3L79-22

en
Calcium
Calcium 3L79-32 3L79
ARCHITECT 3L79-42 G95986R03
B3LS90
Revised June 2018.

Package insert instructions must be carefully followed. Reliability of Warnings and Precautions
assay results cannot be guaranteed if there are any deviations from •
the instructions in this package insert. • For In Vitro Diagnostic Use
NAME Safety Precautions
Calcium CAUTION: This product requires the handling of human specimens.
INTENDED USE It is recommended that all human-sourced materials be considered
potentially infectious and handled in accordance with the OSHA
The Calcium assay is used for the quantitation of calcium in human Standard on Bloodborne Pathogens. Biosafety Level 2 or other
serum, plasma, or urine. appropriate biosafety practices should be used for materials that
SUMMARY AND EXPLANATION OF THE TEST contain or are suspected of containing infectious agents.3-6
The majority of calcium in the body is present in bones. The The following warnings and precautions apply to:
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- WARNING: Contains methylisothiazolone.
term lithium therapy has been reported to cause hyperparathyroidism H317 May cause an allergic skin reaction.
in some individuals, with resulting hypercalcemia.2 H319 Causes serious eye irritation.
Hypocalcemia can result from hypoparathyroidism, hypoalbuminemia, H316* Causes mild skin irritation.
renal insufficiency, and pancreatitis.1 Prevention
Calcium has traditionally been difficult to measure accurately and P261 Avoid breathing mist / vapors / spray.
precisely, and a large variety of methods have been developed. P264 Wash hands thoroughly after handling.
Among these are flame photometry, oxalate precipitation P272 Contaminated work clothing should not be
with titration, atomic absorption spectrophotometry, EDTA allowed out of the workplace.
chelation, and more recently calcium dye complexes which are P280 Wear protective gloves / protective
measured spectrophotometrically. Examples of calcium dyes are clothing / eye protection.
o-cresolphthalein complexone and Arsenazo III, the latter being the Response
dye used for calcium determination in this method. P305+P351+P338 IF IN EYES: Rinse cautiously with water
PRINCIPLES OF THE PROCEDURE for several minutes. Remove contact
Arsenazo-III dye reacts with calcium in an acid solution to form a lenses, if present and easy to do.
blue‑purple complex. The color developed is measured at 660 nm Continue rinsing.
and is proportional to the calcium concentration in the sample. P337+P313 If eye irritation persists: Get medical
Methodology: Arsenazo III advice / attention.
For additional information on system and assay technology, refer to P302+P352 IF ON SKIN: Wash with plenty of water.
the ARCHITECT System Operations Manual, Section 3. P333+P313 If skin irritation or rash occurs: Get
medical advice / attention.
REAGENTS P362+P364 Take off contaminated clothing and wash
Kit Contents it before reuse.
Calcium 3L79. Disposal
Supplied as a liquid, ready-to use single-reagent kit. P501 Dispose of contents / container in
accordance with local regulations.
3L79-22 3L79-32 3L79-42
* Not applicable where regulation EU 1272/2008 (CLP) or OSHA
1500* 11440* 24370* Hazard Communication 29CFR 1910.1200 (HCS) 2012 have been
implemented.
5 x 13 mL 10 x 41 mL 10 x 84 mL
Safety Data Sheets are available at [Link] or
*Calculation is based on the minimum reagent fill volume per kit. contact your local representative.
Reactive Ingredients Concentration For a detailed discussion of safety precautions during system
operation, refer to the ARCHITECT System Operations Manual,
Section 8.
Arsenazo-III dye 0.94 mmol/L
Sodium acetate 271 mmol/L

