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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
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

These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.
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