| NS016 |
| NS016 |
| CI | CII | |||
| QC Control Lot No. | G6NI1801AK | G6NI1801AL | ||
| ReagentKit | PE (ND-1000) | |||
| 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) | 0 | 3818 | 0 | 3818 |
| Mean (U/gHb) | - | 1.3 | - | 5.3 |
| SD | - | 0.11 | - | 0.33 |
| CV (%) | - | 8.5 | - | 6.2 |
| Target Value (U/gHb) | 1.4 | 1.4 | 5.8 | 5.8 |
| Total Error (%) | - | 24.1 | - | 21.1 |
| TEa (%) | 20 | 20 | 20 | 20 |
| σ | - | 1.5 | - | 1.8 |
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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 : 1.4 ; SD : 0.20 ( ●) | ||
| Lot No.: G6NI1801AL ; Duration : 2019-02-01 to 2024-08-31 ; Target : 5.8 ; SD : 0.40 ( □) |
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| CI SDI QC Chart |
| Lot No.: G6NI1801AK ; Duration : 2019-02-01 to 2024-08-31 ; Target : 1.4 ; SD : 0.20 |
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| CII SDI QC Chart |
| Lot No.: G6NI1801AL ; Duration : 2019-02-01 to 2024-08-31 ; Target : 5.8 ; SD : 0.40 |
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