Magnesium

Catalog Number: 20737593322

SYSTEM INFORMATION

Test MG, test ID 0-059; test MGU, test ID 0-159

INTENDED USE

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

STORAGE AND STABILITY

Shelf life at 15-25 °C See expiration date on cobas c pack label
COBAS INTEGRA 400 plus system
On-board in use at 10-15 °C 8 weeks
COBAS INTEGRA 800 system
On-board in use at 8 °C 12 weeks

Specimen collection and preparation

COBAS INTEGRA 400 PLUS TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction direction Decrease
Wavelength A 652 nm
Calc. first/last 33/40
Unit mmol/L
Serum, plasma
Reaction mode R1-S-SR
Urine
Reaction mode D-R1-S-SR
Predilution factor 5

Pipetting parameters

PIPETTING PARAMETERS

Serum, plasma, and urine Diluent (H2O)
R1 165 µL
Sample 2 µL 50 µL
SR 28 µL
Total volume 245 µL

Serum, plasma, and urine Diluent (H2O)
R1 165 µL
Sample 2 µL 50 µL
SR 28 µL
Total volume 245 µL

Calibration

COBAS INTEGRA 800 TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction direction Decrease
Wavelength A 659 nm
Calc. first/last 43/49
Unit mmol/L
Serum, plasma
Reaction mode R1-S-SR
Urine
Reaction mode D-R1-S-SR
Predilution factor 5

Pipetting parameters

PIPETTING PARAMETERS

Serum, plasma, and urine Diluent (H2O)
R1 165 µL
Sample 2 µL 50 µL
SR 28 µL
Total volume 245 µL

Calibration

CALIBRATION

Traceability: This method has been standardized against atomic absorption spectrometry.

Calibrator Calibrator f.a.s.Use deionized water as zero calibrator.
Calibration mode Linear regression
Calibration replicate Duplicate recommended
Calibration interval Each lot and as required following quality control procedures.

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

Serum/plasma

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test:

SPECIFIC PERFORMANCE DATA

Representative performance data on the COBAS INTEGRA 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 and intermediate precision (2 aliquots per run, 2 runs per day, 20 days). The following results were obtained:

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY AND INTERMEDIATE PRECISION (2 ALIQUOTS PER RUN, 2 RUNS PER DAY, 20 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

CV INTERMEDIATE PRECISION

CV INTERMEDIATE PRECISION

METHOD COMPARISON

Magnesium values for human samples obtained on a COBAS INTEGRA 700 analyzer with the COBAS INTEGRA Magnesium reagent (y) were compared with those determined using reagents for magnesium on a COBAS MIRA analyzer (x) and a commercially available alternative clinical chemistry system (x). Samples were measured in duplicate. Sample size (n) represents all replicates.