INSTRUCTIONS FOR USE
Mg
Magnesium
VITROS Chemistry Products Mg Slides
825 5093
192 1204
Rx ONLY
Intended Use
For in vitro diagnostic use only.
VITROS Chemistry Products Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine
using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Summary and Explanation of the Test
Magnesium is predominantly an intracellular cation and is essential in enzyme reactions. Magnesium deficiency may cause
weakness, tremors, tetany, and convulsions. Hypomagnesemia is associated with hypocalcemia, alcoholism, some types of
malnutrition, malabsorption, chronic hemodialysis, and pregnancy. Increased serum magnesium concentrations occur in
patients with renal failure, dehydration, and Addison’s disease. 1
Principles of the Procedure
The VITROS Mg Slide method is performed using the VITROS Mg Slides and the VITROS Chemistry Products Calibrator
Kit 1 on VITROS 250/350/95/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
The VITROS Mg Slide is a multilayered, analytical element coated on a polyester support.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers.
Magnesium (both free and protein-bound) from the sample then reacts with the formazan dye derivative in the reagent
layer; the high magnesium affinity of the dye dissociates magnesium from binding proteins. The resulting magnesium-dye
complex causes a shift in the dye absorption maximum. The amount of dye complex formed is proportional to the
magnesium concentration present in the sample and is measured by reflection density.
Test Type and Conditions
Test Type
Colormetric
VITROS System
5600, 4600,
5,1 FS, 950,
250/350
Approximate
Incubation Time
5 minutes
Temperature
Wavelength
Reaction Sample
Volume
37 °C (98.6 °F)
630 nm
5 µL
NOTE: The reaction sample volume depends on the format of the slide and is determined automatically by the analyzer.
Slides with coating numbers <3201 require a 10 µL reaction sample volume.
Not all products and systems are available in all countries.
Reaction Scheme
chelator
Mg2 + Ca+2
Mg+2 + formazan dye derivative
Mg+2 + Ca+2-chelator complex
pH 9.75
Mg+2-dye complex
Warnings and Precautions
For in vitro diagnostic use only.
WARNING:
Version 10.0
Take care when handling materials and samples of human origin. Since no test
method can offer complete assurance that infectious agents are absent, consider
all clinical specimens, controls, and calibrators potentially infectious. Handle
specimens, solid and liquid waste, and test components in accordance with local
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Mg
INSTRUCTIONS FOR USE
Magnesium
Reagents
regulations and CLSI Guideline M29 2 or other published biohazard safety
guidelines.
For specific warnings and precautions for calibrators, quality control materials, and other components, refer to the
Instructions for Use for the appropriate VITROS product, or to other manufacturer’s product literature.
Reagents
Slide Diagram
Slide Ingredients
Reactive Ingredients per cm2
1. Upper slide mount
2. Spreading layer (TiO2)
3. Reagent layer
• calcium chelator
• buffer, pH 9.75
• formazan dye
1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-tetraacetic acid
(calcium chelator) 242 µg and 1,5-bis(2-hydroxy-3,5dichlorophenyl)-3-cyanoformazan (dye) 38 µg.
4. Support layer
5. Lower slide mount
Other Ingredients
Pigment, binders, buffer, dye solubilizer, surfactants, crosslinking agent and stabilizer.
Reagent Handling
Caution:
•
•
Do not use slide cartridges with damaged or incompletely sealed packaging.
Inspect the packaging for signs of damage.
Be careful when opening the outer packaging with a sharp instrument so as to avoid damage to the individual product
packaging.
Reagent Preparation
IMPORTANT:
The slide cartridge must reach room temperature, 18–28 °C (64–82 °F), before it is
unwrapped and loaded into the slide supply.
1. Remove the slide cartridges from storage.
2. Warm the wrapped cartridge at room temperature for 60 minutes.
3. Unwrap and load the cartridge into the slide supply.
Note:
Load the cartridges within 24 hours after they reach room temperature, 18–28 °C
(64–82 °F).
Reagent Storage and Stability
VITROS Mg Slides are stable until the expiration date on the carton when they are stored and handled as specified. Do not
use beyond the expiration date.
