ABSTRACT
Peptide immunohistochemistry (IHC) controls are a new quality control format for verifying proper IHC assay performance, offering advantages in high throughput automated manufacture and standardization. We previously demonstrated that formalin-fixed peptide epitopes, covalently attached to glass microscope slides, behaved (immunochemically) in a similar fashion to the native protein in tissue sections. To convert this promising idea into a practical clinical laboratory quality control tool, we tested the hypothesis that the quality assurance information provided by peptide IHC controls accurately reflects IHC staining performance among a diverse group of clinical laboratories. To test the hypothesis, we first designed and built an instrument for reproducibly printing the controls on microscope slides and a simple software program to measure the color intensity of stained controls. Automated printing of peptide spots was reproducible, with coefficients of variation of 4% to 8%. Moreover, the peptide controls were stable at Subject(s)
Epitopes/analysis
, Immunohistochemistry/standards
, Peptides/analysis
, Staining and Labeling/standards
, Breast Neoplasms/diagnosis
, Cell Line, Tumor
, Epitopes/immunology
, Humans
, Immunohistochemistry/instrumentation
, Peptides/immunology
, Quality Control
, Receptor, ErbB-2/analysis
, Receptor, ErbB-2/immunology
, Reference Standards
, Software