
| - Basic Performance |
[ Accuracy of High Sensitive Keratan Sulfate ELISA Kit ]
The basic performance of the High Sensitive Keratan Sulfate ELISA Kit was evaluated.
Difference between wells on the same plate
4 types of sample (diluted serum) were measured in accordance with the protocol using six wells per sample (on the same plate).
| Sample | Measured value (ng/mL) | Average value (ng/mL) | SD | C.V. (%) | |||||
| Well 1 | Well 2 | Well 3 | Well 4 | Well 5 | Well 6 | ||||
| 1 | 2.21 | 2.16 | 2.37 | 2.33 | 2.70 | 2.40 | 2.36 | 0.19 | 8.0 |
| 2 | 1.70 | 1.56 | 1.57 | 1.67 | 1.67 | 1.56 | 1.62 | 0.06 | 4.0 |
| 3 | 0.89 | 0.81 | 0.75 | 0.78 | 0.80 | 0.74 | 0.80 | 0.05 | 6.8 |
| 4 | 0.47 | 0.46 | 0.41 | 0.41 | 0.44 | 0.38 | 0.43 | 0.03 | 8.0 |
| Average C.V. (%) | 6.7 | ||||||||
Difference between kits
4 types of sample (diluted serum) were measured in accordance with the protocol by using four kits (from the same lot).
| Sample | Measured value (ng/mL) | Average value (ng/mL) | SD | C.V. (%) | |||
| Kit 1 | Kit 2 | Kit 3 | Kit 4 | ||||
| 1 | 2.43 | 2.26 | 2.55 | 2.52 | 2.44 | 0.13 | 5.3 |
| 2 | 1.64 | 1.48 | 1.70 | 1.68 | 1.63 | 0.10 | 6.3 |
| 3 | 0.79 | 0.75 | 0.84 | 0.84 | 0.81 | 0.04 | 5.3 |
| 4 | 0.43 | 0.42 | 0.48 | 0.44 | 0.44 | 0.03 | 6.1 |
| Average C.V. (%) | 5.7 | ||||||
Difference when measurements carried out on different dates
4 types of sample (diluted serum) were measured in accordance with the protocol by using the kits (from the same lot) on four different dates.
| Sample | Measured value (ng/mL) | Average value (ng/mL) | SD | C.V. (%) | |||
| Day 1 | Day 2 | Day 3 | Day 4 | ||||
| 1 | 2.26 | 2.52 | 2.36 | 2.63 | 2.44 | 0.16 | 6.6 |
| 2 | 1.48 | 1.69 | 1.62 | 1.71 | 1.62 | 0.10 | 6.3 |
| 3 | 0.75 | 0.83 | 0.80 | 0.85 | 0.81 | 0.04 | 5.3 |
| 4 | 0.42 | 0.41 | 0.43 | 0.45 | 0.42 | 0.02 | 4.1 |
| Average C.V. (%) | 5.6 | ||||||
Conclusion
CV values were <10% in each of the above evaluations, demonstrating good reproducibility within plates, between kits, and on different dates.