INSTRUCTIONS FOR USE BUN/UREA

VITROS Chemistry Products BUN/UREA Slides Blood Urea Nitrogen

810 2204

Rx ONLY

Intended Use
For in vitro diagnostic use only.
VITROS Chemistry Products BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen
(BUN) or as urea (UREA), 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.

Summary and Explanation of the Test

The major pathway of nitrogen excretion is in the form of urea that is synthesized in the liver, released into the blood, and
cleared by the kidneys. A high serum urea nitrogen occurs in glomerulonephritis, shock, urinary tract obstruction,
pyelonephritis, and other causes of acute and chronic renal failure. Severe congestive heart failure, hyperalimentation,
diabetic ketoacidosis, dehydration, and bleeding from the gastrointestinal tract elevate urea nitrogen. Low urea nitrogen
often occurs in normal pregnancy, with decreased protein intake, in acute liver failure, and with intravenous fluid
administration. 1

Principles of the Procedure

The VITROS BUN/UREA 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.
Water and nonproteinaceous components then travel to the underlying reagent layer, where the urease reaction generates
ammonia. The semipermeable membrane allows only ammonia to pass through to the color-forming layer, where it reacts
with the indicator to form a dye.
The reflection density of the dye is measured and is proportional to the concentration of urea 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) 670 nm 5.5 μL
Colorimetric 7600, XT 3400
Note: The reaction sample volume depends on the format of the slide and is
determined automatically by the analyzer. Slides with coating numbers <3201
require a 10 μL reaction sample drop volume.
Not all products and systems are available in all countries.

Reaction Scheme
urease
H2NCONH2 + H2O 2NH3 + CO2

NH3 + ammonia indicator dye

Warnings and Precautions

For in vitro diagnostic use only.

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 BUN/UREA INSTRUCTIONS FOR USE
Blood Urea Nitrogen Reagents

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 or other published biohazard safety
guidelines.
For specific warnings and precautions for calibrators, quality control materials, and other components, refer to the
Instructions for Use for the appropriate VITROS product, or to other manufacturer’s product literature.

Reagents
Slide Diagram
Slide Ingredients 1. Upper slide mount
2. Spreading layer (TiO2)
Reactive Ingredients per cm2 3. Reagent layer
• urease
Urease (jack bean) 1.2 U and N-propyl-4-(2,6-dinitro-4- • buffer, pH 7.8
chlorobenzyl)-quinolinium ethane sulfonate (ammonia indicator) 4. Semipermeable membrane
5. Indicator layer: ammonia
0.26 mg. indicator
6. Support Layer
Other Ingredients 7. Lower slide mount
Pigment, binders, buffer, surfactants, stabilizers, chelator and
cross‑linking agent

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 BUN/UREA 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 ≤ 2 weeks
On-analyzer System turned off ≤ 2 hours
• Do not store with or near ammonia, ammonia compounds, or amines.
• 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.

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 INSTRUCTIONS FOR USE BUN/UREA
Specimen Collection, Preparation and Storage Blood Urea Nitrogen

Specimen Collection, Preparation and Storage

Specimens Recommended
• Serum
• Plasma: 3
– EDTA
– 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: 3 Sodium fluoride (Fluoride inhibits the enzyme urease.)
• Urine:
– Glacial acetic acid as a preservative
– Concentrated hydrochloric acid as a preservative
– Boric acid (in any form) as a preservative

Serum and Plasma

Specimen Collection and Preparation
Collect specimens using standard laboratory procedures. 5 6

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
• For the effect of sample hemolysis on test results, refer to “Limitations of the Procedure.”
• Centrifuge serum and plasma specimens and remove the serum or plasma from the cellular material within 4 hours of
collection. 3
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 3

Storage Temperature Stability
Room temperature 18–28 °C (64–82 °F) ≤ 1 day
Refrigerated 2–8 °C (36–46 °F) ≤ 5 days
Frozen ≤-18 °C (≤0 °F) ≤ 6 months

Urine
Specimen Collection and Preparation
• Collect specimens using standard laboratory procedures. 7
• Keep urine specimens 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
None

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 BUN/UREA INSTRUCTIONS FOR USE
Blood Urea Nitrogen Specimen Pretreatment

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: Urine

Storage Temperature Stability
Refrigerated 2–8 °C (36–46 °F) Refrigerate specimens that
cannot be analyzed immediately.

