Related Experiment Videos
General Guidelines for Quality Assurance of Immunohistochemistry in a Mohs Lab
Carrie G Kinas1, Bryan T Carroll
1*Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia;†Department of Dermatology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
Insights
Mohs laboratories can improve regulatory compliance and reagent performance by implementing a structured immunohistochemistry (IHC) validation and quality assurance (QA) program. This ensures adherence to evolving clinical laboratory regulations for IHC technologies.
Area of Science:
- Clinical Laboratory Science
- Pathology
- Regulatory Affairs
Background:
- Mohs laboratories face unique challenges adopting new immunohistochemistry (IHC) protocols.
- Understanding IHC performance validation and clinical laboratory regulations is crucial for these evolving technologies.
Purpose of the Study:
- To review Food and Drug Administration (FDA) IHC reagent classifications.
- To outline IHC validation protocols and quality assurance (QA) procedures.
- To detail necessary documentation for IHC test guidelines.
Main Methods:
- Focused review of FDA IHC reagent classifications and clinical testing guidelines.
- Utilized PubMed and FDA source documents for analysis.
Main Results:
- IHC regulation requirements depend on FDA reagent classifications (in vitro diagnostic, analyte-specific, research use only).
- Routine validation and QA programs enhance IHC reagent performance and manage variability.
- Presents IHC adoption procedures for QA and documentation in a Mohs laboratory setting.
Conclusions:
- A well-organized IHC validation and QA program enhances regulatory compliance in Mohs laboratories.
- Implementation of such programs improves overall reagent performance for IHC tests.
Background:
The adoption of recently created protocols introduces Mohs laboratories to the principles of immunohistochemistry (IHC) performance validation and clinical laboratory regulations that are unique to these evolving technologies.
Objective:
To review Food and Drug Administration (FDA) IHC reagent classifications, IHC validation protocols, and quality assurance (QA) procedures and documentation needed in conjunction with IHC test guidelines.
Methods:
A focused review of IHC reagent classifications and guidelines in clinical testing laboratories was conducted using PubMed and FDA source documents.
Results:
The IHC regulation requirements are determined by the 3 FDA classifications of reagents: in vitro diagnostic reagents, analyte-specific reagents, and research use only reagents. To account for performance variability, IHC reagents benefit from routine validation and QA programs. We present our IHC adoption procedures for QA and documentation of IHC tests in a Mohs laboratory.
Conclusion:
Incorporating a well-organized IHC validation and QA program into Mohs laboratories can increase regulatory compliance and reagent performance.