ISO/NP 16944

Biotechnology — Guidance and requirements for assays used in the detection of anti-adeno-associated viruses (AAV) antibodies when evaluating preexisting immunity to AAV

Scope

This document provides best practices for the selection of methods, reporting and the analysis of the data collected from anti-AAV assays; specifically total antibody (TAb) assays and transduction inhibition (TI) assays. This document is intended to be used by researchers in academia and industry and by therapeutic developers and clinicians.
Assays intended to measure cellular immune responses, cellular immunity and competitive-ligand binding transduction inhibition, and clinical cut off determinations are outside of the scope of this standard.
This standard is applicable to the detection of anti-AAV antibodies to determine pre-existing immunity and the emerging immune response after the administration of the AAV based genomic therapies.