1
Reagent Handling To convert results from mmol/L to mmol/day (24 hour urinary
• Do not use reagents beyond the expiration date. excretion)
• Do not pool reagents within a kit or between kits. 24 hour excretion = [(V × c) ÷ 1000] mmol/day
• Do not use components from one lot with components from Where:
another lot. V = 24 hour urine volume (mL)
• Do not invert reagent cartridges prior to use. Reagents are c = analyte concentration (mmol/L)
susceptible to the formation of foam and bubbles.
To convert results from mg/day to mmol/day, multiply mg/day by
• Remove any air bubbles present in the reagents with a new
0.025. To covert mmol/day to mg/day divide mmol/day by 0.025.
applicator stick, or allow the reagents to sit at the appropriate
storage temperature to allow the bubbles to dissipate. To SPECIMEN COLLECTION AND PREPARATION FOR
minimize volume depletion, do not use a transfer pipette to ANALYSIS
remove bubbles.
Specimen Types
CAUTION: Bubbles may interfere with proper detection of
Verified specimen types to be used with this assay.
reagent level in the cartridge and cause insufficient reagent
aspiration which could impact results. Specimen Type Collection Vessel
For a detailed discussion of handling precautions during system Serum Glass or plastic tubes with or without gel
operation, refer to the ARCHITECT System Operations Manual, barrier
Section 7. Plasma Glass or plastic tubes
Reagent Storage Acceptable anticoagulants are:
lithium heparin (with or without gel
Maximum
barrier)
Storage Storage Additional Storage
Temperature Time Instructions sodium heparin
Unopened 15-30°C Until Urine (random specimens Collect random specimens in a bottle
expiration or timed specimens containing 1 to 2 mL of 6 mol/L
date collected over intervals HCL in order to prevent calcium salt
shorter than 24 hours) precipitation.7
On board System 30 days After 30 days, the reagent
temperature kit must be discarded. Urine (24 hour) Collect 24 hour specimens in a bottle
containing 20 to 30 mL of 6 mol/L
For information on tracking
HCl in order to prevent calcium salt
onboard time, refer to
precipitation.7
the ARCHITECT System
Operations Manual, Section Other specimen types and collection tube types/anticoagulants have
5. not been verified with this assay.
For information on unloading reagents, refer to the ARCHITECT The instrument does not provide the capability to verify specimen
System Operations Manual, Section 5. type. It is the responsibility of the operator to verify that the correct
specimen types are used in the assay.
Indications of Reagent Deterioration
Specimen Conditions
Instability or deterioration should be suspected if there are
precipitates, visible signs of leakage or contamination, turbidity, or if Liquid anticoagulants may have a dilution effect resulting in lower
calibration or controls do not meet the appropriate package insert concentrations for individual patient specimens.
and/or ARCHITECT System Operations Manual criteria. For accurate results, serum and plasma specimens should be free of
For troubleshooting information, refer to the ARCHITECT System fibrin, red blood cells, and other particulate matter. Serum specimens
Operations Manual, Section 10. from patients receiving anticoagulant or thrombolytic therapy may
contain fibrin due to incomplete clot formation and this may cause
INSTRUMENT PROCEDURE erroneous results.
The Calcium assay file must be installed on the ARCHITECT cSystem For accurate results, plasma specimens should be free of platelets
prior to performing the assay. and other particulate matter. Ensure centrifugation is adequate to
For detailed information on assay file installation and viewing remove platelets.
and editing assay parameters, refer to the ARCHITECT System For additional information on specimen conditions, refer to the
Operations Manual, Section 2. Interference section of this package insert.
For information on printing assay parameters or for a detailed Preparation for Analysis
description of system procedures, refer to the ARCHITECT System Serum: Ensure complete clot formation has taken place prior
Operations Manual, Section 5. to centrifugation. Centrifuge according to tube manufacturer’s
Alternate Result Units specifications to ensure proper separation of serum from blood cells.
The Conventional result unit for the Calcium assay is mg/dL. The Plasma: Centrifuge according to tube manufacturer’s specifications
corresponding SI result unit is mmol/L. To convert mg/dL to mmol/L, to remove platelets and ensure proper separation of plasma from
multiply mg/dL by 0.25. To convert mmol/L to mg/dL, divide mmol/L blood cells.
by 0.25. Frozen specimens must be completely thawed before mixing.
When converting to units other than those listed, refer to the Mix thawed specimens thoroughly.
ARCHITECT System Operations Manual, Section 2. Visually inspect thawed specimens. If layering or stratification
To convert results from mg/dL to mg/day (24 hour urinary excretion) is observed, mix until specimens are visibly homogeneous. If
24 hour excretion = [(V × c) ÷ 100] mg/day specimens are not mixed thoroughly, inconsistent results may be
Where: obtained.
V = 24 hour urine volume (mL) NOTE: Stored specimens must be inspected for particulates. If
c = analyte concentration (mg/dL) present, mix and centrifuge the specimen to remove particulates
prior to testing.

