Hycult Biotech ELISAs are highly validated with each kit undergoing 50-100 experiments before release. Hycult Biotech also tests ELISA cross reactivity with species and family members, compare manual wash with automated wash and perform long-term stability studies on their ELISAs.
Validation methods
• Optimal coat-tracer concentration is validated & optimal buffer composition is determined
• Stability, robustness and linearity
• Optimal sample type (CHES) determined
• Optimal assay range determined
• 50-100 experiments carried out on each kit before release
• QC controls used to reduce batch to batch variability
• Matrix influenced tested
• Spike recovery tested
• Influence of carriers on assay performance tested
• Tested by two independent operators before batch release
• Validated using both diseased & healthy samples together with an external reference centre
• Batch is only released with a pre-determined set of lot-specific components
This validation ensures that kits have:
• Wide sample compatibility
• Wide standard range
• Low detection level
• Great reliability and reproducibility