Reagent
Slide Cartridges
Opened
Frozen
On-analyzer
On-analyzer
Storage Condition
≤-18 °C (≤0 °F)
System turned on
System turned off
Stability
Until expiration date
≤ 2 weeks
≤ 2 hours
Verify performance with quality control materials:
• If the system is turned off for more than 2 hours.
• After reloading cartridges that have been removed from the slide supply and stored for later use.
Specimen Collection, Preparation and Storage
Caution:
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Protective gloves manufactured with magnesium stearate (talc) powders may
cause elevated test results because of the contamination of sample handling
supplies (for example, pipette tips, transfer pipettes, sample cups and caps).
Supplies that have come in contact with powdered gloves may subsequently
contaminate the test specimen during sample metering.
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INSTRUCTIONS FOR USE
Mg
Specimen Collection, Preparation and Storage
Note:
Magnesium
Gloves labeled as “powder-free” may contain some contaminating powder
agents on the inside of the glove.
Specimens Recommended
•
•
Serum
Plasma: 3 Heparin
Urine
•
IMPORTANT:
Certain collection devices have been reported to affect other analytes and tests. 4
Owing to the variety of specimen collection devices available, Ortho-Clinical
Diagnostics is unable to provide a definitive statement on the performance of its
products with these devices. Confirm that your collection devices are compatible
with this test.
Specimens Not Recommended
•
Plasma: 5
– EDTA
– Fluoride oxalate
– Citrate
•
Urine: 6 Boric acid with sodium formate as a preservative
Serum and Plasma
Specimen Collection and Preparation
Collect specimens using standard laboratory procedures. 7,
Note:
8
For details on minimum fill volume requirements, refer to the operating
instructions for your system.
Patient Preparation
No special patient preparation is necessary.
Special Precautions
• Hemolyzed specimens can cause falsely elevated results due to intracellular magnesium levels. 9
•
Centrifuge specimens and remove the serum or plasma from the cellular material as soon as possible after collection. 1
Specimen Handling and Storage
•
•
Handle and store specimens in stoppered containers to avoid contamination and evaporation.
Mix samples by gentle inversion and bring to room temperature, 18–28 °C (64–82 °F), prior to analysis.
Specimen Storage and Stability: Serum and Plasma 5
Storage
Room temperature
Refrigerated
Frozen
Temperature
18–28 °C (64–82 °F)
2–8 °C (36–46 °F)
≤-18 °C (≤0 °F)
Stability
≤ 1 week
≤ 1 week
≤ 1 month
Urine
Specimen Collection and Preparation
•
•
•
Collect specimens using standard laboratory procedures. 6
Use metal-free containers for collection and dilution.
Keep refrigerated until analysis.
Note:
For details on minimum fill volume requirements, refer to the operating
instructions for your system.
Patient Preparation
No special patient preparation is necessary.
Special Precautions
Urine specimens must be pretreated prior to processing. Refer to “Specimen Pretreatment” for instructions.
Specimen Handling and Storage
•
•
Version 10.0
Handle and store specimens in stoppered containers to avoid contamination and evaporation.
Mix samples by gentle inversion and bring to room temperature, 18–28 °C (64–82 °F), prior to analysis.
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Mg
INSTRUCTIONS FOR USE
Magnesium
Specimen Pretreatment
Specimen Storage and Stability: Urine 5
Storage
Room temperature
Refrigerated
Frozen
Temperature
18–28 °C (64–82 °F)
2–8 °C (36–46 °F)
≤-18 °C (≤0 °F)
Stability
≤ 1 week
≤ 1 week
≤ 1 month
Specimen Pretreatment
Urine
Acidification Procedure
IMPORTANT:
The acidification procedure is intended for patient specimens only. Do not adjust
the pH of quality-control or calibration materials.
IMPORTANT:
If running multiple assays from a single acidified sample, ensure that the pH of the
sample is appropriate for all assays programmed.
1. Thoroughly mix the urine specimen.
2. Pipette a 5 mL aliquot of urine into a separate test tube.
3. Dropwise, add 6 N HCl, mixing thoroughly after the addition of each drop. Check the pH frequently to obtain a pH
between 3.0 and 4.0.
