Magnesio ING

MAGNESIUM
7D70-20 and 7D70-30
30-3864/R10
MAGNESIUM
This package insert contains information to run the Magnesium assay on the ARCHITECT c Systems™ and the
AEROSET System.
NOTE: Changes Highlighted
NOTE: This package insert must be read carefully prior to product use. Package insert instructions must be
followed accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the
instructions in this package insert.
Customer Support
United States:
Canada:
International:
1-877-4ABBOTT
1-800-387-8378 (English speaking customers)
1-800-465-2675 (French speaking customers)
Call your local Abbott representative
Symbols in Product Labeling
Calibrators 1 and 2
Catalog number/List number
Concentration
Serial number
Authorized Representative in the
European Community
Consult instructions for use
Ingredients
Manufacturer
In vitro diagnostic medical device
Temperature limitation
Batch code/Lot number
Use by/Expiration date
Reagent 1
ABBOTT LABORATORIES
Abbott Park, IL 60064, USA
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
September 2006
©2002, 2006 Abbott Laboratories
1
NAME
WARNINGS AND PRECAUTIONS (Continued)
MAGNESIUM
The Magnesium assay is used for the quantitation of magnesium in
human serum, plasma, or urine.
5. CAUTION: This product requires the handling of human specimens.
It is recommended that all human sourced materials be considered
potentially infectious and handled in accordance with the OSHA
Standard on Bloodborne Pathogens.2 Biosafety Level 23 or other
appropriate biosafety practices4,5 should be used for materials that
contain or are suspected of containing infectious agents.
SUMMARY AND EXPLANATION OF TEST
SPECIMEN COLLECTION AND HANDLING
INTENDED USE
Magnesium is an essential nutrient which is involved in many
biochemical functions. It has a structural role in nucleic acids and
ribosomal particles, required as an activator for many enzymes and has
a role in energy producing oxidative phosphorylation.
The normal body contains between 21 to 28 g magnesium, more than
50% of which is complexed with calcium and phosphate in bone. Only
approximately 1% of the total magnesium is found in the extracellular
fluid; hence, it tends to enter and leave cells under the same
conditions as potassium. Approximately 35% of plasma magnesium
is protein-bound, mainly to albumin, and therefore changes in albumin
concentration may affect magnesium.
Hypomagnesemia results in the impairment of neuromuscular function
and may develop in severe prolonged diarrhea, malabsorption
syndromes, hyperaldosteronism, and diuretic therapy. Hypermagnesemia
is seen in renal glomerular failure and diabetic coma.
Suitable Specimens
Serum, plasma, and urine are acceptable specimens.
• Serum: Use nonhemolyzed serum collected by standard
venipuncture techniques into glass or plastic tubes with or without
gel barriers. Ensure complete clot formation has taken place prior to
centrifugation. Separate serum from red blood cells or gel as soon
after collection as possible.
Some specimens, especially those from patients receiving
anticoagulant or thrombolytic therapy, may take longer to complete
their clotting processes. Fibrin clots may subsequently form in these
sera and the clots could cause erroneous test results.
• Plasma: Use plasma collected by standard venipuncture techniques
into glass or plastic tubes. Acceptable anticoagulants are lithium
heparin (with or without gel barrier) and sodium heparin. Ensure
centrifugation is adequate to remove platelets. Separate plasma from
red blood cells or gel as soon after collection as possible.
• Urine: Urine specimens should be collected in HCl, 20 to 30 mL
of 6 mol/L for a 24 hour specimen, to prevent precipitation of
magnesium complexes.1
PRINCIPLES OF PROCEDURE
This method utilizes an arsenazo dye which binds preferentially with
magnesium. The absorbance of the arsenazo-magnesium complex
is measured at 572 nm and is proportional to the concentration of
magnesium present in the sample. Calcium interference is prevented by
incorporation of a calcium chelating agent.
Methodology: Arsenazo
Refer to the specimen collection tube manufacturer’s instructions for
processing and handling requirements.
For total sample volume requirements, refer to the instrument-specific
ASSAY PARAMETERS section of this package insert and Section 5 of
the instrument-specific operations manual.
REAGENTS
Specimen Storage
Reagent Kit
Serum, plasma, and urine
Magnesium is supplied as a liquid, ready-to-use, single reagent kit
which contains:
7D70-20
10 x 84 mL
Estimated tests per kit: 3,622*
Temperature
Maximum Storage
Bibliographic
Serum/Plasma
Urine*
Reference
20 to 25°C
7 days
3 days
6
2 to 8°C
7 days
3 days
6, 7
-20°C
1 year
1 year
6
* Acidify to pH < 2.
