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