● Before clinical treatment: NAb assay can inform the selection of AAV serotypes, administration routes, and drug doses for personalized AAV gene therapy regimens.

● During clinical treatment: By monitoring NAb trends, AAV NAb assay can evaluate whether gene therapy medications have achieved effective therapeutic dosage levels, assess drug efficacy, and determine the duration of therapeutic effects.

1.AAV NAb Assay (Transfection Inhibition, TI)

Using our various AAV serotypes, we simulate the biological process of antibodies blocking AAV entry into cells to detect the neutralizing activity of serum/antibodies against AAV and calculate the NAb titers.

●Cell selection: HEK 293

●Assay design:

AAVs are pre-incubated with serially diluted serum/antibody samples before being used to infect cells. After 48 hours, fluorescence intensity is measured across all dilutions using a multi-mode microplate reader. By comparing the infection efficiency in the presence and absence of serum/antibodies, we can determine the IC50 value and evaluate the neutralizing capacity of the tested antibodies or serum.

●Samples:

a. Sample types: serum, body fluid, vitreous humor, etc., transported on dry ice;

b. Sample volume: > 30 μl (customizable for special needs);

c. Sample requirements: sterile, negative for Hepatitis B, Hepatitis C, HIV, Syphilis, EB, CMV, etc.

d. Species: Human, monkey, mouse, etc.

Why choose us

We utilize the Luciferase reporter gene system to mimic the natural process of antibodies blocking AAV entry into cells, providing a more intuitive and systematic representation of the neutralization process. This assay is characterized by high sensitivity, high specificity, high throughput and high accuracy.

Data Presentation

Figure 2. Detection of NAbs in AAV2 and AAV9 serum samples

2. AAV Total Antibody (TAb) Assay

To assess the levels of Tabs (IgG, IgM) present in serum following vaccination.

●Assay design:

We employ the ELISA method to precisely quantify IgG and IgM levels in serum samples, providing a comprehensive assessment of antibody expression.

●Samples:

a. Sample type: serum, transported on dry ice;

b. Sample volume: 100 μL (customizable);

c. Sample requirements: sterile, negative for Hepatitis B, Hepatitis C, HIV, Syphilis, EBV, and CMV.

Why choose us

We employ the ELISA method to precisely quantify antibody levels, such as IgG and IgM, in samples, ensuring high sensitivity and accuracy.

Data Presentation

Figure 3. ELISA results for TAb in AAV9 serum sample

3.AAV Neutralizing Antibody (NAb) Test Kit

Genevoyager also offers AAV NAb test kits for detecting NAbs against AAV5, AAV8, and AAV9. Our kits provide everything you need for accurate and reliable testing, 

including 293T cells, AAV virus, and complete reagents.

4.Detectable AAV Serotypes

5.Available AAV Serotypes for Testing

We offer a range of AAV products specifically designed for NAb assay.

Reference

1 Schulz M, Levy DI, Petropoulos CJ, Bashirians G, Winburn I, Mahn M, Somanathan S, Cheng SH, Byrne BJ. Binding and neutralizing anti-AAV antibodies: Detection and implications for rAAV-mediated gene therapy. Mol Ther. 2023 Mar 1;31(3):616-630.