Article

Statistical Methods for Evaluating Contrived Sample Functional Characterization Studies for Next-generation Sequencing-based Qualitative Assays

2025-11-10

Abstract excerpt

Evaluation of new clinical assays involves numerous studies using patient samples to verify performance. Due to limited patient sample availability, supplementary surrogate samples may be needed. To evaluate functional comparability between surrogate and patient samples, a contrived sample functional characterization (CSFC) study has been recommended. Alongside this, a statistical analysis framework has been propo...

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Literature Corpus work: 213c1b13-8f33-5a5c-8d6f-b78c7d225be9
DOI: 10.1101/2025.11.08.25339816

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