GTCDxᵀᴹ Human Anti-AAV1 Antibody ELISA Kit

Sample

serum, plasma

Species Reactivity

Human

Intended Use

The Anti-AAV1 Antibody ELISA is used as an analytical tool for qualitative determination of antibodies to AAV1 in serum and plasma.

Storage

1. All reagents should be stored at 2ºC to 8ºC for stability.
2. All the reagents and wash solutions should be used within 12 months from manufacturing date.
3. Before using, bring all components to room temperature (18-25ºC). Upon assay completion ensure all components of the kit are returned to appropriate storage conditions.
4. The Substrate is light-sensitive and should be protected from direct sunlight or UV sources.

General Description

Researchers have used AAV-based vectors in pre-clinical research and in clinical trials in which AAV-based vectors have demonstrated a good safety profile. AAVs have also demonstrated lasting therapeutic gene expression following a single treatment in preclinical and clinical studies.
Scientists today have used the AAV1 variant, or serotype, of vector in potential product candidates in hemophilia B and Huntington's disease. Research suggests that a greater portion of patients can be effectively treated with AAV1 gene therapy, compared to other AAV-based gene therapies.
AAV1 gene therapies present a favorable immunogenicity profile. To date, insect-cell manufactured AAV1 gene therapies have been administered to 22 patients across three clinical studies by a leading gene therapy company without any evidence of AAV1 capsid-specific cellular immune responses or long-term safety complications.
One of the major challenges in AAV-based gene therapy is the presence of circulating anti-AAV neutralizing antibodies, which can pre-exist in patients and may prevent successful gene transfer. High levels of circulating anti-AAV neutralizing antibodies can develop after a single administration of gene therapy and can prevent successful gene transfer in patients.