| NS004 |
| NS004 |
| CI | CII | |||
| QC Control Lot No. | G6NI1801AK | G6NI1801AL | ||
| ReagentKit | ||||
| Duration of the Analyzing | Month (2023/02) | CUM (2019/02/01~2024/08/31) | Month (2023/02) | CUM (2019/02/01~2024/08/31) |
| Runs (N) | 27 | 885 | 27 | 885 |
| Mean (U/gHb) | 1.5 | 1.4 | 5.4 | 5.5 |
| SD | 0.10 | 0.19 | 0.23 | 0.57 |
| CV (%) | 6.7 | 13.6 | 4.3 | 10.4 |
| Target Value (U/gHb) | 1.2 | 1.2 | 4.6 | 4.6 |
| Total Error (%) | 38.3 | 43.8 | 25.9 | 40.3 |
| TEa (%) | 20 | 20 | 20 | 20 |
| σ | -0.7 | 0.2 | 0.6 | 0.0 |
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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 2024-08-31 ; Target : 1.2 ; SD : 0.11 ( ●) | ||
| Lot No.: G6NI1801AL ; Duration : 2019-02-01 to 2024-08-31 ; Target : 4.6 ; SD : 0.32 ( □) |
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| CI SDI QC Chart |
| Lot No.: G6NI1801AK ; Duration : 2019-02-01 to 2024-08-31 ; Target : 1.2 ; SD : 0.11 |
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| CII SDI QC Chart |
| Lot No.: G6NI1801AL ; Duration : 2019-02-01 to 2024-08-31 ; Target : 4.6 ; SD : 0.32 |
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