# Introduction to ivdtools

## What is ivdtools

`ivdtools` is an R package providing statistical workflows used in the evaluation of in vitro diagnostic (IVD) reagents, covering data inspection, statistical analysis, result summarization, and visualization. The current version requires R >= 4.1.0 and is distributed under the MIT license.

The package provides the following analysis modules:

Module | Main entry points | Related CLSI guideline
--- | --- | ---
Method comparison | `mcr()` | EP09
Precision | `precision()` | EP05
Qualitative agreement | `raw_to_table()` and others | EP12
Reference interval | `reference_interval()` | EP28
Stability | `stability_*()`, `arrhenius()`, `mkt()` | EP25
Linearity / curve fitting | `fit_equation()` family | EP06
Analytical sensitivity | `lob_lod_loq()` | EP17
Bottle-to-bottle ANOVA | `bottle_anova()` | EP15
ROC analysis | `roc()` family | EP24
Quality control | `qc_chart()`, `youden_plot()` | Westgard rules
Sample size | `sample_size_*()` | General

Statistical results should be interpreted in the context of a pre-specified study protocol, applicable standards, and clinical or analytical acceptance limits; they are not a substitute for professional judgment.

## Quick start

Install and load the package:

    install.packages("ivdtools")
    library(ivdtools)

A simple method-comparison example:

    obj <- mcr(ivd_mcr_example, "sid", "test", "ref")
    summary(obj)
    plot(obj)

## Detailed tutorials

Detailed tutorials — covering data import, analysis environment setup, complete worked examples for every analysis module, and AI-assisted automated analysis — are available on the project homepage:

https://github.com/hiox-tech/ivdtools

## Feedback

Bug reports, feature requests, and feedback:

https://github.com/hiox-tech/ivdtools/issues