Guder et al.6 suggest storage of frozen specimens at -20°C for
no longer than the time intervals cited above. However, limitations
of laboratory equipment make it necessary in practice for clinical
laboratories to establish a range around -20°C for specimen storage.
This temperature range may be established from either the freezer
manufacturer’s specifications or your laboratory standard operating
procedure(s) for specimen storage.
NOTE: Stored specimens must be inspected for particulates. If present,
mix and centrifuge the specimen to remove particulates prior to testing.
7D70-30
6 x 84 mL
Estimated tests per kit: 2,173*
*Calculation is based on the minimum reagent fill volume per kit.
Reactive Ingredients
TRIS Buffer
Arsenazo Dye
Sodium Azide
Concentration
100 mmol/L
0.13 mmol/L
0.1%
REAGENT HANDLING AND STORAGE
Reagent Handling
PROCEDURE
Remove air bubbles, if present in the reagent cartridge, with a new
applicator stick. Alternatively, allow the reagent to sit at the appropriate
storage temperature to allow the bubbles to dissipate. To minimize
volume depletion, do not use a transfer pipette to remove the bubbles.
CAUTION: Reagent bubbles may interfere with proper detection of
reagent level in the cartridge, causing insufficient reagent aspiration
which could impact results.
Materials Provided
Reagent Storage
Assay Procedure
7D70 Magnesium Reagent Kit
Materials Required but not Provided
•
1E69 Iron/Magnesium Calibrator,
3 x 5 mL
• Control Material
• Saline (0.85% to 0.90% NaCl) for specimens that require dilution
Unopened reagents are stable until the expiration date when stored at
15 to 30°C.
Reagent stability is 21 days if the reagent is uncapped and onboard.
For a detailed description of how to run an assay, refer to Section 5 of
the instrument-specific operations manual.
Specimen Dilution Procedures
WARNINGS AND PRECAUTIONS
The ARCHITECT c Systems and the AEROSET System have automatic
dilution features; refer to Section 2 of the instrument-specific operations
manual for additional information.
Serum and plasma: Specimens with magnesium values exceeding
7.8 mEq/L (3.90 mmol/L) are flagged and may be diluted using the
Automated Dilution Protocol or the Manual Dilution Procedure.
Urine: Urine samples are automatically diluted 1:5 by the system using
the Standard dilution option, then the system automatically corrects the
concentration by multiplying the result by the appropriate dilution factor.
This dilution extends urine Magnesium linearity to 21.7 mEq/L
(10.85 mmol/L). Samples exceeding this concentration are flagged and
may be diluted using the Automated Dilution Protocol or the Manual
Dilution Procedure.
Precautions for Users
1. For in vitro diagnostic use.
2. Do not use components beyond the expiration date.
3. Do not mix materials from different kit lot numbers.
4.
contains sodium azide. For a specific listing, refer to the
REAGENTS section. Contact with acids liberates very toxic gas. This
material and its container must be disposed of in a safe way.
NOTE: Refer to Section 8 of the instrument-specific operations
manual for proper handling and disposal of reagents containing
sodium azide.
2
PROCEDURE (Continued)
EXPECTED VALUES
Serum/Plasma Automated Dilution Protocol
If using the Automated Dilution Protocol, the system performs a dilution
of the specimen and automatically corrects the concentration by
multiplying the result by the appropriate dilution factor. To set up the
automatic dilution feature, refer to Section 2 of the instrument-specific
operations manual for additional information.
Reference Range
Serum/Plasma8
Range (mEq/L) Range (mg/dL) Range (mmol/L)
Newborn, 2 to 4 days
1.2 to 1.8
1.5 to 2.2
5 months to 6 years
1.4 to 1.9
1.7 to 2.3
0.62 to 0.91
0.70 to 0.95
Urine Automated Dilution Protocol
If using the Automated Dilution Protocol, the system performs a 1:10
dilution of the specimen and automatically corrects the concentration by
multiplying the result by the appropriate dilution factor.
6 to 12 years
1.4 to 1.7
1.7 to 2.1
0.70 to 0.86
12 to 20 years
1.4 to 1.8
1.7 to 2.2
0.70 to 0.91
Adult
1.3 to 2.1
1.6 to 2.6
0.66 to 1.07
Manual Dilution Procedure
Manual dilutions should be performed as follows:
• Use saline (0.85% to 0.90% NaCl) to dilute the sample.
• The operator must enter the dilution factor in the patient or control
order screen. The system uses this dilution factor to automatically
correct the concentration by multiplying the result by the entered
factor.
• If the operator does not enter the dilution factor, the result must be
multiplied by the appropriate dilution factor before reporting the result.
NOTE: If a diluted sample result is flagged indicating it is less than the
linear low limit, do not report the result. Rerun using an appropriate
dilution.
For detailed information on ordering dilutions, refer to Section 5 of the
instrument-specific operations manual.
