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testassay  

A Hypothesis Testing Framework for Validating an Assay for Precision
View on CRAN: Click here


Download and install testassay package within the R console
Install from CRAN:
install.packages("testassay")

Install from Github:
library("remotes")
install_github("cran/testassay")

Install by package version:
library("remotes")
install_version("testassay", "0.1.1")



Attach the package and use:
library("testassay")
Maintained by
Michael C Sachs
[Scholar Profile | Author Map]
All associated links for this package
First Published: 2016-11-29
Latest Update: 2020-06-03
Description:
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. This is an implementation of the methods described in Fay, Sachs, and Miura (2018) <doi:10.1002/sim.7528>.
How to cite:
Michael C Sachs (2016). testassay: A Hypothesis Testing Framework for Validating an Assay for Precision. R package version 0.1.1, https://cran.r-project.org/web/packages/testassay. Accessed 15 Jul. 2026.
Previous versions and publish date:
(2026-07-09 07:12), 0.1.0 (2016-11-29 18:10)
Other packages that cited testassay R package
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Complete documentation for testassay
Functions, R codes and Examples using the testassay R package
Some associated functions: gia . lognormConstCVCI . normConstCVCI . predict.assaytest . print.assaytest . testassay . 
Some associated R codes: testassay.R .  Full testassay package functions and examples
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