Magnesium XL FS*

Order Information 2. In very rare cases, samples of patients with gammopathy might
Cat. No. Kit size give falsified results [3].
1 4610 99 10 021 6x 25 mL 3. In case of product malfunction or altered appearance that could
1 4610 99 10 026 6x 100 mL affect the performance, contact the manufacturer.
1 4610 99 10 704 8x 50 mL 4. Any serious incident related to the product must be reported to
1 4610 99 10 930 6x 20 mL the manufacturer and the competent authority of the Member
Kits for use in conjunction with DiaSys CE applications. State where the user and/or patient is located.
5. Please refer to the safety data sheets (SDS) and take the
Intended Use necessary precautions for the use of laboratory reagents. For
diagnostic purposes, the results should always be assessed
Diagnostic reagent for quantitative in vitro determination of with the patient’s medical history, clinical examinations and
magnesium in human serum, heparin plasma or urine on automated other findings.
photometric systems. 6. For professional use only.
Summary Waste Management
The essential trace element magnesium is the fourth most common Refer to local legal requirements for chemical disposal regulations
cation in the human body and the second most common intracellular as stated in the relevant SDS to determine the safe disposal.
cation. It is mainly localized in the skeletal system (53%), muscles Warning: Handle waste as potentially biohazardous material.
(27%) and in non-muscular tissue (19%). Only 1% of the total body Dispose of waste according to accepted laboratory instructions and
magnesium stores is located in extracellular fluid [1]. Magnesium is procedures.
a pivotal cofactor in many enzymatic processes. Furthermore, it is
important in processes like oxidative phosphorylation, glycolysis, Reagent Preparation
cell replication, nucleotide metabolism and protein biosynthesis [2].
Deficiency of magnesium is a quite common disorder, which can be The reagent is ready to use.
caused by malnutrition, malabsorption, renal loss and
endocrinological disturbances. Complications associated with Materials Required
decreased magnesium concentrations are neuromuscular irritability General laboratory equipment
(e.g. tremor, seizures) and cardiac symptoms (e.g. tachycardia,
arrhythmia). Decreased magnesium concentrations are often Specimen
related to decreased calcium and potassium levels, taking into Human serum, heparin plasma or urine
account that hypomagnesemia may be the primary cause of
hypocalcemia. Elevated magnesium values can be observed in Only use suitable tubes or collection containers for specimen
dehydration, renal disorders and after intake of excessive amounts collection and preparation.
of antacids. Additionally, enhanced magnesium concentrations can When using primary tubes, follow the manufacturer's instructions.
be associated with weakness of reflexes and low blood pressure
[1,2]. Stability in serum/plasma [4]:
7 days at 20 – 25°C
Method 7 days at 4 – 8°C
1 year at -20°C
Photometric test using xylidyl blue
Magnesium ions form a purple colored complex with xylidyl blue in Stability in urine [4]:
alkaline solution. In presence of GEDTA, which complexes calcium 3 days at 20 – 25°C
ions, the reaction is specific. The intensity of the purple color is 3 days at 4 – 8°C
proportional to the magnesium concentration. 1 year at -20°C
Acidify urine with some drops of conc. HCl to pH 3 – 4, then dilute
Reagents 1+4 with dist. water; multiply the result by 5.
Components and Concentrations
Ethanolamine pH 11.0 750 mmol/L Only freeze once. Discard contaminated specimens.
Glycoletherdiamine-tetraacetic acid (GEDTA) 60 µmol/L
Xylidyl blue 110 µmol/L Assay Procedure
Basic settings for BioMajesty® JCA-BM6010/C
Storage and Stability
Reagent is stable up to the date of expiry indicated on the kit, if Wavelength 545/694 nm
stored at 2 – 8°C and contamination is avoided. Do not freeze. Temperature 37°C
Measurement Endpoint
The open-vial stability of the reagent is 18 months until expiry date. Sample/Calibrator 1.0 µL
Warnings and Precautions Reagent 100 µL
Addition reagent Cycle 19 (286 s)
1. Components contained in Magnesium XL FS are classified Absorbance Cycle 41/42 (586 s/600 s)
according to EC regulation 1272/2008 (CLP) as follows: Calibration Linear
Reagent: Danger. Contains Ethanolamine. H315
Causes skin irritation. H318 Causes serious eye Calculation
damage. P264 Wash hands and face thoroughly after With Calibrator
handling. P280 Wear protective gloves/protective A Sample
clothing/eye protection. P305+P351+P338 IF IN Magnesium [mg/dL] = x Conc. Cal. [mg/dL]
EYES: Rinse cautiously with water for several A Cal.
minutes. Remove contact lenses, if present and easy Conversion Factor
to do. Continue rinsing. P310 Immediately call a Magnesium [mg/dL] x 0.4114 = Magnesium [mmol/L]
POISON CENTER/doctor. Magnesium in Urine [mg/24 h] x 0.0411 = Magnesium [mmol/24 h]

Magnesium XL FS – Page 1 844 4610 10 02 42 April 2024/1

Calibrators and Controls Urine
DiaSys TruCal U is recommended for calibration. Calibrator values
have been made traceable to the reference method Atomic Precision
Absorption Spectrometry (AAS). Magnesium Standard FS may be Repeatability (n=20) Sample 1 Sample 2 Sample 3
used alternatively for calibration. Use TruLab N and TruLab P or Mean [mg/dL] 2.93 6.19 10.0
TruLab Urine Level 1 and Level 2 for internal quality control. Quality
control must be performed after calibration. Control intervals and CV [%] 1.16 1.31 0.516
limits have to be adapted to the individual requirements of each Between day (n=20) Sample 1 Sample 2 Sample 3
laboratory. Results must be within the defined ranges. Follow the Mean [mg/dL] 2.95 6.13 10.1
relevant legal requirements and guidelines. Each laboratory should
establish corrective action in case of deviations in control recovery. CV [%] 1.44 0.971 1.16

