Assay Development Services

Assay Validation Steps

1. Purpose/Method: Aim to investigate the feasibility of the assay according to the project specific established methods.
2. 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.
3. Specificity: Testing cross reactivity using expected interfering analytes/matrices and determining if the assay will detect only the specified species/analyte.
4. Accuracy: Determination of the accuracy of the standard curve within the acceptance criteria.
5. Precision and Reproducibility: Ensuring validation study is within the acceptance criteria over >3 sets of verification samples run in triplicate. Recovery will be calculated.
6. Dilution Linearity: Determination of dilution linearity for tested samples at different dilutions within the detection range.
7. 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.