Nanopia P-FDP

  • Suitable for use with plasma or serum- uses a monoclonal antibody specific to the D fraction of FDP.
  • Total FDP is always higher than the D-dimer value (when using Nanopia D-dimer).
  • *This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.

Description

*Read carefully the package insert before use.

Performance Data

Within-run reproducibility

(µg/mL)

  Sample 1 Sample 2
1 3.5 9.5
2 3.6 9.5
3 3.5 9.4
4 3.4 9.3
5 3.5 9.5
6 3.5 9.3
7 3.5 9.4
8 3.6 9.5
9 3.5 9.3
10 3.5 9.4
Mean 3.5 9.4
S.D. 0.06 0.09
C.V. (%) 1.6 1.0
Max. 3.6 9.5
Min. 3.4 9.3
Range 0.2 0.2

On-Board Stability (After Reconstitution)

[on Coapresta 2000]

On-Board Stability (After Reconstitution)

Interference

  Concentration Measured Value(µg/mL)
Base Plasma Including Interfering Substance
Unconjugated Bilirubin 20mg/dL 2.70 2.80
Conjugated Bilirubin 20mg/dL 2.80 2.80
Hemoglobin 500mg/dL 2.12 2.14
Chyle 2500 FTU 2.17 2.04

Linearity

Linearity

Correlation

1) Correlation between serum and plasma

2) Correlation between SEKISUI and existing product

Assay Procedure on Corepresta 2000

Assay Procedure on Corepresta 2000

Nanopia P-FDP

Additional information

Nanopia P-FDP | P-FDP Buffer Solution 1

1×10.5mL, Storage: 2-10℃

Nanopia P-FDP | P-FDP Latex Reagent 2

1×10mL, Storage: 2-10℃

FDP Calibrator N*

1×5conc.×0.5mL(lyophilized), Storage: 2-10℃

FDP Control*

3×2conc.×1mL(lyophilized), Storage: 2-10℃

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