Open access
Jul 2026
Validation of advanced immunoassays under ISO/IEC 17025:2017: a strategic framework for immunogenicity assays
Validation of analytical methods is a mandatory requirement for testing laboratories accredited under ISO/IEC 17025:2017. Immune response to vaccination is inherently heterogeneous, multidimensional, and distributed along continua rather than binary outcomes. ISO/IEC 17025:2017 provides valuable principles and a struct...
Andrea Palencia-Reyes, Esmeralda Juárez, Carlos Blancas-Ruiíz et al.
· Accreditation and Quality As... · 0 citations