Aidia Investment Group
Clinical reference laboratory based in Research Triangle Park, NC, providing ELISA-based assay development and testing, analytical performance studies for in vitro diagnostics (IVD), GLP method validation, and clinical performance studies. Services are performed in-house and aligned with regulatory guidelines for CE marking, FDA submissions and CLIA operations.
Industries
Nr. of Employees
small (1-50)
Aidia Investment Group
Durham, North Carolina, United States, North America
Products
HTLV-I/II Antibody Test (CPV005, CPT 86790)
Serological antibody test for HTLV-I and HTLV-II using ELISA methods. Specimen: serum or plasma. Turnaround time listed as 1-3 days. Specimen stability and transport conditions provided.
HIV-1 Antibody Test (CPV006, CPT 87390)
HIV-1 antibody screening by ELISA. Accepts serum, plasma, oral fluid, or dried blood spot. Turnaround time 1-3 days. Specimen labeling and stability requirements defined.
HIV Antibody / p24 Antigen Test (CPV007, CPT 87389)
Fourth-generation HIV screen detecting HIV-1 antibody, HIV-2 antibody and HIV-1 p24 antigen by ELISA. Specimen: serum or plasma. Turnaround time 1-3 days.
HIV-1 & 2 Confirmatory Test (CPV004, CPT 86701/86702)
Confirmatory serology profile for HIV-1 and HIV-2. Accepts serum, plasma, oral fluid, or dried blood spot. Turnaround time 1-7 days; specimen labeling and stability requirements provided.
HTLV-I/II Antibody Test (CPV005, CPT 86790)
Serological antibody test for HTLV-I and HTLV-II using ELISA methods. Specimen: serum or plasma. Turnaround time listed as 1-3 days. Specimen stability and transport conditions provided.
HIV-1 Antibody Test (CPV006, CPT 87390)
HIV-1 antibody screening by ELISA. Accepts serum, plasma, oral fluid, or dried blood spot. Turnaround time 1-3 days. Specimen labeling and stability requirements defined.
HIV Antibody / p24 Antigen Test (CPV007, CPT 87389)
Fourth-generation HIV screen detecting HIV-1 antibody, HIV-2 antibody and HIV-1 p24 antigen by ELISA. Specimen: serum or plasma. Turnaround time 1-3 days.
HIV-1 & 2 Confirmatory Test (CPV004, CPT 86701/86702)
Confirmatory serology profile for HIV-1 and HIV-2. Accepts serum, plasma, oral fluid, or dried blood spot. Turnaround time 1-7 days; specimen labeling and stability requirements provided.
Services
Custom development of ELISA assays for detection and quantitation of target analytes.
Validation of ELISA methods under GLP standards, including performance characteristics and documentation.
Organize and execute analytical performance studies, identify acceptable specimen matrices, and evaluate storage/shipping conditions.
Design and conduct clinical performance studies to demonstrate device performance in real-world clinical use and produce study reports.
Provide CLIA-subcontracted laboratory testing services for clinical programs.
Custom development of ELISA assays for detection and quantitation of target analytes.
Validation of ELISA methods under GLP standards, including performance characteristics and documentation.
Organize and execute analytical performance studies, identify acceptable specimen matrices, and evaluate storage/shipping conditions.
Design and conduct clinical performance studies to demonstrate device performance in real-world clinical use and produce study reports.
Provide CLIA-subcontracted laboratory testing services for clinical programs.
Expertise Areas
- ELISA assay development
- Analytical validation for IVDs
- Clinical performance study management
- GLP method validation
Key Technologies
- ELISA (enzyme-linked immunosorbent assay)
- Immunoassay-based diagnostics
- IVD analytical performance evaluation
- GLP method validation workflows