Assay Development Services
As leaders in immunoassay and other assay development, we continually strive to meet the needs of the biomedical research community. Let us develop a customized assay to suit your research needs. RayBiotech's labs are fully GMP-compliant and outfitted with state-of-the-art equipment. Our capabilities include drug screening, pharmacokinetics, efficacy or mechanism of action evaluation, bioprocessing solutions, analyte modification or interaction analysis, and more. Our scientific team can help you with every step of the development process, from design to validation.
Assay Validation Steps
- Purpose/Method: Aim to investigate the feasibility of the assay according to the project specific established methods.
- Sensitivity: Testing upper and lower limit of quantitation as well as low, middle and high levels of quality control to a acceptable coefficient of variation.
- Specificity: Testing cross reactivity using expected interfering analytes/matrices and determining if the assay will detect only the specified species/analyte.
- Accuracy: Determination of the accuracy of the standard curve within the acceptance criteria.
- Precision and Reproducibility: Ensuring validation study is within the acceptance criteria over >3 sets of verification samples run in triplicate. Recovery will be calculated.
- Dilution Linearity: Determination of dilution linearity for tested samples at different dilutions within the detection range.
- Sample/Analyte Stability: Stability of tested samples stored at varying temperatures, over time, and undergoing freeze/thaw cycles according to the needs of the assay.