Specificity

This assay has high sensitivity and excellent specificity for detection of D-Dimer (D2D). No significant cross-reactivity or interference between D-Dimer (D2D) and analogues was observed.

Recovery

Matrices listed below were spiked with certain level of recombinant D-Dimer (D2D) and the recovery rates were calculated by comparing the measured value to the expected amount of D-Dimer (D2D) in samples.

Precision

Intra-assay Precision (Precision within an assay): 3 samples with low, middle and high level D-Dimer (D2D) were tested 20 times on one plate, respectively.

Inter-assay Precision (Precision between assays): 3 samples with low, middle and high level D-Dimer (D2D) 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 D-Dimer (D2D) and their serial dilutions. The results were demonstrated by the percentage of calculated concentration to the expected.

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.