CALCIUM

7D61-20
30-3979/R5

CALCIUM
This package insert contains information to run the Calcium 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: 1-877-4ABBOTT
Canada: 1-800-387-8378 (English speaking customers)
1-800-465-2675 (French speaking customers)
International: Call your local Abbott representative

Symbols in Product Labeling

Calibrators 1 and 2 Catalog number/List number

Concentration Serial number

Authorized Representative in the
Consult instructions for use
European Community
Ingredients Manufacturer

In vitro diagnostic medical device Temperature limitation

Batch code/Lot number Use by/Expiration date

Reagent 1

ABBOTT LABORATORIES ABBOTT

Abbott Park, IL 60064, USA Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
June 2007
©2002, 2007 Abbott Laboratories

1
NAME
CALCIUM
INTENDED USE
The Calcium assay is used for the quantitation of calcium in human
serum, plasma, or urine.
SUMMARY AND EXPLANATION OF TEST
The majority of calcium in the body is present in bones. The remainder
of the calcium is in serum and has various functions. For example,
calcium ions decrease neuromuscular excitability, participate in blood
coagulation, and activate some enzymes.
Hypercalcemia can result from hyperparathyroidism, hypervitaminosis D,
multiple myeloma, and some neoplastic diseases of bone.1 Long-term
lithium therapy has been reported to cause hyperparathyroidism in
some individuals, with resulting hypercalcemia.2
Hypocalcemia can result from hypoparathyroidism, steatorrhea,
nephrosis, nephritis, and pancreatitis.1
Calcium has traditionally been difficult to measure accurately and
precisely, and a large variety of methods have been developed. Among
these are flame photometry, oxalate precipitation with titration, atomic
absorption spectrophotometry, EDTA chelation, and more recently
calcium dye complexes which are measured spectrophotometrically.
Examples of calcium dyes are o-cresolphthalein complexone and
Arsenazo III, the latter being the dye used for calcium determination in
this method.
PRINCIPLES OF PROCEDURE
Arsenazo-III dye reacts with calcium in an acid solution to form a
blue-purple complex. The color developed is measured at 660 nm and
is proportional to the calcium concentration in the sample.
Methodology: Arsenazo III
REAGENTS
Reagent Kit
7D61 Calcium is supplied as a liquid, ready-to-use, single reagent
kit which contains:
10 x 84 mL
Estimated tests per kit: 3,032
Calculation is based on the minimum reagent fill volume per kit.
Reactive Ingredient Concentration
Arsenazo-III Dye ≥ 0.15 mmol/L
REAGENT HANDLING AND STORAGE
Reagent Handling
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.
Reagent Storage
Unopened reagents are stable until the expiration date when stored
at 15 to 30°C.
Reagent stability is 41 days if the reagent is uncapped and onboard.
WARNINGS AND PRECAUTIONS
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.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.3 Biosafety Level 24 or other
appropriate biosafety practices5,6 should be used for materials that
contain or are suspected of containing infectious agents.
For reagents not classified as dangerous per European Directive
1999/45/EC as amended, safety data sheet available for professional
user on request.
2
SPECIMEN COLLECTION AND HANDLING
Suitable Specimens
Serum, plasma, and urine are acceptable specimens.
• Serum: Use 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.
NOTE: Excess amounts of heparin in sample may cause depressed
or elevated calcium results. Ensure collection tubes are filled per
manufacturer’s specifications, IV line is cleared of solutions before
filling blood collection tubes, and current patient medications are
considered when evaluating calcium results.
