ELISA Testing
ELISA Services to Complement Your Studies
Traditional ELISA testing can be performed in conjunction with ImmunoSpot® to extract additional information on the production of antibodies or other cytokines. This method does not require additional blood draws, as the supernatant from ImmunoSpot® plates can be used in ELISA. Together, these technologies can provide a more comprehensive view of the trial subject and/or patient immune response.
With more than 20 years of experience using custom 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)
ELISA for diagnostic testing
Laboratory developed tests (LDTs) are in vitro diagnostic tests that are designed, manufactured and used within a single laboratory. These tests use analyte-specific reagents (ASR) so researchers and health care providers can gain insight into the efficacy and safety of their product of interest.
ASRs are antibodies (polyclonal and monoclonal), receptor proteins, ligands, nucleic acid sequences, or other reagents intended for diagnostic purposes. Through specific reactions in a biological specimen, ASRs can identify and quantify an individual chemical substance of interest.
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.
Diagnostic ELISA assays 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-adeno-associated virus (AAV)9 IgG ELISA assay
- Human anti-SMN IgG ELISA validated and submitted
- Human anti-SARSCoV-2 IgG ELISA validated and submitted
