Creative Diagnostics, a leading manufacturer and supplier of antibodies, antigens and assay kits, is proud to announce the launch of its state-of-the-art Anti-AAV Antibody ELISA Kits for the most commonly used AAV serotypes. These kits are designed to accelerate gene therapy research by enabling the accurate detection and quantification of anti-adeno-associated virus (AAV) antibodies.

The first human AAV was identified in 1965 as a contaminant of adenovirus preparations. AAV is one of the smallest viruses, with an envelope-free icosahedral capsid of approximately 22 nm. Although AAV has a high seropositivity rate in humans (approximately 80% of individuals are seropositive for AAV2), the virus has not been associated with any human disease.

AAV gene therapy vectors are capable of infecting both dividing and quiescent cells and can persist in an extrachromosomal state without integrating into the host cell genome, whereas native viruses carry genes that integrate into the host genome. These characteristics make AAV a very attractive candidate viral vector for gene therapy and for modeling homologous human diseases.

Because AAV is of viral origin, its capsid induces cellular and humoral immune responses that lead to neutralization of the vector by anti-AV antibodies, preventing transduction in the patient. Binding antibodies to certain AAV serotypes are present in more than 90% of the population. Some of these antibodies are so neutralizing that they lose their efficacy upon initial administration. Therefore, there is an urgent need to increase awareness of the risk of AAV immunogenicity and to develop techniques to assess and mitigate this response.

Methods for detecting pre-existing AAV immunity include cell-based in vitro TI assays, in vivo (e.g., mouse) TI assays, and enzyme-linked immunosorbent assay (ELISA)-based assays for the detection of total anti-capsid antibody (TAb) assays. TAb assays may be able to detect inefficient NAbs below the threshold of the TI assay, but may not be able to detect non-antibody neutralizing factors.

Creative Diagnostics has developed a series of anti-AAV antibody ELISA kits for the most commonly used AAV serotypes. These standardized assays designed to screen for AAV seropositivity have proven to be an important tool in screening patients for pre-existing antibodies, minimizing safety concerns and improving the efficacy of AAV-based gene therapy.

For example, Anti-AAV9 antibody ELISA Kit (Catalog # DEIASL348) can be used as an analytical tool for qualitative determination of antibodies to AAV9 in serum. Creative Diagnostics’ AAV6 Titration ELISA Kit (Catalog # DEIAAV6) provides a rapid, sensitive and reproducible method for titrating intact wild-type AAV9 viruses, recombinant AAV9 viruses or assembled and intact empty AAV9 capsids.

Creative Diagnostics offers a wide range of quality Anti-AAV Antibody ELISA Kits for gene therapy. For more information on the new products, please visit https://www.creative-diagnostics.com/news-anti-aav-antibody-elisa-kit.htm.

About Creative Diagnostics

Creative Diagnostics is a leading manufacturer and supplier of antibodies, viral antigens, innovative diagnostic components, and critical assay reagents. In addition to providing contract RD and biologic manufacturing services for diagnostic manufacturers along with GMP biologics manufacturing for the biopharmaceutical market, the company aims to continue to act as a trusted source for all researchers’ assay development and manufacturing needs.