INSTRUCTIONS FOR USE Ca

VITROS Chemistry Products Ca Slides Calcium

145 0261

Rx ONLY

Intended Use
For in vitro diagnostic use only.
VITROS Chemistry Products Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine
using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic
renal disease and tetany (intermittent muscular contractions or spasms).

Summary and Explanation of the Test

Calcium is the major mineral component of bone; 99% of the body’s calcium is in bone. Calcium ions play an important role
in the transmission of nerve impulses and in maintaining normal muscle contraction. Abnormal concentrations of serum
calcium may indicate malfunction of the parathyroid glands, bone diseases, carcinoma, malnutrition and malabsorption
syndrome, vitamin D deficiency, overdose with calcium-containing antacids, and renal diseases. 1

Principles of the Procedure

The VITROS Ca Slide is a multilayered, analytical element coated on a polyester support.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers.
The bound calcium is dissociated from binding proteins, allowing the calcium to penetrate through the spreading layer into
the underlying reagent layer. There, the calcium forms a complex with Arsenazo III dye, causing a shift in the absorption
maximum.
After incubation, the reflection density of the colored complex is measured spectrophotometrically. The amount of colored
complex formed is proportional to the calcium concentration in the sample.

Test Type and Conditions

Approximate
Incubation Reaction Sample
Test Type VITROS System Time Temperature Wavelength Volume
5600, 4600, 5,1
FS, 250/350, XT 5 minutes 37 °C (98.6 °F) 680 nm 10 μL
Colorimetric 7600, XT 3400
Not all products and systems are available in all countries.

Reaction Scheme
pH 5.6
Ca+2 + Arsenazo III colored complex

Warnings and Precautions

For in vitro diagnostic use only.
WARNING: Take care when handling materials and samples of human origin. Since no test
method can offer complete assurance that infectious agents are absent, consider
all clinical specimens, controls, and calibrators potentially infectious. Handle
specimens, solid and liquid waste, and test components in accordance with local
regulations and CLSI Guideline M29 2
For specific warnings and precautions for calibrators, quality control materials, and other components, refer to the
Instructions for Use for the appropriate VITROS product, or to other manufacturer’s product literature.

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 Ca INSTRUCTIONS FOR USE
Calcium Reagents

Reagents
Slide Diagram
Slide Ingredients 1. Upper slide mount
2. Spreading layer (TiO2)
Reactive Ingredients per cm2 3. Reagent layer
• Arsenazo III dye
Arsenazo III dye 60 µg. • buffer, pH 5.6
4. Support Layer
Other Ingredients 5. Lower slide mount
Pigment, binders, surfactants, buffer, cross-linking agent and
mordant.

Reagent Handling
Caution: Do not use slide cartridges with damaged or incompletely sealed packaging.

• Inspect the packaging for signs of damage.

• Be careful when opening the outer packaging with a sharp instrument so as to avoid damage to the individual product
packaging.

Reagent Preparation
IMPORTANT: The slide cartridge must reach room temperature, 18–28 °C (64–82 °F), before it is
unwrapped and loaded into the slide supply.
1. Remove the slide cartridges from storage.
2. Warm the wrapped cartridge at room temperature for 30 minutes when taken from the refrigerator or 60 minutes from the
freezer.
3. Unwrap and load the cartridge into the slide supply.
Note: Load the cartridges within 24 hours after they reach room temperature, 18–28 °C
(64–82 °F).

Reagent Storage and Stability

VITROS Ca Slides are stable until the expiration date on the carton when they are stored and handled as specified. Do not
use beyond the expiration date.

Reagent Storage Condition Stability

Unopened Refrigerated 2–8 °C (36–46 °F) Until expiration date
Frozen ≤-18 °C (≤0 °F) Until expiration date
Opened On-analyzer System turned on ≤ 4 weeks
On-analyzer System turned off ≤ 2 hours
Verify performance with quality control materials:
• If the system is turned off for more than 2 hours.
• After reloading cartridges that have been removed from the slide supply and stored for later use.

