IHC Antibody Validation SOP
Purpose
To ensure the reliability and accuracy of immunohistochemistry (IHC) results through systematic validation of antibodies.
Scope
This SOP applies to all IHC antibody validations conducted in the laboratory.
Responsibilities
- Laboratory Manager: Oversees the validation process
- Technician: Executes validation experiments
- Quality Manager: Reviews and approves validation results
Materials & equipment
- IHC antibodies
- Positive control tissue samples
- Negative control tissue samples
- Blocking solution
- Detection reagents
- Microscope
Procedure
- Select appropriate antibodies for validation.
- Prepare positive and negative control tissue samples.
- Perform IHC staining on control samples using selected antibodies.
- Evaluate staining patterns under a microscope.
- Document the staining intensity and specificity.
- Compare results with established benchmarks for validation.
Records
- Validation results log
- Control sample staining records
- Final validation report
Safety
- Wear appropriate personal protective equipment (PPE) during experiments.
- Handle all reagents according to Safety Data Sheets (SDS).
Disclaimer
This is a template for educational and planning purposes. Laboratories must adapt it to their institutional SOPs, manufacturer instructions, applicable accreditation requirements, and pathologist approval before use.
Unimeditrek Pvt. Ltd. · www.unilabequipments.com · Educational template — adapt to your laboratory.