Cat. No. Kit size Method comparison (n=40)

TruCal U 5 9100 99 10 063 20 x 3 mL Test x Competitor Magnesium
5 9100 99 10 064 6 x 3 mL (BioMajesty® JCA-BM6010/C)
TruLab N 5 9000 99 10 062 20 x 5 mL
5 9000 99 10 061 6 x 5 mL Test y DiaSys Magnesium XL FS
TruLab P 5 9050 99 10 062 20 x 5 mL (BioMajesty® JCA-BM6010/C)
5 9050 99 10 061 6 x 5 mL Slope 0.982
TruLab Urine Level 1 5 9170 99 10 062 20 x 5 mL Intercept -0.053 mg/dL
5 9170 99 10 061 6 x 5 mL
TruLab Urine Level 2 5 9180 99 10 062 20 x 5 mL Coefficient of correlation 0.999
5 9180 99 10 061 6 x 5 mL ** lowest measurable concentration which can be distinguished from zero;
Magnesium 1 4600 99 10 030 6 x 3 mL mean + 3 SD (n = 20) of an analyte free specimen.
Standard FS
Reference Range
Performance Characteristics Serum/Plasma [1]:
Data evaluated on BioMajesty® JCA-BM6010/C Neonates 1.2 – 2.6 mg/dL 0.48 – 1.05 mmol/L
Children 1.5 – 2.3 mg/dL 0.60 – 0.95 mmol/L
Serum/Plasma Women 1.9 – 2.5 mg/dL 0.77 – 1.03 mmol/L
Men 1.8 – 2.6 mg/dL 0.73 – 1.06 mmol/L
Measuring range up to 5 mg/dL, linearity is given within ± 5%.
When values exceed this range, samples should be diluted Urine [8]: 73 – 122 mg/24 h 3 – 5 mmol/24 h
1 + 4 with NaCl solution (9 g/L) and the result multiplied by 5. Each laboratory should check if the reference ranges are
Limit of detection** 0.03 mg/dL transferable to its own patient population and determine own
reference ranges if necessary.
Interference by Interferences Analyte
≤ 10% up to concentration Literature
[mg/dL]
1. Thomas L. Clinical Laboratory Diagnostics [Internet]. Prof.
Ascorbic acid 30 mg/dL 2.08 Lothar Thomas; 2023 [cited 2024 03 05]. Available from:
Bilirubin (conjugated) 60 mg/dL 2.08 https:// www.clinical-laboratory-diagnostics.com
2. Endres DB, Rude RK. Mineral and bone metabolism. In: Burtis
Bilirubin (unconjugated) 60 mg/dL 2.07
CA, Ashwood ER, editors. Tietz Textbook of Clinical
Calcium 25 mg/dL 2.07 Chemistry. 3rd ed. Philadelphia: W.B Saunders Company;
Lipemia (triglycerides) 2000 mg/dL 2.15 1999. p. 1395-1457.
3. Bakker AJ, Mücke M. Gammopathy interference in clinical
Hemolysis interferes because magnesium is released by
chemistry assays: Mechanisms, detection and prevention. Clin
erythrocytes [1].
Chem Lab Med 2007; 45(9): 1240-1243.
For further information on interfering substances, refer to the literature 4. W.G. Guder, F. da Fonseca-Wollheim,W. Heil, et al. Quality of
[5-7]. Diagnostic Samples. German Society for Clinical Chemistry
Precision and Laboratory Medicine. 3rd completely revised edition 2010.
5. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th
Repeatability (n=20) Sample 1 Sample 2 Sample 3
ed. Volume 1 and 2. Washington, DC: The American
Mean [mg/dL] 1.46 2.95 4.28 Association for Clinical Chemistry Press 2000.
CV [%] 1.31 0.797 0.979 6. Young DS. Effects on Clinical Laboratory Tests - Drugs
Disease, Herbs & Natural Products, https://clinfx.wiley.com/
Between day (n=20) Sample 1 Sample 2 Sample 3
aaccweb/aacc/, accessed in March 2024. Published by AACC
Mean [mg/dL] 2.20 4.12 4.59 Press and John Wiley and Sons, Inc.
CV [%] 1.32 0.998 0.992 7. Sonntag O, Scholer A. Drug interference in clinical chemistry:
recommendation of drugs and their concentrations to be used
Method comparison (n=95) in drug interference studies. Ann Clin Biochem. 2001
Test x Competitor Magnesium Jul;38:376-85.
(BioMajesty® JCA-BM6010/C) 8. Sitzmann FC. Normalwerte. München: Hans Marseille Verlag
GmbH: 1986. p. 166.
Test y DiaSys Magnesium XL FS
(BioMajesty® JCA-BM6010/C) Additions and/or changes in the document are highlighted in grey.
Slope 0.942 Deletions are communicated via customer info by stating the edition
no. of the package insert/instruction for use.
Intercept 0.141 mg/dL
DiaSys Diagnostic Systems GmbH
Coefficient of correlation 0.992 Alte Strasse 9 65558 Holzheim
Germany
www.diasys-diagnostics.com

* Fluid Stable

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