Qualitopix

Qualitopix, developed by Visiopharm, is a cloud-based pathology image analysis software designed to help clinical and research laboratories monitor and document the consistency of immunohistochemistry (IHC) staining over time. By combining next-generation standardized reference materials with AI-driven quantification, Qualitopix enables laboratories to objectively measure staining assay performance, detect deviations early, and take corrective action — ultimately reducing the historically high error rates associated with IHC staining and supporting more reliable diagnostic decisions.

Qualitopix is intended for pathology laboratories seeking to strengthen their internal quality control processes, comply with evolving regulatory requirements such as ISO 15189:2022, and prepare for increasing scrutiny of IHC as a regulated diagnostic assay. The platform requires no local installation or system integration, making it accessible to a wide range of laboratory settings.

AI-Driven Staining Quantification and Monitoring

• Measures staining intensity on a daily basis using standardized cell line controls with defined biomarker expression levels.
• Monitors results over time through Levey-Jennings plots, enabling trend analysis and statistical tracking of assay performance.
• Automatically flags any variation from the norm so that immediate corrective action can be taken.
• Provides tools to support troubleshooting when a test result requires attention.

Examples of Issues Detected by Qualitopix

• Bad reagent lot: A sudden rise in HER2 intensity values across all cell line cores was traced to a specific reagent lot number; switching the lot restored normal staining.
• Positional inconsistencies: A drop in PD-L1 intensity at positions 21–29 in a stainer rack was identified and linked to incorrect leveling of the slide rack.
• Insensitive HER2 clone: Absence of signal on 1+ and 2+ cores and weaker-than-expected 3+ core signal across two instruments of the same type was resolved by switching to a different antibody clone.

Intuitive, Frictionless Workflow

1. Purchase standardized reference materials: Ready-to-use cell lines (available from Histocyte and Array Science) with standardized biomarker expression are used as controls. Microbead controls and calibrators from BCS are coming soon.
2. Place on slides and stain: Reference materials are added to slides and processed using the laboratory's routine staining protocol.
3. Scan slides: Slides can be scanned on a variety of compatible scanners. A low-cost single-slide standalone scanner (Grundium) is available on demand for laboratories without scanning capability.
4. Upload images and metadata: No installation is required. Images and key metadata are uploaded via a simple drag-and-drop interface.
5. Receive quantitative results: Shortly after upload, quantitative results are delivered and the user is notified if any test requires attention.

Regulatory Compliance and Future Readiness

• Documentation tools within Qualitopix support compliance with ISO 15189:2022, which now addresses the use of third-party controls and the monitoring of trends and statistics for staining assays.
• Supports the growing regulatory push to treat IHC as a formally regulated assay, as advocated in the editorial "Immunohistochemistry Should Be Regulated As an Assay" by Barbarajean Magnani and Clive Taylor, which calls for the same checks applied to other laboratory assays in order to lower error rates.
• Addresses emerging challenges such as the correct differentiation between HER2 0 and HER2 1+ cases, which has become critical with the focus on accurate scoring of HER2-low patients for novel companion diagnostics.

Qualitopix is a fully cloud-based solution requiring no local installation or integration with existing laboratory systems. An interactive online demo is available upon registration, allowing laboratories to review example staining results and explore the monitoring capabilities before adoption. The platform complements external quality assurance (EQA)-led proficiency testing by providing continuous, internal staining consistency monitoring.