Specificity
This assay has high sensitivity and excellent specificity for detection of Prothrombin Fragment 1+2 (F1+2). No significant cross-reactivity or interference between Prothrombin Fragment 1+2 (F1+2) and analogues was observed.
| Product Details | |
| Product Name | Prothrombin Fragment 1+2 (F1+2) |
| Test Method | Double-antibody Sandwich |
| Assay Length | 3h |
| Sample Type | serum, plasma, tissue homogenates, cell lysates, cell culture supernates and other biological fluids |
Recovery
Matrices listed below were spiked with certain level of recombinant Prothrombin Fragment 1+2 (F1+2) and the recovery rates were calculated by comparing the measured value to the expected amount of Prothrombin Fragment 1+2 (F1+2) in samples.
| Matrix | Recovery range (%) | Average(%) |
| Serum (n=8) | 78-99 | 93 |
| EDTA plasma (n=8) | 96-105 | 101 |
| heparin plasma(n=5) | 97-104 | 101 |
Precision
Intra-assay Precision (Precision within an assay): 3 samples with low, middle and high level Prothrombin Fragment 1+2 (F1+2) were tested 20 times on one plate, respectively
Inter-assay Precision (Precision between assays): 3 samples with low, middle and high level Prothrombin Fragment 1+2 (F1+2) 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 Prothrombin Fragment 1+2 (F1+2) 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) | 90-99% | 78-103% | 85-102% | 98-105% |
| EDTA plasma(n=5) | 88-101% | 83-104% | 84-98% | 84-101% |
| heparin plasma(n=5) | 80-99% | 84-99% | 84-101% | 88-102% |
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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