2
For total sample volume requirements, refer to the ARCHITECT Manual Dilution Procedure
System Operations Manual, Section 5. 1. Dilute the specimen with saline (0.85% to 0.90% NaCl).
Specimen Storage 2. Enter the dilution factor in the Patient or Control order screen.
Analyze fresh specimens if possible. The system uses this dilution factor to automatically correct the
Avoid repeated freeze/thaw cycles. concentration by multiplying the result by the entered factor. If
the operator does not enter the dilution factor, the result must
Storage Maximum Special
be manually multiplied by the appropriate dilution factor before
Specimen Type Temperature Storage Time Instructions
reporting the result.
Serum/Plasma 20-25°C 7 days8
(Volume of Specimen + Volume of Dilution Reagent)
2-8°C 3 weeks8, 9 Manual Dilution Factor =
Volume of Specimen
-20°C* 8 months8
If a diluted specimen result is flagged indicating it is less than
Urine 20-25°C 2 days8 Acidify to pH <2 the linear low limit, do not report the result. Rerun using an
2-8°C 4 days8, 9 Acidify to pH <2 appropriate dilution.
-20°C* 3 weeks8 Acidify to pH <2 For detailed information on ordering dilutions, refer to the ARCHITECT
System Operations Manual, Section 5.
*A tolerance of ± 10% (± 2°C) is assumed not to change the stability Calibration
of the specimen. (W. Guder, personal communication, August 6,
Calibration is stable for approximately 30 days (720 hours), but is
2001).
required with each change in reagent lot number. Verify calibration
Each laboratory may establish a range around -20°C from either the with at least two levels of controls according to the established
freezer manufacturer’s specifications or your laboratory standard quality control requirements for your laboratory. If control results fall
operating procedure(s) for specimen storage. outside acceptable ranges, recalibration may be necessary.
Specimen Shipping The urine application uses the serum calibration.
Package and label specimens in compliance with applicable state, For information on calibrator standardization, refer to the
federal, and international regulations covering the transport of clinical Multiconstituent Calibrator package insert.
specimens and infectious substances. For detailed information on how to perform an assay calibration, refer
PROCEDURE to the ARCHITECT System Operations Manual, Section 6.

Materials Provided Quality Control Procedures

As appropriate, refer to your laboratory standard operating
3L79 Calcium Reagent Kit
procedure(s) and/or quality assurance plan for additional quality
Materials Required but not Provided control requirements and potential corrective actions.
• 1E65 Multiconstituent Calibrator • Two levels of controls (normal and abnormal) are to be run every
• Control material 24 hours.
• Saline (0.85% to 0.90% NaCl) for specimen dilution • If more frequent control monitoring is required, follow the
For information on materials required for operation of the instrument, established quality control procedures for your laboratory.
refer to the ARCHITECT System Operations Manual, Section 1. • If quality control results do not meet the acceptance criteria
For information on materials required for maintenance procedures, defined by your laboratory, patient values may be suspect. Follow
refer to the ARCHITECT System Operations Manual, Section 9. the established quality control procedures for your laboratory.
Assay Procedure Recalibration may be necessary.
For a detailed description of how to run an assay, refer to the • Review quality control results and acceptance criteria following a
ARCHITECT System Operations Manual, Section 5. change of reagent or calibrator lot.
For sample volume requirements, refer to the ASSAY PARAMETERS RESULTS
section of this package insert. Minimum sample volume is calculated Representative performance data are given in the EXPECTED
by the system and printed on the Order List Report. Ensure adequate VALUES and SPECIFIC PERFORMANCE CHARACTERISTICS
sample volume is present prior to running the test. sections of this package insert. Results obtained in individual
Specimen Dilution Procedures laboratories may be different from the data presented.
The ARCHITECT cSystems have an automatic dilution feature; for Calculation
additional information, refer to the ARCHITECT System Operations For additional information on results calculations, refer to the
Manual, Section 2. ARCHITECT System Operations Manual, Appendix C.
Serum and plasma specimens with calcium values exceeding
Interpretation of Results
the 24.0 mg/dL (6.00 mmol/L) are flagged and may be diluted by
following the Manual Dilution Procedure, or the Automatic Dilution As with all analyte determinations, the calcium value should be used
Protocol provided in the assay parameters. If an Automatic Dilution in conjunction with information available from clinical evaluation and
Protocol is not provided, refer to the ARCHITECT System Operations other diagnostic procedures.
Manual, Section 2 for configuration information, and verify results Flags
according to your laboratory’s standard operating procedures. Some results may contain information in the Flags field. For a
Urine specimens with calcium values exceeding 24.0 mg/dL description of the flags that may appear in this field, refer to the
(6.00 mmol/L) are flagged and may be diluted by following the ARCHITECT System Operations Manual, Section 5.
Manual Dilution Procedure, or the Automatic Dilution Protocol
LIMITATIONS OF THE PROCEDURE
provided in the assay parameters.
Automated Dilution Protocol Refer to the SPECIMEN COLLECTION AND PREPARATION FOR
ANALYSIS and SPECIFIC PERFORMANCE CHARACTERISTICS
When using the Automated Dilution Protocol, the system performs a
sections of this package insert.
dilution of the specimen and automatically corrects the concentration
by multiplying the result by the appropriate dilution factor.

