RESUMEN
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 Asunto(s)
Epítopos/análisis
, Inmunohistoquímica/normas
, Péptidos/análisis
, Coloración y Etiquetado/normas
, Neoplasias de la Mama/diagnóstico
, Línea Celular Tumoral
, Epítopos/inmunología
, Humanos
, Inmunohistoquímica/instrumentación
, Péptidos/inmunología
, Control de Calidad
, Receptor ErbB-2/análisis
, Receptor ErbB-2/inmunología
, Estándares de Referencia
, Programas Informáticos