4. If pH is <3.0, discard and begin with another 5 mL aliquot.
Predilution Procedure
IMPORTANT:
If using a VITROS 250/350 Chemistry System, VITROS 5,1 FS/4600 Chemistry
System or VITROS Integrated System in On-Analyzer Dilution Mode, do not
manually dilute samples for analysis and do not multiply by a dilution factor after
analysis. Refer to the operating instructions for your system for more information
on the On-Analyzer Dilution Procedure.
1. Dilute the pH-adjusted urine using 1 part of pH-adjusted urine and 5 parts of reagent-grade water to give a sixfold
dilution.
2. Analyze the diluted sample and multiply the reported result by 6 to obtain the urine magnesium concentration in the
original sample.
Testing Procedure
Materials Provided
VITROS Chemistry Products Mg Slides
Materials Required but Not Provided
•
•
•
•
•
•
VITROS Chemistry Products Calibrator Kit 1
Quality control materials, such as VITROS Chemistry Products Performance Verifier I and II for serum and plasma tests
Isotonic saline or reagent-grade water
6 N HCI
VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline) or VITROS Chemistry Products FS Diluent Pack 3
(Specialty Diluent/Water) (for on-analyzer dilution of serum and plasma samples)
VITROS Chemistry Products FS Diluent Pack 3 (Specialty Diluent/Water) (for on-analyzer dilution of urine samples)
Operating Instructions
•
•
Check reagent inventories at least daily to ensure that quantities are sufficient for the planned workload.
For additional information, refer to the operating instructions for your system.
IMPORTANT:
Bring all fluids and samples to room temperature, 18–28 °C (64–82 °F), prior to
analysis.
Sample Dilution
Serum and Plasma
If samples show magnesium concentrations that exceed the system’s measuring (reportable or dynamic) range:
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INSTRUCTIONS FOR USE
Mg
Calibration
Magnesium
Manual Sample Dilution
1. Dilute sample with an equal volume of isotonic saline or reagent-grade water.
2. Reanalyze.
3. Multiply the results by 2 to obtain an estimate of the original sample’s magnesium concentration.
On-Analyzer Sample Dilution (VITROS Integrated, VITROS 5,1 FS/4600 and 250/350 Systems only)
Refer to the operating instructions for your system for more information on the On-Analyzer Dilution Procedure. For
VITROS Integrated and 5,1 FS/4600 Chemistry Systems, use VITROS Chemistry Products FS Diluent Pack 2 or VITROS
Chemistry Products FS Diluent Pack 3 for the dilution.
Urine
If samples show magnesium concentrations that are above the upper end or below the lower end of the system’s
measuring (reportable or dynamic) range:
VITROS 250/350 and 950 Systems
1. Dilute 1 part sample with reagent-grade water as indicated in the table.
2.
Sample
Concentration
*
Dilution Factor
9 parts reagent-grade water
10
< lower end**
2 parts reagent-grade water
3
> upper
pH-adjusted urine
Diluent/Volume
end*
Above the upper end of the reportable range
**
Below the lower end of the reportable range
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample’s magnesium concentration.
On-Analyzer Sample Dilution (VITROS Integrated and 5,1 FS/4600 Systems only)
Refer to the operating instructions for your system for more information on the On-Analyzer Dilution Procedure. Use
VITROS Chemistry Products FS Diluent Pack 3 for the dilution.
Calibration
Required Calibrators
VITROS Chemistry Products Calibrator Kit 1
Note:
The same VITROS Calibrator Kit is used to calibrate both serum and urine
magnesium. However, specific supplementary assigned values (SAVs) are
applied for each body fluid.
Calibrator Preparation, Handling, and Storage
Refer to the Instructions for Use for VITROS Calibrator Kit 1.
IMPORTANT:
Do not adjust the pH of calibration materials for use with the test for urine
magnesium.
Calibration Procedure
Refer to the operating instructions for your system.
When to Calibrate
Calibrate:
• When the slide lot number changes.
• When critical system parts are replaced due to service or maintenance.
• When government regulations require.
For example, in the USA, CLIA regulations require calibration or calibration verification at least once every six months.
