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 covering data import, analysis environment setup, and complete worked examples for every analysis module are available on the project homepage: