A common way of validating a biological assay for is through a procedure, where m levels of an analyte are measured with n replicates at each level, and if all m estimates of the coefficient of variation (CV) are less than some prespecified level, then the assay is declared validated for precision within the range of the m analyte levels. Two limitations of this procedure are: there is no clear statistical statement of precision upon passing, and it is unclear how to modify the procedure for assays with constant standard deviation. We provide tools to convert such a procedure into a set of m hypothesis tests. This reframing motivates the m:n:q procedure, which upon completion delivers a 100q% upper confidence limit on the CV. Additionally, for a post-validation assay output of y, the method gives an ``effective standard deviation interval'' of log(y) plus or minus r, which is a 68% confidence interval on log(mu), where mu is the expected value of the assay output for that sample. Further, the m:n:q procedure can be straightforwardly applied to constant standard deviation assays. We illustrate these tools by applying them to a growth inhibition assay.

Install the latest version of this package by entering the following in R:

`install.packages("testassay")`

Author | Michael C Sachs and Michael P Fay |

Date of publication | 2016-11-29 18:10:38 |

Maintainer | Michael C Sachs <sachsmc@gmail.com> |

License | MIT + file LICENSE |

Version | 0.1.0 |

**gia:** Growth Inhibition Assay

**lognormConstCVCI:** log-normal constant CV model

**normConstCVCI:** Log-centered confidence intervals from a Normal constant...

**predict.assaytest:** Construct effective standard deviation intervals for observed...

**print.assaytest:** Print the results of an assaytest

**testassay:** Hypothesis testing procedure for assay validation for...

inst

inst/doc

inst/doc/GIAValidationExample.Rmd

inst/doc/GIAValidationExample.R
inst/doc/GIAValidationExample.html

NAMESPACE

NEWS

data

data/gia.rda

R

R/testassay.R
vignettes

vignettes/refs.bib

vignettes/GIAValidationExample.Rmd

README.md

MD5

build

build/vignette.rds

DESCRIPTION

man

man/lognormConstCVCI.Rd
man/predict.assaytest.Rd
man/testassay.Rd
man/print.assaytest.Rd
man/normConstCVCI.Rd
man/gia.Rd
LICENSE

Questions? Problems? Suggestions? Tweet to @rdrrHQ or email at ian@mutexlabs.com.

Please suggest features or report bugs with the GitHub issue tracker.

All documentation is copyright its authors; we didn't write any of that.

Embedding an R snippet on your website

Add the following code to your website.

For more information on customizing the embed code, read Embedding Snippets.