NOTE: Higher values can be expected in females during menses.
To convert results from mEq/L to mg/dL, multiply mEq/L by 1.215.
To convert results from mEq/L to mmol/L, multiply mEq/L by 0.5.
When converting the units for an assay, the following items must be
edited, if applicable, using the appropriate conversion factor.
• Calibrator Values
• Reference Range
• Qualitative/Interpretation Range • Panic/Extreme Range
• Linear Range
• Control Means
• Retest rules ranges (ARCHITECT c Systems Only)
• Constituent assay ranges for calculated assays (ARCHITECT c Systems
• Min and Max Fields (AEROSET System Only)
Urine8
Range (mEq/day)
CALIBRATION
24 hour
Calibration is stable for approximately 1 day (24 hours) and is required
with each reagent cartridge and lot number change. Verify calibration
with at least two levels of controls according to the established quality
control requirements for your laboratory. If control results fall outside
acceptable ranges, recalibration may be necessary.
The urine application uses the serum calibration.
For a detailed description of how to calibrate an assay, refer to Section
6 of the instrument-specific operations manual.
For information on calibrator standardization, refer to the Iron/Magnesium
Calibrator package insert.
6.0 to 10.0
Range (mg/day) Range (mmol/day)
72.9 to 121.5
3.00 to 5.00
To convert results from mEq/day to mmol/day, multiply mEq/day by 0.5.
To convert results from mEq/day to mg/day, multiply mEq/day by 12.15.
It is recommended that each laboratory determine its own reference
range based upon its particular locale and population characteristics.
24 Hour Urinary Excretion
To convert results from mEq/L to mEq/day (24 hour urinary excretion)
Where:
V = 24 hour urine volume (mL)
QUALITY CONTROL
c = analyte concentration (mEq/L)
The following is the recommendation of Abbott Laboratories for quality
control. As appropriate, refer to your laboratory standard operating
procedure(s) and/or quality assurance plan for additional quality control
requirements and potential corrective actions.
• Two levels of controls (normal and abnormal) are to be run every
24 hours.
• If more frequent control monitoring is required, follow the established
quality control procedures for your laboratory.
• If quality control results do not meet the acceptance criteria
defined by your laboratory, patient values may be suspect. Follow
the established quality control procedures for your laboratory.
Recalibration may be necessary.
• Review quality control results and acceptance criteria following a
change of reagent or calibrator lot.
24 hour excretion = [(V × c) ÷ 1000] mEq/day
To convert results from mmol/L to mmol/day (24 hour urinary excretion)
Where:
V = 24 hour urine volume (mL)
c = analyte concentration (mmol/L)
24 hour excretion = [(V × c) ÷ 1000] mmol/day
SPECIFIC PERFORMANCE CHARACTERISTICS
Linearity
Magnesium serum is linear up to 7.8 mEq/L or 9.5 mg/dL (3.90 mmol/L).
Magnesium urine is linear up to 21.7 mEq/L or 26.4 mg/dL
(10.85 mmol/L). Linearity was verified using Clinical and Laboratory
Standards Institute (CLSI) protocol NCCLS EP6-P.9
RESULTS
Refer to the instrument-specific operations manual for information on
results calculations.
• ARCHITECT System Operations Manual—Appendix C
• AEROSET System Operations Manual—Appendix A
Representative performance data are given in the EXPECTED VALUES
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this
package insert. Results obtained in individual laboratories may vary.
Limit of Detection (LOD)
The LOD for Magnesium serum is 0.125 mEq/L or 0.152 mg/dL
(0.063 mmol/L). The LOD for Magnesium urine is 0.625 mEq/L or
0.759 mg/dL (0.313 mmol/L). The LOD is the mean concentration of
an analyte-free sample + 2 SD, where SD = the pooled, within-run
standard deviation of the analyte-free sample. A study performed on an
ARCHITECT c System and an AEROSET System produced an LOD for
Magnesium serum of 0.10 mEq/L or 0.12 mg/dL (0.050 mmol/L) and for
Magnesium urine of 0.44 mEq/L or 0.53 mg/dL (0.220 mmol/L).
LIMITATIONS OF THE PROCEDURE
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC
PERFORMANCE CHARACTERISTICS sections of this package insert.
Limit of Quantitation (LOQ)
The LOQ for Magnesium serum is 0.54 mEq/L or 0.66 mg/dL
(0.270 mmol/L). The LOQ for Magnesium urine is 1.26 mEq/L or
1.53 mg/dL (0.630 mmol/L). The LOQ is the analyte concentration at
which the CV = 20%.
3
SPECIFIC PERFORMANCE CHARACTERISTICS
(Continued)
Interfering
Method Comparison
Correlation studies were performed using CLSI protocol NCCLS EP9-A.14
Serum and urine results from the Magnesium assay on the AEROSET
System were compared with those from a commercially available
calmagite methodology.
