Package: testassay 0.1.1

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. This is an implementation of the methods described in Fay, Sachs, and Miura (2018) <doi:10.1002/sim.7528>.

Authors:Michael C Sachs and Michael P Fay

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NEWS

# Install 'testassay' in R:
install.packages('testassay', repos = c('https://sachsmc.r-universe.dev', 'https://cloud.r-project.org'))

Peer review:

Bug tracker:https://github.com/sachsmc/testassay/issues

Datasets:
  • gia - Growth Inhibition Assay

On CRAN:

3.70 score 6 scripts 113 downloads 3 exports 0 dependencies

Last updated 4 years agofrom:2dd44ce296. Checks:OK: 3 NOTE: 4. Indexed: yes.

TargetResultDate
Doc / VignettesOKNov 01 2024
R-4.5-winNOTENov 01 2024
R-4.5-linuxNOTENov 01 2024
R-4.4-winNOTENov 01 2024
R-4.4-macNOTENov 01 2024
R-4.3-winOKNov 01 2024
R-4.3-macOKNov 01 2024

Exports:lognormConstCVCInormConstCVCItestassay

Dependencies:

Validation of Growth Inhibition Assay using testassay

Rendered fromGIAValidationExample.Rmdusingknitr::rmarkdownon Nov 01 2024.

Last update: 2020-06-01
Started: 2016-10-31