The Gyrolab™ Immunoassay System: A Platform for Automated Bioanalysis and Rapid Sample Turnaround

Abstract

The Gyrolab immunoassay system proved to be a viable alternative to traditional immunoassays and was used to support a regulated preclinical TK study. The speed of analysis that the Gyrolab provides was beneficial in meeting timelines to complete this project as multiple assays and repeat sample analysis could be completed in the same day.

Addressing Matrix Effects in Ligand-Binding Assays Through The Use of New Reagents and Technology

“…The switch in technology to the microfluidic Gyrolab™ xP Workstation (Gyros AB, Uppsala, Sweden) was justified by its higher throughput, which would allow for rapid assay development within constricted timelines and previous observations of higher matrix tolerance [8][9][10][11][12]. The latter due in part to the low sample volumes, column-based format and centrifugal-induced wash steps.…”

Assay Formats: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

“…This assay format allows for small sample and reagent requirements, rapid assay kinetics, short assay run time and extended dynamic range compared to ELISA (8,(14)(15)(16)(17). Both carry-over and reagent stability require evaluation during assay development due to the liquid handling and 'hands-off' aspects of the platform.…”

“…The Gyrolab workstation has been validated through the process of IQ/OQ/PQ to meet the requirement for compliance with 21 CFR Part 11 (14,16,18). The vendor offers IQ/ OQ support and PQ guidance as a service.…”

“…Biacore can be validated through the process of IQ/OQ/ PQ to meet the requirement for compliance with 21 CFR Part 11 (14,16,18). Making the Biacore instrument GLP compliant is not a straightforward process and significant time investment is involved to deal with issues such as data transfer and a proper calibration over time.…”

Lab-on-a-CD: A Fully Integrated Molecular Diagnostic System

“…Fluorescence has been used successfully in conjunction with the centrifugal microfluidic platform for a wide range of applications, including solid phase extraction, 113 analysis of PCR assays, 13,133 and immunoassays. 142,163 In molecular diagnostics, DNA microarray hybridization is commonly used in NA detection, particularly when highthroughput analysis is required. On a microfluidic disc, Peytavi et al implemented a diagnostic microarray for the detection of the DNA of four staphylococcal species.…”