The VITROS Mg test may also need to be calibrated:
• If quality control results are consistently outside acceptable range.
• After certain service procedures have been performed.
For additional information, refer to the operating instructions for your system.
Calculations
Reflectance from the slide is measured at 630 nm after the fixed incubation time. Once a calibration has been performed for
each slide lot, magnesium concentration in unknown samples can be determined using the software-resident endpoint
colorimetric math model and the response obtained from each unknown test slide.
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Mg
INSTRUCTIONS FOR USE
Magnesium
Quality Control
Validity of a Calibration
Calibration parameters are automatically assessed by the system against a set of quality parameters detailed in the
Coefficients and Limits screen (for VITROS Integrated and 5,1 FS/4600 Systems, see the Review Assay Data screen).
Failure to meet any of the pre-defined quality parameters results in a failed calibration. The calibration report should be
used in conjunction with quality control results to determine the validity of a calibration.
Measuring (Reportable or Dynamic) Range
Conventional Units
(mg/dL)
0.20–10.0
1.20–60.0
Serum
Urine*
*After
SI Units
(mmol/L)
0.08–4.11
0.49–24.68
Alternate Units
(mEq/L)
0.16–8.23
0.99–49.37
multiplying by a 6x dilution factor.
For out-of-range samples, refer to “Sample Dilution.”
Traceability of Calibration
Values assigned to the VITROS Chemistry Products Calibrator Kit 1 for magnesium are traceable to the Certified NIST
(National Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 929. The OrthoClinical Diagnostics calibration laboratory uses SRM® 929 to calibrate the flame atomic absorption spectroscopy method 10
to support magnesium value assignment for VITROS Calibrator Kit 1.
Quality Control
Quality Control Material Selection
IMPORTANT:
•
•
VITROS Performance Verifiers are recommended for use with the VITROS
Chemistry and Integrated Systems. Evaluate the performance of other commercial
control fluids for compatibility with this test before using for quality control.
Control materials other than VITROS Performance Verifiers may show a difference when compared with other
magnesium methods if they:
– Depart from a true human matrix.
– Contain high concentrations of preservatives, stabilizers, or other nonphysiological additives.
Do not use control materials stabilized with ethylene glycol.
Urine
For urine specimens, use commercially available urine control materials.
Quality Control Procedure Recommendations
•
•
•
•
•
•
Choose control levels that check the clinically relevant range.
Analyze quality control materials in the same manner as patient samples, before or during patient sample processing.
To verify system performance, analyze control materials:
– After calibration.
– According to local regulations or at least once each day that the test is being performed.
– After specified service procedures are performed. Refer to the operating instructions for your system.
If control results fall outside your acceptable range, investigate the cause before deciding whether to report patient
results.
For general quality control recommendations, refer to Statistical Quality Control for Quantitative Measurements:
Principles and Definitions; Approved Guideline-Third Edition 11 or other published guidelines.
For additional information, refer to the operating instructions for your system.
Urine
•
•
•
Do not adjust the pH of quality-control materials.
Dilute sixfold as for a patient sample.
Select urine as the fluid when programming the system to run urine controls.
IMPORTANT:
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If using a VITROS 250/350 Chemistry System, VITROS 5,1 FS/4600 Chemistry
System or VITROS Integrated System in On-Analyzer Dilution Mode, do not
manually dilute samples for analysis and do not multiply by a dilution factor after
analysis. Refer to the operating instructions for more information on the OnAnalyzer Dilution Procedure.
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INSTRUCTIONS FOR USE
Mg
Results
Magnesium
Quality Control Material Preparation, Handling, and Storage
Refer to the Instructions for Use for VITROS Chemistry Products Performance Verifier I and II or to other manufacturer's
product literature.
Results
Reporting Units and Unit Conversion
The VITROS Chemistry and Integrated Systems may be programmed to report Mg results in conventional, SI, or alternate
units.
Conventional Units
mg/dL
SI Units
mmol/L (mg/dL x 0.4114)
Alternate Units
mEq/L (mg/dL x 0.8229)
Limitations of the Procedure
Known Interferences
•
•
•
The VITROS Mg Slide method was screened for interfering substances following NCCLS Protocol EP7 12 The
substances listed in the table, when tested at the concentrations indicated, caused the bias shown.
