Skip to main content

Table 4 Recommended standard materials for immune assays

From: Validation of biomarkers to predict response to immunotherapy in cancer: Volume I — pre-analytical and analytical validation

Technology/Assay

Recommended Reference Materials

Blood-based assays

Cell lines or control PBMC donor samples prepared and cryopreserved following SOP (reference samples)

Immunohistochemistry assays

Control cell lines or tissue specimens (e.g., human tonsil for PD-L1 staining) or cell lines processed and embedded in paraffin (not to be used for interpreting patient data)

RNA/DNA based assays (NGS, TCR/BCR sequencing, gene expression profiling)

Synthetic mimic libraries, TCR/BCR DNA synthetic templates, synthetic vectors, company or WHO and NIST references