Implications of stain quality in the diagnostic lab
Dr. Mogens Vyberg provides examples from his time at NordicQC to discuss the need to standardize sample staining in the clinic.
In quality runs conducted by NordiQC from 2003-2015, about 30% of the stains in the general module and 20% in the Breast Cancer Module showed insufficient staining as assessed by the external quality assessment (EQA). While EQA’s give laboratories valuable feedback on the performance of laboratories regularly, there are typically at least 3 to 6 months between assessments due to bandwidth limitations at EQAs.
The variability between EQA runs represents a real problem in terms of standardization and a concomitant lack of robustness in tissue diagnostic testing. This is a problem both in routine diagnostics and in clinical trials.
Fig. Two sections from the same tissue sample, stained with PD-L1 at two different labs. Lab A has insufficient staining, while Lab B has sufficient staining.
Qualitopix™ is the only solution that enables you to continuously monitor and document your stain quality through objective AI-driven standardisation.
 Vyberg M, Nielsen S. Proficiency testing in immunohistochemistry – experiences from Nordic Immunohistochemical Quality Control (NordiQC). Virchows Arch. 2016 Jan;468(1):19-29. DOI: 10.1007/s00428-015-1829-1. Epub 2015 Aug 26. PMID: 26306713; PMCID: PMC4751198.
 Sophia Apple, MD, MS, et al., The Effect of Delay in Fixation, Different Fixatives, and Duration of Fixation in Estrogen and Progesterone Receptor Results in Breast Carcinoma, American Journal of Clinical Pathology, Volume 135, Issue 4, April 2011, Pages 592–598.
 Kohlberger T, Liu Y, Moran M, et al. Whole-slide image focus quality: Automatic assessment and impact on ai cancer detection. J Pathol Inform. 2019;10(1):39. doi:10.4103/jpi.jpi_11_19