Serum and urine results from the Magnesium assay on an
ARCHITECT c System were compared with those from the Magnesium
assay on the AEROSET System.
Substances10
Interference studies were conducted using CLSI protocol NCCLS
EP7-P.11 Interference effects were assessed by Dose Response and
Paired Difference methods, at the medical decision level of the analyte.
Interfering
Substance
Bilirubin
Hemoglobin
Interferent Concentration
N
30 mg/dL (513 µmol/L)
3
Target Observed
(mEq/L) (% of Target)
1.7
Serum
100.3
AEROSET vs.
Comparative Method
ARCHITECT vs.
AEROSET
60 mg/dL (1,026 µmol/L)
3
1.7
96.2
N
94
84
62 mg/dL (0.62 g/L)
3
1.4
107.4
Y - Intercept
0.044
0.015
125 mg/dL (1.25 g/L)
3
1.4
118.2
Correlation Coefficient
0.993
0.998
750 mg/dL (8.5 mmol/L)
4
2.5
95.1
Slope
1.02
0.965
4
2.5
94.3
Range (mEq/L)*
0.69 to 3.96
0.20 to 7.10
AEROSET vs.
Comparative Method
ARCHITECT vs.
AEROSET
Human
triglyceride 1,000 mg/dL (11.3 mmol/L)
*AEROSET Range
Bilirubin solutions at the above concentrations were prepared by
addition of a bilirubin stock to human serum pools. Hemoglobin
solutions at the above concentrations were prepared by addition of
hemolysate to human serum pools. Human triglyceride solutions at the
above concentrations were prepared by mixing an elevated triglyceride
human serum pool with a normal triglyceride human serum pool.
For the urine application, protein up to 50 mg/dL, glucose up to
1,000 mg/dL, sodium oxalate up to 60 mg/dL, ascorbate up to
200 mg/dL, boric acid up to 250 mg/dL, 6 N hydrochloric acid up
to 2.5 mL/dL, 6 N nitric acid up to 5.0 mL/dL, sodium fluoride up to
400 mg/dL, and sodium carbonate up to 1.25 g/dL demonstrated less
than 10% interference. 8.5 N acetic acid up to 6.25 mL/dL demonstrated
10% interference.
Urine
N
62
67
Y - Intercept
-0.622
0.34
Correlation Coefficient
0.980
0.994
Slope
1.01
0.96
1.32 to 17.40
0.49 to 18.83
Range (mEq/L)*
*AEROSET Range
Precision
BIBLIOGRAPHY
Serum
The imprecision of the Magnesium serum assay is ≤ 4% Total CV.
Representative data from studies using CLSI protocol NCCLS EP5-T212
are summarized below.
1. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry,
2nd ed. Philadelphia, PA: WB Saunders; 1994:1913.
2. US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030. Occupational Exposure to
Bloodborne Pathogens.
3. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories. HHS Publication (CDC),
4th ed. Washington, DC: US Government Printing Office, May 1999.
4. World Health Organization. Laboratory Biosafety Manual. Geneva: World
Health Organization, 2004.
5. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved Guideline—
Third Edition (M29-A3). Wayne, PA: Clinical and Laboratory Standards
Institute, 2005.
6. Guder WG, Narayanan S, Wisser H, et al. List of analytes—preanalytical
variables. Annex In: Samples: From the Patient to the Laboratory.
Darmstadt, Germany: GIT Verlag; 1996:Annex 18–9, 38–9.
7. US Pharmacopeial Convention, Inc. General notices. In: US
Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18). Rockville,
MD: The US Pharmacopeial Convention, Inc; 1994:11.
8. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry,
3rd ed. Philadelphia, PA: WB Saunders; 1999:1825.
9. Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity of
Quantitative Analytical Methods; Proposed Guideline (EP6-P). Villanova,
PA: The National Committee for Clinical Laboratory Standards, 1986.
10. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
Washington, DC: AACC Press; 1995:3-410–3-414.
11. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in Clinical
Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The National
Committee for Clinical Laboratory Standards, 1986.
12. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Performance of Clinical Chemistry Devices—Second Edition; Tentative
Guideline (EP5-T2). Villanova, PA: The National Committee for Clinical
Laboratory Standards, 1992.
13. Garber CC, Clark LW, Garrett PE, et al. Preliminary Evaluation of
Quantitative Clinical Laboratory Methods—Second Edition; Tentative
Guideline (EP10-T2). Villanova, PA: The National Committee for Clinical
Laboratory Standards, 1993.
14. Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison and
Bias Estimation Using Patient Samples; Approved Guideline (EP9-A).
