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Published on: July 26, 2019
Quality control in immunohistochemistry. Report of a workshop sponsored by the Biological Stain Commission
J M Elias1, A M Gown, R M Nakamura
1University of New York, Stony Brook School of Medicine.
Insights
Standardizing immunohistochemistry reagents and methods is crucial for reliable diagnostic pathology. This workshop proposed quality control measures for antibodies and consistent reporting to improve clinical comparisons.
Area of Science:
- Histopathology
- Immunohistochemistry
- Diagnostic Pathology
Background:
- Immunohistochemical methods are widely used in diagnostic histopathology.
- Lack of standardization in immunoreagents and reporting hinders reliable comparisons.
- Quality control and standardization are needed for commercial antibodies and publication methods.
Purpose of the Study:
- To address the lack of standardization in immunohistochemistry (IHC).
- To propose quality control measures for commercial antibodies and IHC procedures.
- To standardize reporting of IHC methods in publications.
Main Methods:
- Convened a Biological Stain Commission-sponsored workshop.
- Discussed a manufacturers' testing program for antibody probity.
- Addressed standardization of package inserts and reporting in Materials and Methods.
- Proposed a reagent and procedure clearing house.
- Investigated effects of fixation and environmental conditions on antigen-antibody interactions.
Main Results:
- Recommendations were made for a manufacturers' testing program.
- Development of a manual for performance criteria and quality control is proposed.
- Standardization of package inserts and publication reporting is recommended.
- A clearing house for reagents and procedures was suggested.
- Further studies on fixation and environmental conditions are needed.
Conclusions:
- Standardization of immunoreagents and methods is essential for diagnostic histopathology.
- Implementing proposed quality control measures will improve reliability and comparability of IHC results.
- Consistent reporting in publications is vital for meaningful comparisons among clinicians.
Abstract:
Although immunohistochemical methods are increasingly applied in diagnostic histopathology, there has been little standardization or quality control of immunoreagents; and published reports have not standardized Material and Methods for meaningful comparisons of results among clinicians. The Biological Stain Commission-sponsored workshop was convened to address the following issues: a manufacturers' testing program for probity of commercial antibodies, development of a manual for performance criteria and quality control assurance procedures, standardization of package inserts, standardization of information provided in the Materials and Methods sections of publications, establishment of a reagent and procedure clearing house, study of the effects of different fixation regimes on tissue antigens, and investigation of the environmental conditions needed for antigen-antibody interaction. The recommendations of the ad hoc committee and their implications for the future are discussed.
