ユーザーズマニュアル目次Intended Use3For in vitro diagnostic use3Required training3Summary and Explanation3Background3Clinical Concordance Summary Leica BOND-MAX System4Clinical Concordance Summary Leica BOND-III System4Principle of Procedure4Components Provided5Directions For Use5Storage and Stability5Specimen Preparation5Warnings and Precautions6Procedure6A. Reagents required but not supplied6B. Equipment required but not supplied6C. Methodology7D. Bond Enzyme Pretreatment7E. Default Staining Protocol7F. Procedure Steps7G. Slide Storage8Signal Assessment and Enumeration9Recommended Method for LSI HER2 to CEP17 Ratio Determination10Leica HER2 FISH System - 30 Test Interpretation Guide11Sample Score Sheet12Quality Control13Limitations13A. General Limitations13B. Product Specific Limitations142x2 Concordance Results Leica BOND-MAX System152x2 Concordance Results Leica BOND-III System16Precision Testing – Leica BOND-MAX System17A. Within Run Precision Study17B. Within Instrument Precision Study17C. Between Run Precision Study17D. Between Laboratory Precision Study17E. Between Observer Precision Study17F. Lot-to-Lot Precision Study18Precision Testing – Leica BOND-III System18G. Within Run Precision Study18H. Within Instrument Precision Study18I. Between Run Precision Study18J. Between Laboratory Precision Study18K. Between Observer Precision Study19L. Lot-to-Lot Precision Study19Assay Robustness19Troubleshooting21References23License Agreement24サイズ: 458KBページ数: 24Language: Englishマニュアルを開く