Wayne, PA: The National Committee for Clinical Laboratory Standards,
1995.
Control
Level 1
Level 2
N
80
80
Mean (mg/dL)
Within Run
Between Run
1.4
4.0
SD
0.04
0.05
%CV
2.6
1.2
0.00
SD
1.01
%CV
0.6
0.0
SD
0.05
0.13
Between Day
Total
%CV
3.5
3.2
SD
0.06
0.14
%CV
4.4
3.4
Urine
The imprecision of the Magnesium urine assay is ≤ 6% Total CV.
Representative data from studies using CLSI protocol NCCLS EP10-T213
are summarized below.
Control
Level 1
N
50
50
Mean (mg/dL)
5.2
11.7
0.17
Within Run
Between Run
Level 2
SD
0.20
%CV
3.8
1.5
SD
0.00
0.05
%CV
0.0
0.4
SD
0.12
0.29
%CV
2.4
2.5
SD
0.23
0.34
%CV
4.5
2.9
TRADEMARKS
AEROSET and ARCHITECT are registered trademarks of Abbott
Laboratories.
c System is a trademark of Abbott Laboratories.
All other trademarks, brands, product names, and trade names are the
property of their respective companies.
Between Day
Total
4
ARCHITECT c SYSTEMS ASSAY PARAMETERS
Magnesium Serum/Plasma—Conventional and SI Units
Configure assay parameters — SmartWash
Configure assay parameters — General
● General
о Calibration о SmartWash о Results
о General о Calibration ● SmartWash о Results о Interpretation
Assay:
Mg
COMPONENT REAGENT / ASSAY WASH
Volume Replicates
R1
CHOL0
Detergent A
345
1
R1
CK000
0.5% Acid Wash
345
1
R1
ALBG0
Detergent A
345
1
R1
ALKP0
Detergent A
345
1
R1
CO200
Detergent A
345
1
R1
GLU00
Detergent A
345
1
R1
ICTD0
0.5% Acid Wash
345
1
Cuvette
Trig
10% Detergent B*** 345
*** Select “Detergent B” for software prior to Version 2.2.
о Interpretation
Assay: Mg
Type: Photometric
Version: †
Number: 1009
● Reaction definition о Reagent / Sample о Validity checks
Reaction mode: End up
Primary Secondary
Read times
Wavelength: 572 / 604
Main: 10 – 12
Last required read: 12
Absorbance range: ___–___
Color Correction: ___–___
Sample blank type: None
о Reaction definition
Reagent: MG000
Diluent: Saline
Diluent dispense mode: Type 0
Diluted
Dilution name Sample sample
STANDARD : 2.4
___
_________ : ___
___
_________ : ___
___
● Reagent / Sample о Validity checks
Reagent volume:
Water volume:
Dispense mode:
Diluent
___
___
___
о Reaction definition
Reaction check:
None
R1
200
___
Type 0
Water Dilution factor
___ =
1:1.00
___ =
___ =
Magnesium Serum/Plasma—Conventional Units
Configure assay parameters — Results — Conventional Units
о General
о SmartWash ● Results о Interpretation
Assay: Mg
Result units: mEq/L
Assay defaults:
‡
Low-Linearity:
0.6
High-Linearity: 7.8
Gender and age specific ranges:*
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
1.3 – 2.1
Default
dilution
●
о
о
о Reagent / Sample ● Validity checks
Configure result units — Conventional Units
Maximum absorbance variation: ___
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
Configure assay parameters — Calibration
о General
Assay:
● Calibration о SmartWash о Results
Mg
● Calibrators
Calibrator set:
FeMg
Replicates: 3
о Calibrators
[Range 1 – 3]
о Intervals
Calibrator level:
Blank: Water
Cal 1: FeMg1
Cal 2: FeMg2
● Volumes
о Intervals
Calibrator: FeMg
Calibrator level
Blank: Water
Cal 1: FeMg1
Cal 2: FeMg2
о Calibrators
о Volumes
Calibration intervals:
Full interval: 24
Calibration type:
Adjust type: None
о Calibrators
о Volumes
Blank absorbance range:
Span:
Span absorbance range:
Expected cal factor:
Expected cal factor tolerance %:
*
†
‡
††
‡‡
о Interpretation
Calibration method: Linear
о Volumes
Sample
2.4
2.4
2.4
Diluted
sample
___
___
___
● Intervals
о Calibration
Mg
8
mEq/L
1
[Range 0 – 4]
1.0000
0.0000
о Validity checks
Concentration:
0‡‡
††
††
Magnesium Serum/Plasma—SI Units
Configure assay parameters — Results — SI Units
о General
о SmartWash ● Results о Interpretation
Assay: Mg
Result units: mmol/L
Assay defaults:
Low-Linearity:
0.27‡
High-Linearity: 3.90
Gender and age specific ranges:*
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
0.66 – 1.07
о Validity checks
Diluent
___
___
___
Water
___
___
___
о Calibration
о Validity checks
(hours)
Configure result units — SI Units
о Intervals
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
● Validity checks
_____ – _____
Blank – Blank
_____ – _____
0.00
0
Mg
5
mmol/L
2
[Range 0 – 4]
1.0000
0.0000
User defined.