3
EXPECTED VALUES Bilirubin solutions at the above concentrations were prepared by
Reference Range addition of a bilirubin stock to human serum pools. Hemoglobin
solutions at the above concentrations were prepared by addition of
Serum/Plasma10
hemolysate to human serum pools. Intralipid solutions at the above
Range Range concentrations were prepared by addition of intralipid to human
(mg/dL) (mmol/L) serum pools.
Cord 8.2 to 11.2 2.05 to 2.80 For the urine application, glucose up to 500 mg/dL (27.8 mmol/L),
Newborn ascorbate up to 100 mg/dL (5.7 mmol/L), protein up to 30 mg/dL
Premature 6.2 to 11.0 1.55 to 2.75 (0.3 g/L), hydrochloric acid (6 N) up to 2.5 mL/dL (150 mmol/L),
0 to 10 days 7.6 to 10.4 1.90 to 2.60 and boric acid up to 250 mg/dL (40 mmol/L) demonstrated ≤ 5% or
10 days to 24 9.0 to 11.0 2.25 to 2.75 ± 0.2 mg/dL (0.05 mmol/L) interference, whichever is greater. Acetic
months acid (8.5 N) up to 6.25 mL/dL (531 mmol/L) and nitric acid (6 N) up
Child, 2 to 12 years 8.8 to 10.8 2.20 to 2.70 to 5.0 mL/dL (300 mmol/L) demonstrated > 10% interference.
Adult 8.4 to 10.2 2.10 to 2.55 Interferences from medications or endogenous substances may
Male > 60 years 8.8 to 10.0 2.20 to 2.50 affect results.11
Precision
Urine10
The imprecision of the Calcium assay is ≤ 3% Total CV. For serum,
Range Range representative data from studies using Clinical and Laboratory
Calcium in diet (mg/day) (mmol/day) Standards Institute (CLSI) protocol NCCLS EP5-A212 are summarized
Calcium-free 5 to 40 0.13 to 1.00 below.
Low to average 50 to 150 1.25 to 3.75 Serum
Average (800 mg/day 100 to 300 2.50 to 7.50 Control Level 1 Level 2
or 20 mmol/day) N 80 80
It is recommended that each laboratory determine its own reference Mean (mg/dL) 8.81 11.77
range based upon its particular locale and population characteristics. Mean (mmol/L) 2.20 2.94
SPECIFIC PERFORMANCE CHARACTERISTICS SD (mg/dL) 0.05 0.07
Within Run SD (mmol/L) 0.01 0.02
Linearity %CV 0.5 0.6
The linearity of Calcium serum and urine is 2.0 to 24.0 mg/dL (0.50 SD (mg/dL) 0.05 0.03
to 6.00 mmol/L). Calcium is linear within ± 5% or ± 0.2 mg/dL, Between Run SD (mmol/L) 0.01 0.008
whichever is greater from 2.0 to 18.0 mg/dL (0.50 to 4.50 mmol/L)
%CV 0.5 0.3
and within ± 10% from > 18.0 to 24.0 mg/dL (> 4.50 to 6.00 mmol/L)
SD (mg/dL) 0.09 0.08
with 95% confidence.
Between Day SD (mmol/L) 0.02 0.02
Limit of Detection (LOD) %CV 1.0 0.7
The LOD for Calcium serum and urine is 0.5 mg/dL (0.125 mmol/L). SD (mg/dL) 0.11 0.11
The LOD is the mean concentration of an analyte-free sample + Total SD (mmol/L) 0.028 0.028
2 SD, where SD = the pooled, within-run standard deviation of the
%CV 1.2 1.0
analyte-free sample.
Limit of Quantitation (LOQ) For urine, representative data from studies using CLSI protocol
NCCLS EP10-A213 are summarized below.
The LOQ for Calcium serum and urine is 1.0 mg/dL (0.25 mmol/L).
The LOQ is the analyte concentration at which the CV = 20%. Urine
Control Level 1 Level 2
Interference
N 50 50
Interference effects were assessed by Dose Response and Paired
Mean (mg/dL) 7.59 11.00
Difference methods, at the medical decision levels of the analyte.
Mean (mmol/L) 1.90 2.75
Medical Decision Level 1
SD (mg/dL) 0.05 0.05
Interfering Target Observed
Within Run SD (mmol/L) 0.01 0.01
Substance Interferent Concentration N (mg/dL) (mmol/L) (% of Target)
%CV 0.6 0.5
30 mg/dL (513 μmol/L) 4 8.0 2.00 99.4
Bilirubin SD (mg/dL) 0.01 0.03
60 mg/dL (1,026 μmol/L) 4 8.0 2.00 98.2
Between Run SD (mmol/L) 0.003 0.008
1,000 mg/dL (10.0 g/L) 4 7.6 1.90 100.3
Hemoglobin %CV 0.2 0.3
2,000 mg/dL (20.0 g/L) 4 7.6 1.90 101.4
SD (mg/dL) 0.02 0.04
500 mg/dL (5.0 g/L) 4 7.2 1.80 103.6
Intralipid Between Day SD (mmol/L) 0.005 0.01
750 mg/dL (7.5 g/L) 4 7.2 1.80 105.7
%CV 0.3 0.3
Medical Decision Level 2 SD (mg/dL) 0.05 0.07
Interfering Target Observed Total SD (mmol/L) 0.01 0.02
Substance Interferent Concentration N (mg/dL) (mmol/L) (% of Target) %CV 0.7 0.7
30 mg/dL (513 μmol/L) 4 12.7 3.18 98.8
Bilirubin Method Comparison
60 mg/dL (1,026 μmol/L) 4 12.7 3.18 97.4
Correlation studies were performed using CLSI protocol NCCLS
1,000 mg/dL (10.0 g/L) 4 11.3 2.83 99.9
Hemoglobin EP9-A2.14
2,000 mg/dL (20.0 g/L) 4 11.3 2.83 99.9
Serum and urine results from the Calcium assay on the AEROSET
500 mg/dL (5.0 g/L) 4 10.9 2.73 102.9
Intralipid System and an ARCHITECT cSystem were compared with those
750 mg/dL (7.5 g/L) 4 10.9 2.73 104.8 from a commercially available Arsenazo Dye methodology (Abbott
Calcium 7D61).

