A large clinical laboratory was manually executing DOE (multi-parameter experiments). The average time to acquire and analyze data was 10 days and required 3 staff members. The resulting assay required an overnight acid dissociation step that pushed the assay time to around 24 hours.
GeNovu deployed our ADA DOE methods on a fully automated assay system allowing the client to optimize:
- High, Low and Negative Controls of 3 PCs
- 3 MRDs
- 6 Assay Diluents
- 2 Drug Concentrations
- 3 Acid Treatment Options
- 32 Master Mix conditions
Because of the optimization, the client was able to eliminate the overnight acid dissociation step. In addition, the screening assay sensitivity improved by almost 50% and the confirmatory assay sensitivity improved by a factor of 3. This resulted in an assay that took 2 hours to run versus the manually developed assay that took about 24 hours.
Further, this evaluation was performed by 2 operators and produced a more robust and reproducible assay in 2 days vs. the previous development time of 10 days.