Specimen Pretreatment
Urine
Predilution
Pretreatment is managed by the analyzer, no operator intervention is required.

Testing Procedure
Materials Provided
VITROS Chemistry Products BUN/UREA 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
• VITROS Chemistry Products 7% BSA
• Isotonic saline or reagent-grade water
• VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline) (for on-analyzer dilution of serum and plasma samples)
• VITROS Chemistry Products FS Diluent Pack 3 (Specialty Diluent/Water) (for on-analyzer dilution of urine samples)

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

Sample Dilution
Serum and Plasma
If urea nitrogen 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 for the dilution.
For VITROS 250/350 and VITROS XT 3400 Chemistry Systems, use VITROS 7% BSA for the dilution.
Manual Sample Dilution

1. Dilute the sample with VITROS 7% BSA.

2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample’s urea nitrogen concentration.

Urine
If urea nitrogen 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, use VITROS Chemistry Products FS Diluent Pack 3 for the
dilution.
For VITROS 250/350 and VITROS XT 3400 Chemistry Systems, use isotonic saline or reagent-grade water for the dilution.

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 INSTRUCTIONS FOR USE BUN/UREA
Calibration Blood Urea Nitrogen

Manual Sample Dilution

1. Dilute the prediluted sample with isotonic saline or reagent-grade water.

2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample’s urea nitrogen concentration.

Calibration
Required Calibrators
VITROS Chemistry Products Calibrator Kit 1
Note: The same VITROS Calibrator Kit is used to calibrate serum, plasma, and urine.
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.
Note: After reconstituting calibrators, do not dilute further when calibrating for urine.

Calibration Procedure
Refer to the operating instructions for your system.

When to Calibrate
Calibrate:
• When the slide lot number changes.
• When critical system parts are replaced due to service or maintenance.
• When government regulations require.
For example, in the USA, CLIA regulations require calibration or calibration verification at least once every six months.
The VITROS BUN/UREA 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 670 nm after the fixed incubation time. Once a calibration has been performed for
each slide lot, urea nitrogen concentration in unknown samples can be determined using the software-resident endpoint
colorimetric math model and the response obtained from each unknown test slide.

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 System (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 urea N) (mmol/L urea) (mg/dL urea)
Serum 2.0–120.0 0.71–42.83 4.29–257.40
Urine* 67–2520 23.91–899.39 143.72–5405.40
* After multiplying by a 21x dilution factor.
For out-of-range samples, refer to “Sample Dilution.”

Traceability of Calibration
Values assigned to the VITROS Chemistry Products Calibrator Kit 1 for BUN/UREA are traceable to the Certified NIST
(National Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 912. The Ortho
Clinical Diagnostics calibration laboratory uses SRM® 912 to calibrate the CDC Urease/GLDH method 8 to support
BUN/UREA value assignment for Vitros Calibrator Kit 1.

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 BUN/UREA INSTRUCTIONS FOR USE
Blood Urea Nitrogen Quality Control

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 urea
nitrogen 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.
Serum
• Some controls that are low in carbon dioxide concentration may show a negative bias (>10% at CO2 <8 mmol/L) that
may be avoided by reconstituting lyophilates with a bicarbonate diluent instead of with water.
• Ammonium bicarbonate diluent should not be used as it will cause a positive bias in test results.
• Proficiency survey samples may show a negative bias similar to controls low in CO2. Contact the testing agency for
instructions because reconstituting with special diluents may affect other analyte values (e.g., reconstituting with sodium
bicarbonate will affect sodium proficiency scores).
Urine
For urine specimens, use commercially available urine control materials.
IMPORTANT: If using a VITROS 250/350 or 5,1 FS/4600/XT 3400 Chemistry System or
VITROS 5600/XT 7600 Integrated System in On-Analyzer Dilution Mode, do not
manually dilute samples for analysis and do not multiply by a dilution factor after
analysis. Refer to the operating instructions for your system for more information
on the On-Analyzer Dilution Procedure.

