| NS016 |
| NS016 |
| CI | CII | |||
| QC Control Lot No. | G6NI1703AI | G6NI1703AJ | ||
| ReagentKit | ||||
| Duration of the Analyzing | Month (2018/09) | CUM (2017/05/01~2019/06/30) | Month (2018/09) | CUM (2017/05/01~2019/06/30) |
| Runs (N) | 358 | 5934 | 358 | 5934 |
| Mean (U/gHb) | 1.9 | 1.8 | 6.0 | 5.7 |
| SD | 0.17 | 0.18 | 0.40 | 0.42 |
| CV (%) | 8.9 | 10.0 | 6.7 | 7.4 |
| Target Value (U/gHb) | 1.7 | 1.7 | 5.4 | 5.4 |
| Total Error (%) | 29.7 | 25.9 | 24.4 | 20.3 |
| TEa (%) | 20 | 20 | 20 | 20 |
| σ | 0.9 | 1.4 | 1.3 | 2.0 |
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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.: G6NI1703AI ; Duration : 2017-05-01 to 2019-06-30 ; Target : 1.7 ; SD : 0.10 ( ●) | ||
| Lot No.: G6NI1703AJ ; Duration : 2017-05-01 to 2019-06-30 ; Target : 5.4 ; SD : 0.30 ( □) |
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| CI SDI QC Chart |
| Lot No.: G6NI1703AI ; Duration : 2017-05-01 to 2019-06-30 ; Target : 1.7 ; SD : 0.10 |
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| CII SDI QC Chart |
| Lot No.: G6NI1703AJ ; Duration : 2017-05-01 to 2019-06-30 ; Target : 5.4 ; SD : 0.30 |
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