HK-Dtech proposes custom development of immunoassays that is subjected to a thorough and rigorous process to guarantee excellent quality and reproducibility.
We offer three kinds of services:
- Development, validation and manufacturing of a ready-to-use ELISA kit that fits with the customer’s needs
- Routine testing of customer samples
- Assay transfer and on-site training
The first step of the development process is to define the specifications of the project and the best strategy to apply. One or more recommendations could be suggested in function of:
- Type of test: indirect or sandwich FLISA
- Target to be quantified/detected: antibody, protein, biomolecules, peptide, small molecule, etc.
- The expected amount of antigen present
- Matrix: serum, plasma, culture supernatant, etc.
- Choice of primary material: samples, antigen, antibodies, etc.
Precise and optimal performance conditions are studied at each step of the test protocol. At this point, we evaluate and optimize the best parameters/conditions (coating, saturation, antigen capture, detection, washing, incubation time and temperature, etc.).
Validating the method ensures results are reproducible, reliable, robust, and accurate. Validation of the analytical method will be subject to the following experimental checks:
- Specificity (the method must differentiate the targeted analyte from all other matrix components)
- Linearity (range, LLOQ)
- Sensitivity (LOD)
- Accuracy (spiking recovery test)
- Precision (repeatability = intra assay, inter assay; reproducibility = inter laboratory assay, or on different days or different plates)
- Robustness (defined as the ability to remain unaffected by small variations in method parameters. These parameters could be incubation temperature, temperature of used components or varied incubation time due to time delay during pipetting).