| NS007 |
| NS007 |
| CI | CII | |||
| QC Control Lot No. | G6NI1801AK | G6NI1801AL | ||
| ReagentKit | PE GSP Neonatal G6PD (3310-0010) | |||
| Duration of the Analyzing | Month (2024/08) | CUM (2019/02/01~2024/10/31) | Month (2024/08) | CUM (2019/02/01~2024/10/31) |
| Runs (N) | 14 | 244 | 14 | 244 |
| Mean (U/gHb) | 9.3 | 10.0 | 65.8 | 70.2 |
| SD | 0.44 | 0.85 | 6.76 | 7.42 |
| CV (%) | 4.7 | 8.5 | 10.3 | 10.6 |
| Target Value (U/gHb) | 10.3 | 10.3 | 73.6 | 73.6 |
| Total Error (%) | 19.2 | 19.9 | 31.1 | 25.8 |
| TEa (%) | 20 | 20 | 20 | 20 |
| σ | 2.2 | 2.0 | 0.9 | 1.5 |
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Bias (%) = [ (│Mean - Target│) / Target ] x 100% TE：Total Error(%) = Bias (%) + 2 × CV (%) σ (Sigma) = [TEa% - Bias (%)] / CV (%) |
| CI and CII SDI QC Chart |
| Lot No.: G6NI1801AK ; Duration : 2019-02-01 to 2024-10-31 ; Target : 10.3 ; SD : ( ●) | ||
| Lot No.: G6NI1801AL ; Duration : 2019-02-01 to 2024-10-31 ; Target : 73.6 ; SD : ( □) |
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| CI SDI QC Chart |
| Lot No.: G6NI1801AK ; Duration : 2019-02-01 to 2024-10-31 ; Target : 10.3 ; SD : |
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| CII SDI QC Chart |
| Lot No.: G6NI1801AL ; Duration : 2019-02-01 to 2024-10-31 ; Target : 73.6 ; SD : |
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