Early Dynamics of Hepatitis B Virus (HBV)-DNA and Surface Antigen (HBsAg) in Ramp-Up Phase of Viremia: Implications for Performance Evaluation of Blood Screening Assays

Early Dynamics of Hepatitis B Virus (HBV)-DNA and Surface Antigen (HBsAg) in Ramp-Up Phase of Viremia: Implications for Performance Evaluation of Blood Screening Assays

The Common Specifications/EU 2017/746 regulation for market approval of class D in vitro diagnostic devices (IVDs) intended for detection of blood borne viruses requires testing of the International Standard and 10–30 seroconversion panels to demonstrate ‘state of the art’ assay performance. We exam...

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Bibliographic Details
Main Authors:	Harry van Drimmelen, Nico Lelie
Format:	Article
Language:	English
Published:	MDPI AG 2022-08-01
Series:	Viruses
Subjects:	HBV-DNA HBsAg seroconversion panel standard dilutions analytical sensitivity genotype
Online Access:	https://www.mdpi.com/1999-4915/14/9/1942

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