Specimen Collection, Preparation and Storage

Caution: Protective gloves manufactured with calcium carbonate powders may cause
elevated test results because of the contamination of sample handling supplies (for
example, pipette tips, transfer pipettes, sample cups and caps). Supplies that have
come in contact with powdered gloves may subsequently contaminate the test
specimen during sample metering.

Note: Gloves labeled as “powder-free” may contain some contaminating powder agents
on the inside of the glove.

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Specimen Collection, Preparation and Storage Calcium

Specimens Recommended
• Serum
• Plasma: 3 Heparin
• Urine
IMPORTANT: Certain collection devices have been reported to affect other analytes and tests. 4
Owing to the variety of specimen collection devices available, Ortho Clinical
Diagnostics is unable to provide a definitive statement on the performance of its
products with these devices. Confirm that your collection devices are compatible
with this test.

Specimens Not Recommended

• Plasma: 5
– EDTA*
– Fluoride oxalate*
– Citrate*
• Do not use blood from patients on EDTA therapy.
• Urine:
– Boric acid with sodium formate as a preservative
– 10% thymol as a preservative
*These substances chelate calcium, causing negative bias 5.

Serum and Plasma

Specimen Collection and Preparation
Collect specimens using standard laboratory procedures. 6 7

Note: For details on minimum fill volume requirements, refer to the operating instructions
for your system.
Patient Preparation
No special patient preparation is necessary.
Special Precautions
• Results from recumbent patients may be 3% lower. 8
• Blood collected with stasis may have calcium concentrations 15% higher. 8
• Centrifuge specimens and remove the serum or plasma from the cellular material within 2 days of collection. 9
Specimen Handling and Storage
• Handle and store specimens in stoppered containers to avoid contamination and evaporation.
• Mix samples by gentle inversion and bring to room temperature, 18–28 °C (64–82 °F), prior to analysis.

Specimen Storage and Stability: Serum and Plasma

Storage Temperature Stability
Room Temperature 18–28 °C (64–82 °F) ≤ 4 hours
Refrigerated 9 2–8 °C (36–46 °F) ≤ 22 days
Frozen 9 ≤-18 °C (≤0 °F) ≤ 1 year

Urine
Specimen Collection and Preparation
• Collect specimens using standard laboratory procedures. 10
• Keep refrigerated until analysis.
Note: For details on minimum fill volume requirements, refer to the operating instructions
for your system.
Patient Preparation
No special patient preparation is necessary.
Special Precautions
Urine specimens must be pretreated prior to processing. Refer to “Specimen Pretreatment” for instructions.
Specimen Handling and Storage
• Handle and store specimens in stoppered containers to avoid contamination and evaporation.

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 Ca INSTRUCTIONS FOR USE
Calcium Specimen Pretreatment

• Mix samples by gentle inversion and bring to room temperature, 18–28 °C (64–82 °F), prior to analysis.

Specimen Storage and Stability: Urine 9

Storage Temperature Stability
Room Temperature 18–28 °C (64–82 °F) ≤ 5 days
Refrigerated 2–8 °C (36–46 °F) ≤ 5 weeks
Frozen ≤-18 °C (≤0 °F) ≤ 6 months

Specimen Pretreatment
Urine
Acidification
IMPORTANT: The acidification procedure is intended for patient specimens only. Do not adjust
the pH of quality control or calibration materials.
IMPORTANT: Acidified urine specimens should have a pH range of 1.5 to 5.0. Samples with urine
pH below 1.5 may result in a negative bias.
IMPORTANT: If running multiple assays from a single acidified sample, ensure that the pH of the
sample is appropriate for all assays programmed. For example, when processing
samples for urine Ca and urine Mg, verify that the sample pH range is 3.0 to 4.0.
Refer to Instructions for Use VITROS Chemistry Products Mg Slides for
pretreatment instructions.
You may acidify either the entire volume or an aliquot of a 24-hour collection. Acidifying an aliquot is recommended if the
specimen is needed for other analyses that do not require acidification. 11
Acidification of an Entire Specimen
• Add 20 mL of 6N HCl to the container prior to collection of the urine (use 1 mL of 6N HCl for a random specimen).
• If specimens are collected without the addition of HCl, acidify as described above and allow them to stand at least 1 hour
before analysis. 12
Acidification of an Aliquot

1. Thoroughly mix the entire urine specimen and remove a 5 mL aliquot.

2. Add 100 µL of 6 N HCl and mix thoroughly.
3. Verify that the specimen pH is 1.5 to 5.0 and adjust, if necessary.
4. Analyze the sample.

