Product Matrix Testing—Assembled Components
| False Positive | |||
|---|---|---|---|
| Manufacturing Location | Set | ScanRDI Counts | Reference Method cfu |
| United States | 1 | 13 | 0 |
| 2 | 14 | 0 | |
| 3 | 112 | 29 | |
| France | 1 | 14 | 0 |
| 2 | 9 | 0 | |
| 3 | 83 | 9 | |
| Average counts | 41 | 6 | |
| False Negative | |||
|---|---|---|---|
| Manufacturing location | Set | Diluent | ScanRDI Counts |
| United States | 1 | 200 mL BSS | 2664 |
| 2 | 200 mL BSS | 3598 | |
| 3 | 200 mL BSS | 3753 | |
| Mean ± SD counts | 3338 ± 589 | ||
| United States | 1 | 200 mL PW | 3083 |
| 2 | 200 mL PW | 2650 | |
| 3 | 200 mL PW | 2738 | |
| Mean ± SD counts | 2824 ± 229 | ||
| France | 1 | 75 mL BSS | 1612 |
| 2 | 75 mL BSS | 1476 | |
| 3 | 75 mL BSS | 1366 | |
| Mean ± SD counts | 1485 ± 123 | ||
| France | 1 | 75 mL PW | 1745 |
| 2 | 75 mL PW | 1672 | |
| 3 | 75 mL PW | 1672 | |
| Mean ± SD counts | 1696 ± 42 | ||