ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
| Kit | Validation parameter | Sample concentration | |||||
|---|---|---|---|---|---|---|---|
| 20 IU/L | 60 IU/L | 100 IU/L | 140 IU/L | ||||
| Kit A | Intra-laboratory | Day | Mean (IU/L) | 19.59 | 60.59 | 100.91 | 140.14 |
| RSD (%) | 3.23 | 1.18 | 1.41 | 1.22 | |||
| Recovery (%) | 97.96 | 100.99 | 100.91 | 100.10 | |||
| Analyst | Mean (IU/L) | 19.66 | 60.02 | 100.42 | 138.32 | ||
| RSD (%) | 1.94 | 2.38 | 2.11 | 2.43 | |||
| Recovery (%) | 98.28 | 100.03 | 100.42 | 98.80 | |||
| Instrument | Mean (IU/L) | 20.75 | 60.24 | 99.81 | 141.03 | ||
| RSD (%) | 5.24 | 2.28 | 1.81 | 0.98 | |||
| Recovery (%) | 103.75 | 100.40 | 99.81 | 100.74 | |||
| Inter-laboratory | Mean (IU/L) | 20.22 | 58.82 | 97.20 | 137.50 | ||
| RSD (%) | 5.52 | 4.76 | 6.36 | 3.72 | |||
| Recovery (%) | 101.12 | 98.03 | 97.20 | 98.21 | |||
| Kit B | Intra-laboratory | Day | Mean (IU/L) | 24.04 | 71.60 | 115.64 | 152.81 |
| RSD (%) | 6.50 | 6.02 | 4.96 | 3.23 | |||
| Recovery (%) | 120.18 | 119.34 | 115.64 | 109.15 | |||
| Analyst | Mean (IU/L) | 22.92 | 66.09 | 108.90 | 146.19 | ||
| RSD (%) | 8.06 | 6.25 | 4.89 | 4.82 | |||
| Recovery (%) | 114.60 | 110.15 | 108.90 | 104.42 | |||
| Instrument | Mean (IU/L) | 23.35 | 66.91 | 114.52 | 154.41 | ||
| RSD (%) | 4.42 | 6.18 | 3.77 | 4.60 | |||
| Recovery (%) | 116.75 | 111.52 | 114.52 | 110.29 | |||
| Inter-laboratory | Mean (IU/L) | 21.56 | 63.95 | 103.05 | 141.47 | ||
| RSD (%) | 9.01 | 9.86 | 9.41 | 8.68 | |||
| Recovery (%) | 107.81 | 106.58 | 103.05 | 101.05 | |||
| Kit C | Intra-laboratory | Day | Mean (IU/L) | 21.06 | 61.99 | 99.96 | 141.01 |
| RSD (%) | 3.20 | 2.12 | 0.98 | 5.12 | |||
| Recovery (%) | 105.30 | 103.32 | 99.96 | 100.72 | |||
| Analyst | Mean (IU/L) | 21.90 | 63.02 | 101.23 | 141.62 | ||
| RSD (%) | 6.49 | 2.84 | 2.13 | 4.37 | |||
| Recovery (%) | 109.51 | 105.03 | 101.23 | 101.16 | |||
| Instrument | Mean (IU/L) | 22.60 | 60.94 | 98.16 | 134.00 | ||
| RSD (%) | 4.36 | 1.19 | 1.17 | 0.81 | |||
| Recovery (%) | 113.00 | 101.57 | 98.16 | 95.71 | |||
| Inter-laboratory | Mean (IU/L) | 22.00 | 62.53 | 100.52 | 138.83 | ||
| RSD (%) | 5.01 | 3.19 | 2.64 | 3.99 | |||
| Recovery (%) | 109.99 | 104.21 | 100.52 | 99.16 | |||