Some Considerations for Introducing New Virus Detection Technologies
| • Demonstrate that test article components do not interfere |
| – Intact cells or lysate of cells and culture medium |
| – Unprocessed bulk harvest |
| – Cell-free supernatant |
| – Final product |
| • Include relevant and appropriate controls to determine assay specificity and sensitivity |
| • Develop standards for assay validation |
| • Define path for follow-up of results |
| • Update the databases with novel viruses |