---
title: "Introduction to ivdtools"
output:
  rmarkdown::html_vignette:
vignette: >
  %\VignetteIndexEntry{Introduction to ivdtools}
  %\VignetteEngine{knitr::rmarkdown}
  %\VignetteEncoding{UTF-8}
---

```{r setup, include = FALSE}
knitr::opts_chunk$set(
  collapse = TRUE,
  comment = "#>",
  fig.align = "center",
  warning = FALSE,
  message = FALSE
)
```

## 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 |
| Reference-material commutability | `commutability()` | EP14  EP30 and IFCC Part 2 |
| Precision | `precision()` | EP05 and EP15 |
| Qualitative agreement | `raw_to_table()` and others | EP12 |
| C5/C95 estimation | `c5_c95()` | EP12 |
| Reference interval | `reference_interval()` | EP28 |
| Stability | `stability_*()`, `arrhenius()`, `mkt()` | EP25 |
| Linearity | `linearity()` and `linearity_*()` | EP06 |
| Curve fitting | `fit_equation()` family | General |
| Interference | `interference_*()` | EP07 |
| Dilution, spiking, and hook effect | `dilution_recovery()`, `spike_recovery()`, `hook_effect()` | EP34 |
| Measurement uncertainty | `uncertainty_*()` | EP29 |
| Reference-material bias | `reference_bias()` | YY/T 1789.2 |
| Analytical sensitivity | `sensitivity_lob()` / `sensitivity_lod()` / `sensitivity_loq()` | EP17 |
| Bottle-to-bottle ANOVA | `bottle_anova()` | EP15 |
| ROC analysis | `roc()` family | EP24 |
| Quality control | `qc_chart()`, `youden_plot()` | Westgard rules |
| Outliers and normal test | `outliers_test()`、`normal_test()` | General |
| 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.

## Detailed tutorials

Detailed tutorials covering data import, analysis environment setup, and complete worked examples for every analysis module 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>