Table 1 Validation parameters of the PD-L1 digital assay.
Validation parameter | Parameter definition | Pass/fail |
|---|---|---|
Analytical Specificity | The assay demonstrates acceptable staining as identified by specific cell type and subcellular localization of staining | Pass |
Analytical Sensitivity | The assay demonstrates acceptable target cell staining at various intensities and acceptable background staining. Background staining must be < 1 + staining intensity for acceptability | Pass |
Accuracy | The assay demonstrates acceptable concordance with an orthogonal measurement of the assay’s determinant | Pass |
Precision | The assay demonstrates acceptably reproducible staining over 3 runs | Pass |
