The extreme reliability of Gyrolab assays
Whatever your needs in immunoassays, you will almost certainly appreciate an assay that consistently delivers high precision and accuracy. Scientists at Pfizer have reported a retrospective study of pharmacokinetics (PK) data that highlights the reliability of Gyrolab assays.
Immunoassays that hit the target, time and time again
Best practices for PK bioanalysis in protein therapeutics recommend analysis in duplicate and often with concurrently run standard curves. With this in mind, the group of scientists at Pfizer decided to see just how reliable Gyrolab assays were by analyzing data from a large number of PK assays. Their retrospective study involved over 23,000 replicate pairs comprising standards, QCs, and animal samples using 23 assays run on a range of matrices. As well as looking at precision and accuracy, the group used the concordance correlation coefficient (CCC) to measure agreement and compared the first replicate from Gyrolab assays with the results of analyzing duplicates. They also examined AUC and Cmax PK parameters. The results were exceptional.
Data reproduced from Clark et al, 2016
The authors concluded that their results “demonstrated that singlet versus duplicate measurements yielded nearly indistinguishable results with respect to PK parameters, AUC and Cmax.” They also pointed out the value of Gyrolab Viewer as a unique quality control and troubleshooting tool for Gyrolab assays that is invaluable when examining potentially aberrant results.
Gyrolab assays – a stable foundation to build on
This is just one, albeit spectacular, example of the reliability of Gyrolab assays. The impressive results from this study could indeed stimulate the development of new ways of working. These and other findings prompted the authors to suggest that singlet analysis might even be sufficient. However, a survey run in 2016 by the Global Bioanalytical Forum indicated that over half of the bioanalytical community surveyed would not consider singlet analysis even if the replicate variation of Gyrolab assays were less than 5%.
But whatever you do, singlets or duplicates, Gyrolab assays clearly deliver data you can depend on.
Find out more
Find out more about how Gyrolab assays consistently deliver high precision and accuracy in a number of application areas such as PK, Host Cell Protein (HCP) analysis and drug analysis
References:
Feasibility of Singlet Analysis for Ligand Binding Assays: a Retrospective Examination of Data Generated Using the Gyrolab Platform. Clark, TH et al. AAPS J. 2016 Sep;18(5):1300-8. doi: 10.1208/s12248-016-9944-8