The respective assay versions for Conventional and SI Units are listed in the Configure result units screens on this page.
The linear low value (Low-Linearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.
Refer to concentration specified on calibrator labeling or value sheet.
Displays the number of decimal places defined in the decimal places parameter field.
5
ARCHITECT c SYSTEMS ASSAY PARAMETERS
Magnesium Urine—Conventional and SI Units
Configure assay parameters — General
● General
Configure assay parameters — SmartWash
о Calibration о SmartWash о Results
о Interpretation
о General о Calibration ● SmartWash о Results о Interpretation
Assay:
Mg-U
COMPONENT REAGENT / ASSAY WASH
Volume Replicates
R1
CHOL0
Detergent A
345
1
R1
CK000
0.5% Acid Wash
345
1
R1
ALBG0
Detergent A
345
1
R1
ALKP0
Detergent A
345
1
R1
CO200
Detergent A
345
1
R1
GLU00
Detergent A
345
1
R1
ICTD0
0.5% Acid Wash
345
1
Cuvette
Trig
10% Detergent B*** 345
*** Select “Detergent B” for software prior to Version 2.2.
Assay: Mg-U
Type: Photometric
Version: †
Number: 1040
● Reaction definition о Reagent / Sample о Validity checks
Reaction mode: End up
Primary Secondary
Read times
Wavelength: 572 / 604
Main: 10 – 12
Last required read: 12
Absorbance range: ___–___
Color Correction: ___–___
Sample blank type: None
о Reaction definition
Reagent: MG000
Diluent: Saline
Diluent dispense mode: Type 0
Diluted
Dilution name Sample sample
STD(1:5) : 30.0
2.4
1:10
: 15.0
2.4
_________ : ___
___
о Reaction definition
Reaction check:
None
● Reagent / Sample о Validity checks
Reagent volume:
Water volume:
Dispense mode:
Diluent
120
135
___
R1
200
___
Type 0
Water Dilution factor
___ =
1:5.00
___ =
1:10.00
___ =
Magnesium Urine—Conventional Units
Configure assay parameters — Results — Conventional Units
о General
о SmartWash ● Results о Interpretation
Assay: Mg-U
Result units: mEq/L
Assay defaults:
‡
Low-Linearity:
0.3
High-Linearity: 4.3‡
Gender and age specific ranges:
GENDER
AGE (UNITS)
NORMAL
EXTREME
Default
dilution
●
о
о
о Reagent / Sample ● Validity checks
Configure result units — Conventional Units
Maximum absorbance variation: ___
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
Configure assay parameters — Calibration
о General
Assay:
● Calibration о SmartWash о Results
Mg-U
о Calibration
о Interpretation
Calibration method: Use Cal Factor/Blank
Use Cal factor from: Mg
Mg-U
8
mEq/L
1
[Range 0 – 4]
1.0000
0.0000
Magnesium Urine—SI Units
Configure assay parameters — Results — SI Units
о General
о Calibration
о SmartWash ● Results о Interpretation
Assay: Mg-U
Result units: mmol/L
Assay defaults:
Low-Linearity:
0.13‡
High-Linearity: 2.17‡
Gender and age specific ranges:
GENDER
AGE (UNITS)
NORMAL
EXTREME
Configure result units — SI Units
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
†
‡
Mg-U
5
mmol/L
2
[Range 0 – 4]
1.0000
0.0000
The respective assay versions for Conventional and SI Units are listed in the Configure result units screens on this page.
The linear low value (Low-Linearity) is LOQ divided by the Standard dilution factor, then rounded up to the number of decimal places defined in
the decimal places parameter field. The linear high value (High-Linearity) is Linearity divided by the Standard dilution factor.
