Catalog Number: 03183696122
Test IRON2, test ID 0-596
In vitro test for the quantitative determination of iron in human serum and plasma on COBAS INTEGRA systems.
| Shelf life at 2-8 °C | See expiration date on cobas c pack label | |
| COBAS INTEGRA 400 plus systems | ||
| On-board in use at 10-15 °C | 6 weeks | |
| COBAS INTEGRA 800 systems | ||
| On-board in use at 8 °C | 6 weeks | |
When removing the cobas c pack during use from the instrument, please immediately store at 2-8 °C.
COBAS INTEGRA 400 plus test definition
| Measuring mode | Absorbance |
| Abs. calculation mode | Endpoint |
| Reaction mode | R1-S- -SR |
| Reaction direction | Increase |
| Wavelength A/B | 552/659 nm |
| Calc. first/last | 49/55 |
| Unit | µmol/L |
Pipetting parameters
| Diluent (H2O) | ||
| R1 | 100 µL | |
| Sample | 8.5 µL | 11.5 µL |
| SR | 20 µL | 20 µL |
| Total volume | 160 µL |
| Diluent (H2O) | ||
| R1 | 100 µL | |
| Sample | 8.5 µL | 11.5 µL |
| SR | 20 µL | 20 µL |
| Total volume | 160 µL | |
COBAS INTEGRA 800 test definition
Calibration
| Measuring mode | Absorbance |
| Abs. calculation mode | Endpoint |
| Reaction mode | R1-S-R2 (late) |
| Reaction direction | Increase |
| Wavelength A/B | 552/659 nm |
| Calc. first/last | 103/113 |
| Unit | µmol/L |
Pipetting parameters
| Diluent (H2O) | ||
| R1 | 100 µL | |
| Sample | 8.5 µL | 11.5 µL |
| SR | 20 µL | 20 µL |
| Total volume | 160 µL | |
Calibration
Traceability:7 This method has been standardized against an internal method traceable to a primary reference material (SRM937).
| Calibrator | Calibrator f.a.s.Use deionized water as zero calibrator. |
| Calibration mode | Linear regression |
| Calibration replicate | Duplicate recommended |
| Calibration interval | ▪Each cobas c pack▪every 7 days▪as required following quality control procedures. |
Measuring range
0.9-179 µmol/L (5-1000 µg/dL)
Lower detection limit of the test:
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (1 aliquot per run, 1 run per day, 21 days). The following results were obtained:
Iron values for human serum and plasma samples obtained on a COBAS INTEGRA 700 analyzer with the COBAS INTEGRA Iron Gen.2 reagent (y) were compared with those determined using the same reagent on a Roche/Hitachi 917 analyzer (x) and with the previous IRON reagent on a COBAS INTEGRA 700 analyzer (x).