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 9or 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 BUN/UREA results in conventional, SI, and
alternate units.

Conventional Units SI Units Alternate Units

mg/dL urea N mmol/L urea (mg/dL urea N x mg/dL urea (mg/dL urea N x
0.3569) 2.145)

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 INSTRUCTIONS FOR USE BUN/UREA
Limitations of the Procedure Blood Urea Nitrogen

Limitations of the Procedure

Known Interferences
Ammonium ions may cause an increase in measured BUN/UREA value equivalent to the specimen’s nitrogen content. 11

Serum and Plasma

The VITROS BUN/UREA Slide method was screened for interfering substances following NCCLS Protocol EP7. 12 The
substances listed in the table, when tested at the concentrations indicated, caused the bias shown.
For substances that were tested and did not interfere, refer to “Specificity.”

Blood Urea Nitrogen Average Bias

Concentration
Interferent Conv. SI Conv. SI
Interferent* Concentration (mg/dL) (mmol/L) (mg/dL) (mmol/L)
Serum and Plasma
Hemoglobin 50 mg/dL (0.5 g/L) 28 10 1.1 0.4
*Itis possible that other interfering substances may be encountered. These results are representative; however, your results may differ
somewhat due to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

Other Limitations
Certain drugs and clinical conditions are known to alter blood urea nitrogen concentration in vivo. For additional information,
refer to one of the published summaries. 13 14

Expected Values
Reference Interval
The serum reference interval is the central 95% of results from an internal study of 3160 apparently healthy adults from a
working population (612 females and 2548 males).
The urine reference interval is based on an external study. 10

Conventional Units SI Units Alternate Units

(mg/dL urea N) (mmol/L urea) (mg/dL urea)
Serum
Male 9–20 3.2–7.1 19–43
Female 7–17 2.5–6.1 15–36
Urine
24–hour 12–20 g/day* 428–714 mmol/day** 26–43 g/day*
* Urea nitrogen concentration (mg/dL) x 24-hour volume (dL) = mg/day. To convert mg/day to g/day, divide by 1000.
** Urea nitrogen concentration (mmol/L) x 24-hour volume (L) = mmol/day.
Each laboratory should confirm the validity of these intervals for the population it serves.

Performance Characteristics
Method Comparison
The plots and tables below for serum and urine show the results of a comparison of samples analyzed on the VITROS 750
System with those analyzed using the urease/GLDH comparative method. 15
The tables, for serum and urine respectively, summarize the results of regression analyses of data obtained from
measurements with both the VITROS 250 and 950 Systems compared to measurements with the VITROS 750 System.
Regression analyses of data for serum and urine samples measured on the VITROS 5,1 FS System compared to
measurements with the VITROS 950 System are also provided.
In addition, the tables for serum and urine summarize the regression analysis of comparisons of results for serum, plasma
and urine samples measured on the VITROS 5600 Integrated System and the VITROS 5,1 FS Chemistry System. Testing
followed NCCLS Protocol EP9. 16
The urine table also summarizes the regression analysis of results obtained in a comparison between the VITROS 750
System and a commercially available method.

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 BUN/UREA INSTRUCTIONS FOR USE
Blood Urea Nitrogen Performance Characteristics

Serum
Conventional Units SI Units

VITROS 750 System (mmol/L)

VITROS 750 System (mg/dL)

Comparative Method: Urease/GLDH Comparative Method: Urease/GLDH

(mg/dL) (mmol/L)

Conventional Units SI Units

(mg/dL urea N) (mmol/L urea)
Correlation Range of Range of
n Slope Coefficient Sample Conc. Intercept Sy.x Sample Conc. Intercept Sy.x
750 vs. comparative
method 158 0.99 0.999 2–120 +0.64 1.32 0.8–42.7 +0.23 0.47
250 vs. 750 85 1.00 0.999 2–117 +0.50 0.78 0.8–41.7 +0.18 0.28
950 vs. 750 120 0.99 0.999 5–119 +0.02 0.37 1.6–42.4 0.00 0.13
5,1 FS† vs. 950 135 1.00 1.000 5–118 -0.18 0.44 1.8–42.1 -0.06 0.16
5600†† vs. 5,1 FS† 106 1.00 1.000 6–118 0.00 0.88 2.1–42.1 0.00 0.31
† 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: Urease/GLDH Comparative Method: Urease/GLDH