• Urine: Collect 24 hour specimens in a bottle containing 20 to 30 mL
of 6 mol/L HCl (1 to 2 mL for a random specimen) in order to
prevent calcium salt precipitation.7
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.
Refer to the specimen collection tube manufacturer’s instructions for
processing and handling requirements.
Specimen Storage
Serum, plasma, and urine
Maximum Storage Bibliographic
Temperature
Serum/Plasma Urine* Reference
20 to 25°C 7 days 2 days 8
2 to 8°C 3 weeks 4 days 8, 9
-20°C 8 months 3 weeks 8
* Acidify to pH < 2.
Guder et al.8 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.
PROCEDURE
Materials Provided
7D61 Calcium Reagent Kit
Materials Required but not Provided
• 1E65 Multiconstituent Calibrator, 3 x 5 mL
• Control Material
• Saline (0.85% to 0.90% NaCl) for specimens that require dilution
Assay Procedure
For a detailed description of how to run an assay, refer to Section 5 of
the instrument-specific operations manual.
Specimen Dilution Procedures
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 calcium values exceeding
26.1 mg/dL (6.53 mmol/L) are flagged and may be diluted using the
Automated Dilution Protocol or the Manual Dilution Procedure.
Urine: Specimens with calcium values exceeding 27.4 mg/dL
(6.85 mmol/L) are flagged and may be diluted using the Automated
Dilution Protocol or the Manual Dilution Procedure.
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.
PROCEDURE (Continued) EXPECTED VALUES
Manual Dilution Procedure Reference Range (Continued)
Manual dilutions should be performed as follows: Serum/Plasma (Continued)
• Use saline (0.85% to 0.90% NaCl) to dilute the sample.
• The operator must enter the dilution factor in the patient or control The following ranges were obtained from literature citations12 and
order screen. The system uses this dilution factor to automatically represent the CPC (O-cresolphthalein complexone) and AAS (atomic
correct the concentration by multiplying the result by the entered absorption spectrophotometry) methods. Refer to the METHOD
factor. COMPARISON section of this package insert for comparison of CPC
• If the operator does not enter the dilution factor, the result must with the AEROSET Calcium assay (Arsenazo III method).
be multiplied by the appropriate dilution factor before reporting the Range (mg/dL) Range (mmol/L)
result.
Cord 8.2 to 11.2 2.05 to 2.80
NOTE: If a diluted sample result is flagged indicating it is less than the Newborn
linear low limit, do not report the result. Rerun using an appropriate Premature 6.2 to 11.0 1.55 to 2.75
dilution. 0 to 10 days 7.6 to 10.4 1.90 to 2.60
For detailed information on ordering dilutions, refer to Section 5 of the 10 days to 24 months 9.0 to 11.0 2.25 to 2.75
instrument-specific operations manual. Child, 2 to 12 years 8.8 to 10.8 2.20 to 2.70
Adult 8.4 to 10.2 2.10 to 2.55
CALIBRATION Male > 60 years 8.8 to 10.0 2.20 to 2.50
Calibration is stable for approximately 41 days (984 hours) and is To convert results from mg/dL to mmol/L, multiply mg/dL by 0.25.
required with each change in reagent lot number. Verify calibration
curve with at least two levels of controls according to the established Urine
quality control requirements for your laboratory. If control results fall Range Range
outside acceptable ranges, recalibration may be necessary. Ca in diet
(mg/day) (mmol/day)
The urine application uses the serum calibration. Ca-free 5 to 40 0.13 to 1.00
For a detailed description of how to calibrate an assay, refer to Low to average 50 to 150 1.25 to 3.75
Section 6 of the instrument-specific operations manual. Average (800 mg/day or 20 mmol/day) 100 to 300 2.50 to 7.50
For information on calibrator standardization, refer to the
Multiconstituent Calibrator package insert.
To convert results from mg/day to mmol/day, multiply mg/day by 0.025.
