Table 3.

Analytical performance metrics evaluated for CIMAC assays

• Analytes

• Technical platform(s)

• Reagents, controls, and calibrators

• Quality control parameters for specimens/analytes (e.g., cell viability, RNA/protein quality/integrity)

• Critical pre-analytic variables

• Analytical performance characteristics for each assay:

◾ Current status and results of studies defining the sensitivity, specificity, accuracy, precision, reproducibility, reportable range, reference ranges/intervals (normal values), turnaround time, and failure rate of the assay.

◾ Use of positive and negative controls, calibrators, and reference standards.

◾ Number of samples in the reproducibility study.

◾ How run-to-run variation (Coefficient of Variation; CV) was assessed and handled.

◾ How inter-laboratory variability in the measurements was assessed and how these sources of variation were minimized to maintain performance at all sites within acceptable limits and to prevent drift or bias in the assay.

◾ Scoring procedures and type of data to be acquired:

• Quantitative/continuously distributed

• Semi-quantitative/ordered categorical

• Qualitative/non-ordered categorical

Adapted from “Study Checklist for CTEP-Supported Early Phase Trials with Biomarker Assays”, found at http://ctep.cancer.gov/protocolDevelopment/ancillary_correlatives.htm