Version May 2024
| Patient identification information |
| Physician identification |
| Date of service |
| Specimen site and type |
| Specimen identification (case and block number) |
| Fixative |
| Cold ischemia time (time between removal and fixation) |
| Duration of fixation |
| Staining method utilized: |
| Primary antibody and vendor |
| Assay details and other reagents/vendors |
| References supporting validation of assay (note: most commonly, these will be published studies performed by others that the testing laboratory is emulating) |
| Status of FDA approval |
| Controls (high protein expression, low-level protein expression, negative protein expression, internal elements or from normal breast tissue included with sample) |
| Adequacy of sample for evaluation |
| Results: |
| Percentage of invasive tumor cells exhibiting nuclear staining |
| Intensity of staining: Strong, medium, weak |
| Interpretation: |
| - Positive (for ER or PR receptor protein expression), negative (for ER or PR protein expression), uninterpretable |
| - Internal and external controls (positive, negative, not present) |
| - Standard assay conditions met/not met (including cold ischemic time and fixation parameters) |
| - Optional score and scoring system |
| - Comment: Should explain reason for uninterpretable result and or any other unusual conditions, if applicable. May report on status of any DCIS staining in the sample. Should also provide correlation with histologic type of the tumor. May provide information about laboratory accreditation status. |
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