Testing Procedure
Materials Provided
VITROS Chemistry Products Ca Slides

Materials Required but Not Provided

• VITROS Chemistry Products Calibrator Kit 1
• Quality control materials, such as VITROS Chemistry Products Performance Verifier I and II for serum and plasma
• Isotonic saline or reagent-grade water
• 6N HCl
• VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline) or VITROS Chemistry Products FS Diluent Pack 3
(Specialty Diluent/Water) (for on-analyzer dilution)

Operating Instructions
• Check reagent inventories at least daily to ensure that quantities are sufficient for the planned workload.
• For additional information, refer to the operating instructions for your system.
IMPORTANT: Bring all fluids and samples to room temperature, 18–28 °C (64–82 °F), prior to
analysis.

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Calibration Calcium

Sample Dilution
Serum and Plasma
If calcium concentrations exceed the system’s measuring (reportable or dynamic) range:
On-Analyzer Sample Dilution (VITROS 5600/XT 7600 Integrated and VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry
Systems only)
Refer to the operating instructions for your system for more information on the On-Analyzer Dilution Procedure. For
VITROS 5600/XT 7600 Integrated and VITROS 5,1 FS/4600 Chemistry Systems, use VITROS Chemistry Products FS
Diluent Pack 2 or VITROS Chemistry Products FS Diluent Pack 3 for the dilution.
For VITROS 250/350 and VITROS XT 3400 Chemistry Systems, use reagent-grade water or isotonic saline for the dilution.
Manual Sample Dilution

1. Dilute with an equal volume of reagent-grade water or isotonic saline.

2. Reanalyze.
3. Multiply the results by 2 to obtain an estimate of the original sample’s calcium concentration.

Acidified Urine
If calcium concentrations exceed the system’s measuring (reportable or dynamic) range:
On-Analyzer Sample Dilution (VITROS 5600/XT 7600 Integrated and VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry
Systems only)
Refer to the operating instructions for your system for more information on the On-Analyzer Dilution Procedure. For
VITROS 5600/XT 7600 Integrated and VITROS 5,1 FS/4600 Chemistry Systems, use VITROS Chemistry Products FS
Diluent Pack 3 for the dilution.
For VITROS 250/350 and VITROS XT 3400 Chemistry Systems, use reagent-grade water for the dilution.
Manual Sample Dilution

1. Dilute the acidified sample with an equal volume of reagent-grade water.

2. Reanalyze.
3. Multiply the results by 2 to obtain an estimate of the original sample’s calcium concentration.

Calibration
Required Calibrators
VITROS Chemistry Products Calibrator Kit 1
Note: The same VITROS Calibrator Kit is used to calibrate both serum and urine calcium.
However, specific supplementary assigned values (SAVs) are applied for each
body fluid.

Calibrator Preparation, Handling, and Storage

Refer to the Instructions for Use for VITROS Calibrator Kit 1.

Calibration Procedure
Refer to the operating instructions for your system.
IMPORTANT: Do not adjust the pH of calibration materials for use with the test for urine calcium.

When to Calibrate
Calibrate:
• When the slide lot number changes.
• When critical system parts are replaced due to service or maintenance.
• When government regulations require.
For example, in the USA, CLIA regulations require calibration or calibration verification at least once every six months.
The VITROS Ca test may also need to be calibrated:
• If quality control results are consistently outside acceptable range.
• After certain service procedures have been performed.
For additional information, refer to the operating instructions for your system.

Calculations
Reflectance from the slide is measured at 680 nm after the fixed incubation time. Once a calibration has been performed for
each slide lot, calcium concentration in unknown samples can be determined using the software-resident endpoint
colorimetric math model and the response obtained from each unknown test slide.

