Iron Gen.2

Catalog Number: 05169291190

SYSTEM INFORMATION

IRON2: ACN 8661

INTENDED USE

In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

IRON2
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 2 weeks
On-board on the Reagent Manager: 24 hours
When removing the cobas c pack from the instrument during use, please immediately store at 2-8 °C.Do not shake the cobas c pack to avoid foaming.Store protected from light.

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

cobas c 701/702 test definition
Assay type 2-Point End
Reaction time / Assay points 10 / 18-30
Wavelength (sub/main) 700/570 nm
Reaction direction Increase
Units µmol/L (µg/dL, mg/L)
Reagent pipetting Diluent (H2O)
R1 100 µL
R3 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (H2O)
Normal 8.5 µL
Decreased 4.0 µL
Increased 17.0 µL

Calibration

CALIBRATION

Traceability: This method has been standardized against a primary reference material (SRM 937).

Calibrators S1: H2OS2: C.f.a.s.
Calibration mode Linear
Calibration frequency 2-point calibration▪after cobas c pack change▪as required following quality control procedures

CALIBRATION MODE

CALIBRATION FREQUENCY

2-POINT CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.90-179 µmol/L (5.00-1000 µg/dL, 0.05-10.0 mg/L)

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 (3 aliquots 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 (3 ALIQUOTS 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 Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).