Processing and Analyzing of Diagnostics Trials

Provides methods and functions to analyze the quantitative or qualitative performance for diagnostic assays, and outliers detection, reader precision and reference range are discussed. Most of the methods and algorithms refer to CLSI (Clinical & Laboratory Standards Institute) recommendations and NMPA (National Medical Products Administration) guidelines. In additional, relevant plots are constructed by 'ggplot2'.

mcradds

The mcradds R package is a complement to mcr package, contains common and solid functions for designing, analyzing and visualization in In Vitro Diagnostic trials. Most of the methods and algorithms refer to CLSI recommendations and NMPA guidelines.

The package provides a series of typical functionality, as shown below:

• Estimation of sample size for trials, NMPA guideline.
• Diagnostic accuracy with/without standard/golden reference, CLSI EP12-A2.
• Regression analysis and plot in method comparison, CLSI EP09-A3.
• Bland-Altman analysis and plot in method comparison, CLSI EP09-A3.
• Outlier detection with 4E method from CLSI EP09-A2 and ESD from CLSI EP09-A3.
• Evaluation of bias in medical decision level, CLSI EP09-A3.
• Pearson and Spearman correlation adding hypothesis test and confidence interval.
• Establishing of Reference Range/Interval, CLSI EP28-A3 and NMPA guideline.
• Paired ROC/AUC test for superiority and non-inferiority trials, CLSI EP05-A3/EP15-A3.
• Reproducibility analysis (reader precision) for immunohistochemical assays, CLSI I/LA28-A2 and NMPA guideline.
• Evaluation of precision of quantitative measurements, CLSI EP05-A3.
• Descriptive statistics summary.

Installation

mcradds is available on CRAN and you can install the latest released version with:

install.packages("mcradds")

or you can install the development version directly from GitHub with:

if (!require("devtools")) {
  install.packages("devtools")
}
devtools::install_github("kaigu1990/mcradds")

See package vignettes browseVignettes(package = "mcradds") for usage of this package.