R Package "ivdtools"

What is ivdtools · 功能介绍

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.

ivdtools 是一个用于体外诊断（IVD）试剂评价的 R 软件包，提供数据检查、统计分析、结果汇总和可视化等统计工作流程。当前版本要求 R >= 4.1.0，并采用 MIT 许可证发布。

The package provides the following analysis modules:

该软件包提供以下分析模块：

Module · 模块	Main entry points · 主要入口函数	Related CLSI guideline · 相关 CLSI 指南
Method comparison · 方法学比较	`mcr()`	EP09
Reference-material commutability · 参考物质互换性	`commutability()`	EP14, EP30, and IFCC Part 2
Precision · 精密度	`precision()`	EP05 and EP15
Qualitative agreement · 定性一致性	`raw_to_table()` and others	EP12
C5/C95 estimation · C5/C95 估计	`c5_c95()`	EP12
Reference interval · 参考区间	`reference_interval()`	EP28
Stability · 稳定性	`stability_*()`, `arrhenius()`, `mkt()`	EP25
Linearity · 线性	`linearity()` and `linearity_*()`	EP06
Curve fitting · 曲线拟合	`fit_equation()` family	General · 通用
Interference · 干扰	`interference_*()`	EP07
Dilution, spiking, and hook effect · 稀释、加标和钩状效应	`dilution_recovery()`, `spike_recovery()`, `hook_effect()`	EP34
Measurement uncertainty · 测量不确定度	`uncertainty_*()`	EP29
Reference-material bias · 参考物质偏倚	`reference_bias()`	YY/T 1789.2
LoB/LoD/LoQ · 空白限、检出限、定量限	`sensitivity_lob()` / `sensitivity_lod()` / `sensitivity_loq()`	EP17
Bottle-to-bottle ANOVA · 瓶间差方差分析	`bottle_anova()`	EP15
ROC analysis · ROC 分析	`roc()` family	EP24
Quality control · 质量控制	`qc_chart()`, `youden_plot()`	Westgard rules · Westgard 规则
Outliers and normality tests · 异常值与正态性检验	`outliers_test()`, `normal_test()`	General · 通用
Sample size · 样本量	`sample_size_*()`	General · 通用

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.

统计结果应结合预先规定的研究方案、适用标准以及临床或分析性能接受限进行解释；统计结果不能替代专业判断。