AAV NAB Testing
AAV Neutralizing Antibody (NAB)
AAV Neutralizing Antibodies (NABs) are antibodies that specifically recognize and bind to the outer capsid of an adeno-associated virus (AAV). When these antibodies bind to the AAV particle, they prevent the virus from entering or transducing cells, effectively blocking gene delivery. They are part of the body’s natural immune response, usually formed because people (or animals) have been exposed to wild-type AAV in the past.
Understanding pre-existing or treatment-induced anti-AAV immunity is critical for the success of any AAV-based gene therapy program. AAVnerGene provides comprehensive AAV Neutralizing Antibody (NAB) Testing Services to support research teams, biotech companies, and clinical programs in making informed decisions about vector selection, dosing, and patient eligibility.
AAV NAB Testing Service: Price and Turnaround
| Method | Price | Sample Requirements | Turnaround | Notes | |
| ELISA-Based Anti-AAV Antibody Assay | <10 samples | 2000/Plate | Supports serum or plasma samples from any species | <1 week | Two dilution; Three Repeats |
| ≥10 samples | 200/Sample | ||||
| Cell-Based NAB Functional Assay | <10 samples | $600/Sample | 1-2 weeks | Eight dilution; Three Repeats | |
| ≥10-24 samples | $550/Sample | ||||
| ≥25-48 samples | $500/Sample | ||||
| ≥49-96 samples | $450/Sample | ||||
| ≥96 samples | $450/Sample | ||||
NAB Testing Platforms
1. ELISA-Based Anti-AAV Antibody Assay
A high-throughput and cost-effective method for detecting total anti-AAV antibodies.
Key Features:
Quantification of total binding antibodies (IgG/IgM)
Suitable for large sample sets
Supports major AAV serotypes (AAV1–AAVrh10, Anc80, engineered capsids, and custom requests)
Useful for initial immune profiling and comparing relative antibody levels
This assay identifies samples with higher vs. lower antibody burden, enabling efficient pre-screening before more expensive functional assays.
At AAVnerGene, we offer over 1,000 different AAV capsids, enabling rapid screening of neutralizing antibodies (NABs) across multiple serotypes at once.
2. Cell-Based NAB Functional Assay
A gold-standard assay that measures true neutralizing activity against AAV transduction.
Key Features:
Direct measurement of antibody-mediated inhibition of AAV infection
Quantitative IC50/ID50 NAB titers
Supports adherent or suspension cell models
Applicable to multiple AAV serotypes and engineered capsids
Essential for regulatory submissions and IND-enabling studies
This assay provides accurate, functional insights into whether antibodies will impact AAV vector performance in vivo.
At AAVnerGene, we have developed HEK293R and HEK293RR cell lines that can be efficiently infected by most common AAV serotypes. These cell lines significantly increase the sensitivity and detection efficiency for a wide range of AAV serotypes, making them ideal for various applications such as neutralizing antibody assays and vector screening.
Pre-NAB testing is essential for large animal studies
Pre-existing Immunity Impact: Many large animals, including non-human primates (NHPs), often have pre-existing neutralizing antibodies against AAV vectors due to natural exposure to wild-type AAV viruses. These antibodies can bind and neutralize the therapeutic AAV vectors, reducing or completely blocking their ability to deliver the gene of interest.
Ensuring Vector Efficacy: Neutralizing antibodies interfere with the transduction efficiency of the AAV vectors. By performing pre-NAB testing, researchers can identify animals with low or no neutralizing antibodies to ensure effective gene delivery and therapeutic outcomes.
Reducing Variability: Large-animal studies are costly and limited in the number of subjects. Pre-screening for NABs helps select animals with similar immune status, reducing variability in experimental results and improving data reliability.
Avoiding False Negatives: If animals with high NAB titers are included without screening, the study might falsely conclude that the gene therapy vector is ineffective, when in reality, the vector was neutralized by antibodies.
Safety Considerations: Pre-existing antibodies may lead to immune complex formation and inflammatory responses upon vector administration, potentially causing adverse effects. Pre-NAB testing helps mitigate these risks by excluding high-titer animals or adjusting dosing strategies.
In summary, pre-NAB testing is critical for selecting appropriate animal subjects, ensuring vector efficacy, and generating meaningful, reproducible data in large-animal gene therapy studies.