Magnesium XL FS*

Diagnostic reagent for quantitative in vitro determination of magnesium in serum, plasma or urine on
BioMajesty JCA-BM6010/C

Order Information Calibrators and Controls

For calibration, DiaSys TruCal U calibrator is recommended. For
Cat. No. 1 4610 99 10 961 internal quality control DiaSys TruLab N and P or TruLab Urine
6 x 160 tests controls should be assayed. The assigned values of the calibrator
have been made traceable to the reference method Atomic
Method Absorption Spectrometry (AAS). Each laboratory should establish
Photometric test using xylidyl blue corrective action in case of deviations in control recovery.
Principle Kit size
Magnesium ions form a purple colored complex with xylidyl blue in TruCal U 5 9100 99 10 063 20 x 3 mL
alkaline solution. In presence of GEDTA, which complexes calcium 5 9100 99 10 064 6 x 3 mL
ions, the reaction is specific. The intensity of the purple color is TruLab N 5 9000 99 10 062 20 x 5 mL
proportional to the magnesium concentration. 5 9000 99 10 061 6 x 5 mL
TruLab P 5 9050 99 10 062 20 x 5 mL
Reagents 5 9050 99 10 061 6 x 5 mL
TruLab Urine Level 1 5 9170 99 10 062 20 x 5 mL
Components and Concentrations 5 9170 99 10 061 6 x 5 mL
Ethanolamine pH 11.0 750 mmol/L TruLab Urine Level 2 5 9180 99 10 062 20 x 5 mL
GEDTA (Glycoletherdiamine tetraacetic acid) 60 µmol/L 5 9180 99 10 061 6 x 5 mL
Xylidyl blue 110 µmol/L
Storage Instructions and Reagent Stability
Performance Characteristics
Measuring range up to 5 mg/dL (2 mmol/L) magnesium (in case of higher
The reagent is stable up to the end of the indicated month of concentrations re-measure samples after manual dilution with NaCl
expiry, if stored at 2 – 8 °C and contamination is avoided. Do not solution (9 g/L) or use rerun function).
freeze the reagent! Limit of detection** 0.03 mg/dL (0.012 mmol/L)
Warnings and Precautions magnesium
On-board stability 4 weeks
1. Reagent: Danger. H315 Causes skin irritation. H318 Causes Calibration stability 12 days
serious eye damage. P264 Wash hands and face thoroughly
after handling. P280 Wear protective gloves / protective Interferences < 10% by
clothing / eye protection. P305+P351+P338 If in eyes: Rinse Ascorbate up to 30 mg/dL
cautiously with water for several minutes. Remove contact ilirubin (conjugated and unconjugated) up to 60 mg/dL
lenses, if present and easy to do. Continue rinsing. P310 Calcium up to 25 mg/dL
Immediately call a poison center or doctor/physician. Lipemia (triglycerides) up to 2000 mg/dL
2. In very rare cases, samples of patients with gammopathy Hemolysis interferes because magnesium is released by erythrocytes
might give falsified results [8]. [2]
3. Please refer to the safety data sheets and take the necessary For further information on interfering substances refer to Young DS [7].
precautions for the use of laboratory reagents. For diagnostic
Precision (Serum)
purposes, the results should always be assessed with the
patient’s medical history, clinical examinations and other Within run (n=20) Sample 1 Sample 2 Sample 3
findings. Mean [mg/dL] 1.46 2.95 4.28
4. For professional use only! Mean [mmol/L] 0.60 1.21 1.76
Coefficient of variance [%] 1.31 0.80 0.98
Waste Management
Between run (n=20) Sample 1 Sample 2 Sample 3
Please refer to local legal requirements. Mean [mg/dL] 2.20 4.12 4.59
Reagent Preparation Mean [mmol/L] 0.90 1.69 1.89
Coefficient of variance [%] 1.32 1.00 0.99
The reagent is ready to use. The bottles are placed directly into the
reagent trays. Method comparison (Serum; n=95)
Test x Competitor Magnesium
Specimen Test y DiaSys Magnesium XL FS
Serum, plasma or urine (do not use EDTA plasma!) Slope 0.942
Stability [1]: Intercept 0.058 mmol/L (0.141 mg/dL)
in serum/plasma 7 days at 20 – 25°C Coefficient of correlation r = 0.992
7 days at 4 – 8°C
Precision (Urine)
1 year at –20°C Within run (n=20) Sample 1 Sample 2 Sample 3
In urine: 3 days at 20 – 25°C Mean [mg/dL] 2.93 6.19 10.0
3 days at 4 – 8°C Mean [mmol/L] 1.20 2.55 4.13
1 year at –20°C Coefficient of variance [%] 1.16 1.31 0.52

