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Test ID: 60198    
HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual

Method Description Describes how the test is performed and provides a method-specific reference

Testing is performed on formalin-fixed paraffin-embedded tissue sections using Ventana Pathway Immunoperoxidase HER2 (4B5) rabbit monoclonal primary antibody and a proprietary detection system. (Package insert: PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody). No expression (HER2 score of 0), low expression (HER2 score of 1+) and high expression (HER2 score of 3+) controls are used.

 

Scoring:

Scoring is performed for surgical and biopsy specimens according to the following article: Ruschoff J, Dietel M, Baretton G, et al: HER2 diagnostics in gastric cancer-guideline validation and development of standardized immunohistochemical testing. Virchows Arch Sep;457(3):299-307

 

Surgical Specimen:

Score of 0 is no reactivity or membranous reactivity (staining) in <10% of invasive tumor cells. Score of 1+ is faint/barely perceptible membranous reactivity (staining) in > or =10% of invasive tumor cells; cells are reactive (stained) only in part of their membrane. Score of 2+ is weak to moderate complete, basolateral, or lateral membranous reactivity (staining) in > or =10% of invasive tumor cells. Score of 3+ is strong complete, basolateral, or lateral membranous reactivity (staining) in > or =10% of invasive tumor cells.

 

Biopsy Specimen:

Score of 0 is no reactivity or no membranous reactivity (staining) in any invasive tumor cells. Score of 1+ is tumor cell cluster with a faint/barely perceptible membranous reactivity (staining) irrespective of percentage of invasive tumor cells stained. Score of 2+ is tumor cell cluster with a weak to moderate complete, basolateral, or lateral membranous reactivity (staining) irrespective of percentage of invasive tumor cells stained. Score of 3+ is tumor cell cluster with a strong complete, basolateral, or lateral membranous reactivity (staining) irrespective of percentage of invasive tumor cells stained.

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Monday through Friday

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

2 days

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

10 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Until 1 week after results are reported

Performing Laboratory Location The location of the laboratory that performs the test

Rochester