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PD-L1 Lung (Nivolumab), IHC
Test Code93359
CPT Codes
88360
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue block
Other Acceptable Specimens
Minimum: 5 unstained, charged (+) slides
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 Container
IHC Specimen Transport Kit
Transport Temperature
Tissue block: Room temperature
Slides: Refrigerated (cold packs)
Slides: Refrigerated (cold packs)
Specimen Stability
Tissue block
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Slides
Room temperature: Unacceptable
Refrigerated: 30 days
Frozen: Unacceptable
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
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 than formalin
Methodology
Immunohistochemical Stain
Setup Schedule
Set up: Mon-Fri a.m.; Report available: 4-6 days
Reference Range
See Laboratory Report
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).