QUALITY CONTROL It is recommended that each laboratory determine its own reference
The following is the recommendation of Abbott Laboratories for quality range based upon its particular locale and population characteristics.
control. As appropriate, refer to your laboratory standard operating 24 Hour Urinary Excretion
procedure(s) and/or quality assurance plan for additional quality control To convert results from mg/dL to mg/day (24 hour urinary excretion)
requirements and potential corrective actions.
• Two levels of controls (normal and abnormal) are to be run every Where:
24 hours. V = 24 hour urine volume (mL)
• If more frequent control monitoring is required, follow the established c = analyte concentration (mg/dL)
quality control procedures for your laboratory. 24 hour excretion = [(V × c) ÷ 100] mg/day
• If quality control results do not meet the acceptance criteria To convert results from mmol/L to mmol/day (24 hour urinary excretion)
defined by your laboratory, patient values may be suspect. Follow
the established quality control procedures for your laboratory. Where:
Recalibration may be necessary. V = 24 hour urine volume (mL)
• Review quality control results and acceptance criteria following a c = analyte concentration (mmol/L)
change of reagent or calibrator lot. 24 hour excretion = [(V × c) ÷ 1000] mmol/day
RESULTS SPECIFIC PERFORMANCE CHARACTERISTICS
Refer to the instrument-specific operations manual for information on
results calculations. Linearity
• ARCHITECT System Operations Manual—Appendix C Calcium serum is linear up to 26.1 mg/dL (6.53 mmol/L). Calcium urine
• AEROSET System Operations Manual—Appendix A is linear up to 27.4 mg/dL (6.85 mmol/L). Linearity was verified using
Representative performance data are given in the EXPECTED VALUES CLSI protocol NCCLS EP6-P.13
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this Limit of Detection (LOD)
package insert. Results obtained in individual laboratories may vary.
The LOD for Calcium serum is 0.4 mg/dL (0.1 mmol/L). The LOD
for Calcium urine is 0.4 mg/dL (0.1 mmol/L). The LOD is the mean
LIMITATIONS OF THE PROCEDURE concentration of an analyte-free sample + 2 SD, where SD = the
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC pooled, within run standard deviation of the analyte-free sample.
PERFORMANCE CHARACTERISTICS sections of this package insert. A study performed on an ARCHITECT c System and an AEROSET
System produced an LOD for Calcium serum of 0.09 mg/dL
EXPECTED VALUES (0.023 mmol/L) and an LOD for Calcium urine of 0.04 mg/dL
Reference Range (0.010 mmol/L).
Serum/Plasma Limit of Quantitation (LOQ)
A study was conducted using 145 serum samples from 88 female The LOQ for Calcium serum is 1.05 mg/dL (0.263 mmol/L). The LOQ
and 57 male volunteers. Data were analyzed as described by Solberg10 for Calcium urine is 0.08 mg/dL (0.020 mmol/L). The LOQ is the analyte
and Clinical and Laboratory Standards Institute (CLSI) protocol concentration at which the CV = 20%.
NCCLS C28-A.11 From this study, 95% of specimens fell within 8.9 to Interfering Substances14
10.0 mg/dL, with samples ranging from 8.8 to 10.3 mg/dL.
Interference studies were conducted using CLSI protocol NCCLS
Range (mg/dL) Range (mmol/L) EP7-P.15 Interference effects were assessed by Dose Response and
Adult 8.9 to 10.0 2.23 to 2.50 Paired Difference methods, at the medical decision level of the analyte.
Serum
Interfering Interferent Concentration N Target Observed
Substance (mg/dL) (% of Target)
30 mg/dL (513 μmol/L) 3 6.9 99.3
Bilirubin
60 mg/dL (1,026 μmol/L) 3 6.9 93.3
1,000 mg/dL (10.0 g/L) 3 5.4 103.5
Hemoglobin
2,000 mg/dL (20.0 g/L) 3 5.4 106.9
Human 750 mg/dL (8.5 mmol/L) 4 10.6 99.0
triglyceride 1,000 mg/dL (11.3 mmol/L) 4 10.6 98.8

