Cat.

No 4-229

PRESTIGE 24i LQ MG

DIAGNOSTIC KIT REFERENCE VALUES 6

FOR DETERMINATION OF serum / plasma mg/dl mmol/l

MAGNESIUM CONCENTRATION newborn 2–4d 1.5 – 2.2 0.62 – 0.91

children 5 mo – 6 y 1.7 – 2.3 0.70 – 0.95
INTRODUCTION 6 – 12 y 1.7 – 2.1 0.70 – 0.86
Magnesium in human organism occurs mainly in bone (about 50%) but is 12 – 20 y 1.7 – 2.2 0.70 – 0.91
present also intracellularly in other tissues. Magnesium serves as a cofactor
adults 1.6 – 2.6 0.66 – 1.07
for multiple enzymatic reactions involved in nucleic acids synthesis, transport
and production of energy. Magnesium is important in neuromuscular 24-hours urine: mg/24h mmol/24h
conduction and activation. Reduced magnesium level generates: concentration 72.9 – 145.8 3–5
disturbances, fatigue, muscle tremor, anxiety state. It is recommended for each laboratory to establish its own reference ranges
for local population.
METHOD PRINCIPLE
Magnesium forms a purple coloured complex in alkaline solution. In the QUALITY CONTROL
presence of EGTA, the reaction is specific. The intensity of the purple colour For internal quality control it is recommended to use the CORMAY SERUM
is proportional to the magnesium concentration. HN (Cat. No 5-172) and CORMAY SERUM HP (Cat. No 5-173) for
determination in serum or CORMAY URINE CONTROL LEVEL 1
REAGENTS (Cat. No 5-161) and LEVEL 2 (Cat. No 5-162) for determination in urine with
Package each batch of samples.
Cat. No 4-229 For the calibration of automatic analysers systems the CORMAY
(24-TRAY) MULTICALIBRATOR LEVEL 1 (Cat. No 5-174; 5-176) and LEVEL 2
1-Reagent 4 x 60 ml (Cat. No 5-175; 5-177) is recommended.
The calibration curve should be prepared every week (Prestige 24i, Biolis 24i
The reagent is stable up to the kit expiry date printed on the package when Premium), with change of reagent lot number or as required e.g. quality
stored at 2-8 C. Stability on board of the analyser at 2-10 C: Prestige 24i – control findings outside the specified range.
3 weeks, Biolis 24i Premium – 3 weeks. The reagent is air sensitive, to extend
reagents stability it is recommended to keep reagent’s bottles recapped on the PERFORMANCE CHARACTERISTICS
board of analyser. Protect from light and avoid contamination! These metrological characteristics have been obtained using the automatic
analysers Prestige 24i and Biolis 24i Premium. Results may vary if a different
Concentrations in the test instrument or a manual procedure is used.
xylidyl blue 0.15 mmol/l
EGTA 0.1 mmol/l  Sensitivity (Prestige 24i): 0.14 mg/dl (0.057 mmol/l).
buffer (pH 11.5) Sensitivity (Biolis 24i Premium): 0.06 mg/dl (0.025 mmol/l).
detergent
 Linearity (Prestige 24i): up to 7.3 mg/dl (2.99 mmol/l).
Warnings and notes Linearity (Biolis 24i Premium): up to 7.6 mg/dl (3.12 mmol/l).
 Product for in vitro diagnostic use only.
 The reagents contain sodium azide (< 0.1%) as a preservative. Avoid  Specificity / Interferences
contact with skin and mucous membranes. Haemoglobin up to 0.313 g/dl, ascorbate up to 62 mg/l, bilirubin up to
 It is recommended to use disposable plastic materials. If it is not 15 mg/dl, triglycerides up to 1000 mg/dl and calcium up to
possible, the glassware should be washed with 1% HCl solution and 20 mg/dl do not interfere with the test.
rinsed with plenty of distilled water.
 Precision (Prestige 24i)
SPECIMEN Repeatability (run to run) Mean SD CV
Serum, heparinized plasma free from hemolysis, 24-hours urine. n = 10 [mg/dl] [mg/dl] [%]
Recommended anticoagulants: heparine lithium, sodium or ammonium salt. level 1 2.03 0.02 0.75
Serum should be separated from red blood cells as soon as possible after level 2 4.24 0.03 0.64
blood collection, because erythrocytes contain approximately 3 times the
magnesium concentration found in normal serum. Reproducibility (day to day) Mean SD CV
Urine preparation: acidify urine with some drops of concentrated n = 10 [mg/dl] [mg/dl] [%]
hydrochloride acid to pH 1.0. Then dilute 1 part of acidified urine with 4 parts
level 1 1.94 0.05 2.32
of distilled water. Multiply the result by 5. Mix well samples before analysis.
level 2 3.93 0.10 2.42
Serum and plasma can be stored up to 7 days at 2-8ºC. For longer storage
samples should be frozen at -20ºC.
Precision (Biolis 24i Premium)
24-hours urine samples can be stored up to 7 days at 2-8ºC.
Nevertheless it is recommended to perform the assay with freshly collected Repeatability (run to run) Mean SD CV
samples! n = 10 [mg/dl] [mg/dl] [%]
level 1 2.05 0.02 1.07
PROCEDURE level 2 4.21 0.04 0.93
This reagent may be used in automatic analysers Prestige 24i, Biolis 24i,
Sapphire 400 and Prestige 24i Premium, Biolis 24i Premium, Sapphire 400 Reproducibility (day to day) Mean SD CV
Premium. n = 10 [mg/dl] [mg/dl] [%]
1-Reagent is ready to use. level 1 1.97 0.04 2.12
Avoid foaming. level 2 4.16 0.07 1.76
1-Reagent put on basic position in reagent tray.
For reagent blank deionized water is recommended.  Method comparison
A comparison between magnesium values determined at Prestige 24i (y) and
at ADVIA 1650 (x) using 93 samples gave following results:
y = 1.0422 x - 0.1068 mg/dl;
R = 0.970 (R – correlation coefficient)