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 Ca INSTRUCTIONS FOR USE
Calcium Quality Control

Validity of a Calibration
Calibration parameters are automatically assessed by the system against a set of quality parameters detailed in the
Coefficients and Limits screen on VITROS 250/350 Systems (on the VITROS 5600/XT 7600 Integrated and VITROS 5,1
FS/4600/XT 3400 Chemistry Systems, see the Review Assay Data screen). Failure to meet any of the pre-defined quality
parameters results in a failed calibration. The calibration report should be used in conjunction with quality control results to
determine the validity of a calibration.
Measuring (Reportable or Dynamic) Range

Conventional Units SI Units Alternate Units

(mg/dL) (mmol/L) (mg/L)
Serum 1.00–14.00 0.25–3.49 10.00–140.00
Urine 1.00–17.80 0.25–4.44 10.00–178.00
For out-of-range samples, refer to “Sample Dilution.”

Traceability of Calibration
Values assigned to the VITROS Chemistry Products Calibrator Kit 1 for calcium are traceable to the Certified NIST
(National Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 915. The Ortho
Clinical Diagnostics calibration laboratory uses SRM® 915 to calibrate the flame atomic absorption spectroscopy method 13
to support calcium value assignment for VITROS Calibrator Kit 1.

Quality Control
Quality Control Material Selection
IMPORTANT: VITROS Performance Verifiers are recommended for use with VITROS Chemistry
and Integrated Systems. Evaluate the performance of other commercial control
fluids for compatibility with this test before using for quality control.
• Control materials other than VITROS Performance Verifiers may show a difference when compared with other calcium
methods if they:
– Depart from a true human matrix.
– Contain high concentrations of preservatives, stabilizers, or other nonphysiological additives.
• Do not use control materials stabilized with ethylene glycol.
Urine
For urine specimens, use commercially available urine control materials.
No special treatment is required for urine controls or proficiency materials because they do not contain undissolved
calcium.

Quality Control Procedure Recommendations

• Choose control levels that check the clinically relevant range.
• Analyze quality control materials in the same manner as patient samples, before or during patient sample processing.
• To verify system performance, analyze control materials:
– After calibration.
– According to local regulations or at least once each day that the test is being performed.
– After specified service procedures are performed. Refer to the operating instructions for your system.
• If control results fall outside your acceptable range, investigate the cause before deciding whether to report patient
results.
• For general quality control recommendations, refer to Statistical Quality Control for Quantitative Measurements:
Principles and Definitions; Approved Guideline-Third Edition 14 or other published guidelines.
• For additional information, refer to the operating instructions for your system.

Quality Control Material Preparation, Handling, and Storage

Refer to the Instructions for Use for VITROS Chemistry Products Performance Verifier I and II or to other manufacturer's
product literature.

Results
Reporting Units and Unit Conversion
The VITROS Chemistry and Integrated Systems may be programmed to report Ca results in conventional, SI, and alternate
units.

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Limitations of the Procedure Calcium

Conventional Units SI Units Alternate Units

mg/dL mmol/L (mg/dL × 0.2495) mg/L (mg/dL × 10.0)

Limitations of the Procedure

Known Interferences
Serum
• Blood from patients receiving Hypaque radiographic contrast agent cannot be used.
• Suramin, an antiparasitic drug, has been reported to cause a bias of -10% in calcium results at a suramin concentration
of 300 µg/mL. 16

Urine
None identified.

Other Limitations
Keeping the sample in an open container at room temperature may increase the reported calcium concentration by up to
0.4 mg/dL (0.1 mmol/L). Changes are due to the loss of carbon dioxide, which results in an increase in pH of the specimen.
The increase is minimized by anaerobic handling procedures and prompt analysis. Adherence to these procedures is
especially important for pediatric samples where the sample volume is small.
Certain drugs and clinical conditions are known to alter calcium concentration in vivo. For additional information, refer to
one of the published summaries. 17 18

Expected Values
Reference Interval
These reference intervals are based on an external study. 15

Conventional Units SI Units Alternate Units

Serum 8.4–10.2 mg/dL 2.10–2.55 mmol/L 84.0–102.0 mg/L
Urine — Dietary Ca Intake:
Ca-free 5–40 mg/day* 0.13–1.00 mmol/day** 5–40 mg/day***
Low to average 50–150 mg/day* 1.25–3.75 mmol/day** 50–150 mg/day***
Average 100–300 mg/day* 2.50–7.50 mmol/day** 100–300 mg/day***
*Calcium concentration (mg/dL) × 24-hour volume (dL) = mg/day.
**Calcium concentration (mmol/L) × 24-hour volume (L) = mmol/day.
***Calcium concentration (mg/L) × 24-hour volume (L) = mg/day.

