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Themcradds R package is a complement tomcr package, containscommon and solid functions for designing, analyzing and visualization inIn Vitro Diagnostic trials. Most of the methods and algorithms refer toCLSI 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, CLSIEP12-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 CLSIEP09-A3.
• Evaluation of bias in medical decision level, CLSI EP09-A3.
• Pearson and Spearman correlation adding hypothesis test and confidenceinterval.
• Establishing of Reference Range/Interval, CLSI EP28-A3 and NMPAguideline.
• Paired ROC/AUC test for superiority and non-inferiority trials, CLSIEP05-A3/EP15-A3.
• Reproducibility analysis (reader precision) for immunohistochemicalassays, CLSI I/LA28-A2 and NMPA guideline.
• Evaluation of precision of quantitative measurements, CLSI EP05-A3.
• Descriptive statistics summary.

mcradds is available on CRAN and you can install the latest releasedversion 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 vignettesbrowseVignettes(package = "mcradds") for usageof this package.