4
Serum and urine results from the Calcium assay on an ARCHITECT Key to Symbols
cSystem were compared with those from the Calcium assay on the
AEROSET System. Consult instructions for use
Serum AEROSET vs. ARCHITECT vs. Manufacturer
Comparative Comparative ARCHITECT vs.
Method Method AEROSET
N 102 96 121 Sufficient for
Y-Intercept (mg/dL) 0.31 0.31 0.04
Y-Intercept 0.078 0.078 0.010 Temperature limitation
(mmol/L)
Correlation 0.999 0.999 0.998 Use by/Expiration date
Coefficient
Slope 0.96 0.96 1.00
Distributed in the USA by
Range (mg/dL) 2.4 to 24.6 2.4 to 24.6 2.3 to 23.4
Range (mmol/L) 0.60 to 6.15 0.60 to 6.15 0.58 to 5.85 Do not shake/agitate
Urine AEROSET vs. ARCHITECT vs. Identifies products to be used
Comparative Comparative ARCHITECT vs. together
Method Method AEROSET Information needed for United
N 47 47 47 States of America only
Y-Intercept (mg/dL) 0.17 0.17 0.00 In Vitro Diagnostic Medical
Y-Intercept 0.043 0.043 0.00 Device
(mmol/L) Lot Number
Correlation 0.999 0.999 0.999 Manufactured for
Coefficient
Product of United Kingdom
Slope 0.95 0.94 0.99
Range (mg/dL) 2.2 to 25.2 2.2 to 25.2 2.2 to 23.9 Reagent 1
Range (mmol/L) 0.55 to 6.30 0.55 to 6.30 0.55 to 5.98 List Number
Serial number
BIBLIOGRAPHY
1. Jacobs DS, DeMott WR, Oxley DK, et al. Laboratory Test Handbook.
Hudson, OH: Lexi-Comp; 2001:131–133. The ARCHITECT cSystem family of instruments consists of c4000,
2. Bendz H, Sjödin I, Toss G, et al. Hyperparathyroidism and long-term c8000, and c16000 instruments.
lithium therapy—a cross-sectional study and the effect of lithium AEROSET, ARCHITECT, c4000, c8000, c16000, cSystem, and
withdrawal. J Intern Med 1996;240:357–365. SmartWash are trademarks of Abbott Laboratories in various
3. US Department of Labor, Occupational Safety and Health jurisdictions.
Administration, 29 CFR Part 1910.1030, Bloodborne pathogens. All other trademarks are property of their respective owners.
4. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories. 5th ed. Washington, DC: Abbott GmbH & Co. KG
US Government Printing Office; December 2009. Max-Planck-Ring 2
5. World Health Organization. Laboratory Biosafety Manual. 3rd ed. 65205 Wiesbaden
Geneva: World Health Organization; 2004. Germany
6. Clinical and Laboratory Standards Institute (CLSI). Protection +49-6122-580
of Laboratory Workers From Occupationally Acquired Infections;
Approved Guideline—Fourth Edition. CLSI Document M29-A4. Wayne,
PA: CLSI; 2014. Abbott Laboratories
7. Burtis CA, Ashwood ER, editors. Tietz Fundamentals of Clinical
Chemistry, 5th ed. Philadelphia, PA: WB Saunders; 2001:800. Abbott Laboratories
8. Guder WG, Narayanan S, Wisser H, et al. List of Analytes— Abbott Park, IL 60064 USA
Preanalytical Variables. Annex In: Samples: From the Patient to the
Laboratory. Darmstadt, Germany: GIT Verlag; 1996:Annex 10–1, Customer Service: Contact your local representative
36–7. or find country-specific contact information on
9. US Pharmacopeial Convention, Inc. General notices. In: US [Link]
Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18). Revised June 2018.
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
©2017, 2018 Abbott Laboratories
10. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry,
2nd ed. Philadelphia, PA: WB Saunders; 1994:2180.
11. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
Washington, DC: AACC Press; 1995:3-115–3-124.
12. National Committee for Clinical Laboratory Standards (NCCLS).
Evaluation of Precision Performance of Quantitative Measurement
Methods; Approved Guideline—Second Edition. NCCLS Document
EP5-A2. Wayne, PA: NCCLS; 2004.
13. Krouwer JS, Tholen DW, Garber CC, et al. Preliminary Evaluation
of Quantitative Clinical Laboratory Methods; Approved Guideline—
Second Edition (EP10-A2). Wayne, PA: The National Committee for
Clinical Laboratory Standards, 2002.
14. National Committee for Clinical Laboratory Standards (NCCLS).
Method Comparison and Bias Estimation Using Patient Samples;
Approved Guideline—Second Edition. NCCLS Document EP9-A2.
Wayne, PA: NCCLS; 2002.

