ELISA method transfer/development and validation
The aim of the assay is to detect and quantify the target molecules in biological matrices (serum, plasma, urine, saliva, stool, liquor, cell lysate or cell culture medium etc.).
The bioanalytical method can be established in the laboratory, alternatively commercially available kits can be used.
- Determination of the ELISA method (commercially available or to be developed in-house; direct, indirect, sandwich, competitive ELISA)
- Establishment/transfer of the method, selection of suitable reagents, setting up the validation targets and acceptance criteria
- Performance of validation testing the following parameters:
- Quantification range (LLOQ, ULOQ)
- Accuracy at different levels
- Precision at different levels
- Selectivity and matrix effect
- Spiking recovery
- Dilution linearity
- Stability of target molecules in the matrix
Concentration of target molecules in the matrix