Prestige 24i LQ MG User Manual

PRESTIGE 24i LQ MG page 1

Cat. No 4-229

PRESTIGE 24i LQ MG

DIAGNOSTIC KIT

FOR DETERMINATION OF

MAGNESIUM CONCENTRATION

INTRODUCTION

Magnesium in human organism occurs mainly in bone (about 50%) but is
present also intracellularly in other tissues. Magnesium serves as a cofactor
for multiple enzymatic reactions involved in nucleic acids synthesis, transport
and production of energy. Magnesium is important in neuromuscular
conduction and activation. Reduced magnesium level generates: concentration
disturbances, fatigue, muscle tremor, anxiety state.

METHOD PRINCIPLE

Magnesium forms a purple coloured complex in alkaline solution. In the
presence of EGTA, the reaction is specific. The intensity of the purple colour
is proportional to the magnesium concentration.

REAGENTS

Package

Cat. No 4-229

(24-TRAY)

4 x 60 ml

1-Reagent

The reagent is stable up to the kit expiry date printed on the package when
stored at 2-8 C. Stability on board of the analyser at 2-10 C: Prestige 24i –
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

board of analyser. Protect from light and avoid contamination!

Concentrations in the test

xylidyl blue

0.15 mmol/l

EGTA

0.1 mmol/l

buffer (pH 11.5)

detergent

Warnings and notes

 Product for in vitro diagnostic use only.
 The reagents contain sodium azide (< 0.1%) as a preservative. Avoid

contact with skin and mucous membranes.

 It is recommended to use disposable plastic materials. If it is not

possible, the glassware should be washed with 1% HCl solution and
rinsed with plenty of distilled water.

SPECIMEN

Serum, heparinized plasma free from hemolysis, 24-hours urine.
Recommended anticoagulants: heparine lithium, sodium or ammonium salt.
Serum should be separated from red blood cells as soon as possible after
blood collection, because erythrocytes contain approximately 3 times the
magnesium concentration found in normal serum.
Urine preparation: acidify urine with some drops of concentrated
hydrochloride acid to pH 1.0. Then dilute 1 part of acidified urine with 4 parts
of distilled water. Multiply the result by 5. Mix well samples before analysis.
Serum and plasma can be stored up to 7 days at 2-8ºC. For longer storage
samples should be frozen at -20ºC.
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
samples!

PROCEDURE

This reagent may be used in automatic analysers Prestige 24i, Biolis 24i,
Sapphire 400 and Prestige 24i Premium, Biolis 24i Premium, Sapphire 400
Premium.
1-Reagent is ready to use.
Avoid foaming.
1-Reagent put on basic position in reagent tray.
For reagent blank deionized water is recommended.

REFERENCE VALUES

6

serum / plasma

mg/dl

mmol/l

newborn 2 – 4 d

1.5 – 2.2

0.62 – 0.91

children 5 mo – 6 y

1.7 – 2.3

0.70 – 0.95

6 – 12 y

1.7 – 2.1

0.70 – 0.86

12 – 20 y

1.7 – 2.2

0.70 – 0.91

adults

1.6 – 2.6

0.66 – 1.07

24-hours urine:

mg/24h

mmol/24h

72.9 – 145.8

3 – 5

It is recommended for each laboratory to establish its own reference ranges
for local population.

QUALITY CONTROL

For internal quality control it is recommended to use the CORMAY SERUM
HN (Cat. No 5-172) and CORMAY SERUM HP (Cat. No 5-173) for
determination in serum or CORMAY URINE CONTROL LEVEL 1
(Cat. No 5-161) and LEVEL 2 (Cat. No 5-162) for determination in urine with
each batch of samples.
For the calibration of automatic analysers systems the CORMAY
MULTICALIBRATOR LEVEL 1 (Cat. No 5-174; 5-176) and LEVEL 2
(Cat. No 5-175; 5-177) is recommended.
The calibration curve should be prepared every week (Prestige 24i, Biolis 24i
Premium), with change of reagent lot number or as required e.g. quality
control findings outside the specified range.

PERFORMANCE CHARACTERISTICS
These metrological characteristics have been obtained using the automatic
analysers Prestige 24i and Biolis 24i Premium. Results may vary if a different
instrument or a manual procedure is used.

 Sensitivity (Prestige 24i): 0.14 mg/dl (0.057 mmol/l).

Sensitivity (Biolis 24i Premium): 0.06 mg/dl (0.025 mmol/l).

 Linearity (Prestige 24i): up to 7.3 mg/dl (2.99 mmol/l).

Linearity (Biolis 24i Premium): up to 7.6 mg/dl (3.12 mmol/l).

 Specificity / Interferences

Haemoglobin up to 0.313 g/dl, ascorbate up to 62 mg/l, bilirubin up to
15 mg/dl, triglycerides up to 1000 mg/dl and calcium up to
20 mg/dl do not interfere with the test.