PRESTIGE 24i LQ MG page 1

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 A comparison between magnesium values determined at Biolis 24i Premium APPLICATION for Prestige 24i Premium, Biolis 24i Premium and
(y) and at ADVIA 1650 (x) using 119 samples gave following results: Sapphire 400 Premium
y = 0.9195 x + 0.036 mg/dl; Item No. 22 Item Name MG Optical
R = 0.980 (R – correlation coefficient)
Data information Calibration
WASTE MANAGEMENT Units mg/dl Type Linear2
Please refer to local legal requirements. Decimals 2 Std sample conc.
Blank 0 #1 * #2 *
Analysis #3 #4 #5
LITERATURE
Type END method #6
1. C.K., Mann, J.H., Yoe, Anal. Chem. 28 (2), 202-205 (1956).
Main Wave Length 505 nm
2. C. Bohuon, Clin. Chim. Acta 7, 811-817 (1962).
Sub Wave Length 700 nm
3. C.A, Burtis, E.R. Ashwood, eds. Tietz Fundamentals of Chemical
Method Xylidyl blue
Clinical Chemistry 4th ed. W.B. Saunders, 690-691, (1996).
4. A. J. Pesce, L.A. Kaplan, ed., Methods in Clinical Chemistry, Mosby,
Correlation
1021-1026 (1987).
5. W.R. Faulkner, S. Meites, ed. Selected Methods for the Small Clinical Slope Intercept
Laboratory, AACC Press, 277-281 (1982). Y= 1 X+ 0
6. C.A. Burtis, E.R. Ashwood, ed. Tietz Textbook of Clinical Chemistry,
3rd ed. Philadelphia, PA: Moss D. W., Henderson A. R. 1825 (1999). Item No. 22 Item Name MG Optical

Aspiration Data Process

Kind Single Read Start End
APPLICATION for Prestige 24i, Biolis 24i and Sapphire 400 Vol. Main 31 32
Item name 22 MG Kind Vol. Add Units Sub 9 10
Sample 3 5 µl
Data information Calibration Reagent 1 250 10 µl Abs.Limit Low High
Units mg/dl Type Linear -0.1 ~ 2
Decimals 2 Standard
#1 * #4 Blank value Correction value
Analysis #2 * #5 Water Blank Blank correction
Type END #3 #6 End Point Limit 2
Main W.Length1 505 nm Reaction Monitor Linear Check (%)
Sub W.Length2 700 nm Normal Range 0 Level Point 1
Method Xylidyl blue Male Female Span 3 Prozone Check
Low High Low High Start End Limit (%)
Corr Serum 1.6 2.6 1.6 2.6 Third mixing First
Slope Inter Urine OFF Second Low
Y= 1.000 X+ 0.000 Plasma 1.6 2.6 1.6 2.6
CSF
Item No. 22 Item Name MG Optical
Dialysis
Other
Normal Range Panic Range
Male Female Male Female
Item name 22 MG Low High Low High Low High Low High
Serum 1.6 2.6 1.6 2.6 Serum
Aspiration Data Process Urine Urine
Kind Single Read Absorbance Limit Plasma 1.6 2.6 1.6 2.6 Plasma
Start End Low -0.100 CSF CSF
Volume Main 53 54 High 2.000 Dialysis Dialysis
Sample 3 Sub 7 11 Other Other
Reagent1 250 µl
Reagent2 Factor Endpoint Limit 2.000
Item No. 22 Item Name MG Optical
Blank correction 1.000 Linear Check (%)
Auto Rerun SW Auto Rerun Condition
Third Mix. OFF Dilution
ON (Absorbance)
R1 Blank Water-Blank Diluent 100:Dil2
Lower OFF
Auto Rerun Range (Conc.) Higher OFF
Monitor Prozone Check
First Low High
0 Level Point 1 Start End Limit (%)
Dil Re Value Dil Re Value Dil Auto Rerun Condition
Span 3.000 First
Serum 0.06 7.6 (Prozone)
Second Low
Urine OFF
Third Low Plasma
CSF Dilution
Item name 22 MG Dialysis 100:Dil2
Other
Auto Rerun SW Auto Rerun Condition (Absorbance)
ON Absorbance Range
Lower OFF
Auto Rerun Range (Result) Higher OFF Date of issue: 07. 2013.
ON ON
Lower Higher Prozone Range OFF
Serum 0.14 7.3
Urine
Plasma
CSF
Dialysis
Other

MANUFACTURER

PZ CORMAY S.A.
22 Wiosenna Street,
05-092 Łomianki, POLAND
tel.: +48 (0) 22 751 79 10
fax: +48 (0) 22 751 79 14
http://www.cormay.pl

07/13/07/13
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