Erythrocytes in urine can produce falsely elevated results due to intracellular magnesium levels.
For substances that were tested and did not interfere, refer to “Specificity.”
Interferent*
Serum and Plasma
Calcium
Urine
Inorganic
phosphorus
Calcium
Sodium fluoride
Interferent
Concentration
Magnesium Concentration
Conv.
SI
(mg/dL)
(mmol/L)
Average Bias
Conv.
SI
(mg/dL)
(mmol/L)
20 mg/dL
(5.0 mmol/L)
2.3
0.9
+0.3
+0.12
300 mg/dL
(96.8 mmol/L)
7.2
3.0
-2.4
-1.00
300 mg/dL
40 mg/dL
10 mg/mL
(74.9 mmol/L)
(10.0 mmol/L)
(238 mmol/L)
20.6
21.6
7.0
8.5
8.9
2.9
+7.0
+0.5
-3.0
+2.9
+0.2
-1.2
*It
is possible that other interfering substances may be encountered. These results are representative; however, your results may differ
somewhat due to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.
Other Limitations
Certain drugs and clinical conditions are known to alter magnesium concentrations in vivo. For additional information, refer
to one of the published summaries. 9, 14
Expected Values
Reference Interval
The serum reference interval is the central 95% of results from an internal study of 288 apparently healthy individuals from
a working population (58 females and 230 males).
The urine reference interval is based on an external study. 1
Serum
Urine (24-Hour)
*Magnesium
Conventional Units
(mg/dL)
1.6–2.3
73.0–122.0 mg/day*
SI Units
(mmol/L)
0.7–1.0
3.0–5.0 mmol/day**
Alternate Units
(mEq/L)
1.3–1.9
6.0–10.0 mEq/day***
concentration (mg/dL) x 24-hour volume (dL) = mg/day. To convert mg/day to g/day divide by 1000.
**Magnesium
concentration (mmol/L) x 24-hour volume (L) = mmol/day
***Magnesium
concentration (mEq/L) x 24-hour volume (L) = mEq/day
Each laboratory should confirm the validity of these intervals for the population it serves.
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INSTRUCTIONS FOR USE
Mg
Magnesium
Performance Characteristics
Performance Characteristics
Method Comparison
The plots and tables show the results of a comparison of serum and urine samples analyzed on the VITROS 750 System
with those analyzed using the atomic absorption comparative method. 10 Testing followed NCCLS Protocol EP9. 15
The tables, for serum and urine respectively, summarize the results of regression analyses of data obtained from
measurements with both the VITROS 250 and 950 Systems compared to measurements with the VITROS 750 System.
Regression analyses of data for serum and urine samples measured on the VITROS 5,1 FS System compared to
measurements with the VITROS 950 System are also provided.
In addition, the tables for serum and urine summarize the regression analysis of comparisons of results for serum, plasma
and urine samples measured on the VITROS 5600 Integrated System and the VITROS 5,1 FS Chemistry System. Testing
followed NCCLS Protocol EP9. 16
Serum
SI Units
VITROS 750 System (mg/dL)
VITROS 750 System (mmol/L)
Conventional Units
Comparative Method: Atomic Absorption
(mg/dL)
Comparative Method: Atomic Absorption
(mmol/L)
Conventional Units (mg/dL)
SI Units (mmol/L)
n
Slope
Correlation
Coefficient
750 vs. comparative
method
160
1.01
0.999
0.3–9.6
-0.02
0.10
0.1–3.9
-0.01
0.04
250 vs. 750
88
0.99
1.000
0.6–9.7
0.00
0.08
0.2–4.0
0.00
0.03
950 vs. 750
126
1.00
1.000
0.4–9.5
-0.01
0.03
0.2–3.9
0.00
0.01
5,1 FS vs. 950
124
0.99
1.000
0.2–9.2
+0.03
0.05
0.1–3.8
+0.01
0.02
5600 vs. 5,1 FS
110
1.00
0.999
0.5–9.7
+0.01
0.13
0.2–4.0
0.00
0.05
Range of
Sample Conc
Intercept
Sy.x
Range of
Sample Conc.