5
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: CaC Type: Photometric Version: † Assay: CaC
Number: 1066
COMPONENT REAGENT / ASSAY WASH Volume Replicates
Run controls for onboard reagents by: Lot
R1 PHNO9 0.5% Acid Wash 345 2
● Reaction definition о Reagent / Sample о Validity checks
Reaction mode: End up
Primary Secondary Read times Calcium Serum/Plasma—Conventional Units
Wavelength: 660 / 700 Main: 10 – 14
Last required read: 14 Configure assay parameters — Results
Absorbance range: ___ – ___ Color correction: ___ – ___
Sample blank type: None
о General о Calibration о SmartWash ● Results о Interpretation
Assay: CaC Assay number: 1066
Dilution default range: Result units: mg/dL
о Reaction definition ● Reagent / Sample о Validity checks Low-Linearity: 2.0
R1 High-Linearity: 24.0
Reagent: CAC99 Reagent volume: 32 Gender and age specific ranges:
Diluent: Saline Water volume: 126 GENDER AGE (UNITS) NORMAL EXTREME
Diluent dispense mode: Type 0 Dispense mode: Type 0 Either 0 – 130 (Y) 8.4 – 10.2
Diluted Default
Dilution name Sample sample Diluent Water Dilution factor dilution
STANDARD : 2.6 ___ ___ ___ = 1:1.00 ● Configure result units
_________ : ___ ___ ___ ___ = о Assay: CaC
_________ : ___ ___ ___ ___ = о Version: †
Result units: mg/dL
Decimal places: 1 [Range 0 – 4]
о Reaction definition о Reagent / Sample ● Validity checks Correlation factor: 1.0000
Reaction check: None Intercept: 0.0000

