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Artículo

Demonstrating Clinical Performance of the Elecsys Anti-SARS-CoV-2 Anti-Nucleocapsid Immunoassay Using Real-World Data to Support Regulatory Decision-Making in the USA.

Research record from Infect Dis Ther, 2026-04-04. PMID 41934527.

Artículo

Outbreak-ready: validation and regulatory groundwork to prepare before the next PHEIC

Prepare for the next public-health emergency now: validation groundwork, WHO EUL familiarity, platform flexibility, and the documentation emergency reviewers will ask for.

Artículo

Viral hepatitis elimination: a procurement checklist for viral-load platforms

Procurement checklist for HBV/HCV viral-load platforms in hepatitis elimination programmes: dynamic range, result discipline, supply at programme volume, and regulatory status.

Artículo

When tests don't fit the rules: regulatory challenges for agnostic metagenomic next-generation sequencing in infectious diseases diagnostics.

Research record from J Clin Microbiol, 2026-09-10. PMID 42720301.

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Buscar en IVDmap

Demonstrating Clinical Performance of the Elecsys Anti-SARS-CoV-2 Anti-Nucleocapsid Immunoassay Using Real-World Data to Support Regulatory Decision-Making in the USA.

Outbreak-ready: validation and regulatory groundwork to prepare before the next PHEIC

Viral hepatitis elimination: a procurement checklist for viral-load platforms

When tests don't fit the rules: regulatory challenges for agnostic metagenomic next-generation sequencing in infectious diseases diagnostics.