PD-L1 22C3 IHC with Combined Positive Score (CPS) Interpretation, pembrolizumab (KEYTRUDA)
Use for gastric/gastroesophageal junction (GEJ) adenocarcinomas, urothelial carcinoma, cervical carcinomas (squamous cell carcinomas and adenocarcinomas), esophageal squamous cell carcinoma (ESCC), and head and neck squamous cell carcinoma (HNSCC) specimens only, to aid in prediction of response to pembrolizumab (KEYTRUDA). Refer to the PD-L1 Testing Algorithm for more information.
Formalin fix (10 percent neutral buffered formalin) and paraffin embed specimen. Protect paraffin block and/or slides from excessive heat. Transport tissue block or 5 unstained (3- to 5-micron thick sections), positively charged slides in a tissue transport kit (ARUP supply #47808 recommended but not required), available online through eSupply using ARUP Connector contact ARUP Client Services at (800) 522-2787. (Min: 3 slides) If sending precut slides, do not oven bake.
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
Paraffin block with no tumor tissue remaining; specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens. Specimens with fewer than 100 viable tumor cells. Non-indicated tumor types, including non-small cell lung carcinomas.
Include surgical pathology report and indicate tissue site with the test order. For additional technical details, please contact ARUP Client Services at (800) 522-2787.
Slides: Ambient: 5 months (Must be stored in the dark); Refrigerated: 5 months (Must be stored in the dark); Frozen: Unacceptable
Paraffin Block: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Refer to report.
No compliance statements are in use for this test.
This test code includes pathologist interpretation. At least 100 viable tumor cells are required for interpretation.
|Component Test Code*||Component Chart Name||LOINC|
|2012108||PD-L1 Client Block ID||57723-9|
|2013285||PDL1 Tissue Source||31208-2|
|2013286||Adequacy of Specimen|
|3000223||Combined Positive Score||83053-9|
|3000224||PDL1 22C3 IHC Result||83052-1|