2797

AU/DxC AU MG
Instructions For Use Magnesium
© 2022 Beckman Coulter, Inc. All rights reserved.
OSR6189 4 x 40 mL R1

For in vitro diagnostic use only.

PRINCIPLE
INTENDED PURPOSE

Magnesium reagent is an in vitro diagnostic medical device intended to be used by healthcare professionals for the
quantitative photometric colour measurement of magnesium in human serum, plasma and urine using the automated
Beckman Coulter AU/DxC AU analyzers.
Measurement of magnesium is intended to be used as an aid in the diagnosis and treatment of hypomagnesemia
(abnormally low) and hypermagnesemia (abnormally high).

SUMMARY AND EXPLANATION

Reference1,2
Magnesium is an essential factor in many important enzymatic reactions, either as an integral part of a metalloenzyme
or as an activator, and plays an important role in glycolysis, cellular respiration and transmembranous calcium transport.
Magnesium is mainly regulated by the rate of renal magnesium excretion, which along with calcium is subject to the
effects of parathyroid hormone. Increasing calcium reabsorption thus leads to competitive inhibition of magnesium
absorption.
Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low) and
hypermagnesemia (abnormally high). The best-defined manifestation of magnesium deficiency is impairment of
neuromuscular function e.g. hyperirritability, tetany, convulsions, and electrocardiographic changes. Hypomagnesemia
is observed in cases of diabetes, chronic alcoholism, forced diuresis, hyperthyroidism, hypoparathyroidism,
hypocalcemia, malabsorption and acute pancreatitis. Increased serum magnesium levels have been found in cases of
renal failure, dehydration, severe diabetic acidosis and Addison’s Disease.

METHODOLOGY

Reference3,4,5
The Magnesium reagent utilises a direct method in which magnesium ions form a coloured complex with xylidyl blue
in a strongly basic solution. The colour produced is measured bichromatically at 520/800 nm and is proportional to the
magnesium concentration in the sample. Calcium interference is eliminated by glycoletherdiamine-N,N,N`,N`-tetraacetic
acid (GEDTA).

CHEMICAL REACTION SCHEME

pH 11.4
Mg2+ + Xylidyl blue Purple complex

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SPECIMEN
TYPE OF SPECIMEN

Serum, Na/Li-heparinized plasma or Urine 6 Do not use EDTA, oxalate or citrate plasma.
Separate serum from red blood cells immediately.
Haemolysed samples should be avoided due to the higher magnesium concentration in erythrocytes.

SPECIMEN STORAGE AND STABILITY

Magnesium in serum is stable for 7 days when stored at 20°C.1

Urine:7 Acidified with 6M HCL. Collect timed 24 hour specimen using standard laboratory procedures.
Store at 2…8°C.
Specimen storage and stability information provides guidance to the laboratory. Based on specific needs, each laboratory
may establish alternative storage and stability information according to good laboratory practice or from alternative
reference documentation.

REAGENTS
WARNING AND PRECAUTIONS

Exercise the normal precautions required for handling all laboratory reagents.
Dispose of all waste material in accordance with local guidelines.
This product contains material of animal origin. The product should be considered as potentially capable of transmitting
infectious diseases.

ACTIVE INGREDIENTS

Final concentration of active ingredients:

∈-Amino-n Caproic Acid 450 mmol/L

Tris 100 mmol/L
Glycoletherdiamine-N,N,N’,N’ tetraacetic acid 0.12 mmol/L
Xylidyl blue 0.18 mmol/L
Preservative
The concentrations of the components of the reagents shown on the kit label are the actual concentrations in the
individual R1/R2 vials. The reagent composition which is shown in the Instructions For Use is the final concentration of
these components in the reaction cuvette after addition of R1, Sample, and R2.

CAUTION
Sodium azide preservative may form explosive compounds in metal drain lines.
See NIOSH Bulletin: Explosive Azide Hazard (8/16/76).
To avoid the possible build-up of azide compounds, flush wastepipes with
water after the disposal of undiluted reagent. Sodium azide disposal must be in
accordance with appropriate local regulations.

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GHS HAZARD CLASSIFICATION

Magnesium DANGER

H316 Causes mild skin irritation.

H360 May damage fertility or the unborn child.
P201 Obtain special instructions before use.
P280 Wear protective gloves, protective clothing
and eye/face protection.
P308+P313 IF exposed or concerned: Get medical
advice/attention.
P332+P313 If skin irritation occurs: Get medical
advice/attention.
N,N-Dimethylformamide 0.1 - 0.2%
Tris(hydroxymethyl)– aminomethane 1 - 5%
Aminocaproic Acid 5 - 8%

Safety Data Sheet is available at beckmancoulter.com/techdocs

REAGENT PREPARATION

The reagent is ready for use and can be placed directly on board the instrument.

REAGENT STORAGE AND STABILITY

Closed vial shelf life per stability study: 24 months.

