Regulatory Considerations in Validating ELISA Methods for Clinical Use

Biomarkers are central to diagnosing and managing patients in clinical medicine. ELISA assays are frequently used to measure biomarkers in clinical samples. However, the ELISA method differs in quality and may introduce systematic and random errors. Hence, clinical analysis requires more rigorous assay performance. ELISA assay validation demonstrates the suitability of an ELISA assay to […]