Magnesium Gen.2

Catalog Numbers: 05171911190, 06407358190

SYSTEM INFORMATION

INTENDED USE

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

STORAGE AND STABILITY

MG2
Shelf life at 15‑25 °C: See expiration date on cobas c pack label.
On‑board in use and refrigerated on the analyzer: 10 days
On‑board on the Reagent Manager 24 hours
Diluent NaCl 9 %
Shelf life at 2‑8 °C: See expiration date on cobas c pack label.
On‑board in use and refrigerated on the analyzer: 4 weeks
On‑board on the Reagent Manager 24 hours

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 / 18‑27(STAT 4 / 6‑15)
Wavelength (sub/main) 505/600 nm
Reaction direction Decrease
Units mmol/L (mg/dL, mval/L)
Reagent pipetting Diluent (H2O)
R1 97 µL
R3 (STAT R2) 97 µL
Sample volumes Sample Sample dilution
Sample Diluent (H2O)
Normal 3 µL
Decreased 1.5 µL
Increased 6 µL

Application for urine

CALIBRATION

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

 Calibrators S1: H2OS2: C.f.a.s.
Calibration mode Linear
Calibration frequency 2‑point calibration- after 2 days on board- after reagent lot change- as required following quality control procedures

CALIBRATION MODE

CALIBRATION FREQUENCY

2‑POINT CALIBRATION

CALIBRATION INTERVAL MAY BE EXTENDED BASED ON ACCEPTABLE VERIFICATION OF CALIBRATION BY THE LABORATORY.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

Serum/plasma

LOWER LIMITS OF MEASUREMENT

Limit of Blank and Limit of Detection

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, 10 days).

RESULTS FOR INTERMEDIATE PRECISION IN URINE WERE OBTAINED ON THE ROCHE/HITACHI MODULAR P SYSTEM.

METHOD COMPARISON

Magnesium values for human serum/plasma and urine samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 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, PART III. J CLIN CHEM CLIN BIOCHEM 1988 NOV;26(11):783-790.