Magnesium Gen.2

Catalog Number: 06481647190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

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

MG
Shelf life at 15-25 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 12 weeks
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: 12 weeks

APPLICATION FOR SERUM AND PLASMA

cobas c 311 test definition
Assay type 2-Point End
Reaction time / Assay points 10 / 6-17 (STAT 4 / 6-17)
Wavelength (sub/main) 505/600 nm
Reaction direction Decrease
Units mmol/L (mg/dL, mval/L)
Reagent pipetting Diluent (H2O)
R1 97 µL
R2 97 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 3 µL
Decreased 9 µL 20 µL 100 µL
Increased 3 µL

 

CALIBRATION

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

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

CALIBRATION MODE

CALIBRATION FREQUENCY

2-POINT CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

Serum/plasma

LOWER LIMITS OF MEASUREMENT

Limit of Blank (LoB) and Limit of Detection (LoD)

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 accordance with the CLSI (Clinical and Laboratory Standards Institue) EP5 requirements with repeatability and intermediate precision (2 aliquots per run, 2 runs per day, 21 days).

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

METHOD COMPARISON

Magnesium values for human serum/plasma and urine samples obtained on a Roche/Hitachi cobas c 501 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,