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Test ID: IH PD-L1 22C3
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PD-L1 22C3
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Immunohistochemistry Stain
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Useful For
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Use in the detection of PD-L1 protein in non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction (GEJ) adenocarcinoma, esophageal squamous cell carcinoma (ESCC), cervical cancer, urothelial carcinoma, head and neck squamous cell carcinoma (HNSCC) and it is indicated as an aid in identifying triple negative breast cancer (TNBC).
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Method name and description
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- Monoclonal Mouse Anti-PD-L1, Clone 22C3
- A qualitative immunohistochemical assay on formalin-fixed, paraffin-embedded (FFPE) tissue section
- (Companion diagnostic test).
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Clinical information
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PD-L1 protein expression in NSCLC is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. PD-L1 protein expression in gastric or GEJ adenocarcinoma, ESCC, cervical cancer, urothelial carcinoma, HNSCCAND triple-negative breast cancer (TNBC) is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells multiplied by 100.
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Specimen type / Specimen volume / Specimen container
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- Specimen type: Well-fixed tissue in 10% neutral buffered formalin.
- Submit 2 unstained (3-4 µm thick) paraffin embedded tissue section mounted on a clean positively charged glass slide (sections to be cut within 6 weeks.) or formalin-fixed, paraffin-embedded (FFPE) tissue block
- One slide will be stained for PD-L1 antibody and the other slide will be stained for the negative control tissue (the use of the negative control tissue is to verify the specificity of the primary antibody and to provide an indication of specific bakground staining).
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Storage and transport instructions
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- Slides or blocks are stored in cork box at room temperature away from sun light and any source of heat.
- Follow your local regulation shipping guidelines.
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Specimen Rejection Criteria
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- Broken slides
- Unlabeled slides with patient/case identification
- Contaminated slides
- Slides/paraffin blocks mismatch
- Uncharged slides
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Factors affecting test performance and result interpretation
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- Fixation time (FT)
- Fixative Type
- Storage time in paraffin
- Storage temperature
- Age of the cut sections
- Section thickness
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Turnaround time / Days and times test performed / Specimen retention time
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- Turnaround time for the test in platform: 3-4 hours
- Days and times test performed: Twice daily (Sunday to Wednesday)
- First batch: 0600H-1400H
- Second batch; 1230H - overnight
- Thursday (one batch only): 0600H-1400H
- Note: Request received after 1230H will be stained the following working day.
- Shelf-life of the paraffin section slides: ≤6 weeks
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