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]
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
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
Coagpia Fbg
