Time Requirements for Conventional Extraneous Agent Testing
| Activity | Time Needed | |
|---|---|---|
| Test preparation and preparation of neutralizing antiserum | Antigen preparation/purification from independent source | ≥4 weeks |
| Hyperimmunization or preparation and selection of monoclonal antibodies | 10 weeks | |
| Antiserum/antibody purification (optional) | 4 weeks | |
| Neutralization pre-tests in vitro | 4 weeks | |
| Qualification tests in in vitro methods | ≥6 weeks | |
| Qualification tests in in vivo methods | ≥12 weeks | |
| ≥40 weeks | ||
| In vivo testing (longest time period for guinea pig testing) | Order to delivery of animals | 1 (−4) weeks |
| Adaptation period | 1 week | |
| Inoculation, observation period | 7 weeks | |
| Pathology and histopathology, additional cell culture tests and/or subinoculations in case of suspicious findings | 6 weeks | |
| Reporting including review and approval | 3 weeks | |
| Timing/logistic gaps | 4 weeks | |
| 22 weeks | ||
| Total sum | ≥62 weeks |