6
AEROSET SYSTEM ASSAY PARAMETERS
Magnesium Serum/Plasma—Conventional Units
Magnesium Serum/Plasma—SI Units
Assay Configuration: Outline Page
Assay Configuration: Outline Page
Assay Name
Assay #
Mg
9
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
L-Reference-H
0.0
0.6**
1.3
2.1
L-Linear Range-H
Reference Ranges*
Age
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
Qualitative Ranges
Assay Name
Assay #
Mg
9
Quantitative Ranges
Min Text
Min Panic-L
Line
B-Line
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
Max
0.0
7.8
0.0*
0.0
0.0
0.0
0.0
Max
Text
*
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
0.0*
0.66
1.07
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
Qualitative Ranges
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
Max
0.0
3.90
0.0
0.0
0.0
0.0
0.0*
Female
– 0.0
– 0.0
– 0.0
– 0.0
Assay Configuration: Base Page
Wavelength-Prim/
Read time-Main/Flex
AbsMaxVar
Sec
END UP
572 / 604
10 – 12 / 0 – 0
0.0
Sample Blank Test
Blank Read Time
Abs Window
Abs Limits
_____ ( ___ )
0–0
0–0
0.0 – 0.0
S.Vol DS.Vol D.Vol
W.Vol
Standard
2.4
0.0
0
0
Rgt Name/Pos
Dil 1
2.4
0.0
0
0
Diluent: _____ _–__*
Dil 2
2.4
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol
W.Vol Type#
Reagent 1
MG00061 – ___* 200
0
0
Reaction Check
Read Time – A/B
Range
Minimum
____________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
2
mmol/L
Reaction Mode
Assay Configuration: Calibration Page
Assay Configuration: Calibration Page
Calib Mode
Linear
Blank/Calib Replicates
3/3
Sample
S.Vol
BLK Water
2.4
C1
FeMg 1
2.4
C2
FeMg 2
2.4
Interval (H)
24
Span
Span Abs Range
BLK – 1
0.0 – 0.0
W.Vol
Blk Abs Range
0
0.0 – 0.0
0
Cal Deviation
0
0.0
FAC Limit (%)
10
Assay Configuration: SmartWash Page
Extrapolation %
0
DS.Vol
D.Vol
0.0
0
0.0
0
0.0
0
Interval (H)
24
Span
Span Abs Range
BLK – 1
0.0 – 0.0
W.Vol
Blk Abs Range
0
0.0 – 0.0
0
Cal Deviation
0
0.0
FAC Limit (%)
10
Assay Configuration: SmartWash Page
Rgt Probe
Rgt Probe
Reagent
ALKP061
ALBG061
CHOL061
CK00061
CO20051
GLU0061
ICTD061
ALKP051
CO2C951
CO2C961
Wash
AlkW
AlkW
AlkW
AlkW
AlkW
Water
AcidW
AlkW
AlkW
AlkW
Vol
345
345
345
345
345
345
345
345
345
345
Reagent
ALKP061
ALBG061
CHOL061
CK00061
CO20051
GLU0061
ICTD061
ALKP051
CO2C951
CO2C961
Cuvette
Wash
AlkW
AlkW
AlkW
AlkW
AlkW
Water
AcidW
AlkW
AlkW
AlkW
Vol
345
345
345
345
345
345
345
345
345
345
Cuvette
Assay Name
—
Wash
—
Max
Text
*
N/A
Assay Configuration: Base Page
Wavelength-Prim/
Read time-Main/Flex
AbsMaxVar
Sec
END UP
572 / 604
10 – 12 / 0 – 0
0.0
Sample Blank Test
Blank Read Time
Abs Window
Abs Limits
_____ ( ___ )
0–0
0–0
0.0 – 0.0
S.Vol DS.Vol D.Vol
W.Vol
Standard
2.4
0.0
0
0
Rgt Name/Pos
Dil 1
2.4
0.0
0
0
Diluent: _____ _–__*
Dil 2
2.4
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol
W.Vol Type#
Reagent 1
MG00061 – ___* 200
0
0
Reaction Check
Read Time – A/B
Range
Minimum
____________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
1
mEq/L
Reaction Mode
Extrapolation %
0
DS.Vol
D.Vol
0.0
0
0.0
0
0.0
0
L-Reference-H
0.0
0.27**
Reference Ranges*
Age
N/A
Calib Mode
Linear
Blank/Calib Replicates
3/3
Sample
S.Vol
BLK Water
2.4
C1
FeMg 1
2.4
C2
FeMg 2
2.4
Line
B-Line
Vol
—
Assay Name
—
Sample Probe
Wash
—
Vol
—
Sample Probe
Wash
—
Wash
—
Refer to Assay Configuration in Section 2 of the AEROSET System Operations Manual for information regarding assay parameters.
* User defined or instrument defined.
