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.

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...

testassay

testassay/inst

testassay/inst/doc

testassay/inst/doc/GIAValidationExample.Rmd

testassay/inst/doc/GIAValidationExample.R

testassay/inst/doc/GIAValidationExample.html

testassay/NAMESPACE

testassay/NEWS

testassay/data

testassay/data/gia.rda

testassay/R

testassay/R/testassay.R
testassay/vignettes

testassay/vignettes/refs.bib

testassay/vignettes/GIAValidationExample.Rmd

testassay/README.md

testassay/MD5

testassay/build

testassay/build/vignette.rds

testassay/DESCRIPTION

testassay/man

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

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