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veRification: an R Shiny application for laboratory method verification and validation.

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This study introduces an open-source software for Bayesian analysis of clinical laboratory assay verification data, making complex statistical methods more accessible and promoting collaborative development.

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Area of Science:

  • Clinical Laboratory Science
  • Biostatistics
  • Bioinformatics

Background:

  • International standards mandate assay performance verification before clinical implementation.
  • Traditional verification analysis relies on frequentist methods and proprietary software.
  • There is a need for accessible, open-source tools for assay verification data analysis.

Purpose of the Study:

  • To develop an open-source software application for Bayesian analysis of clinical laboratory assay verification data.
  • To make advanced Bayesian statistical methods more accessible to laboratory professionals.
  • To encourage the use and development of open-source software in the clinical laboratory community.

Main Methods:

  • Developed an R package using the Shiny application framework.
  • The software is freely available on GitHub.
  • The codebase is fully open-source.

Main Results:

  • The application enables analysis of imprecision and trueness data.
  • It supports analysis against external quality assurance and reference materials.
  • Method comparison and diagnostic performance data can also be analyzed using Bayesian and frequentist approaches.

Conclusions:

  • The software lowers the barrier to entry for Bayesian analysis in clinical laboratories.
  • It promotes the dissemination and collaborative development of open-source tools.
  • Provides a framework for sharing and iterating on Shiny applications for scientific analysis.