Statistical Framework for Clinical DNAemia Assays (SJ-18-0039)

St. Jude Reference #SJ-18-0039


Researchers at St. Jude have proposed a new statistical method to evaluate the performance of various viral testing assays in a quantitative way. It could be used by clinical and scientific investigators to evaluate viral testing results from different assays or labs, and to directly assess intra-assay as well as inter-assay agreement. A series of manuscripts describing the method are published or submitted for publication. Two different versions of the software; one using R software (www.r-project.organd another using SAS software ( available.


Quantification, DNAemia, clinical practice, research, reference materials, assays, commutability performance, assay agreement

Granted Patents or Published Applications

Related Scientific References

Tang L., Su Y., Gu Z., Pounds S. and Hayden R. A Comprehensive Statistical Framework for Determination of Commutability, Accuracy and Agreement in Clinical DNAemia Assays. (being submitted)

Tang L., Su Y., Pounds S. and Hayden R. Quantitative Inference of Commutability for Clinical Viral Load Testing. In press by Journal of Clinical Microbiology.

Tang L., Sun Y., Buelow D., Gu Z., Caliendo A.M., Pounds S. and Hayden R. Quantitative Assessment of Commutability for Clinical Viral Load Testing Using a Digital PCR-based Reference Standard. Journal of Clinical Microbiology 2016; 54:1616-1623. PMID: 27076654 DOI: 10.1128/JCM.03346-15

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