Beyond Sensitivity: Building A Robust Multi-Matrix AAV Shedding Assays

If you're running AAV gene therapy trials, shedding data isn't optional — it's a regulatory requirement, and the complexity of collecting it across multiple biomatrices is routinely underestimated. Whole blood, saliva, semen, serum, and urine each present their own extraction headaches: high cellularity, low biomass, viscosity, inhibitor interference. One protocol does not fit all.

This brochure details a fully validated multi-matrix shedding assay built around matrix-specific extraction strategies. KingFisher Flex with MagMAX Ultra 2.0 handles high-throughput blood and serum processing; mechanical bead disruption improves lysis in semen; easyMAG is optimized for serum and urine. Quantification runs on the ABI 7500 SDS with TaqMan chemistry and a seven-point standard curve spanning 5 to 5×10⁶ copies per reaction, returning R² values above 0.995 across all matrices.

Performance data are what regulators actually want to see: LODs of 38 to 544 copies/mL, blinded accuracy of 99 to 100%, and 100% selectivity in unspiked donor samples. The workflow is validated against FDA, EMA, and ICH M10 guidelines, with reagent lifecycle management built in for longitudinal study consistency.

Download now to evaluate whether this validated framework fits your clinical shedding study design.