Calcium Serum/Plasma—SI Units

Maximum absorbance variation: ___
Configure assay parameters — Results
Configure assay parameters — Calibration о General о Calibration о SmartWash ● Results о Interpretation
о General ● Calibration о SmartWash о Results о Interpretation Assay: CaC Assay number: 1066
Assay: CaC Calibration method: Linear Dilution default range: Result units: mmol/L
● Calibrators о Volumes о Intervals о Validity checks Low-Linearity: 0.50
Calibrator set: Calibrator level: Concentration: High-Linearity: 6.00
MCC Blank: Water 0‡ Gender and age specific ranges:
Cal 1: MCC1 †† GENDER AGE (UNITS) NORMAL EXTREME
Replicates: 3 [Range 1 – 3] Cal 2: MCC2 †† Either 0 – 130 (Y) 2.10 – 2.55

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

Calibrator: MCC Diluted Assay: CaC
Calibrator level Sample sample Diluent Water Version: †
Blank: Water 2.6 ___ ___ ___ Result units: mmol/L
Cal 1: MCC1 2.6 ___ ___ ___ Decimal places: 2 [Range 0 – 4]
Cal 2: MCC2 2.6 ___ ___ ___ Correlation factor: 1.0000
Intercept: 0.0000
о Calibrators о Volumes ● Intervals о Validity checks
Calibration intervals:
Full interval: 720 (hours)
Calibration type:
Adjust type: None

о Calibrators о Volumes о Intervals ● Validity checks

Blank absorbance range: _____ – _____
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 the concentration specified on calibrator labeling or value sheet. These values are defined on the Configure calibrator set screen.

6
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: CaCU Type: Photometric Version: † Assay: CaCU
Number: 1097
COMPONENT REAGENT / ASSAY WASH Volume Replicates
Run controls for onboard reagents by: Lot
R1 PHNO9 0.5% Acid Wash 345 2
● Reaction definition о Reagent / Sample о Validity checks
Reaction mode: End up
Primary Secondary Read times Calcium Urine—Conventional Units
Wavelength: 660 / 700 Main: 10 – 14
Last required read: 14 Configure assay parameters — Results
Absorbance range: ___ – ___ Color correction: ___ – ___
Sample blank type: None
о General о Calibration о SmartWash ● Results о Interpretation
Assay: CaCU Assay number: 1097
Dilution default range: Result units: mg/dL
о Reaction definition ● Reagent / Sample о Validity checks Low-Linearity: 2.0
R1 High-Linearity: 24.0
Reagent: CAC99 Reagent volume: 32 Gender and age specific ranges:
Diluent: Saline Water volume: 126 GENDER AGE (UNITS) NORMAL EXTREME
Diluent dispense mode: Type 0 Dispense mode: Type 0
Diluted Default
Dilution name Sample sample Diluent Water Dilution factor dilution
STANDARD : 2.6 ___ ___ ___ = 1:1.00 ● Configure result units
_________ : ___ ___ ___ ___ = о Assay: CaCU
_________ : ___ ___ ___ ___ = о Version: †
Result units: mg/dL
Decimal places: 1 [Range 0 – 4]
о Reaction definition о Reagent / Sample ● Validity checks Correlation factor: 1.0000
Reaction check: None Intercept: 0.0000

Calcium Urine—SI Units

Maximum absorbance variation: ___
Configure assay parameters — Results
Configure assay parameters — Calibration
о General о Calibration о SmartWash ● Results о Interpretation
о General ● Calibration о SmartWash о Results о Interpretation Assay: CaCU Assay number: 1097
Assay: CaCU Calibration method: Use Cal Factor/Blank Dilution default range: Result units: mmol/L
Use Cal factor from: CaC Low-Linearity: 0.50
High-Linearity: 6.00
Gender and age specific ranges:
GENDER AGE (UNITS) NORMAL EXTREME

Configure result units

Assay: CaCU
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.