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Synthetic Antigen Controls for Immunohistochemistry
Published on: August 23, 2021
Quality control in diagnostic immunohistochemistry: integrated on-slide positive controls
A Bragoni1, A Gambella1, S Pigozzi1,2
1Histopathology Unit, Department of Surgical Sciences and Integrated Diagnostics (DISC), University of Genoa, Genoa, Italy.
Insights
This study introduces a cost-effective method for creating integrated positive controls in immunohistochemistry using a punch biopsy tool. This technique enhances quality control and reduces laboratory expenses.
Area of Science:
- Pathology
- Laboratory Medicine
- Biotechnology
Background:
- Standardization and cost containment are critical in modern pathology.
- Routine positive controls are essential for validating immunohistochemistry (IHC) procedures.
- External positive controls can be costly and may not always be available for every slide.
Purpose of the Study:
- To develop a low-cost, integrated positive control method for immunohistochemistry.
- To utilize a punch biopsy (PB) tool for creating these controls.
- To assess the feasibility, reliability, and cost-effectiveness of the proposed technique.
Main Methods:
- Selected 16 frequently used control blocks.
- Obtained cylindrical samples using a 5-mm diameter punch biopsy tool.
- Re-embedded samples and integrated PB-control sections onto patient slides before immunostaining.
Main Results:
- Achieved a saving of 4.75% in total direct laboratory costs.
- Demonstrated technical feasibility and reliability of the integrated PB-control technique.
- Confirmed the method is easy to perform with readily available tools.
Conclusions:
- The integrated punch biopsy control method is a cost-effective and reliable approach for immunohistochemistry.
- This technique ensures a specific control is available for each slide, improving quality assurance.
- The method is accessible to all pathology laboratories, enhancing standardization and cost containment efforts.
Abstract:
Standardization in immunohistochemistry is a priority in modern pathology and requires strict quality control. Cost containment has also become fundamental and auditing of all procedures must take into account both these principles. Positive controls must be routinely performed so that their positivity guarantees the appropriateness of the immunohistochemical procedure. The aim of this study is to develop a low cost (utilizing a punch biopsy-PB-tool) procedure to construct positive controls which can be integrated in the patient's tissue slide. Sixteen frequently used control blocks were selected and multiple cylindrical samples were obtained using a 5-mm diameter punch biopsy tool, separately re-embedding them in single blocks. For each diagnostic immunoreaction requiring a positive control, an integrated PB-control section (cut from the appropriate PB-control block) was added to the top right corner of the diagnostic slide before immunostaining. This integrated control technique permitted a saving of 4.75% in total direct lab costs and proved to be technically feasible and reliable. Our proposal is easy to perform and within the reach of all pathology labs, requires easily available tools, its application costs is less than using external paired controls and ensures that a specific control for each slide is always available.

