Iron Gen.2

Catalog Number: 03183696122

SYSTEM INFORMATION

Test IRON2, test ID 0-596

INTENDED USE

In vitro test for the quantitative determination of iron in human serum and plasma on COBAS INTEGRA systems.

STORAGE AND STABILITY

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.

APPLICATION FOR SERUM AND PLASMA

COBAS INTEGRA 400 plus test definition

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

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

COBAS INTEGRA 800 TEST DEFINITION

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

PIPETTING PARAMETERS

Diluent (H2O)
R1 100 µL
Sample 8.5 µL 11.5 µL
SR 20 µL 20 µL
Total volume 160 µL

Calibration

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.

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.9-179 µmol/L (5-1000 µg/dL)

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test:

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

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:

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:

INTERMEDIATE PRECISION

METHOD COMPARISON

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).

BABLOK W, PASSING H, BENDER R, ET AL. A GENERAL REGRESSION PROCEDURE FOR METHOD TRANSFORMATION. APPLICATION OF LINEAR REGRESSION PROCEDURES FOR METHOD COMPARISON STUDIES IN CLINICAL CHEMISTRY,