of zinc-formalin as a fixative agent is as suitable as the fixation with 4% buffered formalin. A cohort of samples fixed by zinc-formalin and by 4% buffered formalin was performed on fresh samples, then cut and stained by HPS. The slides were interpreted by three pathologists (one of them was outside our centre) ``blind'' to the fixative agent and they evaluated four criteria (general quality of the staining, components of the extracellular matrix, cytoplasmic details, and nuclear details) and scored them (from 0to 3) according to the Association française en assurance qualité (AFAQAP) recommendations. The cohort included 43samples. The results of the analysis showed that for samples fixed by zinc-formalin, three of the four criteria obtained significantly a better score than the samples fixed by classical formalin. Our results show that the zinc-formalin fixative does not constitute an ``interfering'' agent for the quality of the HPS staining for neuropathological samples.