CLIA Kit for Prothrombin Fragment 1+2 (F1+2)

  • CLIA Kit for Prothrombin Fragment 1+2 (F1+2) Packages (Simulation)
  • CLIA Kit for Prothrombin Fragment 1+2 (F1+2) Packages (Simulation)
  • CLIA Kit for Prothrombin Fragment 1+2 (F1+2) Results demonstration
  • SCA710Ra.jpg Typical Standard Curve
  • Certificate ISO9001: 2008, ISO13485: 2003 Registered

Specificity of the CLIA Kit for Prothrombin Fragment 1+2 (F1+2)

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.

Recovery of the CLIA Kit for Prothrombin Fragment 1+2 (F1+2)

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=5) 95-104 98
EDTA plasma(n=5) 80-89 84
heparin plasma(n=5) 84-104 101

Precision of the CLIA Kit for Prothrombin Fragment 1+2 (F1+2)

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 of the CLIA Kit for Prothrombin Fragment 1+2 (F1+2)

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) 88-95% 79-91% 98-105% 93-103%
EDTA plasma(n=5) 94-101% 96-104% 78-99% 78-101%
heparin plasma(n=5) 99-105% 79-104% 90-101% 91-103%

Stability of the CLIA Kit for Prothrombin Fragment 1+2 (F1+2)

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.

Assay procedure summary of the CLIA Kit for Prothrombin Fragment 1+2 (F1+2)

1. Prepare all reagents, samples and standards;
2. Add 100µL standard or sample to each well. Incubate 1 hours at 37°C;
3. Aspirate and add 100µL prepared Detection Reagent A. Incubate 1 hour at 37°C;
4. Aspirate and wash 3 times;
5. Add 100µL prepared Detection Reagent B. Incubate 30 minutes at 37°C;
6. Aspirate and wash 5 times;
7. Add 100µL Substrate Solution. Incubate 10 minutes at 37°C;
8. Read RLU value immediately.

Test principle of the CLIA Kit for Prothrombin Fragment 1+2 (F1+2)

Average the duplicate readings for each standard, control, and samples and subtract the average zero standard relative light unit (RLU). Create a standard curve on log-log graph paper, with F1+2 concentration on the y-axis and the RLU value on the x-axis. Draw the best fit straight line through the standard points and it can be determined by regression analysis. Using some plot software, such as curve expert 1.30, is also recommended. If samples have been diluted, the concentration read from the standard curve must be multiplied by the dilution factor.

Related products

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