Performance Characteristics
Method Comparison
The plots and tables show the results of a comparison of serum and urine samples analyzed on the VITROS 750 System
with those analyzed using the Atomic Absorption comparative method. 13 Testing followed NCCLS Protocol EP9. 19
The tables, for serum and urine respectively, summarize the results of regression analyses of data obtained from
measurements with both the VITROS 250 and 950 Systems compared to measurements with the VITROS 750 System.
Regression analyses of data for serum and urine samples measured on the VITROS 5,1 FS System compared to
measurements with the VITROS 950 System are also provided.
In addition, the tables for serum and urine summarize the regression analysis of comparisons of results for serum, plasma
and urine samples measured on the VITROS 5600 Integrated System and the VITROS 5,1 FS Chemistry System. Testing
followed NCCLS Protocol EP9. 20
The urine table also shows the results of comparisons between the VITROS 750 System and a commercially available
method.

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 Ca INSTRUCTIONS FOR USE
Calcium Performance Characteristics

Serum
Conventional Units SI Units

VITROS 750 System (mmol/L)

VITROS 750 System (mg/dL)

Comparative Method: Atomic Absorption Comparative Method: Atomic Absorption

(mg/dL) (mmol/L)

Conventional Units (mg/dL) SI Units (mmol/L)

Correlation Range of Range of
n Slope Coefficient Sample Conc. Intercept Sy.x Sample Conc. Intercept Sy.x
750 vs. comparative
78 0.99 0.999 1.9–14.0 +0.13 0.13 0.46–3.48 +0.03 0.03
method
250 vs. 750 72 0.99 0.999 3.4–14.0 +0.08 0.09 0.86–3.49 +0.02 0.02
950 vs. 750 117 1.00 1.000 1.3–14.0 -0.04 0.06 0.33–3.48 -0.01 0.01
5,1 FS† vs. 950 122 1.00 0.999 1.6–13.7 +0.07 0.09 0.40–3.42 +0.02 0.02
5600†† vs. 5,1 FS† 108 1.00 0.999 1.4–13.6 -0.03 0.12 0.35–3.39 -0.01 0.03
† Performance characteristics for the VITROS 5,1 FS System are applicable to the VITROS 4600 System.
†† Performance characteristics for the VITROS 5600 System are applicable to the VITROS XT 3400 and XT 7600 Systems.

Urine
Conventional Units SI Units
VITROS 750 System (mmol/L)
VITROS 750 System (mg/dL)

Comparative Method: Atomic Absorption Comparative Method: Atomic Absorption

(mg/dL) (mmol/L)

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Performance Characteristics Calcium

Conventional Units (mg/dL) SI Units (mmol/L)

Correlation Range of Range of
n Slope Coefficient Sample Conc. Intercept Sy.x Sample Conc. Intercept Sy.x
750 vs. comparative
66 0.97 0.997 1.5–17.4 +0.21 0.31 0.37–4.35 +0.05 0.08
method
250 vs. 750 80 0.99 0.999 1.0–16.9 -0.23 0.21 0.26–4.20 -0.06 0.05
950 vs. 750 115 0.99 1.000 1.2–17.0 -0.07 0.13 0.29–4.24 -0.02 0.03
5,1 FS† vs. 950 107 1.00 0.999 1.1–17.6 -0.26 0.18 0.27–4.39 -0.06 0.04
5600†† vs. 5,1 FS† 110 0.98 0.999 1.0–17.4 +0.08 0.15 0.25–4.34 +0.02 0.04
750 vs. commercial
73 1.04 0.986 0–15.3 +0.55 0.74 0–3.82 +0.14 0.18
method*
* Boehringer Mannheim Calcium/EDTA (Hitachi 747)
† Performance characteristics for the VITROS 5,1 FS System are applicable to the VITROS 4600 System.
†† Performance characteristics for the VITROS 5600 System are applicable to the VITROS XT 3400 and XT 7600 Systems.

