In the Zone: the importance of monitoring assay performance and maintenance

Upon validation of any assay, monitoring its performance is a critical portion. There are two major aspects of assay monitoring: assay performance and assay maintenance. Monitoring assay performance is an integral part of successfully completing high throughput clinical sample testing.

Assay performance can be achieved through trending assessment and proficiency panel testing. For trending assessment, multiple parameters of the validated assay can be trended or monitored. Proficiency panels are used to assess the ability of the laboratory to perform the assay consistently and accurately. The results of proficiency panels are compared with the previously established ranges to monitor the assay performance. On the other hand, assay maintenance primarily includes critical reagent bridging, qualification or validation of a new instrument, and training of staff through analyst qualification. This In the Zone feature will discuss key aspects of assay monitoring and how PPD clinical research business of Thermo Fisher Scientific ensures the highest standards of personnel qualifications, quality control and proficiency testing.

[Video by Kristian Baycroft-Willmott]

INFOGRAPHIC

Infographic: Assay monitoring – the importance of performance and maintenance

In this infographic, we illustrate the two major aspects of assay monitoring: assay performance and assay maintenance. We detail the principles of assay performance and the key challenges to overcome in assay maintenance, as well as provide a future perspective on how the key components of an assay can impact the long-term maintenance of assay performance.

INTERVIEW

Challenges and solutions in monitoring assay performance for vaccine development: an interview with Atul Chaudhari

In this interview, we spoke to Atul Chaudhari who is the Manager of Research and Development in the Vaccine Sciences Lab at PPD Laboratory Services (NC, USA). Atul explored the benefits of qualification and validation when developing cell and virus neutralization assays, how assay maintenance contributes to the advancement of vaccine development, and the best approach to maintain assay performance long-term without affecting the quality. 

RESOURCES

2023 White Paper on recent issues in bioanalysis

End-to-end innovation in a regulated environment: applying spectral flow cytometry to clinical sample testing

Technology Digest: single-analyte biomarker assays for pharmacodynamic or safety assessment during biotherapeutic development

In association with