Glyoxal acid-free (GAF) histological fixative is a suitable alternative to formalin: results from an open-label comparative non-inferiority study.

Autor: Ryska A; The Fingerland Department of Pathology, Charles University and Faculty Hospital, Hradec Kralove, Czech Republic., Sapino A; Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Turin, Italy.; Department of Medical Sciences, University of Turin, Turin, Italy., Landolfi S; Pathology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain., Valero IS; Pathology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain., Cajal SRY; Pathology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain., Oliveira P; Department of Pathology, The Christie NHS Foundation Trust, Manchester, UK., Detillo P; ADDAX Biosciences Srl., Turin, Italy., Lianas L; Data-Intensive Computing Division, Center for Advanced Studies, Research and Development in Sardinia (CRS4), Pula, Italy., Frexia F; Data-Intensive Computing Division, Center for Advanced Studies, Research and Development in Sardinia (CRS4), Pula, Italy., Nicolosi PA; 1MED SA, Agno, Switzerland., Monti T; 1MED SA, Agno, Switzerland., Bussolati B; Department of Molecular Biotechnology and Health Sciences, University of Turin, Turin, Italy., Marchiò C; Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Turin, Italy.; Department of Medical Sciences, University of Turin, Turin, Italy., Bussolati G; Department of Medical Sciences, University of Turin, Turin, Italy. gianni.bussolati@unito.it.
Jazyk: angličtina
Zdroj: Virchows Archiv : an international journal of pathology [Virchows Arch] 2024 Aug; Vol. 485 (2), pp. 213-222. Date of Electronic Publication: 2023 Nov 24.
DOI: 10.1007/s00428-023-03692-6
Abstrakt: Formalin, an aqueous solution of formaldehyde, has been the gold standard for fixation of histological samples for over a century. Despite its considerable advantages, growing evidence points to objective toxicity, particularly highlighting its carcinogenicity and mutagenic effects. In 2016, the European Union proposed a ban, but a temporary permission was granted in consideration of its fundamental role in the medical-diagnostic field. In the present study, we tested an innovative fixative, glyoxal acid-free (GAF) (a glyoxal solution deprived of acids), which allows optimal tissue fixation at structural and molecular level combined with the absence of toxicity and carcinogenic activity. An open-label, non-inferiority, multicentric trial was performed comparing fixation of histological specimens with GAF fixative vs standard phosphate-buffered formalin (PBF), evaluating the morphological preservation and the diagnostic value with four binary score questions answered by both the central pathology reviewer and local center reviewers. The mean of total score in the GAF vs PBF fixative groups was 3.7 ± 0.5 vs 3.9 ± 0.3 for the central reviewer and 3.8 ± 0.5 vs 4.0 ± 0.1 for the local pathologist reviewers, respectively. In terms of median value, similar results were observed between the two fixative groups, with a median value of 4.0. Data collected indicate the non-inferiority of GAF as compared to PBF for all organs tested. The present clinical performance study, performed following the international standard for performance evaluation of in vitro diagnostic medical devices, highlights the capability of GAF to ensure both structural preservation and diagnostic value of the preparations.
(© 2023. The Author(s).)
Databáze: MEDLINE
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