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PD-L1 Lung (Nivolumab), IHC
Test Code93359
CPT Codes
88360
Preferred Specimen
Formalin-fixed, paraffin embedded tissue in IHC specimen transport kit
Other Acceptable Specimens
5 unstained charged(+) slides in IHC specimen transport kit
Instructions
FFPE: State any other type of fixative used. A pathology report which includes the paraffin block number, and both macroscopic and microscopic evaluation and diagnosis, should be sent with the specimen.
Transport Temperature
Tissue: Room temperature
Slides: Refrigerated (cold packs)
Slides: Refrigerated (cold packs)
Specimen Stability
Formalin-fixed paraffin embedded tissue
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Unstained charged(+) slides
Room temperature: Unacceptable
Refrigerated: 30 days
Frozen: Unacceptable
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Unstained charged(+) slides
Room temperature: Unacceptable
Refrigerated: 30 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Baked or melted slides • Previously stained slides • Cytospins • Tissue types other than lung cancer specimens • Cytology cell block • Decalcified specimens • Fixatives other then formalin
Methodology
Immunohistochemical Stain
Setup Schedule
A.M. Sets up 5 days a week.
Report Available
Reports in 3 to 5 days.
Clinical Significance
The PD-L1 IHC 28-8pharmaDx qualitative assay is intended for use in the detection of PD-L1 expression in formalin-fixed, paraffin embedded (FFPE) non-squamous non-small cell lung carcinoma (NSCLC). PD-L1 expression in non-squamous NSCLC may be associated with enhanced survival from OPDIVO (nivolumab).