Precision
Precision was evaluated with quality control materials on VITROS 250 and 5,1 FS Systems following NCCLS
Protocol EP5. 21 Precision was evaluated with quality control materials on VITROS 5600 Integrated System following
NCCLS protocol EP5. 22
The data presented are a representation of test performance and are provided as a guideline. Variables such as sample
handling and storage, reagent handling and storage, laboratory environment, and system maintenance can affect
reproducibility of test results.

Serum
Conventional Units (mg/dL) SI Units (mmol/L)
Mean Within Within Lab Mean Within Within Lab Within Lab No. No.
Conc. Day SD* SD** Conc. Day SD* SD** CV%** Observ. Days
9.2 0.07 0.14 2.3 0.02 0.04 1.5 78 20
250
12.0 0.08 0.15 3.0 0.02 0.04 1.3 78 20
8.9 0.08 0.12 2.2 0.02 0.03 1.4 83 21
5,1 FS†
12.6 0.12 0.20 3.1 0.03 0.05 1.6 87 22
9.1 0.12 0.17 2.3 0.03 0.04 1.9 88 22
5600††
12.0 0.09 0.16 3.0 0.02 0.04 1.3 88 22
* Within Day precision was determined using two runs/day with at least two replications.
** Within Lab precision was determined using a single lot of slides and calibrating weekly.
† Performance characteristics for the VITROS 5,1 FS System are applicable to the VITROS 4600 System.
†† Performance characteristics for the VITROS 5600 System are applicable to the VITROS XT 3400 and XT 7600 Systems.

Urine
Conventional Units (mg/dL) SI Units (mmol/L)
Mean Within Within Lab Mean Within Within Lab Within Lab No.
Conc. Day SD* SD** Conc. Day SD* SD** CV%** Observ. No. Days
5.7 0.06 0.23 1.4 0.02 0.06 4.0 88 22
7.9 0.09 0.34 2.0 0.02 0.08 4.3 88 22
250
11.2 0.11 0.34 2.8 0.03 0.08 3.0 84 21
12.0 0.09 0.31 3.0 0.02 0.08 2.6 88 22
8.1 0.12 0.13 2.0 0.03 0.03 1.6 101 25
5,1 FS†
11.2 0.15 0.20 2.8 0.04 0.05 1.8 102 25
7.9 0.09 0.16 2.0 0.02 0.04 2.0 88 22
5600††
11.1 0.09 0.20 2.8 0.02 0.05 1.8 88 22
* Within Day precision was determined using two runs/day with at least two replications.
** Within Lab precision was determined using a single lot of slides and calibrating weekly.
† Performance characteristics for the VITROS 5,1 FS System are applicable to the VITROS 4600 System.
†† Performance characteristics for the VITROS 5600 System are applicable to the VITROS XT 3400 and XT 7600 Systems.

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 Ca INSTRUCTIONS FOR USE
Calcium References

Specificity
Substances that do not Interfere
The substances listed in the table were tested with VITROS Ca Slides following NCCLS Protocol EP7 23, 24 and found not
to interfere, bias <0.2 mg/dL (<0.05 mmol/L), at the concentration shown.
Compound Concentration Compound Concentration
Acetylsalicylic acid 30 mg/dL 2 mmol/L Gentisic acid 0.5 mg/dL 32 µmol/L
Para-Aminosalicylic acid 23 mg/dL 2 mmol/L Hemoglobin 550 mg/dL 5.5 g/L
Bilirubin 40 mg/dL 684 µmol/L Intralipid 800 mg/dL 8 g/L
Chlorothiazide 3 mg/dL 101 µmol/L Magnesium 4.32 mg/dL 2 mmol/L
Cyclosporin 20 µg/mL 17 µmol/L Sodium 156 mmol/L 156 mmol/L
Dextran 1000 mg/dL 250 µmol/L Triglycerides 800 mg/dL 9 mmol/L
Ethanol 300 mg/dL 65 mmol/L Urea nitrogen 100 mg/dL 36 mmol/L