3
SPECIFIC PERFORMANCE CHARACTERISTICS BIBLIOGRAPHY
Interfering Substances (Continued) 1. Tietz NW, editor. Fundamentals of Clinical Chemistry. Philadelphia,
PA: WB Saunders; 1970:638.
Bilirubin solutions at the above concentrations were prepared by 2. Bendz H, Sjödin I, Toss G, et al. Hyperparathyroidism and long-term
addition of a bilirubin stock to human serum pools. Hemoglobin lithium therapy — a cross-sectional study and the effect of lithium
solutions at the above concentrations were prepared by addition of withdrawal. J Intern Med 1996;240:357–65.
hemolysate to human serum pools. Human triglyceride solutions at the 3. US Department of Labor, Occupational Safety and Health
above concentrations were prepared by mixing an elevated triglyceride Administration. 29 CFR Part 1910.1030, Occupational Exposure to
human serum pool with a normal triglyceride human serum pool. Bloodborne Pathogens.
For the urine application, glucose up to 1,000 mg/dL, ascorbate 4. US Department of Health and Human Services. Biosafety in
up to 200 mg/dL, protein up to 50 mg/dL, acetic acid (8.5N) up to Microbiological and Biomedical Laboratories. 5th ed. Washington,
6.25 mL/dL, hydrochloric acid (6N) up to 2.5 mL/dL, nitric acid (6N) DC: US Government Printing Office, January 2007.
up to 5.0 mL/dL, and boric acid up to 250 mg/dL demonstrated less
than 10% interference. Sodium oxalate, sodium fluoride, and sodium 5. World Health Organization. Laboratory Biosafety Manual. Geneva:
carbonate demonstrated greater than 10% interference. World Health Organization, 2004.
6. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
Precision Workers from Occupationally Acquired Infections; Approved
The imprecision of the Calcium assay is ≤ 3% Total CV. Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and
Representative data from studies using CLSI protocol NCCLS EP5-A16 Laboratory Standards Institute, 2005.
are summarized below. 7. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical
Chemistry, 2nd ed. Philadelphia, PA: WB Saunders; 1994:1905.
Serum
8. Guder WG, Narayanan S, Wisser H, et al. List of analytes—
Control Level 1 Level 2 preanalytical variables. Annex In: Samples: From the Patient to the
N 80 80 Laboratory. Darmstadt, Germany: GIT Verlag; 1996:Annex 10–1,
Mean (mg/dL) 8.7 12.2 36–7.
SD 0.06 0.07 9. US Pharmacopeial Convention, Inc. General notices. In: US
Within Run Pharmacopeia National Formulary, 1995 ed. (USP 23/NF 18).
%CV 0.7 0.6 Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
SD 0.00 0.03 10. Solberg HE. Establishment and use of reference values. In: Burtis
Between Run
%CV 0.0 0.3 CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry, 2nd
SD 0.14 0.12 ed. Philadelphia, PA: WB Saunders; 1994:454–84.
Between Day 11. Sasse EA, Aziz KJ, Harris EK, et al. How to Define and Determine
%CV 1.6 1.0
SD 0.15 0.15 Reference Intervals in the Clinical Laboratory; Approved Guideline
Total (C28-A). Villanova, PA: The National Committee for Clinical
%CV 1.7 1.2 Laboratory Standards, 1995.
Representative data from studies using CLSI protocol NCCLS EP10-A17 12. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical
are summarized below. Chemistry, 2nd ed. Philadelphia, PA: WB Saunders; 1994:2180.
13. Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity
Urine of Quantitative Analytical Methods; Proposed Guideline (EP6-P).
Control Level 1 Level 2 Villanova, PA: The National Committee for Clinical Laboratory
Standards, 1986.
N 50 50
14. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
Mean (mg/dL) 8.0 13.0 Washington, DC: AACC Press; 1995:3-115–3-124.
SD 0.06 0.10 15. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in
Within Run
%CV 0.8 0.7 Clinical Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The
SD 0.04 0.03 National Committee for Clinical Laboratory Standards, 1986.
Between Run 16. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
%CV 0.5 0.2
SD 0.00 0.03 Performance of Clinical Chemistry Devices; Approved Guideline
Between Day (EP5-A). Wayne, PA: The National Committee for Clinical
%CV 0.0 0.2 Laboratory Standards, 1999.
SD 0.08 0.10 17. Krouwer JS, Castaneda-Mendez K, Dawson JM, et al. Preliminary
Total
%CV 1.0 0.8 Evaluation of Quantitative Clinical Laboratory Methods; Approved
Guideline (EP10-A). Wayne, PA: The National Committee for
Method Comparison Clinical Laboratory Standards, 1998.
Correlation studies were performed using CLSI protocol NCCLS 18. Kennedy JW, Carey NR, Coolen RB, et al. Method Comparison and
EP9-A.18 Bias Estimation Using Patient Samples; Approved Guideline (EP9-A).
Wayne, PA: The National Committee for Clinical Laboratory
Serum and urine results from the Calcium assay on the AEROSET Standards, 1995.
System were compared with those from a commercially available
O-CPC methodology.
TRADEMARKS
Serum and urine results from the Calcium assay on the ARCHITECT
c System were compared with the Calcium assay on the AEROSET AEROSET and ARCHITECT are registered trademarks of Abbott
System. Laboratories.
c System is a trademark of Abbott Laboratories.
Serum All other trademarks, brands, product names, and trade names are the
AEROSET ARCHITECT property of their respective companies.
vs. Comparative Method vs. AEROSET
N 100 102
Y - Intercept -0.13 -0.158
Correlation Coefficient 0.987 0.999
Slope 1.05 1.019
Range (mg/dL)* 4.5 to 14.5 2.8 to 25.5
*AEROSET Range
Urine
AEROSET ARCHITECT
vs. Comparative Method vs. AEROSET
N 91 98
Y - Intercept -0.27 -0.018
Correlation Coefficient 0.996 0.999
Slope 1.03 0.976
Range (mg/dL)* 0.3 to 16.1 0.3 to 26.0
*AEROSET Range
4
ARCHITECT c SYSTEMS ASSAY PARAMETERS

