Improving Success by Balanced Critical Evaluations of Assay Methods

Abstract

The ability to make optimal and efficient use of new assay technologies is dependent in part on accurate and reliable descriptions of experimental protocols in the scientific literature. In all such studies, and especially when one technology is compared to another, the utmost effort must be made to provide a fair and unbiased evaluation of their merits and limitations. The very nature of drug discovery and development, dependent on the seemingly infinite diversity inherent in biological processes, ensures that no single assay technology will supplant the use of all others. On the contrary, available methods and techniques often complement each other, and it is use of more than one assay protocol that allows for the most accurate interpretations to emerge.

Given the issues that arose from recent articles published in Assay and Drug Development Technologies,^1,2 which are the subject of the correspondence in this issue (available online at www.liebertonline.com/adt),^3,4 the editors believe it is necessary to provide more guidance for authors wishing to publish comparative evaluations of emerging technologies. To this end, while the following are important for all articles, we will ask authors to be particularly mindful of these criteria in studies that compare assay technologies:

A Z-factor analysis along with the formula used to calculate the Z-factor must be included, especially if formats are fundamentally different, e.g., a ratiometric vs. a single readout assay. The authors should describe the plate format, number of wells, and plates used to obtain this statistic.

Discrepancies in the ability to reproduce an activity of published controls must be carefully explained. Particular attention should be paid to experimental parameters and reagent properties that differ from those previously reported (e.g., enzyme specific activity, protein or compound purity).

Product comparisons may be supported by reference to data from peer-reviewed publications. In the absence of prior peer-reviewed publication, data to support (or critique) a specific product should be presented in the manuscript so that it will be subjected to peer review upon submission to Assay and Drug Development Technologies. Selective use of literature to support an advantage over an existing technology is inappropriate, as is selective omission of literature references to create the appearance of a competitive advantage. In general, existing literature relevant to the reported assay technology should be cited comprehensively, and negative and positive aspects should be discussed in a scientific and unbiased manner.

Vendor manuals available online may be referenced when a method is based on a commercial kit or performed “according to the manufacturer's instructions.” Reviewers, however, may require details to be included in the manuscript. Data in manuals, application notes, and posters that have not been subjected to peer review may not be used to compare one product with another or to support a central argument in an article.

The use of promotional or marketing-like statements is not permitted.

Reviewers will receive these guidelines in addition to other pertinent guidance that may be necessary at the time of review.

References

Zegzouti

, Zdanovskaia

, Hsiao

, Goueli

. ADP-Glo: a bioluminescent and homogeneous ADP monitoring assay for kinases. Assay Drug Dev Technol, 2009; 7:560–572. www.liebertonline.com/doi/pdfplus/10.1089/adt.2009.0222.

Vidugiriene

, Zegzouti

, Goueli

. Evaluating the utility of a bioluminescent ADP-detecting assay for lipid kinases. Assay Drug Dev Technol, 2009; 7:585–597. www.liebertonline.com/doi/pdfplus/10.1089/adt.2009.0223.

Lowery

, Vogel

, Till

. ADP detection technologies. Assay Drug Dev Technol, 2010, 10.1089/adt.2010.0987.letlow www.liebertonline.com/doi/pdfplus/10.1089/adt.2010.0987.letlow.

Goueli

, Zegzouti

, Vidugiriene . Response to the letter of Lowery et al.: ADP detection technologies. Assay Drug Dev Technol, 2010, 10.1089/adt.2010.0654.resplow www.liebertonline.com/doi/pdfplus/10.1089/adt.2010.0654.resplow.