Programmed Death-Ligand 1 (PD-L1) (SP263), Semi-Quantitative Immunohistochemistry, Manual
Use
Programmed cell death 1-ligand 1 (PD-L1) is a transmembrane protein involved in immune response regulation. Overexpression in neoplasms, such as those in the urinary bladder, lung, and other tissues, has implications for prognosis and therapy. This test identifies neoplasms expressing PD-L1 using clone SP263, aiding in therapy decisions with PD-L1 inhibitors.
Special Instructions
This test requires submission of formalin-fixed, paraffin-embedded tissue blocks or unstained glass slides. A pathology report and patient history are necessary for accurate test processing. Ensure 'Attention Pathology' label is attached to samples.
Limitations
The test results should not be solely relied upon for treatment decisions as other markers, like tumor mutation burden and microsatellite instability, also matter. The test is validated for non-decalcified formalin-fixed tissue blocks; alternative fixatives or decalcification invalidate results. Sample slides' age and storage conditions can affect immunoreactivity.
New York Approved
Methodology
Immunoassay (IHC)
Biomarkers
LOINC Codes
- 59465-5
- 19139-5
- 81178-6
- 62364-5
- 80398-1
Result Turnaround Time
5-7 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
Formalin-fixed, paraffin-embedded tissue block or 3 unstained glass slides
Collection Instructions
Submit formalin-fixed, paraffin-embedded block or 3 unstained slides with 4-micron thickness.
Causes for Rejection
Decalcified paraffin embedded tissue, wet/frozen tissue, nonformalin fixed tissues, nonparaffin embedded tissue, noncharged slides, ProbeOn or Snowcoat slides.