Coagpia Fbg

  • Easy-to-use liquid reagent
  • Excellent on-board stability
  • No interference from heparin sodium (up to 8 U/mL)
  • Calibrator values assigned based on WHO reference material
  • *This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
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Description

*Read carefully the package insert before use.

Performance Data

Within-run reproducibility

(mg/dL)

  Sample 1 Sample 2 Sample 3
1 253 124 84
2 249 116 81
3 255 120 82
4 249 115 82
5 259 115 85
6 255 115 85
7 259 113 88
8 261 116 79
9 247 117 87
10 255 123 85
Mean 254 117 84
S.D. 4.7 3.7 2.8
C.V. (%) 1.9 3.1 3.3
Max. 261 124 88
Min. 247 113 79
Range 14 11 9

On-Board Stability

[on Coapresta 2000]

On-Board Stability

Interference

  Concentration Measured Value(mg/dL)
Base
Plasma
Including
Interfering Substance
Unconjugated
Bilirubin
25 mg/dL 270 281
Conjugated
Bilirubin
25 mg/dL 270 279
Hemoglobin 500 mg/dL 328 330
Chyle 3000 FTU 270 280
Heparin
Sodium
8 U/mL 270 259

Linearity

Linearity

Correlation

Correlation

Traceability – Accuracy Verification of Calibrator N for Coagpia

Measured values of Calibrator N for Coagpia were verified using WHO reference material as a calibrator. The closer the measured value is to the calibrator’s assigned value (i.e. recovery is closer to 100%), the more closely the sample resembles the reference. Calibrator N for Coagpia was shown to precisely resemble the WHO reference material.

Assay conditions

  • Reagent: Coagpia Fbg
  • Calibrator: WHO 2nd international standard for plasma Fibrinogen NIBSC CODE 98/612
    Assigned value 295 mg/dL
  • Analyzer: Coapresta 2000

Sample Measured value with Coagpia Fbg(mg/dL) Mean(mg/dL) Recovery (%)
Calibrator N for Coagpia
Lot A
Assigned value 295mg/dL
305 299.0 101.4
287
305
Calibrator N for Coagpia
Lot B
Assigned value 296mg/dL
298 305.3 103.5
309
309

Assay Procedure

Automatic sample dilution

Automatic sample dilution

Coagpia Fbg

Additional information

Coagpia Fbg Sample Dilution Solution

10×10mL, Storage: 2-10℃

Coagpia Fbg Thrombin Reagent

10×3mL, Storage: 2-10℃

Calibrator N for Coagpia*

10×1mL(lyophilized), Storage: 2-8℃

Control P-N for Coagpia*

5×2conc.×1mL(lyophilized), Storage: 2-8℃

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