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HelpTest Code 288PD Programmed Death-Ligand 1 (PD-L1) (28-8), Semi-Quantitative Immunohistochemistry, Manual
Ordering Guidance
In patients with specific tumor types, programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) is indicated to predict response to treatment with PD-L1 inhibitors. The specific PD-L1 clone, scoring method, and eligibility requirements depend on the tumor type, stage of malignancy, previous treatment outcomes, and specific PD-L1 inhibitor under consideration. For assistance with PD-L1 test selection as well as answers to frequently asked questions, see PD-L1 Immunohistochemistry Testing on MayoClinicLabs.com.
Shipping Instructions
Attach the green pathology address label included in the kit to the outside of the transport container.
Necessary Information
A pathology/diagnostic report and a brief history, including primary site of neoplasm, are required.
Specimen Required
Specimen Type: Tissue
Supplies: Pathology Packaging Kit (T554)
Collection Instructions: Formalin-fixed, paraffin-embedded tissue block; or 3 unstained glass, "positively charged" slides with 4-microns formalin-fixed, paraffin-embedded tissue
Additional Information: One slide will be stained with hematoxylin and eosin and returned.
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763)
-Oncology Test Request (T729)
Useful For
Identification of neoplasms expressing programmed cell death 1-ligand 1(clone 28-8)
Method Name
Immunohistochemistry (IHC)
Reporting Name
PD-L1 (28-8), SemiQuant IHC, ManualSpecimen Type
SpecialSpecimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Special | Ambient (preferred) | ||
| Refrigerated | |||
Interpretation
The results of the test will be reported in form of scores. The scoring system is based on type and origin of tumor. If additional interpretation or analysis is needed, order PATHC / Pathology Consultation along with this test.
Clinical Reference
1. Garcia A, Recondo G, Greco M et al. Correlation between PD-L1 expression (clones 28-8 and SP263) and histopathology in lung adenocarcinoma. Heliyon. 2020;6(6):e04117
2. Kintslera S, Cassataroa MA, Drosch M, Holenya P, Knuechel R, Braunschweig T. Expression of programmed death ligand (PD-L1) in different tumors. Comparison of several current available antibody clones and antibody profiling. Ann Diagn Pathol. 2019;41:24-37
3. O'Malley DP, Yang Y, Boisot S, et al. Immunohistochemical detection of PD-L1 among diverse human neoplasms in a reference laboratory: observations based upon 62,896 cases. Mod Pathol. 2019;32(7):929-942
4. Koppel C, Schwellenbach H, Zielinski D, et al. Optimization and validation of PD-L1 immunohistochemistry staining protocols using the antibody clone 28-8 on different staining platforms. Mod Pathol. 2018;31(11):1630-1644
5. Phillips T, Simmons P, Inzunza HD, et al. Development of an automated PD-L1 immunohistochemistry (IHC) assay for non-small cell lung cancer. Appl Immunohistochem Mol Morphol. 2015;23(8):541-549
6. Magaki S, Hojat SA, Wei B, So A, Yong WH. An introduction to the performance of immunohistochemistry. Methods Mol Biol. 2019;1897:289-298. doi:10.1007/978-1-4939-8935-5_25
Day(s) Performed
Monday through Friday
Report Available
5 to 7 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
88360
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| 288PD | PD-L1 (28-8), SemiQuant IHC, Manual | 85148-5 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 609995 | Interpretation | 83056-2 |
| 609996 | Participated in the Interpretation | No LOINC Needed |
| 609997 | Report electronically signed by | 19139-5 |
| 609998 | Material Received | 81178-6 |
| 609999 | Disclaimer | 62364-5 |
| 610000 | Case Number | 80398-1 |