References
1. Tietz NW (ed). Fundamentals of Clinical Chemistry. ed. 3. Philadelphia: WB Saunders; 705–713; 1987.
2. CLSI. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline – Fourth Edition.
CLSI document M29-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.
3. Doumas BT, et al. Differences Between Values for Plasma and Serum in Tests Performed in the Ektachem 700 XR
Analyzer, and Evaluation of “Plasma Separator Tubes (PST).”Clin. Chem. 35:151–153; 1989.
4. Calam RR. Specimen Processing Separator Gels: An Update. J Clin Immunoassay. 11:86-90; 1988.
5. Tietz NW. Textbook of Clinical Chemistry. ed. 2. Philadelphia: WB Saunders; 66–67, 1900; 1994.
6. CLSI.Collection of Diagnostic Venous Blood Specimens. 7th ed. CLSI standard GP41. Wayne, PA: Clinical and
Laboratory Standards Institute; 2017.
7. NCCLS. Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard –
Fifth Edition. NCCLS document H4-A5 [ISBN 1-56238-538-0]. CLSI, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2004.
8. Tietz NW. Textbook of Clinical Chemistry. ed. 2. Philadelphia: WB Saunders; 60, 80; 1994.
9. Clinical Laboratory Handbook for Patient Preparation and Specimen Handling. Fascicle VI: Chemistry/Clinical
Microscopy. Northfield, IL: College of American Pathologists; 1992.
10. NCCLS. Urinalysis and Collection, Transportation, and Preservation of Urine Specimens; Approved Guideline. NCCLS
Document GP16. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA; 1995.
11. Ng RH, Menon M, Ladenson JH. Clin. Chem. 30:467–471; 1984.
12. Burtis CA, Ashwood ER. eds. Textbook of Clinical Chemistry. ed. 2. Philadelphia: WB Saunders; 1905; 1994.
13. Cali JP, et al. Atomic Absorption. NBS Reference Method (modified). Clin. Chem. 19:1208; 1987.
14. CLSI. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline – Third
Edition. CLSI document C24-A3 (ISBN 1-56238-613-1). CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA; 2006.
15. Tietz NW (ed). Fundamentals of Clinical Chemistry. ed. 3. Philadelphia: WB Saunders; 947; 1987.
16. Gregory, et al. Suramin Interferes with Measurements of Total Calcium and Serum Amylase by the Kodak Ektachem
700 Analyzer and May Inhibit Liver Enzyme Activity. Clin. Chem. 38:2552–2553; 1992.
17. Young DS. Effects of Drugs on Clinical Laboratory Tests. ed. 4. Washington D.C.: AACC Press; 1995.
18. Friedman RB, Young DS. Effects of Disease on Clinical Laboratory Tests. Washington, D.C.: AACC Press; 1990.
19. CLSI. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS Document EP9.
CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA; 1995.
20. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS document
EP9‑A2 [ISBN 1-56238-472-4]. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA;
2002.
21. CLSI. User Evaluation of Precision Performance with Clinical Chemistry Devices. NCCLS Document EP5. CLSI, 940
West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA; 1992.
22. NCCLS. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second
Edition. NCCLS document EP5-A2 [ISBN 1-56238-542-9]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA; 2004
23. NCCLS. Interference Testing in Clinical Chemistry. NCCLS Document EP7. CLSI, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898 USA; 1986.
24. CLSI. Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition. CLSI Document EP7-A2.
Wayne, PA: Clinical and Laboratory Standards Institute; 2005.

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 INSTRUCTIONS FOR USE Ca
Glossary of Symbols Calcium

Glossary of Symbols

Revision History
Date of Revision Version Description of Technical Changes*
2020-04-16 16.0 Intended Use: Revised for clarity
* The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document.

When this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory
policies, as appropriate.

Signature Obsolete Date

Version 16.0 Pub. No. MP2-10_EN 11 of 12

 Ca INSTRUCTIONS FOR USE
Calcium Revision History

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