Specificity
This assay has high sensitivity and excellent specificity for detection of High Sensitive Albumin (ALB). No significant cross-reactivity or interference between High Sensitive Albumin (ALB) and analogues was observed.
Recovery
Matrices listed below were spiked with certain level of recombinant High Sensitive Albumin (ALB) and the recovery rates were calculated by comparing the measured value to the expected amount of High Sensitive Albumin (ALB) in samples.
| Matrix | Recovery range (%) | Average(%) |
| serum(n=5) | 90-98 | 95 |
| EDTA plasma(n=5) | 79-91 | 80 |
| heparin plasma(n=5) | 80-91 | 88 |
Precision
- Intra-assay Precision (Precision within an assay): 3 samples with low, middle and high level High Sensitive Albumin (ALB) were tested 20 times on one plate, respectively.
- Inter-assay Precision (Precision between assays): 3 samples with low, middle and high level High Sensitive Albumin (ALB) were tested on 3 different plates, 8 replicates in each plate
- CV(%) = SD/meanX100
- Intra-Assay: CV<10%
- Inter-Assay: CV<12%
Linearity
The linearity of the kit was assayed by testing samples spiked with appropriate concentration of High Sensitive Albumin (ALB) and their serial dilutions. The results were demonstrated by the percentage of calculated concentration to the expected.
| Sample | 1:2 | 1:4 | 1:8 | 1:16 |
| serum(n=5) | 80-102% | 80-104% | 96-105% | 80-96% |
| EDTA plasma(n=5) | 86-96% | 79-103% | 91-99% | 79-88% |
| heparin plasma(n=5) | 90-101% | 85-98% | 83-90% | 79-101% |
Stability
The stability of kit is determined by the loss rate of activity. The loss rate of this kit is less than 5% within the expiration date under appropriate storage condition. To minimize extra influence on the performance, operation procedures and lab conditions, especially room temperature, air humidity, incubator temperature should be strictly controlled. It is also strongly suggested that the whole assay is performed by the same operator from the beginning to the end.
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