ELISA AAV Testing Services
Complement your ELISPOT analysis with ELISA AAV Testing Services
While ELISPOT/ImmunoSpot® is the gold standard immunoassay in cellular immune monitoring, traditional AAV ELISA testing can provide additional information on the production of antibodies or other cytokines without requiring additional blood draws or samples. When performing ELISPOT and ELISA in conjunction for our clients, we reuse supernatant from ImmunoSpot® plates for ELISA, saving time and resources.
Together, the data from these assays can provide a more comprehensive view of the trial subject and/or patient immune response for evaluating or publication.
With more than 20 years of experience using custom immunoassay approaches, we can:
- Develop and qualify/validate a specific sandwich and/or direct ELISA assay for measuring antigen, total, and specific immunoglobulins
- Further qualify/validate the developed ELISA assays
- Test samples in the client-specific ELISA assay protocol, following the respective regulatory scope in which the test is intended (e.g., preclinical or clinical trials)
Diagnostic Laboratory-Developed Tests in a Regulated Environment
Our CRO specializes in Laboratory-Developed Tests (LDTs), which are in vitro diagnostic tests designed, manufactured, and used within a single laboratory. These custom tests use analyte-specific reagents (ASRs) to identify and quantify an individual chemical substance of interest. ASRs include antibodies (polyclonal or monoclonal), receptor proteins, nucleic acid sequences, or other reagents intended for diagnostic purposes.
Our high-complexity, CLIA-certified contract laboratory specializes in LDT development tailored to your needs in accordance with FDA Bioanalytical Method Validation Guidance for Industry. We assist with preclinical and clinical investigational or research applications.
These diagnostic ELISA assays are available through our CRO:
- ELISA-based method for detection of AAV9 capsid IgG antibody in serum and plasma specimens approved by NY Project ID: 62201 PFI: 9337: Human anti-AAV9 IgG ELISA assay
- Human anti-SMN IgG ELISA validated and submitted
- Human anti-SARSCoV-2 IgG ELISA validated and submitted
