AAV Serology Assay   

 

 

About AAV Serology

The AAV seroprevalence in the human population is know to be between 20-90%. However, this depends on the AAV serotype and the demography of the population (e.g. georaphical location and age). Sero-positivity can have a major impact on the success of an AAV-based gene therapy, since pre-existing antibodies might inhibit the gene transfer via AAV. Therefore, it is indispensible to pre-test for the presence of AAV specific antibodies in patient sera of potential clinical trial cohorts. Furthermore, natural infection studies are currently scarce and antibody levels after AAV gene therapy transfer might differ compared to those after naturally accquired infections. Therefore, it is important to also monitor antibody levels in patient sera after infection, i.e. natural infections and after AAV gene therapy treatment.

For this reason PROGEN is developing an anti-AAV Antibody Kit to facilitate 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.

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AAV Serology Assay

Ready-to-use kits for the determination of AAV antibodies in human sera


We are in the development of a quantitative, serotype-specific serological assay for the reliable determination of AAV antibodies in human sera. The kits are expected to be commercially available by spring 2025. 

We are on the look out for potential beta tester who would be willing to test our assay before the official release and share some data and feedback on the performance, quality and convenience of the product. Beta tests are set to start in August 2024.

Interested in beta testing?


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Your 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 ELISA kits and our well-established quality control strategy.

Convenient: Available for several 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: The AAV Serology Assay is well suited for automation and the 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. 

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. 

  1. HRP-coupled anti-human IgG antibodies are bound to the AAV particle antibodies from the human serum sample. 

  2. 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.

Want to become a beta tester?


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How it works

  1. Prepare 1:101 dilutions of your serum samples. Add the ready-to-use standards, your samples and the included controls in duplicates to the provided microplate. Incubate at RT for 30min.
  2. Wash three times.
  3. Add the ready-to-use detection antibody to each well. Incubate at RT for 30min.
  4. Repeat step 2.
  5. Add the substrate (TMB) and incubate at RT for 15min.
  6. Add the Stop solution to your reactions and incubate at RT for 5min.
  7. Read and evaluate:
    • Create a standard curve by plotting the mean absorbance (OD) value of each dilution of the human chimeric antibody standards (y-axis, linear scale) against the corresponding unit (x-axis, logarithmic scale).
    • Use a best fit curve to calculate the results of your corresponding human serum sample. 
    • Calculate the concentration/units of anti-AAV antibodies in each of your human serum samples accordingly.

AAV Serology Assay beta tester


Sign up to get more information on how to become a beta tester as well as the latest news on our new anti-AAV Human Antibody Assays. Be the first to know the specific release date and get the chance to place your order before all the others?

 

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