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 postvalidation 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  20161129 18:10:38 
Maintainer  Michael C Sachs <sachsmc@gmail.com> 
License  MIT + file LICENSE 
Version  0.1.0 
Package repository  View on CRAN 
Installation  Install the latest version of this package by entering the following in R:



All man pages Function index File listing
Man pages  

gia: Growth Inhibition Assay  
lognormConstCVCI: lognormal constant CV model  
normConstCVCI: Logcentered 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... 
Functions  

gia  Man page 
lognormConstCVCI  Man page Source code 
normConstCVCI  Man page Source code 
predict.assaytest  Man page Source code 
print.assaytest  Man page Source code 
testassay  Man page Source code 
Files  

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

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