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HCP coverage study per USP 1132

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(@event-participant)
Posts: 77
Member Admin
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For HCP coverage study of commercial kits per USP 1132, what is the %coverage criteria by FDA in BLA?


 
Posted : 14/04/2026 11:38 am
(@quality-experts)
Posts: 75
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The ELISA should cover the majority of HCPs in the early process sample. There is no formal % coverage accepted as it depends on the coverage method, assay settings and other HCP characterization.

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 11:32 am
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