Standardization of immunohistochemistry (IHC) staining quality assurance (QA) is critical for diagnostic accuracy. Pathologists currently assess stain quality subjectively, comparing control sections to patient tissue. Qualitopix (Visiopharm, Denmark), a cloud-based artificial intelligence (AI) platform for IHC staining QA, uses quantitative analysis for scoring cell lines-derived, stained and digitized control slides. To establish the reliability of Qualitopix, we conducted a study to validate the precision of the digital pathology (DP) pipeline consisting of the scanners and the image analysis algorithms used.

Dirk Vossen, PhD¹, Regan Fulton, MD², PhD, Jeppe Thagaard, PhD¹, Henrik Høeg, MSc¹, Stine Amtoft Nielsen, MSc¹, Scott Crawford, PhD², Mateusz Tylicki, BSc (Hons)¹, Andrew M Bellizzi, MD³, Sven van Kempen, Tri Q⁴. Nguyen, MD⁴, Ghlowy Gerritsen⁴

1. Visiopharm A/S
2. Array Science, LLC
3. University of Iowa Hospitals & Clinics
4. UMC Utrecht