The reagents are stable, unopened, up to the stated expiry date when stored at 2…8°C.
Opened bottles of reagent are stable for 14 days when stored in the refrigerated compartment of the analyzer.

INDICATIONS OF DETERIORATION

Visible signs of microbial growth, gross turbidity, precipitate, or change in color may indicate degradation and warrant
discontinuance of use.

CALIBRATION
CALIBRATOR REQUIRED

Use System Calibrator Cat. No. 66300 for serum and plasma application and Urine Calibrator Cat. No. B64606 for
urine application.
The reagent blank and calibration curves should be visually reviewed for acceptability. Instructions on how to perform
the review are provided in the relevant AU/DxC AU analyzer IFU and Reference Manual. Quality control procedures
should be undertaken immediately following calibration in accordance with good laboratory practice.

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Recalibrate the assay every 7 days or when the following occur:
Change in reagent lot or significant shift in control values;
Major preventative maintenance was performed on the analyzer or a critical part was replaced.

TRACEABILITY

The magnesium values of System Calibrator Cat. No. 66300 are traceable to the National Institute of Standards
and Technology (NIST) Standard Reference Material (SRM) 909b Level 2. The magnesium values of the calibrator
Urine Calibrator Cat. No. B64606 are traceable to the National Institute of Standards and Technology (NIST) Standard
Reference Material (SRM) 929a.

QUALITY CONTROL
Controls Cat. No. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter
system may be used for the serum/plasma application.
Control materials with values determined by this Beckman Coulter system may be used for the urine application.
Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be
tested each day patient samples are tested and each time calibration/blanking is performed.
The results obtained by any individual laboratory may vary from the given mean value. It is therefore recommended that
each laboratory generates analyte specific control target values and intervals based on multiple runs according to their
requirements. These target values should fall within the corresponding acceptable ranges given in the relevant product
literature.
If any trends or sudden shifts in values are detected, review all operating parameters.
Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified
limits.

TESTING PROCEDURE(S)
Refer to the appropriate Beckman Coulter AU/DxC AU analyzer Instructions For Use (IFU) for analyzer-specific assay
instructions for the sample type as listed in the Intended Purpose statement.

CALCULATIONS
The Beckman Coulter analysers automatically compute the magnesium concentration of each sample.

REPORTING RESULTS
REFERENCE INTERVALS

Reference1
Serum Men 0.73 - 1.06 mmol/L 1.8 - 2.6 mg/dL
Serum Women 0.77 - 1.03 mmol/L 1.9 - 2.5 mg/dL
Urine Adults 3 - 5 mmol/24 h 73 - 122 mg/24h
Expected values may vary with age, sex, sample type, diet and geographical location. Each laboratory should verify
the transferability of the expected values to its own population, and if necessary determine its own reference interval
according to good laboratory practice. For diagnostic purposes, results should always be assessed in conjunction with
the patient's medical history, clinical examinations and other findings.

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PROCEDURAL NOTES
INTERFERENCES

Results of serum studies conducted to evaluate the susceptibility of the method to interference were as follows:

Icterus: Interference less than 10% or 0.12 mmol/L up to 28 mg/dL or 479 μmol/L bilirubin
Calcium: Interference less than 3% or 0.12 mmol/L up to 30 mg/dL or 7.5 mmol/L calcium
Haemolysis: Interference less than 10% or 0.12 mmol/L up to 1.5 g/L haemoglobin
Lipemia: Interference less than 10% or 0.12 mmol/L up to 500 mg/dL Intralipid
Results of urine studies conducted to evaluate the susceptibility of the method to interference were as follows:

Calcium: Interference less than 10% up to 40 mg/dL or 10 mmol/L calcium

Eltrombopag and its metabolites may interfere with this assay causing erroneously high patient results.
Further information on interfering substances is available.8

PERFORMANCE CHARACTERISTICS
PERFORMANCE CHARACTERISTICS

Data contained within this section is representative of performance on Beckman Coulter systems. Data obtained in your
laboratory may differ from these values.

ANALYTICAL MEASURING RANGE/LINEARITY

mmol/L mg/dL
Serum and Plasma 0.2 - 3.3 0.5 - 8.0
Urine (AU480/AU680) 0.2 - 9.25 0.5 - 22.5
Urine (AU5800/DxC 700 AU) 0.2 - 7.8 0.5 - 18.9

SENSITIVITY

Correctly operating AU/DxC AU Systems should exhibit the following sensitivity values:

Lowest Detectable Level (LDL) ≤0.2 mmol/L (≤ 0.5 mg/dL)

The lowest detectable level in serum on a DxC 700 AU analyzer was estimated at 0.012mmol/L.
The lowest detectable level in urine on a DxC 700 AU analyzer was estimated at 0.015 mmol/L.
The lowest detectable level represents the lowest measurable level of magnesium that can be distinguished from zero.
It is calculated as the absolute mean plus three standard deviations of 20 replicates of an analyte free sample.

