Determine AAV Antibodies in Human Sera
Coming soon: AAV Serology Assay
AAV Antibodies are known to be present in 20-90% of the human population, depending on the AAV serotype and population demographics, such as geographical location and age. Sero-positivity can have a major impact on the success of AAV-based gene therapies, as pre-existing antibodies could disrupt a gene transfer via AAV.
PROGEN is developing an anti-AAV Antibody Kit to support the selection of individuals participating in clincal trials and monitor patients receiving an AAV-based gene therapy, reducing the risk of false negative results due to immunological reasons.
We are on the look out for beta testers who would be willing to test the serological assay before the official product launch. To be applicable as a beta tester, you would need to share performance data and feedback with a focus on product quality and convenience.
The Principle
The assay is based on the ELISA technique. Serotype-specific AAV capsids are coated onto a microplate to capture antibodies from human serum samples binding fully assembled AAV particles of the corresponding serotype.
Captured AAV antibodies are detected in a two step process.
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HRP-coupled anti-human IgG antibodies are bound to the AAV particle antibodies from the human serum sample.
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After adding the substrate, the conjugated peroxidase catalyses the substrate reaction producing a bright colour. The absorbance is measured photometrically at 450nm and is relative to the concentration of specifically bound serum antibodies.
Your AAV Serology Assay Benefits
Easy-to-use: ready-to-use kits including serotype-specific, human chimeric AAV antibody standards in six dilutions, as well as human positive and negative control sera.
Reliable: based on PROGEN´s extensive experience in the development of commercially available AAV ELISA kits and on our well-established quality control standards.
Convenient: available for a range of AAV serotypes rendering inhouse development of AAV serology assays unneccessary. Currently in development: AAV2, AAV5, AAV6, AAV8, and AAV9 with more serotypes coming.
Time saving: suitable for automation and for use in an high-throughput environment requiring the analysis of a high number of patient sera.
Ready for use in clinical trial: providing a comprehensive set of ELISA performance data has previously demonstrated to facilitate the in-house validation of PROGEN ELISAs for use in GMP-settings.
POSTER: AAV Serology ELISA for testing pre-existing Immunity to AAV
This poster takes a deep-dive into AAV serological ELISA kits. An easy-to use, straightforward solution for determining anti-AAV antibodies in patient serum, ensuring safety and efficacy in gene transfer by analyzing preexisting immunity before, during and after treatment.
Want to be an AAV Serology Assay Beta Tester?
We are on the look out for beta testers who would be willing to test the serological assay before the official product launch. To be applicable as a beta tester, you would need to share performance data and feedback with a focus on product quality and convenience.