Intercept
Sy.x
Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same
specifications as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been
demonstrated to be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are
therefore applicable to the VITROS 4600 System.
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Mg
INSTRUCTIONS FOR USE
Performance Characteristics
Magnesium
Urine
SI Units
VITROS 750 System (mg/dL)
VITROS 750 System (mmol/L)
Conventional Units
Comparative Method: Atomic Absorption
(mg/dL)
Comparative Method: Atomic Absorption
(mmol/L)
Conventional Units (mg/dL)
SI Units (mmol/L)
n
Slope
Correlation
Coefficient
750 vs. comparative
method
156
1.00
0.998
1.4–58.8
+0.54
0.91
0.6–24.2
+0.22
0.37
250 vs. 750
89
0.99
0.999
2.1–53.6
-0.05
0.41
0.9–22.1
-0.02
0.17
950 vs. 750
159
1.01
1.000
2.0–59.5
-0.06
0.14
0.8–24.5
-0.02
0.06
5,1 FS vs. 950
108
1.01
1.000
1.3–55.1
-0.14
0.40
0.5–22.7
-0.06
0.16
5600 vs. 5,1 FS
108
1.02
1.000
1.4–57.8
-0.12
0.34
0.6–23.8
-0.05
0.14
Range of
Sample Conc.
Intercept
Sy.x
Range of
Sample Conc.
Intercept
Sy.x
Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same
specifications as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been
demonstrated to be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are
therefore applicable to the VITROS 4600 System.
Precision
Precision was evaluated with quality control materials on VITROS 250, 750, 950, and 5,1 FS Systems following NCCLS
Protocol EP5. 17 Precision was also evaluated with quality control materials on VITROS 5600 Integrated System following
NCCLS protocol EP5. 18
The data presented are a representation of test performance and are provided as a guideline. Variables such as sample
handling and storage, reagent handling and storage, laboratory environment, and system maintenance can affect
reproducibility of test results.
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Mg
INSTRUCTIONS FOR USE
Magnesium
Performance Characteristics
Serum
Conventional Units (mg/dL)
250
750
950
5,1 FS
5600
*
SI Units (mmol/L)
Within Lab Within Lab
SD**
CV%**
Mean
Conc.
Within
Day SD*
Within Lab
SD**
Mean
Conc.
Within
Day SD*
2.1
0.03
0.05
0.9
0.01
0.02
2.4
79
20
4.5
0.04
0.08
1.9
0.02
0.03
1.7
78
20
2.2
0.03
0.04
0.9
0.01
0.02
1.6
90
23
4.7
0.05
0.06
1.9
0.02
0.02
1.3
91
23
2.3
0.03
0.03
1.0
0.01
0.01
1.3
90
23
4.8
0.05
0.06
2.0
0.02
0.02
1.2
92
23
2.1
0.02
0.04
0.9
0.01
0.01
1.7
88
22
4.3
0.03
0.04
1.8
0.01
0.02
0.9
89
22
1.8
0.01
0.03
0.7
0.00
0.01
1.7
92
23
4.2
0.03
0.07
1.7
0.01
0.03
1.7
92
23
No.
Observ.
No. Days
Within Day precision was determined using two runs/day with at least two replications.
**
Within Lab precision was determined using a single lot of slides and calibrating weekly.
Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same
specifications as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been
demonstrated to be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are
therefore applicable to the VITROS 4600 System.
Precision for Mg: Urine
Conventional Units (mg/dL)
System
250
750
950
5,1 FS
5600
*
SI Units (mmol/L)
Within Lab Within Lab
CV%**
SD**
Mean
Conc.
Within
Day SD*
Within Lab
SD**
Mean
Conc.
Within
Day SD*
6.2
0.06
0.17
2.5
0.03
0.07
9.2
0.09
0.16
3.8
0.04
11.2
0.08
0.18
4.6
15.4
0.09
0.20
7.0
0.07
32.9
No.
Observ.
