Detection is Critical: Designing Immunoassays with Guidance in Mind

WEBINAR

In 2019 two key documents were published that redefined the landscape for biomarker analysis using ligand binding assays. The ICH-M10 (EMA) and C-Path Institute guidance advised on validation principles for scientists working with biological samples. With this guidance in mind, we started a program to implement changes to ELISAs that would allow researchers to address key concerns such as endogenous sample detection and assay validation and apply long-term lot-to-lot consistency, should it fit their context of use.

This project required:

• Creation of new physiochemically-evaluated critical reagents
• Expansion of existing feasibility testing
• Enhancement of QC criteria (e.g., sample library lot bridging)

This webinar will:

• Detail each of these steps with data from our Conferma^® ELISA development and QC processes
• Describe its impact on their performance
• Discuss if this could become a broadly accepted practice