APPENDIX A Evaluation - Equipment Validation Criteria Salmonella Enumeration - final.pdf

Criteria

Mandatory A B C

Ease of sample and reagent preparation and use:

Platform expands to enumerate other pathogens No (0), Yes (5)

Dilutions required No (5), Yes (0)

Enrichment or incubation required No (5), Yes (0)

Reagent expiration time 3 months (1), 6 months (2), 9 months (3), 12 months (4), > 1 year (5)

Reagent storage temperature -80 (1), -60 (2), -20 (3), 4-8 (4), 20-25 (5)

Active reagent expiration time (once mixed) 24 hours (1), 48 hours (2), 1 week(3), 2 weeks (4), >2 weeks (5)

Hands on time (reagents) 1 step (5), 2 steps (4), 3 steps (3), 4 steps (2), > 5 steps (1)

Hands on time (samples) 1 step (5), 2 steps (4), 3 steps (3), 4 steps (2), > 5 steps (1)

Ease of manipulation (such as cap removal) difficult (1), somewhat difficult (2), neutral or don't notice

(3), somewhat easy (4), very easy (5)

Repetitive motion 1 step (5), 2 steps (4), 3 steps (3), 4 steps (2), > 5 steps (1)

Instrument test run time < 1 hour (3), 1-2 hours (2), > 2 hours (1)

Lysis time 0-15 minutes (3), 15-30 minutes (2), > 30 minutes (1)

Ease of clean-up by analysts < 1 minute (5), 1-5 minutes (4), 6-20 minutes (3), 21-45 minutes (2), > 45 minutes (1) Technical Assistance needed during evaluation period

Number of times customer service was contacted 5 or more (1), 4 (2), 3 (3), 2 (4), 1 or 0 (5)

Response time to customer service < 1 hour (5), 1-2 hours, (4), 2-4 hours (3), 4-8 (2), > 8 hours (1)

Was customer service able to solve the problem Yes or NA (1), No (0)

Retestability after sample prep/lysis 1 day (1), 2 days (2), 3-7 days (3), 7-14 days (4), > 2 weeks

(5)

Incidents of equipment non-reliability and non-robustness 4 or more (1), 3 (2), 2 (3), 1 (4), 0 (5)

Software ease of use:

Set-up 1 step (5), 2 steps (4), 3 steps (3), 4 steps (2), > 5 steps (1)

Viewing results 1 step (5), 2 steps (4), 3 steps (3), 4 steps (2), > 5 steps (1)

Compatible export file available No (0), Yes (1)

Requires special supplies:

Additional supplies for enrichment No (1), Yes (0)

Pipettes No (1), Yes (0)

Pipette tips No (1), Yes (0)

Deep well blocks No (1), Yes (0)

Block temperature -80 (1), -60 (2), -20 (3), 4-8 (4), 20-25 (5)

Total 0 0 0

Appendix A. Criteria for Equipment Evaluation 123A9422R0003 Instrument

Measure Legend

Sheet1