No. Days
2.7
88
22
0.07
1.7
88
22
0.03
0.08
1.6
88
22
6.3
0.04
0.08
1.3
88
22
0.18
2.9
0.03
0.07
2.6
90
23
0.25
0.83
13.5
0.10
0.34
2.5
86
22
7.2
0.12
0.18
3.0
0.05
0.07
2.9
90
23
33.0
0.18
0.72
13.6
0.07
0.30
2.3
86
23
5.6
0.09
0.16
2.3
0.04
0.07
2.9
91
23
13.3
0.11
0.20
5.5
0.04
0.08
1.5
93
23
4.1
0.13
0.20
1.7
0.05
0.08
4.9
92
23
11.4
0.17
0.23
4.7
0.07
0.09
2.0
92
23
Within Day precision was determined using two runs/day with two to three replications.
**
Within Lab precision was determined using a single lot of slides and calibrating weekly.
Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same
specifications as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been
demonstrated to be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are
therefore applicable to the VITROS 4600 System.
Specificity
Substances That Do Not Interfere
The substances listed in the table were tested with VITROS Mg Slides, following NCCLS Protocol EP7 12 and found not to
interfere, bias <0.2 mg/dL (<0.08 mmol/L), at the concentrations shown.
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INSTRUCTIONS FOR USE
Mg
References
Compound
Acetaminophen
Magnesium
Concentration
Compound
5 mg/dL
331 µmol/L
Aluminum
300 µg/dL
111.3 µmol/L
Bilirubin
27 mg/dL
462 µmol/L
Calcium
16 mg/dL
4 mmol/L
Copper
Concentration
Lithium
1 mEq/L
1 mmol/L
Nickel
15 µg/dL
2.6 µmol/L
Potassium
8 mEq/L
8 mmol/L
Salicylate
30 mg/dL
2.2 mmol/L
156 mEq/L
156 mmol/L
500 µg/dL
78.5 µmol/L
Sodium
Cyclosporin
15 µg/dL
125 nmol/L
Total protein
3 g/dL
30 g/L
Hemoglobin
1000 mg/dL
10 g/L
Total protein
10 g/dL
100 g/L
Iron
500 µg/dL
89.5 µmol/L
Triglycerides
1200 mg/dL
13.5 mmol/L
Intralipid
800 mg/dL
8 g/L
Urea nitrogen
100 mg/dL
35.7 mmol/L
5 mg/dL
561 µmol/L
Zinc
300 µg/dL
45.9 µmol/L
L-Alanine
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Version 10.0
Tietz NW (ed). Fundamentals of Clinical Chemistry. ed. 3. Philadelphia: WB Saunders; 521-524; 1987.
CLSI. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline – Third Edition.
CLSI document M29-A3 (ISBN 1-56238-567-4). CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898
USA; 2005.
Doumas BT, et al. Differences Between Values for Plasma and Serum in Tests Performed in the Ektachem 700 XR
Analyzer, and Evaluation of “Plasma Separator Tubes (PST).” Clin. Chem. 35:151–153; 1989.
Calam RR. Specimen Processing Separator Gels: An Update. J Clin Immunoassay. 11:86-90; 1988.
Clinical Laboratory Handbook for Patient Preparation and Specimen Handling. Fascicle VI: Chemistry/Clinical
Microscopy. Northfield, IL: College of American Pathologists; 1992.
NCCLS. Urinalysis and Collection, Transportation, and Preservation of Urine Specimens; Approved Guideline. NCCLS
Document GP16. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA; 1995.
CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard-Sixth Edition.
CLSI document H3-A6 (ISBN 1-56238-650-6). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898 USA; 2007.
NCCLS. Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard—
Fifth Edition. NCCLS document H4-A5 [ISBN 1-56238-538-0]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA, 2004.
Young DS. Effects of Preanalytical Variables on Clinical Laboratory Tests. ed. 2. Washington D.C.: AACC Press;
3-370; 1997.
Kaplan L, Pesce A. Clinical Chemistry: Theory, Analysis, and Correlation. CV Mosby; 1069; 1984.
NCCLS. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline –
Third Edition. CLSI document C24-A3 (ISBN 1-56238-613-1). CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA; 2006.
