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Comparison of Two Process Control Procedures Across Three Immunogenicity Immunoassays at Selected Number of Runs to Calculate Limits
| Method | Total runs | Runs to calculate limits | Alarm detection | ||||||
|---|---|---|---|---|---|---|---|---|---|
| X + EWMA | X + Run Rules | ||||||||
| EWMA chart | X chart | Total | 41s | 22s | X chart (13s) | Total | |||
| ECL | 71 | 20 | 1 | 0 | 1 | 0 | 1 | 0 | 1 |
| 25 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | ||
| 30 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | ||
| ELISA | 48 | 20 | 1 | 1 | 2 | 1 | 0 | 1 | 2 |
| 25 | 2 | 2 | 4 | 0 | 2 | 2 | 4 | ||
| 30 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | ||
| SPR | 106 | 20 | 1 | 6 | 7 | 6 | 6 | 6 | 18 |
| 25 | 4 | 9 | 13 | 4 | 7 | 9 | 20 | ||
| 30 | 1 | 3 | 4 | 5 | 4 | 3 | 12 | ||