(mg/dL) (mmol/L)

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 INSTRUCTIONS FOR USE BUN/UREA
Performance Characteristics Blood Urea Nitrogen

Conventional Units SI Units

(mg/dL urea N) (mmol/L urea)
Correlation Range of Range of
n Slope Coefficient Sample Conc. Intercept Sy.x Sample Conc. Intercept Sy.x
750 vs. comparative
method 223 1.00 0.999 72–2487 +1.59 23.82 26–887 +0.57 8.50
250 vs. 750 88 0.99 0.999 134–1234 +20.01 9.78 47.9–440.3 +7.14 3.49
950 vs. 750 118 1.01 0.999 156–2467 -7.75 16.12 55.7–880.5 -2.77 5.75
5,1 FS† vs. 950 100 1.03 0.999 117–2400 -0.91 24.47 41.8–856.6 -0.32 8.73
5600†† vs. 5,1 FS† 107 0.99 1.000 78–2485 -10.26 20.38 27.8–886.9 -3.66 7.27
750 vs. commercial
method* 96 1.08 0.968 160–1500 +18.39 95.79 57.1–535.4 +6.56 34.19
* Boehringer Mannheim BUN Test (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 250/350 and 5,1 FS Systems following NCCLS
Protocol EP5. 17 Precision was also evaluated with quality control materials on the VITROS 5600 Integrated System
following NCCLS protocol EP5. 18
The data presented are a representation of test performance and are provided as a guideline. Variables such as sample
handling and storage, reagent handling and storage, laboratory environment, and system maintenance can affect
reproducibility of test results.

Serum
Conventional Units (mg/dL urea
N) SI Units (mmol/L urea)
Mean Within Within Lab Mean Within Within Lab Within Lab No.
Conc. Day SD* SD** Conc. Day SD* SD** CV%** Observ. No. Days
250 16 0.2 0.3 5.6 0.08 0.10 1.8 79 20
46 0.5 0.7 16.4 0.19 0.25 1.5 78 20
20 0.2 0.3 7.0 0.07 0.10 1.5 88 22
5,1 FS†
50 0.4 0.8 17.8 0.16 0.29 1.6 87 22
20 0.2 0.6 7.1 0.07 0.21 3.0 92 23
5600††
57 0.4 1.3 20.3 0.14 0.46 2.3 92 23
* 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 urea
N) SI Units (mmol/L urea)
Mean Within Within Lab Mean Within Within Lab Within Lab No.
Conc. Day SD* SD** Conc. Day SD* SD** CV%** Observ. No. Days
412 5.4 9.3 146.9 1.94 3.32 2.3 88 22
250
644 9.6 20.3 230.0 3.42 7.25 3.2 88 22
432 4.2 7.6 154.1 1.49 2.70 1.8 90 22
5,1 FS†
791 8.2 14.9 282.3 2.94 5.31 1.9 88 22
426 3.1 11.5 152.0 1.11 4.10 2.7 88 22
5600††
722 6.0 19.5 257.7 2.14 6.96 2.7 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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 BUN/UREA INSTRUCTIONS FOR USE
Blood Urea Nitrogen References

Specificity
Substances that Do Not Interfere
Serum
The substances listed in the table were tested with VITROS BUN/UREA Slides following NCCLS Protocol EP7 12 and found
not to interfere, bias <1.1 mg/dL urea N (0.39 mmol/L urea), at the concentration shown.
Compound Concentration Compound Concentration
Ascorbic acid 3 mg/dL 170 µmol/L 6-Mercaptopurine 1.5 mg/dL 99 µmol/L
Bilirubin 40 mg/dL 684 µmol/L Phenytoin 2 mg/dL 79 µmol/L
Dextran 1000 mg/dL 250 µmol/L Phenobarbital 3 mg/dL 129 µmol/L
Ethanol 300 mg/dL 65 mmol/L Sulfathiazole 6 mg/dL 235 µmol/L
Hypaque 500 mg/dL 8 mmol/L Tolbutamide 22 mg/dL 814 µmol/L
Intralipid 800 mg/dL 8 g/L Total protein 10 g/dL 100 g/L
Meprobamate 2 mg/dL 92 µmol/L Triglycerides 800 mg/dL 9 mmol/L
Urine
The following preservatives have been tested and demonstrated an effect of less than 3% on urine urea nitrogen results.
Compound Concentration
10% Thymol in isopropanol 6.7 mL/L 6.7 mL/L
Toluene 1.3 mL/L 1.3 mL/L
Sodium fluoride 10 mg/mL 2 mmol/L

