| Recovery: | Matrices listed below were spiked with certain level of recombinant the index and the recovery rates were calculated by comparing the measured value to the expected amount of the index in samples. |
| | Matrix | Recovery range (%) | Average(%) | | Serum (n=5) | 83-100 | 91 | | EDTA plasma (n=5) | 90-98 | 94 | | Heparin plasma (n=5) | 90-99 | 94 |
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| Linearity: | The linearity of the kit was assayed by testing samples spiked with appropriate concentration of the index 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) | 82-96% | 83-98% | 81-99% | 93-101% | | EDTA plasma (n=5) | 88-101% | 86-95% | 90-102% | 80-93% | | Heparin plasma (n=5) | 80-91% | 82-90% | 95-104% | 79-95% | |
| Intra-assay Precision: | Intra-Assay: CV <10%. 3 samples with low, middle and high level the index were tested 20 times on one plate, respectively. |
| Inter-assay Precision: | Inter-Assay: CV <12%. 3 samples with low, middle and high level the index were tested on 3 different plates, 8 replicates in each plate. |
| Stability: | The stability of ELISA 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 conditions. Note: To minimize unnecessary influences on the performance, operation procedures and lab conditions, especially room temperature, air humidity and incubator temperatures should be strictly regulated. It is also strongly suggested that the whole assay is performed by the same experimenter from the beginning to the end. |