Acidify urine with some drops of conc. HCl to pH 3 – 4. Dilution Between run (n=20) Sample 1 Sample 2 Sample 3
1 + 4 with water is automatically done by the instrument. Mean [mg/dL] 2.95 6.13 10.1
Mean [mmol/L] 1.21 2.52 4.17
Freeze only once. Coefficient of variance [%] 1.44 0.97 1.16
Discard contaminated specimens.
Method comparison (Urine; n=40)
Test x Competitor Magnesium
Test y DiaSys Magnesium XL FS
Slope 0.982
Intercept –0.053 mg/dL (–0.0217 mmol/L)
Coefficient of correlation 0.9996
** lowest measurable concentration which can be distinguished from zero
mean + 3 SD (n=20) of an analyte free specimen

Reagent information * fluid stable

Conversion factor Literature
Magnesium [mg/dL] x 0.4114 = Magnesium [mmol/L] 1. Guder WG, Zatwa B et al. The quality of Diagnostic Samples.
Magnesium in Urine [mg/24 h] x 0.0411 = Magnesium [mmol/24 h] 1st ed. Darmstadt: Git Verlag, 2001: 38-39, 50-51.
2. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt:
Reference Range [2,3] TH-Books Verlagsgesellschaft; 1998. p. 339-40.
Serum/Plasma: 3. Sitzmann FC. Normalwerte. München: Hans Marseille Verlag
Neonates 1.2 – 2.6 mg/dL (0.48 – 1.05 mmol/L) GmbH: 1986. p. 166.
Children 1.5 – 2.3 mg/dL (0.60 – 0.95 mmol/L) 4. Endres DB, Rude RK. Mineral and bone metabolism. In:
Women 1.9 – 2.5 mg/dL (0.77 – 1.03 mmol/L) Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical
Men 1.8 – 2.6 mg/dL (0.73 – 1.06 mmol/L) Chemistry. 3rd ed. Philadelphia: W.B Saunders Company;
Urine: 73 – 122 mg/24 h (3 – 5 mmol/24 h) 1999. p. 1395-1457.
5. Mann CK, Yoe JH. Spectrophotometric determination of
Each laboratory should check if the reference ranges are magnesium with 1-Azo-2-hydroxy-3-(2.4-
transferable to its own patient population and determine own dimethylcarboxanilido)-naphthalene-1’-(2-hydroxybenzene).
reference ranges if necessary. Anal Chim Acta 1957; 16 : 155-60.
6. Bohoun C. Microdosage du magnesium dans divers milieux
biologiques. Clin Chim Acta 1962; 7: 811-7.
7. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th
ed. Volume 1 and 2. W ashington, DC: The American
Association for Clinical Chemistry Press 2000.
8. Bakker AJ, Mücke M. Gammopathy interference in clinical
chemistry assays: Mechanisms, detection and prevention.
Clin Chem Lab Med 2007; 45(9): 1240–1243.

Manufacturer
DiaSys Diagnostic Systems GmbH
IVD
Alte Strasse 9 65558 Holzheim Germany

Reagent information
Magnesium XL FS
Chemistry code 10 461

Application for serum, plasma, CSF, urine samples

This application was set up and evaluated by DiaSys. It is based on the standard equipment at that time and
does not apply to any equipment modifications undertaken by unqualified personnel.

Analytical Conditions Endpoint method

R1 volume 100 Re.absorb (u) 9.999
R2e volume 0 Re. Absorb (d) -9.999
R2 volume 0
R1 diluent vol 0 Calculation Method Setting
R2e diluent vol 0 M-DET.P.I 0
R2 diluent vol 0 M-DET.P.m 41
Sample vol (S) 1 M-DET.P.n 42
Sample vol (U) 1 S-DET.P.p 0
Reagent 1 mix weak S-DET.P.r 0
Reagent 2e mix weak Check D.P.I. 0
Reagent 2 mix weak Limit value 0.003
Reaction time 10 Variance 10
Reac.type Inc
Sub-analy. Conditions
Name MG Reaction Rate Method
Digits 2 Cycle 2
M-wave L. 545 Factor 2
S-wave.L 694 E2 corre Not do
Analy.mthd. EPA Blank (u) 9.999
Calc.mthd. STD Blank (d) -9.999
Qualit. judge No Sample (u) 9.999
Sample (d) -9.999
Analysis Test Condition Setting (M)
Sample Type Serum Urine Standards Setting
Reac. sample vol. 1 1 FV #
Diluent method No dil With dil BLK H 9.999
Undil. sample vol. 0 10 BLK L -9.999
Diluent volume 0 40 STD H 9.999
Diluent position 0 0 STD L -9.999
# entered by user

Application BioMajesty JCA-BM6010/C September 2018/7