References
1. Tietz NW (ed). Fundamentals of Clinical Chemistry. ed. 3. Philadelphia: WB Saunders; 967; 1987.
2. CLSI. Protection of Laboratory Workers from Instrument Biohazards and Infectious Diseases Transmitted by Blood,
Body Fluids and Tissue; Approved Guideline – Fourth Edition; CLSI Document M29-A4, Wayne, PA: Clinical and
Laboratory Standards Institute; 2014.
3. Clinical Laboratory Handbook for Patient Preparation and Specimen Handling. Fascicle VI: Chemistry/Clinical
Microscopy. Northfield, IL: College of American Pathologists; 1992.
4. Calam RR. Specimen Processing Separator Gels: An Update. J Clin Immunoassay. 11:86-90; 1988.
5. CLSI. Collection of Diagnostic Venous Blood Specimens. 7th ed. CLSI standard GP41. Wayne, PA: Clinical and
Laboratory Standards Institute; 2017.
6. 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.
7. NCCLS. Urinalysis and Collection, Transportation, and Preservation of Urine Specimens; Approved Guideline. NCCLS
Document GP16. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA; ; 1995.
8. Sampson RI, et al. A coupled-enzyme equilibrium method for measuring urea in serum: optimization and evaluation of
the AACC study group on urea candidate reference method. Clin. Chem. 26:816-26; 1980.
9. 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.
10. Rock RC, Walker WG, Jennings CD. Nitrogen Metabolites and Renal Function. In Tietz NW (ed). Fundamentals of
Clinical Chemistry. ed 3. 669-700.
11. Tietz NW (ed). Fundamentals of Clinical Chemistry. ed. 3. Philadelphia: WB Saunders; 676–679; 1987.
12. NCCLS.Interference Testing in Clinical Chemistry. NCCLS Document EP7. CLSI, 940 West Valley Road, Suite 1400,
Wayne, PA 19087-1898 USA; 1986.
13. Young DS. Effects of Drugs on Clinical Laboratory Tests. ed. 4. Washington D.C.: AACC Press; 1995.
14. Friedman RB, Young DS. Effects of Disease on Clinical Laboratory Tests. Washington, D.C.: AACC Press; 1990.
15. Talke H, Schubert GE. Urease/GLDH System Applied to a Somogyi Deproteinized Supernate. Klin. Wochensch.
43:174; 1965.
16. 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.
17. NCCLS. User Evaluation of Precision Performance with Clinical Chemistry Devices. NCCLS Document EP5. CLSI, 940
West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA; 1992.
18. 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

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 INSTRUCTIONS FOR USE BUN/UREA
Glossary of Symbols Blood Urea Nitrogen

Glossary of Symbols

Revision History
Date of Revision Version Description of Technical Changes*
2019-11-18 12.1 Slide Ingredients: “quinolonium” corrected to “quinolinium”
2019-09-06 12.0 • Added information for the VITROS XT 3400 Chemistry System
• Glossary of Symbols: updated
• Updated EC Representative address
• Method Comparison: updated
* The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document.

Version 12.1 Pub. No. MP2-9_EN 11 of 12

 BUN/UREA INSTRUCTIONS FOR USE
Blood Urea Nitrogen Revision History

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

Ortho-Clinical Diagnostics
1500 Boulevard Sébastien Brant
B.P. 30335
67411 Illkirch
CEDEX, France

Ortho-Clinical Diagnostics, Inc.

100 Indigo Creek Drive
Rochester, NY 14626
USA

VITROS is a registered trademark of Ortho Clinical Diagnostics.

© Ortho Clinical Diagnostics, 2002–2019

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