METHODS COMPARISON

Patient serum samples were evaluated in method comparison studies.

Results of Deming regression analysis were as follows:

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AU5800 versus AU2700

Regression
Equation r n Range
y=1.018x-0.0125 0.988 114 0.215 - 2.971 mmol/L
Patient Urine samples were evaluated in method comparison studies.
Results of Deming regression analysis were as follows:

DxC 700 AU versus AU680

Regression
Equation r n Range
Y=0.983x+0.031 0.999 103 0.4 - 7.8 mmol/L

PRECISION

Correctly operating AU/DxC AU systems should exhibit the following precision values:

Serum/Plasma Urine
TYPE OF
IMPRECISION % CV SD % CV
Repeatability ≤3 ≤0.06 mmol/L @ ≤3
(Within-run) ≤0.62 mmol/L Mg
Within Laboratory ≤5 N/A ≤5
(Total)
Estimates of precision, based on CLSI recommendations9 are consistent with typical performance.

AU5800

n = 80 Repeatability (Within-run) Within Laboratory (Total)

Mean mmol/L SD CV% SD CV%
0.921 0.012 1.3 0.023 2.5
1.087 0.013 1.2 0.026 2.4
3.095 0.038 1.2 0.085 2.8
The following data was obtained on a representative analyzer using 3 urine pools analysed over 20 days.

AU5800

n = 80 Repeatability (Within-run) Within Laboratory (Total)

Mean mmol/L SD CV% SD CV%
0.83 0.008 0.9 0.015 1.9
4.06 0.071 1.8 0.175 4.3
7.09 0.038 0.5 0.100 1.4

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ADDITIONAL INFORMATION
DxC 700 AU analyzers require that each reagent application has a standard format of abbreviated Test Name. This Test
Name is required to allow automated loading of the calibrator information for each application. Refer to the table below
for the Test Name assigned to each application for this assay.

Test Name Description

MG-1N Magnesium (Serum)
MG-1N Magnesium (Urine)

Setting Sheet Footnotes

# User defined
Serum: † System Calibrator Cat. No.: 66300.
Urine: † Urine Calibrator Cat. No: B64606. Ensure relevant value sheet is used.
* Values set for working in SI units (mmol/L). To work in mg/dL multiply by 2.43.

Notice to User
Any serious incident that has occurred in relation to this device should be reported to Beckman Coulter and the competent
authority of the Member State in which the user and/or patient is established.
Refer to the Beckman Coulter Chemistry Systems Reagent Guide (BLGUIDE) for specific chemistry information for the
AU/DxC AU clinical chemistry systems and guidance on symbols used on all AU/DxC AU product labelling.

REVISION HISTORY

Updated based on IVDR 2017/746 requirements.

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REFERENCES
1. Dörner K. Magnesium (Mg). In: Thomas L, ed. Clinical laboratory diagnostics. Use and assessment of clinical
laboratory results. Frankfurt/Main: TH-Books Verlagsgesellschaft mbH, 1998:339-340.

2. Jacob RA. Trace Elements. In: Tietz NW, ed. Fundamentals of clinical chemistry. Philadelphia:WB Saunders
Company, 1987:521-524.

3. Mann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium

1-Azo-2-hydroxy-3-(2,4-dimethylcarboxanilido) naphthalene-1'- (2-hydroxybenzene-5-sulfonate). Anal Chem
1956;28:202-205.

4. Mann CK, Yoe JH. Spectrophotometric determination of magnesium with

1-Azo-2-hydroxy-3-(2,4-dimethylcarboxanilido) naphthalene-1'-(2-hydroxybenzene). Anal
Chim Acta 1957;16:155-160.

5. Bohuon C. Microdosage du magnésium dans divers milieux biologiques. Clin Chim Acta 1962;7:811-817.

6. Kazmierczak SC. Magnesium. In: Kaplan LA, Pesce AJ, eds. Clinical chemistry theory, analysis, and correlation.
St Louis: Mosby, 1996:551pp.

7. NCCLS. Urinalysis and collection, transportation, and preservation of urine specimens; approved guideline.
NCCLS Document GP16-A2, 2nd ed. Pennsylvania: NCCLS, 2001.

8. AACC Effects on Clinical Laboratory Tests: Drugs, Disease, Herbs and Natural Products
https://clinfx.wiley.com/aaccweb/aacc/

9. Clinical and Laboratory Standards Institute. Evaluation of Precision of Quantitative Measurement Procedures;
Approved Guideline - Third Edition. CLSI document EP05-A3, Wayne PA 2014.

Beckman Coulter Ireland Inc., Lismeehan, O’Callaghan’s Mills, Co. Clare, Ireland +(353) (0) 65 683 1100

Beckman Coulter, Inc., 250 S. Kraemer Blvd., Brea, CA 92821 U.S.A.

+(1) 800-854-3633
www.beckmancoulter.com

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