Code
packageVersion("ivdtools")[1] '0.1.1'ivdtools handbook
Welcome
This book is an executable, auditable usage guide for ivdtools, intended for IVD practitioners, statisticians, and readers new to R. It covers everything from data entering the project to result export, experimental scenarios, and the statistical algorithms actually implemented in the package source code. Pedagogical recommendations are not equivalent to regulatory or standard requirements.
ImportantScope of Use
This book is for teaching statistical workflows and verifying implementations. It is not a substitute for product intended use, risk analysis, current regulations, or the original text of CLSI standards. Any performance claims should be supported by approved protocols, real samples, and independent review.
Reader’s Guide
- Beginners read Part 1 in sequence, then move on to the function chapters by task.
- Experienced analysts can directly look up function signatures, object fields, and boundary behavior.
Version and Citation
In papers or reports, at least record: package name and version, R version, functions and key parameters, data snapshot checksums, and analysis date. The software may be cited as: hiox-tech (2026), ivdtools: Statistical Tools for in Vitro Diagnostic Method Evaluation, version 0.1.1. Please submit issues to the project’s issue page.