NCCLS. Interference Testing in Clinical Chemistry. NCCLS Document EP7. CLSI, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898 USA; 1986.
Young DS. Effects of Drugs on Clinical Laboratory Tests. ed. 4. Washington D.C.: AACC Press; 1995.
Friedman RB. Young DS. Effects of Disease on Clinical Laboratory Tests. Washington, D.C.: AACC Press; 1990.
NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS Document
EP9. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA: NCCLS; 1995.
NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS document
EP9-A2 [ISBN 1-56238-472-4]. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA;
2002.
NCCLS. User Evaluation of Precision Performance with Clinical Chemistry Devices. NCCLS Document EP5. CLSI, 940
West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA; 1992.
NCCLS. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second
Edition. NCCLS document EP5-A2 [ISBN 1-56238-542-9]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA; 2004.
Pub. No. MP2-47_EN
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Mg
INSTRUCTIONS FOR USE
Magnesium
Glossary of Symbols
Glossary of Symbols
Revision History
12 of 14
Date of Revision
2015-10-12
Version
10.0
2014-09-05
2012-02-28
2010-11-01
9.0
8.0
7.0
2008-10-22
6.0
2005-12-15
2004-12-23
5.0
4.0
Description of Technical Changes*
• Prescription Use statement added.
• Updated EC Representative address.
• Added USA to legal manufacture address
Glossary of Symbols: added Date of Manufacture
Glossary of Symbols: updated
• Added information for the VITROS 4600 Chemistry System
• Precision – Urine: 5,1 FS: Corrected No. Observ.
• Added information for the VITROS 5600 Integrated System
• Test Type and Conditions – Added statement
• Method Comparison – Added information on sample types
• References – Updated
• Glossary of Symbols – Updated
• Minor wording and formatting changes
Acidification procedure — added “Important”
Note that the Date of Revision for this version (4.0) was corrected to the actual
date of 2004-12-23 after release.
• Materials Required But Not Provided – updated data
• Sample Dilution, Urine – updated data
Pub. No. MP2-47_EN
Version 10.0
INSTRUCTIONS FOR USE
Mg
Revision History
Date of Revision
2004-09-13
Version
3.0
2002-12-16
2.0
2002APR19
1.0 – English
only
Magnesium
Description of Technical Changes*
• Added VITROS 5,1 FS Chemistry System
• Specimen Requirements, Special Precautions – wording update
• Reference Interval – updated data
• Precision, 250 and 950 Systems – updated values
• Specificity – added Intralipid; updated Bilirubin, Hemoglobin
• References – corrected data
• Glossary of Symbols – updated data
• New organization and sections consistent with IVD Directive
• Test Type and Conditions - added sample drop volume for slides with coating
numbers 3201 and above
• Specimens Recommended - plasma: updated to heparin.
• Specimens Not Recommended - urine: updated
• Reportable (Dynamic) Range - urine: corrected alternate units
• Reference Interval - 24 hour urine: corrected unit
• Known Interfering Substances - urine: removed statement that preservatives
cause negative biases
• Known Interfering Substances table - serum and plasma: removed inorganic
phosphorous; urine: added sodium fluoride; updated inorganic phosphorous
and calcium
• Method Comparison - serum: updated all comparisons and plots; urine:
updated 750 System versus comparative method, 250 versus 750 Systems,
and plots
• Precision: serum: updated data for 250 and 750 System; urine: updated data
for 750 System
• Specificity - updated data for total protein
• References – added 2, 3, 4, 12, and 15
New format, technically equivalent to 11/96.
* The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document.
When this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory
policies, as appropriate.
Signature
Version 10.0
Obsolete Date
Pub. No. MP2-47_EN
13 of 14
Mg
INSTRUCTIONS FOR USE
Magnesium
Revision History
Ortho-Clinical Diagnostics
Felindre Meadows
Pencoed
Bridgend
CF35 5PZ
United Kingdom
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, NY 14626
USA
VITROS is a trademark of Ortho-Clinical Diagnostics, Inc.
© Ortho-Clinical Diagnostics, Inc., 2002-2015
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Pub. No. MP2-47_EN
Version 10.0