** The linear low value (L-Linear Range) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.
7
AEROSET SYSTEM ASSAY PARAMETERS
Magnesium Urine—Conventional Units
Magnesium Urine—SI Units
Assay Configuration: Outline Page
Assay Configuration: Outline Page
Assay Name
Assay #
Mg-U
40
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
L-Reference-H
0.0
0.3**
0.0
0.0
L-Linear Range-H
Reference Ranges*
Age
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
Qualitative Ranges
Assay Name
Assay #
Mg-U
40
Quantitative Ranges
Min Text
Min Panic-L
Line
B-Line
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
Max
0.0
4.3**
0.0
0.0
0.0
0.0
0.0*
Max
Text
*
*
Line
B-Line
L-Reference-H
0.0
0.13**
Reference Ranges*
Age
Female
– 0.0
– 0.0
– 0.0
– 0.0
0.0*
0.0
0.0
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
Qualitative Ranges
N/A
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
Max
0.0
0.0*
2.17**
0.0
0.0
0.0
0.0
Max
Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
N/A
Assay Configuration: Base Page
Assay Configuration: Base Page
Wavelength-Prim/
Read time-Main/Flex
AbsMaxVar
Sec
END UP
572 / 604
10 – 12 / 0 – 0
0.0
Sample Blank Test
Blank Read Time
Abs Window
Abs Limits
_____ ( ___ )
0–0
0–0
0.0 – 0.0
S.Vol DS.Vol D.Vol
W.Vol
Standard
30.0
2.4
120
0
Rgt Name/Pos
Dil 1
15.0
2.4
135
0
Diluent: DILUENT D–18*
Dil 2
30.0
2.4
120
0
Type#
0
Rgt Name/Pos
R.Vol
W.Vol Type#
Reagent 1
MG00061 – ___* 200
0
0
Reaction Check
Read Time – A/B
Range
Minimum
____________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
1
mEq/L
Wavelength-Prim/
Read time-Main/Flex
AbsMaxVar
Sec
END UP
572 / 604
10 – 12 / 0 – 0
0.0
Sample Blank Test
Blank Read Time
Abs Window
Abs Limits
_____ ( ___ )
0–0
0–0
0.0 – 0.0
S.Vol DS.Vol D.Vol
W.Vol
Standard
30.0
2.4
120
0
Rgt Name/Pos
Dil 1
15.0
2.4
135
0
Diluent: DILUENT D–18*
Dil 2
30.0
2.4
120
0
Type#
0
Rgt Name/Pos
R.Vol
W.Vol Type#
Reagent 1
MG00061 – ___* 200
0
0
Reaction Check
Read Time – A/B
Range
Minimum
____________
1–1/1–1
0.0 – 0.0
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
2
mmol/L
Reaction Mode
Reaction Mode
Assay Configuration: Calibration Page
Assay Configuration: Calibration Page
Calib Mode
UseFac/Blk
Blank/Calib Replicates
0/0
Sample
S.Vol
BLK
2.0
C1
2.0
C2
2.0
Use Cal Factor from
Mg ( 9 )
Extrapolation %
0
DS.Vol
D.Vol
0.0
0
0.0
0
0.0
0
Calib Mode
UseFac/Blk
Blank/Calib Replicates
0/0
Sample
S.Vol
BLK
2.0
C1
2.0
C2
2.0
Interval (H)
0
Span
Span Abs Range
BLK – 1
0.0 – 0.0
W.Vol
Blk Abs Range
0
0.0 – 0.0
0
Cal Deviation
0
0.0
Assay Configuration: SmartWash Page
Use Cal Factor from
Mg ( 9 )
Extrapolation %
0
DS.Vol
D.Vol
0.0
0
0.0
0
0.0
0
Interval (H)
0
Span
Span Abs Range
BLK – 1
0.0 – 0.0
W.Vol
Blk Abs Range
0
0.0 – 0.0
0
Cal Deviation
0
0.0
Assay Configuration: SmartWash Page
Rgt Probe
Rgt Probe
Reagent
ALKP061
ALBG061
CHOL061
CK00061
CO20051
GLU0061
ICTD061
ALKP051
CO2C951
CO2C961
Wash
AlkW
AlkW
AlkW
AlkW
AlkW
Water
AcidW
AlkW
AlkW
AlkW
Vol
345
345
345
345
345
345
345
345
345
345
Reagent
ALKP061
ALBG061
CHOL061
CK00061
CO20051
GLU0061
ICTD061
ALKP051
CO2C951
CO2C961
Cuvette
Wash
AlkW
AlkW
AlkW
AlkW
AlkW
Water
AcidW
AlkW
AlkW
AlkW
Vol
345
345
345
345
345
345
345
345
345
345
Cuvette
Assay Name
—
Wash
—
Vol
—
Assay Name
—
Sample Probe
Wash
—
Vol
—
Sample Probe
Wash
—
Wash
—
Refer to Assay Configuration in Section 2 of the AEROSET System Operations Manual for information regarding assay parameters.
* User defined or instrument defined.
** The linear low value (L-Linear Range) is LOQ divided by the Standard dilution factor, then rounded up to the number of decimal places defined in
the decimal places parameter field. The linear high value (Linear Range-H) is Linearity divided by the Standard dilution factor.
8