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Qualification of the HCP Elisa assay

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(@event-participant)
Posts: 77
Member Admin
Topic starter
 

Generally we are always facing real problems during the qualification of the HCP Elisa assay specially for the LOQ.


 
Posted : 08/04/2026 9:24 am
(@quality-experts)
Posts: 75
Trusted Member
 

Yes, this is a typical problem for qualification of HCP ELISA. Lack of dilutional linearity is often due to high responder HCPs. And when you have to dilute the sample a lot before linearity, you get a high LOQ.

Ejvind Mørtz, PhD, Co-Founder & COO of Alphalyse in Denmark, discusses the regulatory expectations for HCP analysis, highlighting the importance of USP <1132.1> to improve MS-based data quality. Don’t miss his presentation and expert insights at the panel discussion.

Watch the On-Demand presentation here: https://bio-qc.com/regulatory-expectations-for-your-hcp-analysis-meet-usp-1132-1-to-enhance-the-quality-of-ms-based-data/


 
Posted : 17/04/2026 11:19 am
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