Calcium Serum/Plasma—Conventional and SI Units

Configure assay parameters — General Configure assay parameters — SmartWash
● General о Calibration о SmartWash о Results о Interpretation о General о Calibration ● SmartWash о Results о Interpretation
Assay: Ca Type: Photometric Version: † Assay: Ca
Number: 1008
COMPONENT REAGENT / ASSAY WASH Volume Replicates
● Reaction definition о Reagent / Sample о Validity checks R1 TP000 0.5% Acid Wash 345 1
Reaction mode: End up R1 CREA0 Water 300 1
Primary Secondary Read times
R1 AMY00 Water 300 1
Wavelength: 660 / 700 Main: 7 – 9
R1 TRIG0 Water 300 1
Last required read: 9 Cuvette Trig 10% Detergent B*** 345
Absorbance range: ___ – ___ Color correction: ___ – ___
Sample blank type: None ***Select “Detergent B” for software prior to version 2.2.

о Reaction definition ● Reagent / Sample о Validity checks Calcium Serum/Plasma—Conventional Units

R1
Reagent: CA000 Reagent volume: 240
Configure assay parameters — Results
Diluent: Saline Water volume: ___
Diluent dispense mode: Type 0 Dispense mode: Type 0 о General о Calibration о SmartWash ● Results о Interpretation
Assay: Ca Result units: mg/dL
Diluted Default
Dilution name Sample sample Diluent Water Dilution factor dilution Assay defaults:
STANDARD : 2.4 ___ ___ ___ = 1:1.00 ● Low-Linearity: 1.1‡‡
_________ : ___ ___ ___ ___ = о High-Linearity: 26.1
_________ : ___ ___ ___ ___ = о Gender and age specific ranges:
GENDER AGE (UNITS) NORMAL EXTREME
Either 0 – 130 (Y) 8.4 – 10.2
о Reaction definition о Reagent / Sample ● Validity checks
Reaction check: None
Configure result units
Assay: Ca
Version: †
Maximum absorbance variation: ___ Result units: mg/dL
Decimal places: 1 [Range 0 – 4]
Correlation factor: 1.0000
Configure assay parameters — Calibration Intercept: 0.0000
о General ● Calibration о SmartWash о Results о Interpretation
Assay: Ca Calibration method: Linear
● Calibrators о Volumes о Intervals о Validity checks Calcium Serum/Plasma—SI Units
Calibrator set: Calibrator level: Concentration:
MCC Blank: Water 0††
Cal 1: MCC1 ‡ Configure assay parameters — Results
Replicates: 3 [Range 1 – 3] Cal 2: MCC2 ‡ о General о Calibration о SmartWash ● Results о Interpretation
Assay: Ca Result units: mmol/L
о Calibrators ● Volumes о Intervals о Validity checks Assay defaults:
Calibrator: MCC Diluted Low-Linearity: 0.27‡‡
Calibrator level Sample sample Diluent Water High-Linearity: 6.53
Blank: Water 2.4 ___ ___ ___ Gender and age specific ranges:
Cal 1: MCC1 2.4 ___ ___ ___ GENDER AGE (UNITS) NORMAL EXTREME
Cal 2: MCC2 2.4 ___ ___ ___ Either 0 – 130 (Y) 2.10 – 2.55

