At Vigene, we are constantly developing, optimizing, and validating additional analytical methods, and we will work with you to transfer your existing assays if necessary. We follow all relevant compendial guidance documents (client-local for international clients) to ensure that our methods meet any and all regulatory requirements. As new assays are developed, they are validated and qualified through a rigorous and systematic approach. The implementation of new assays follows a progression through several stages: development, optimization, qualification, and validation. An overview is given below.
Assay development. The data to be collected is identified and the necessary instrumentation, reagents (and/or kits) are selected. The performance parameters are outlined on a preliminary basis.
Assay optimization. In this phase, a series of experiments are conducted in order to document how various sample and assay conditions affect assay performance. This information will be used to set the acceptance criteria for later phases.
Assay qualification. The protocol is formalized and circulated for review and discussion. Following approval, the protocol is tested and a written report is compiled in which all results, analyses, and conclusions are outlined. The report is then circulated for final approval before the method can be implemented. The qualification phase is designed to demonstrate that the optimized method provides meaningful data for the specific samples and under the same conditions to be used when the method is fully applied.
Assay Validation. The protocol is reviewed under the same procedure as in the qualification phase, but in a more comprehensive manner. The performance of the assay is documented with respect to accuracy, linearity, range, limit of detection (LOD), limit of quantitation (LOQ), specificity/selectivity, precision, and suitability. Validation may include inter-laboratory comparisons as well.
Qualified and validated methods are typically reevaluated on a set schedule, to confirm that they are continuing to perform as originally intended. Methods are also reassessed as available technologies develop, or any other factors arise that may necessitate a method change.