testassay: A Hypothesis Testing Framework for Validating an Assay for Precision

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

View on CRAN

Man pages

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...

Files in this package

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