BIOLABO

www.biolabo.fr MAGNESIUM CALMAGITE

MANUFACTURER:
BIOLABO SAS, High Stability-High Linearity
Les Hautes Rives
02160, Maizy, France
Reagent for quantitative determination of magnesium
in human serum, plasma, urines.

REF 98212 R1 2 x 200 mL R2 1 x 10 mL

TECHNICAL SUPPORT AND ORDERS

Tél : (33) 03 23 25 15 50 | IVD IN VITRO DIAGNOSTIC USE

Fax: (33) 03 23 256 256

CLINICAL SIGNIFICANCE (1) REAGENTS PREPARATION

Adult human body (70 Kg) contains 21 to 28 g of magnesium. Of this, Reagents are ready for use.
about 60% is in bone, 20% in skeletal muscle, 19% in other cells, and
about 1% in the extracellular fluids. About 30% of magnesium in STABILITY AND STORAGE
plasma is associated with proteins (primarily albumin). Consequently, Store away from air and light, well cap in the original vial
a change in the concentration in albumin can affect the concentration at 18-25°C.
in magnesium. ● Standard (vial R2): Transfer the requested quantity, recap and store
Hypomagnesaemia may be a secondary effect in hypocalcemic or at 18-25°C.
calcium-deficient tetany. Conditions that have been associated with ● Reagents are stable until expiry date stated on the label when
hypomagnesemia include chronic alcoholism, childhood malnutrition, stored and used as described in the insert and free from
lactation, malabsorption, acute pancreatitis, hypothyroïdism, chronic contamination.
glomerulonephritis, aldosteronism, digitalis intoxication and prolonged
intravenous feeding. • On the board of analyser: Reagent (vial R1) is stable for 24 hours.
Hypermagnesaemia have been observed in dehydratation, severe ● Discard any cloudy reagent (vial R1) if absorbance measured at
diabetic acidosis, and immediately following myocardial infarction. 530 nm is < 0.300.

PRINCIPLE (1) (4) (5) SPECIMEN COLLECTION AND HANDLING

Gindler, Heth and Khayam-Bashi method. Calmagite, a metallochromic Collect in a metal-free container and without preservatives
indicator (1 -[1-hydroxy-4-methyl-2-phenylazo]-2-naphtol-4-sulfonic Unhemolysed serum or heparinised plasma: Collect on fasting. Avoid
acid), forms in basic buffered medium a coloured complex with the oxalate, citrate or EDTA. Separate red cells immediately.
magnesium. The absorbance, measured at 510-550 nm, is Special procedure is required for cloudy or icteric serum (see next
proportional to the concentration of magnesium in the specimen. page).
EGTA reduces Calcium interference, Potassium cyanide (KCN) Magnesium is stable for several days in serum at 2-8°C.
reduces interference of heavy metals and surfactants reduce the 24h urines (acidified pH 1.0): dilute (1+4) with demineralised water
interference of proteins and lipemia. before assay.

REAGENTS COMPOSITION INTERFERENCES (3)

CALMAGITE REAGENT • Give a special care to the specimen, calibrators and controls
Vial R1
handling, to avoid contamination by the environmental magnesium.
Calmagite> 100 µmol/L KCN 6.14 mmol/L The use of disposable tubes or cuvettes and acid washed labware
AMP > 100 mmol/L EGTA 250 µmol/L (well rinsed with demineralised water) is suggested.
Surfactants • Calcium ( < 7.5 mmol/L) does not interfere with this method.
• Plasma, serum: Icterus, lipemia and paraproteins may interfere with
Vial R2 STANDARD the determination. Hemolysis involves an overestimation because of
the important intracellular contents in magnesium.
Magnesium 2 mg/dL (0.822 mmol/L) For a more comprehensive review of factors affecting this assay refer to
the publication of Young D.S.
SAFETY CAUTIONS
BIOLABO reagents are designated for professional, in vitro diagnostic CALIBRATION (6)
use. • Standards (vial R2 or R5) enclosed in the kit or BIOLABO
● Verify the integrity of the contents before use. Multicalibrator REF 95015 traceable to SRM 909b.
• Use adequate protections (overall, gloves, glasses). • Or any calibrator traceable to a reference method or material.
• Do not pipette by mouth. The calibration frequency depends on proper instrument functions and
• In case of contact with skin or eyes wash affected areas with plenty on preservation of the reagent.
of water and seek medical advice. It is recommended to calibrate in the following cases:
• Material Safety Data Sheet is available upon request. 1. When changing batch of reagent.
• Waste disposal: Respect legislation in force in the country. 2. After maintenance operations on the instrument .
All specimens should be handled as potentially infectious, in 3. When control values obtained are out of range, even after using a
accordance with good laboratory practices using appropriate new vial of fresh serum
precautions. Respect legislation in force in the country.

