Key result
Deviation-from-ideal approach shows laboratory-developed test achieves optimal assay commutability with ~0.29 log10 bias.
The DFI approach offers a new method to evaluate the commutability of reference materials for clinical viral load testing.
DFI provides an objective commutability metric for EBV assays; leaves open adoption pending multicenter validation across standards.
Given recent advances in the development of quantitative standards, particularly WHO international standards, efforts to better understand the commutability of reference materials have been made. Existing approaches in evaluating commutability include prediction intervals and correspondence analysis; however, the results obtained from existing approaches may be ambiguous. We have developed a "deviation-from-ideal" (DFI) approach to evaluate commutability of standards and applied it to the assessment of Epstein-Bar virus (EBV) load testing in four quantitative PCR assays, treating digital PCR as a reference assay. We then discuss advantages and limitations of the DFI approach as well as experimental design to best evaluate the commutability of an assay in practice.
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Tang et al. (2016) studied Epstein-Barr virus (EBV) infection (n=194). Deviation-from-ideal (DFI) commutability assessment of four quantitative PCR assays vs. Digital PCR (reference assay) was evaluated on Commutability of reference standards measured by the Deviation-from-Ideal (DFI) metric. The deviation-from-ideal approach quantitatively evaluated assay commutability, demonstrating that a laboratory-developed test had the best performance compared to digital PCR with a DFI of 0.29 log10 IU/ml using WHO standards.
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