о Calibrators о Volumes ● Intervals о Validity checks Configure result units

Calibration intervals:
Full interval: 984 (hours) Assay: Ca
Calibration type: Version: †
Adjust type: None Result units: mmol/L
Decimal places: 2 [Range 0 – 4]
о Calibrators о Volumes о Intervals ● Validity checks Correlation factor: 1.0000
Blank absorbance range: _____ – _____ Intercept: 0.0000
Span: Blank – Blank
Span absorbance range: _____ – _____
Expected cal factor: 0.00
Expected cal factor tolerance %: 0

† Due to differences in instrument systems and unit configurations, version numbers may vary.
†† Displays the number of decimal places defined in the decimal places parameter field.
‡ Refer to concentration specified on calibrator labeling or value sheet.
‡‡ The linear low value (Low-Linearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.

5
ARCHITECT c SYSTEMS ASSAY PARAMETERS

Calcium Urine—Conventional and SI Units

Configure assay parameters — General Configure assay parameters — SmartWash

● General о Calibration о SmartWash о Results о Interpretation о General о Calibration ● SmartWash о Results о Interpretation
Assay: Ca-U Type: Photometric Version: † Assay: Ca-U
Number: 1039 COMPONENT REAGENT / ASSAY WASH Volume Replicates
● Reaction definition о Reagent / Sample о Validity checks R1 TP000 0.5% Acid Wash 345 1
Reaction mode: End up R1 CREA0 Water 300 1
Primary Secondary Read times R1 AMY00 Water 300 1
Wavelength: 660 / 700 Main: 7 – 9 R1 TRIG0 Water 300 1
Last required read: 9 Cuvette Trig 10% Detergent B*** 345
Absorbance range: ___ – ___ Color correction: ___ – ___
Sample blank type: None ***Select “Detergent B” for software prior to version 2.2.

о Reaction definition ● Reagent / Sample о Validity checks Calcium Urine—Conventional Units

R1
Reagent: CA000 Reagent volume: 240
Configure assay parameters — Results
Diluent: Saline Water volume: ___
Diluent dispense mode: Type 0 Dispense mode: Type 0 о General о Calibration о SmartWash ● Results о Interpretation
Assay: Ca-U Result units: mg/dL
Diluted Default
Dilution name Sample sample Diluent Water Dilution factor dilution Assay defaults:
STANDARD : 2.4 ___ ___ ___ = 1:1.00 ● Low-Linearity: 0.1‡‡
_________ : ___ ___ ___ ___ = о High-Linearity: 27.4
_________ : ___ ___ ___ ___ = о Gender and age specific ranges:
GENDER AGE (UNITS) NORMAL EXTREME

о Reaction definition о Reagent / Sample ● Validity checks

Reaction check: None
Configure result units
Assay: Ca-U
Version: †
Maximum absorbance variation: ___ Result units: mg/dL
Decimal places: 1 [Range 0 – 4]
Correlation factor: 1.0000
Configure assay parameters — Calibration Intercept: 0.0000
о General ● Calibration о SmartWash о Results о Interpretation
Assay: Ca-U Calibration method: Use Cal Factor/Blank
Use Cal factor from: Ca
Calcium Urine—SI Units

Configure assay parameters — Results

о General о Calibration о SmartWash ● Results о Interpretation
Assay: Ca-U Result units: mmol/L
Assay defaults:
Low-Linearity: 0.02‡‡
High-Linearity: 6.85
Gender and age specific ranges:
GENDER AGE (UNITS) NORMAL EXTREME

Configure result units

Assay: Ca-U
Version: †
Result units: mmol/L
Decimal places: 2 [Range 0 – 4]
Correlation factor: 1.0000
Intercept: 0.0000

† Due to differences in instrument systems and unit configurations, version numbers may vary.
‡‡ The linear low value (Low-Linearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.

