An open label, non-inferiority, multicentric trial proves that Glyoxal Acid-Free (GAF®) histological fixative is a suitable alternative to Formalin.
The trial was performed following the international standard for performance evaluation of in vitro diagnostic medical devices. The study compared 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 centre reviewers.
Data collected indicate the non-inferiority of GAF® as compared to PBF for all organ tested. The clinical performance study highlights the capability of GAF® to ensure both, structural preservation and diagnostic value of the preparations.
GAF® provides diagnosis accuracy without exposing healthcare professionals to the risk of developing work-related diseases.
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Glyoxal Acid-Free (GAF) histological fixative is a suitable alternative to Formalin