IVD REF LOT →

Manufacturer Use by In vitro diagnostic Temperature limitation Catalogue number See insert Batch number Store away from light sufficient for dilute with

Made in France Latest revision : www.biolabo.fr Revision : 07/09/2011

MATERIAL REQUIRED BUT NOT PROVIDED MANUAL PROCEDURE
1. Basic medical analysis laboratory equipment. In any case:
2. Normal and pathological control sera. • Let stand reagent and specimens at room temperature
• Maintain a constant temperature as the reaction is temperature
sensitive.
QUALITY CONTROL • Reaction is stable for 60 minutes.
• BIOLABO EXATROL-N Level I REF 95010.
• BIOLABO EXATROL-P Level II REF 95011.
• Assayed control sera referring to the same method.
Pipette into well identified test
• External quality control program. tubes:
Blank Standard Assay
It is recommended to control in the following cases:
• At least once a run. Reagent R1 1 mL 1 mL 1 mL
• At least once within 24 hours. Demineralised water 10 µL
• When changing vial of reagent.
• After maintenance operations on the instrument. Standard R2 (2 mg/dL) 10 µL
If control is out of range, apply following actions:
Specimen (Note 1) 10 µL
1. Repeat the test with the same control.
2. If control is still out of range, prepare a fresh control serum and Mix. Let stands for 5 minutes at constant temperature. Read standard and assays
repeat the test. absorbance at 530 nm (510-550) against reagent blank.
3. If control is still out of range, use a new vial of calibrator or a fresh
calibrator and repeat the test. Notes:
4. If control is still out of range, calibrate with a new vial of reagent. 1. Serum, plasma or urines diluted (1+4) with demineralised water.
5. If control is still out of range, please contact BIOLABO technical 2. Cloudy or icteric specimens: Realise a Specimen blank using saline
support or your local Agent. instead of reagent R1 (see § CALCULATION)
3. Specific procedures are available upon request for automated
instruments. Please contact BIOLABO technical support.
EXPECTED VALUES (2)
Serum or Plasma mg/dL [mmol/L]
CALCULATION
Calculate the result as follows:
Newborn 1.5-2.2 [0.62-0.91]
Serum, plasma:
Child 1.7-2.2 [0.70-0.91] Abs (Assay)
Result = x Standard concentration
Abs (Standard)
Adult 1.6-2.6 [0.66-1.07]
Cloudy or icteric serum:
Urines 73-122 mg/24h [3.00-5.00 mmol/24 h] Abs (Assay) - Abs (Specimen Blank)
Result = x Standard concentration
Each laboratory should establish its own normal ranges for the Abs (Standard)
population that it serves.

Urines diluted (1+4): multiply the result by 5 (dilution factor).

LINEARITY
Reaction is linear up to 6.0 mg/dL (2.47 mmol/L)
Above, dilute the specimen with saline solution and reassay taking into REFERENCES
account dilution factor. Linearity limit depends on specimen/reagent
(1) TIETZ N.W. Text book of clinical chemistry, 3rd Ed. C.A. Burtis, E.R.
ratio. Ashwood, W.B. Saunders (1999) p.1034-1036 et 1408-1410.
(2) Clinical Guide to Laboratory Test, 3rd Ed., N.W. TIETZ (2006) p. 706-711
PERFORMANCES (3) YOUNG D.S., Effect of Drugs on Clinical laboratory Tests, 4th Ed. (1995) p.
3-410 to 3-414
(4) GINDLER E.M., HETH D.A., Clin. Chem. (1971), 17, p.662
(5) H. KHAYAM-BASHI, TSAN Z. LIU, VERN W. Clin. Chem. (1977), 23/2, p.289-291
Within run Low Medium High Beetwen-run Low Medium High
(6) SRM: Standard Reference Material ®
N = 20 level level level N = 40 level level level

Mean 1.28 2.60 4.15 Mean 1.36 2.72 4.23

mg/dL mg/dL
S.D. mg/dL 0.025 0.025 0.017 S.D. mg/dL 0.037 0.081 0.096
C.V. % 1.94 0.97 0.42 C.V. % 2.7 3.0 2.3

Detection limit: approximately 0.23 mg/dL

Sensitivity for 2 mg/dL: approximately 0.130 Abs at 530 nm.
Comparison study with commercially available reagent:
y = 0.9649 x + 0.09124 r =0.9942

Made in France Latest revision : www.biolabo.fr Revision : 07/09/2011