6
AEROSET SYSTEM ASSAY PARAMETERS

Calcium Serum/Plasma—Conventional Units Calcium Serum/Plasma—SI Units

Assay Configuration: Outline Page Assay Configuration: Outline Page

Assay Name Assay # Line Assay Name Assay # Line
Ca 8 B-Line Ca 8 B-Line
Quantitative Ranges Quantitative Ranges
Min Text Min Panic-L L-Reference-H Panic-H Max Max Text Min Text Min Panic-L L-Reference-H Panic-H Max Max Text
* 0.0* 0.0 8.4 10.2 0.0 0.0* * * 0.0* 0.0 2.10 2.55 0.0 0.0* *
1.1** L-Linear Range-H 26.1 0.27** L-Linear Range-H 6.53
Reference Ranges* Reference Ranges*
Age Male Female Age Male Female
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0
0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0
0 Year 0 Year
0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0
Qualitative Ranges N/A Qualitative Ranges N/A

Assay Configuration: Base Page Assay Configuration: Base Page

Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar
END UP 660 / 700 7–9/0–0 0.0 END UP 660 / 700 7–9/0–0 0.0
Sample Blank Test Blank Read Time Abs Window Abs Limits Sample Blank Test Blank Read Time Abs Window Abs Limits
_____ ( ___ ) 0–0 0–0 0.0 – 0.0 _____ ( ___ ) 0–0 0–0 0.0 – 0.0
S.Vol DS.Vol D.Vol W.Vol S.Vol DS.Vol D.Vol W.Vol
Standard 2.4 0.0 0 0 Rgt Name/Pos Standard 2.4 0.0 0 0 Rgt Name/Pos
Dil 1 2.4 0.0 0 0 Diluent: _____ _ – __* Dil 1 2.4 0.0 0 0 Diluent: _____ _ – __*
Dil 2 2.4 0.0 0 0 Type# 0 Dil 2 2.4 0.0 0 0 Type# 0
Rgt Name/Pos R.Vol W.Vol Type# Rgt Name/Pos R.Vol W.Vol Type#
Reagent 1 CA00061 – ___* 240 0 0 Reagent 1 CA00061 – ___* 240 0 0
Reaction Check Read Time – A/B Range Minimum Reaction Check Read Time – A/B Range Minimum
____________ 1–1/1–1 0.0 – 0.0 0.0 ____________ 1–1/1–1 0.0 – 0.0 0.0
Factor/Intercept Decimal Places Units Factor/Intercept Decimal Places Units
1.0 / 0.0 1 mg/dL 1.0 / 0.0 2 mmol/L

Assay Configuration: Calibration Page Assay Configuration: Calibration Page

Calib Mode Interval (H) Calib Mode Interval (H)
Linear 984 Linear 984
Blank/Calib Replicates Extrapolation % Span Span Abs Range Blank/Calib Replicates Extrapolation % Span Span Abs Range
3/3 0 BLK – 1 0.0 – 0.0 3/3 0 BLK – 1 0.0 – 0.0
Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range
BLK Water 2.4 0.0 0 0 0.0 – 0.0 BLK Water 2.4 0.0 0 0 0.0 – 0.0
C1 MCC1 2.4 0.0 0 0 Cal Deviation C1 MCC1 2.4 0.0 0 0 Cal Deviation
C2 MCC2 2.4 0.0 0 0 0.0 C2 MCC2 2.4 0.0 0 0 0.0
FAC Limit (%) FAC Limit (%)
10 10

Assay Configuration: SmartWash Page Assay Configuration: SmartWash Page

Rgt Probe Rgt Probe
Reagent Wash Vol Reagent Wash Vol
TP00061 AcidW 345 TP00061 AcidW 345
CREA061 Water 300 CREA061 Water 300
AMY0051 Water 300 AMY0051 Water 300
TRIG061 Water 300 TRIG061 Water 300
Cuvette Cuvette
Assay Name Wash Vol Assay Name Wash Vol
— — — — — —
Sample Probe 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

