| NS015 |
| NS015 |
| 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) | 395 | 3825 | 395 | 3825 |
| Mean (U/gHb) | 1.8 | 1.8 | 5.4 | 5.8 |
| SD | 0.15 | 0.15 | 0.33 | 0.41 |
| CV (%) | 8.3 | 8.3 | 6.1 | 7.1 |
| Target Value (U/gHb) | 1.8 | 1.8 | 5.8 | 5.8 |
| Total Error (%) | 16.7 | 16.7 | 19.1 | 14.1 |
| TEa (%) | 20 | 20 | 20 | 20 |
| σ | 2.4 | 2.4 | 2.1 | 2.8 |
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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.: G6NI1703AI ; Duration : 2017-05-01 to 2019-06-30 ; Target : 1.8 ; SD : 0.15 ( ●) | ||
| Lot No.: G6NI1703AJ ; Duration : 2017-05-01 to 2019-06-30 ; Target : 5.8 ; SD : 0.58 ( □) |
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| CI SDI QC Chart |
| Lot No.: G6NI1703AI ; Duration : 2017-05-01 to 2019-06-30 ; Target : 1.8 ; SD : 0.15 |
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| CII SDI QC Chart |
| Lot No.: G6NI1703AJ ; Duration : 2017-05-01 to 2019-06-30 ; Target : 5.8 ; SD : 0.58 |
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