CASI

Consortium for Analytical Standardization in Immunohistochemistry

CASI aims to improve immunohistochemistry (IHC) test accuracy and reproducibility by integrating fit-for-purpose IHC calibration standards.

What We Do

Conduct Studies

Examining how IHC analytic sensitivity affects test accuracy

Develop

Quantitative guidelines for analytic sensitivity

Educate

Lab directors, pathologists, laboratory technologists, and biomedical scientists

Support

External quality assurance programs by providing fit-for-purpose reference standards

Why CASI is Needed

The absence of analytic standards in diagnostic IHC is a highly unusual situation in laboratory medicine, without which accuracy and reproducibility suffer. There is no precedent for an entire clinical laboratory testing industry (like IHC) to lack analytic standards, especially one so large, well-established, and critically important for patient care as IHC. CASI is the only organization able to address this need.

Our Process

Create Assessment Tool

Assessment Tool for Correlating

Diagnostic Accuracy

Analytic Sensitivity

Tissue Microarray Preparation: designate each sample as a true positive or true negative
Will provide patient diagnostic data
Calibrator Manufacture: characterization & Certificate of Analysis (COA)
Will provide Assay analytic data

Distribute Assessment Tool

Mail to Participating Labs: variability among labs’ assays
Testing & Assessment
Return of Slides & Assessment

Collect Data and Analyze

Read TMAs (pathologists + image analysis)
Calibrator Analysis (LoD & linear range) for Each Laboratory
Identify the LoD Associated with Optimal Diagnostic Accuracy