Calcium Urine—Conventional Units Calcium Urine—SI Units

Assay Configuration: Outline Page Assay Configuration: Outline Page

Assay Name Assay # Line Assay Name Assay # Line
Ca-U 39 B-Line Ca-U 39 B-Line
Quantitative Ranges Quantitative Ranges
Min Text Min Panic-L L-Reference-H Panic-H Max Max Text Min Text Min Panic-L L-Reference-H Panic-H Max Max Text
* 0.0* 0.0 0.0 0.0 0.0 0.0* * * 0.0* 0.0 0.00 0.00 0.0 0.0* *
0.1** L-Linear Range-H 27.4 0.02** L-Linear Range-H 6.85
Reference Ranges* Reference Ranges*
Age Male Female Age Male Female
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.00 – 0.00 0.00 – 0.00
0.0 – 0.0 0.0 – 0.0 0.00 – 0.00 0.00 – 0.00
0 Year 0 Year
0.0 – 0.0 0.0 – 0.0 0.00 – 0.00 0.00 – 0.00
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.00 – 0.00 0.00 – 0.00
Qualitative Ranges N/A Qualitative Ranges N/A

Assay Configuration: Base Page Assay Configuration: Base Page

Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar
END UP 660 / 700 7–9/0–0 0.0 END UP 660 / 700 7–9/0–0 0.0
Sample Blank Test Blank Read Time Abs Window Abs Limits Sample Blank Test Blank Read Time Abs Window Abs Limits
_____ ( ___ ) 0–0 0–0 0.0 – 0.0 _____ ( ___ ) 0–0 0–0 0.0 – 0.0
S.Vol DS.Vol D.Vol W.Vol S.Vol DS.Vol D.Vol W.Vol
Standard 2.4 0.0 0 0 Rgt Name/Pos Standard 2.4 0.0 0 0 Rgt Name/Pos
Dil 1 2.4 0.0 0 0 Diluent: _____ _ – __* Dil 1 2.4 0.0 0 0 Diluent: _____ _ – __*
Dil 2 2.4 0.0 0 0 Type# 0 Dil 2 2.4 0.0 0 0 Type# 0
Rgt Name/Pos R.Vol W.Vol Type# Rgt Name/Pos R.Vol W.Vol Type#
Reagent 1 CA00061 – ___* 240 0 0 Reagent 1 CA00061 – ___* 240 0 0
Reaction Check Read Time – A/B Range Minimum Reaction Check Read Time – A/B Range Minimum
____________ 1–1/1–1 0.0 – 0.0 0.0 ____________ 1–1/1–1 0.0 – 0.0 0.0
Factor/Intercept Decimal Places Units Factor/Intercept Decimal Places Units
1.0 / 0.0 1 mg/dL 1.0 / 0.0 2 mmol/L

Assay Configuration: Calibration Page Assay Configuration: Calibration Page

Calib Mode Use Cal Factor from Interval (H) Calib Mode Use Cal Factor from Interval (H)
UseFac/Blk Ca ( 8 ) 0 UseFac/Blk Ca ( 8 ) 0
Blank/Calib Replicates Extrapolation % Span Span Abs Range Blank/Calib Replicates Extrapolation % Span Span Abs Range
0/0 0 BLK – 1 0.0 – 0.0 0/0 0 BLK – 1 0.0 – 0.0
Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range
BLK 2.0 0.0 0 0 0.0 – 0.0 BLK 2.0 0.0 0 0 0.0 – 0.0
C1 2.0 0.0 0 0 Cal Deviation C1 2.0 0.0 0 0 Cal Deviation
C2 2.0 0.0 0 0 0.0 C2 2.0 0.0 0 0 0.0

Assay Configuration: SmartWash Page Assay Configuration: SmartWash Page

Rgt Probe Rgt Probe
Reagent Wash Vol Reagent Wash Vol
TP00061 AcidW 345 TP00061 AcidW 345
CREA061 Water 300 CREA061 Water 300
AMY0051 Water 300 AMY0051 Water 300
TRIG061 Water 300 TRIG061 Water 300
Cuvette Cuvette
Assay Name Wash Vol Assay Name Wash Vol
— — — — — —
Sample Probe 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.