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H. Çubukçu

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Open access Aug 2026

Model 1b analytical performance specifications – report on the Prague 2025 workshop

Abstract The main purpose of establishing APS is to ensure that test performance aligns with their specific clinical goals. Analytical performance specifications serve multiple functions: as acceptance criteria to verify that in vitro diagnostic medical devices (IVD MD) meet regulatory and quality standards before mark...

A. Horvath, Sverre Sandberg, M. Thelen et al. · 0 citations

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