 Precision (Prestige 24i)

Repeatability (run to run)

n = 10

Mean

[mg/dl]

SD

[mg/dl]

CV

[%]

level 1
level 2

2.03

4.24

0.02

0.03

0.75

0.64

Reproducibility (day to day)

n = 10

Mean

[mg/dl]

SD

[mg/dl]

CV
[%]

level 1
level 2

1.94

3.93

0.05

0.10

2.32

2.42

Precision (Biolis 24i Premium)

Repeatability (run to run)

n = 10

Mean

[mg/dl]

SD

[mg/dl]

CV
[%]

level 1
level 2

2.05

4.21

0.02

0.04

1.07

0.93

Reproducibility (day to day)

n = 10

Mean

[mg/dl]

SD

[mg/dl]

CV
[%]

level 1
level 2

1.97

4.16

0.04

0.07

2.12

1.76

 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 2

A comparison between magnesium values determined at Biolis 24i Premium
(y) and at ADVIA 1650 (x) using 119 samples gave following results:
y = 0.9195 x + 0.036 mg/dl;
R = 0.980 (R – correlation coefficient)

WASTE MANAGEMENT

Please refer to local legal requirements.

LITERATURE

1. C.K., Mann, J.H., Yoe, Anal. Chem. 28 (2), 202-205 (1956).

2. C. Bohuon, Clin. Chim. Acta 7, 811-817 (1962).

3. C.A, Burtis, E.R. Ashwood, eds. Tietz Fundamentals of Chemical

Clinical Chemistry 4th ed. W.B. Saunders, 690-691, (1996).

4. A. J. Pesce, L.A. Kaplan, ed., Methods in Clinical Chemistry, Mosby,

1021-1026 (1987).

5. W.R. Faulkner, S. Meites, ed. Selected Methods for the Small Clinical

Laboratory, AACC Press, 277-281 (1982).

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).

APPLICATION for Prestige 24i, Biolis 24i and Sapphire 400

Item name

22

MG Data information

Calibration

Units

mg/dl

Type

Linear

Decimals

2

Standard

#1 * #4

Analysis

#2 * #5 Type

END

#3 #6 Main W.Length1

505 nm

Sub W.Length2

700 nm

Normal Range

Method

Xylidyl blue

Male

Female

Low

High

Low

High

Corr

Serum

1.6

2.6

1.6

2.6

Slope Inter Urine

Y=

1.000

X+

0.000

Plasma

1.6

2.6

1.6

2.6

CSF

Dialysis

Other

Item name

22

MG

Aspiration

Data Process

Kind

Single Read

Absorbance Limit

Start

End Low

-0.100

Volume

Main

53

54

High

2.000

Sample

3

µl

Sub

7

11

Reagent1

250

Reagent2

Factor

Endpoint Limit

2.000

Blank correction

1.000

Linear Check (%)

Third Mix.

OFF Dilution

R1 Blank

Water-Blank

Diluent

100:Dil2

Monitor

Prozone Check

0 Level Point

1

Start

End

Limit (%)

Span

3.000

First

Second

Low

Third

Low

Item name

22

MG Auto Rerun SW

Auto Rerun Condition (Absorbance)

ON

Absorbance Range

Lower

OFF

Auto Rerun Range (Result)

Higher

OFF ON

ON

Lower

Higher

Prozone Range

OFF

Serum

0.14

7.3

Urine

Plasma

CSF

Dialysis

Other

APPLICATION for Prestige 24i Premium, Biolis 24i Premium and
Sapphire 400 Premium

Item No.

22

Item Name

MG

Optical

Data information

Calibration

Units

mg/dl

Type

Linear2

Decimals

2

Std sample conc.

Blank 0 #1 * #2

*

Analysis

#3 #4 #5 Type

END method

#6

Main Wave Length

505 nm

Sub Wave Length

700 nm

Method

Xylidyl blue

Correlation

Slope Intercept

Y= 1 X+

0

Item No.

22

Item Name

MG

Optical

Aspiration

Data Process

Kind

Single

Read Start

End

Vol.

Main

31

32

Kind

Vol.

Add

Units Sub

9

10

Sample

3

5

µl

Reagent 1

250

10

µl Abs.Limit Low

High

-0.1 ~ 2 Blank value

Correction value

Water Blank

Blank correction

End Point Limit

2

Reaction Monitor

Linear Check (%)

0 Level Point

1

Span

3 Prozone Check

Start

End

Limit (%)

Third mixing

First

OFF

Second

Low

Item No.

22

Item Name

MG

Optical

Normal Range

Panic Range

Male

Female

Male

Female

Low

High

Low

High

Low

High

Low

High

Serum

1.6

2.6

1.6

2.6

Serum

Urine Urine

Plasma

1.6

2.6

1.6

2.6

Plasma

CSF

CSF

Dialysis

Dialysis

Other

Other

Item No.

22

Item Name

MG

Optical

Auto Rerun SW

Auto Rerun Condition
(Absorbance)

ON

Lower

OFF

Auto Rerun Range (Conc.)

Higher

OFF

First

Dil

Low

High

Re

Value

Dil

Re

Value

Dil

Auto Rerun Condition
(Prozone)

Serum

0.06

7.6

Urine

OFF

Plasma

CSF

Dilution

Dialysis

100:Dil2

Other

Date of issue: 07. 2013.

MANUFACTURER

PZ CORMAY S.A.

22 Wiosenna Street,

05-092 Łomianki, POLAND

tel.: [phone]
fax: [phone]

http://www.cormay.pl

07/13/07/13