During preclinical studies and clinical trials, it is important to evaluate the immunogenicity of client specific products and or the induced immune response. With over 15 years of experience of using custom approaches, we can develop and qualify/validate a specific sandwich, and/or direct, ELISA assay for measuring antigen, total and specific immunoglobulins for our clients. We further perform the qualification/validation of the developed ELISA assays, and subsequently 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).
Laboratory Developed Tests (LDTs) are a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. These tests, utilizing distinct customer analyte-specific reagents (ASR), often provide insights to researchers and health care providers as to the efficacy and safety of their product of interest. ASRs are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents, through specific binding or chemical reaction with a substance in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. CTLs high-complexity CLIA certified Contract Laboratory specializes in LDT development to your needs in accordance with FDA Bioanalytical Method Validation Guidance for Industry. Our Laboratory services provide assistance for preclinical and clinical investigational, or research, applications; and are imperative to continued expansion of personalized medicine.
We have the below listed commercially diagnostic ELISA assays available:
- The 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