The CEPI-Centralized Laboratory Network (CLN) was established to standardize immunological assays globally, enabling consistent evaluation of coronavirus vaccines and ensuring data reliability across facilities.
The CLN has processed over 70,000 samples using six standardized immunologic assays: S-ELISA, RBD-ELISA, N-ELISA, MNA, PNA, and IFN-γ ELISpo; all assays have been validated to international regulatory standards (ICH, EMA, FDA, WHO, USP). Quantitative validation of assays across 7 CLN labs showed high reproducibility and accuracy
Transfer of assays across facilities involved gap analysis, inter-lab studies, and revalidation to ensure reproducibility.
Centralized data collection via structured report forms and an internal database allows real-time tracking of assay consistency.
- Schwartz 2025: Monitoring immunological COVID-19 vaccine clinical testing across the CEPI Centralized Laboratory Network
- Azizi 2024: Standardized immunological assays for assessing COVID-19 vaccines by the CEPI-Centralized Laboratory Network
- Manak 2024: Standardised quantitative assays for anti-SARS-CoV-2 immune response used in vaccine clinical trials by the CEPI Centralized Laboratory Network: a qualification analysis