(Code)
(U/gHb)
(U/gHb)
Mean
(%)
(%)
(%)
(U/gHb)
(U/gHb)
Mean
(%)
(%)
(%)
| Monthly |
| CI (Lot No.: G6NI1403AC) | CII (Lot No.: G6NI1403AD) | |||||||||||||||||
| UnitID |
Reagent Kit (Code) |
Target (U/gHb) | Mean (U/gHb) | n for Mean |
SD | CV (%) | TE (%) | TEa (%) | σ | Target (U/gHb) | Mean (U/gHb) | n for Mean |
SD | CV (%) | TE (%) | TEa (%) | σ | |
| NS004 | 15 | 1.6 | 1.6 | 19 | 0.14 | 8.8 | 17.5 | 20 | 2.3 | 4.5 | 4.8 | 19 | 0.36 | 7.5 | 21.7 | 20 | 1.8 | |
| NS007 | 17 | 12.8 | 13.9 | 7 | 0.94 | 6.8 | 22.1 | 20 | 1.7 | 69.8 | 47.5 | 7 | 1.64 | 3.5 | 38.9 | 20 | -3.4 | |
| NS020 | 99 | 5.2 | 5.2 | 17 | 0.36 | 6.9 | 13.8 | 20 | 2.9 | 14.0 | 12.8 | 17 | 1.39 | 10.9 | 30.3 | 20 | 1.0 | |
|
Bias (%) = [ (│Mean - Target│) / Target ] x 100% TE：Total Error(%) = Bias (%) + 2 × CV (%) σ (Sigma) = [TEa% - Bias (%)] / CV (%) |
| Cumulative |
| CI (Lot No.: G6NI1403AC) | CII (Lot No.: G6NI1403AD) | |||||||||||||||||
| UnitID |
Reagent Kit (Code) |
Target (U/gHb) | Mean (U/gHb) | n for Mean |
SD | CV (%) | TE (%) | TEa (%) | σ | Target (U/gHb) | Mean (U/gHb) | n for Mean |
SD | CV (%) | TE (%) | TEa (%) | σ | |
| NS004 | 15 | 1.6 | 1.8 | 179 | 0.18 | 10.0 | 32.5 | 20 | 0.8 | 4.5 | 4.8 | 179 | 0.40 | 8.3 | 23.3 | 20 | 1.6 | |
| NS007 | 15 | 1.7 | 1.7 | 278 | 0.23 | 13.5 | 27.1 | 20 | 1.5 | 4.9 | 4.9 | 278 | 0.71 | 14.5 | 29.0 | 20 | 1.4 | |
| NS007 | 17 | 12.8 | 12.3 | 67 | 1.14 | 9.3 | 22.4 | 20 | 1.7 | 69.8 | 46.5 | 67 | 3.59 | 7.7 | 48.8 | 20 | -1.7 | |
| NS011 | 15 | 1.7 | 1.7 | 237 | 0.10 | 5.9 | 11.8 | 20 | 3.4 | 4.9 | 4.8 | 237 | 0.24 | 5.0 | 12.0 | 20 | 3.6 | |
| NS013 | 15 | 1.7 | 1.7 | 3489 | 0.11 | 6.5 | 12.9 | 20 | 3.1 | 4.8 | 4.8 | 3489 | 0.25 | 5.2 | 10.4 | 20 | 3.8 | |
| NS014 | 15 | 1.6 | 1.7 | 8437 | 0.14 | 8.2 | 22.7 | 20 | 1.7 | 4.4 | 4.6 | 8437 | 0.35 | 7.6 | 19.8 | 20 | 2.0 | |
| NS015 | 15 | 1.7 | 1.7 | 2893 | 0.16 | 9.4 | 18.8 | 20 | 2.1 | 4.5 | 4.7 | 2893 | 0.47 | 10.0 | 24.4 | 20 | 1.6 | |
| NS016 | 15 | 1.5 | 1.6 | 11570 | 0.19 | 11.9 | 30.4 | 20 | 1.1 | 4.5 | 4.6 | 11570 | 0.62 | 13.5 | 29.2 | 20 | 1.3 | |
| NS017 | 15 | 1.7 | 1.8 | 474 | 0.13 | 7.2 | 20.3 | 20 | 2.0 | 4.9 | 4.9 | 474 | 0.24 | 4.9 | 9.8 | 20 | 4.1 | |
| NS019 | 15 | 1.6 | 1.6 | 1969 | 0.14 | 8.8 | 17.5 | 20 | 2.3 | 4.8 | 4.5 | 1969 | 0.40 | 8.9 | 24.0 | 20 | 1.5 | |
| NS020 | 99 | 5.2 | 5.2 | 1961 | 0.76 | 14.6 | 29.2 | 20 | 1.4 | 14.0 | 14.0 | 1961 | 2.05 | 14.6 | 29.3 | 20 | 1.4 | |
|
Bias (%) = [ (│Mean - Target│) / Target ] x 100% TE：Total Error(%) = Bias (%) + 2 × CV (%) σ (Sigma) = [TEa% - Bias (%)] / CV (%) |
| Reagent Kit | Reagent Code |
| PE (ND-1000) | 15 |
| PE GSP Neonatal G6PD (3310-0010) | 17 |
| Laboratory prepared | 99 |