UREA NITROGEN

7D75-20 and 7D75-30

30-3521/R4

UREA NITROGEN
This package insert contains information to run the Urea Nitrogen 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

Reagent 2

ABBOTT LABORATORIES ABBOTT

Abbott Park, IL 60064, USA Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
September 2006
©2002, 2006 Abbott Laboratories

1
NAME WARNINGS AND PRECAUTIONS (Continued)
UREA NITROGEN 5. CAUTION: This product requires the handling of human specimens.
INTENDED USE It is recommended that all human sourced materials be considered
The Urea Nitrogen assay is used for the quantitation of urea nitrogen in potentially infectious and handled in accordance with the OSHA
human serum, plasma, or urine. Standard on Bloodborne Pathogens.3 Biosafety Level 24 or other
appropriate biosafety practices5,6 should be used for materials that
SUMMARY AND EXPLANATION OF TEST contain or are suspected of containing infectious agents.
Measurements obtained by this test are used in the diagnosis of certain For product not classified as dangerous per European Directive
renal and metabolic diseases. The determination of serum urea nitrogen 1999/45/EC as amended, safety data sheet available for professional
is a widely used test for the evaluation of kidney function. The test is user on request.
frequently requested in conjunction with the serum creatinine test for SPECIMEN COLLECTION AND HANDLING
the differential diagnosis of prerenal (cardiac decompensation, water
depletion, increased protein catabolism), renal (glomerulonephritis, Suitable Specimens
chronic nephritis, polycystic kidney, nephrosclerosis, tubular necrosis), Serum, plasma, and urine are acceptable specimens.
and postrenal (obstructions of the urinary tract) hyperuremia. • Serum: Use serum collected by standard venipuncture techniques
PRINCIPLES OF PROCEDURE into glass or plastic tubes with or without gel barriers. Ensure
complete clot formation has taken place prior to centrifugation.
The Urea Nitrogen assay is a modification of a totally enzymatic Separate serum from red blood cells or gel as soon after collection
procedure first described by Talke and Schubert.1 The test is performed as possible.
as a kinetic assay in which the initial rate of the reaction is linear for
a limited period of time. Urea in the sample is hydrolyzed by urease Some specimens, especially those from patients receiving
to ammonia and carbon dioxide. The second reaction, catalyzed by anticoagulant or thrombolytic therapy, may take longer to complete
glutamate dehydrogenase (GLD) converts ammonia and α-ketoglutarate their clotting processes. Fibrin clots may subsequently form in
to glutamate and water with the concurrent oxidation of reduced these sera and the clots could cause erroneous test results.
nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine • Plasma: Use plasma collected by standard venipuncture
dinucleotide (NAD). Two moles of NADH are oxidized for each mole of techniques into glass or plastic tubes. Acceptable anticoagulants
urea present. The initial rate of decrease in absorbance at 340 nm is are lithium heparin (with or without gel barrier) and sodium heparin.
proportional to the urea concentration in the sample. Ensure centrifugation is adequate to remove platelets. Separate
Methodology: Urease plasma from red blood cells or gel as soon after collection as
possible.
REAGENTS • Urine: 24 hour timed urine specimens are preferred.2
Reagent Kit Refer to specimen collection tube manufacturer’s instructions for
processing and handling requirements.
Urea Nitrogen is supplied as a liquid, ready-to-use, two-reagent kit
which contains: For total sample volume requirements, refer to the instrument-specific
ASSAY PARAMETERS section of this package insert and Section 5 of
7D75-20 the instrument-specific operations manual.
10 x 66 mL Specimen Storage
10 x 66 mL Bibliographic
Temperature Maximum Storage
Estimated tests per kit: 17,222* Serum/Plasma Urine* Reference
20 to 25°C 7 days 2 days 7
7D75-30 2 to 8°C 7 days 7 days 7, 8
5 x 35 mL -20°C 1 year 1 month 7
5 x 35 mL * Urine samples can be preserved with thymol to avoid bacterial
action.2
Estimated tests per kit: 4,389*
*Calculation is based on the minimum reagent fill volume per kit. Guder et al.7 suggest storage of frozen specimens at -20°C for
no longer than the time intervals cited above. However, limitations
Reactive Ingredients Concentration of laboratory equipment make it necessary in practice for clinical
NADH 2.95 mmol/L laboratories to establish a range around -20°C for specimen storage.
Sodium Azide < 0.1% This temperature range may be established from either the freezer
manufacturer’s specifications or your laboratory standard operating
α-Ketoglutaric Acid 99.8 mmol/L procedure(s) for specimen storage.
Urease (jack bean) 23.5 KU/L
GLD (beef liver) 63.5 KU/L NOTE: Stored specimens must be inspected for particulates. If present,
Adenosine Diphosphate 7.6 mmol/L mix and centrifuge the specimen to remove particulates prior to testing.
Sodium Azide < 0.2% PROCEDURE
REAGENT HANDLING AND STORAGE Materials Provided
Reagent Handling 7D75 Urea Nitrogen Reagent Kit
Remove air bubbles, if present in the reagent cartridge, with a new Materials Required but not Provided
applicator stick. Alternatively, allow the reagent to sit at the appropriate • 1E65 Multiconstituent Calibrator, 3 x 5 mL
storage temperature to allow the bubbles to dissipate. To minimize • Control Material
volume depletion, do not use a transfer pipette to remove the bubbles. • Saline (0.85% to 0.90% NaCl) for specimens that require dilution
CAUTION: Reagent bubbles may interfere with proper detection of Assay Procedure
reagent level in the cartridge, causing insufficient reagent aspiration For a detailed description of how to run an assay, refer to Section 5 of
which could impact results. the instrument-specific operations manual.
Reagent Storage Specimen Dilution Procedures
Unopened reagents are stable until the expiration date when stored at The ARCHITECT c Systems and the AEROSET System have automatic
2 to 8°C. dilution features; refer to Section 2 of the instrument-specific operations
Reagent stability is 25 days if the reagent is uncapped and onboard. manual for additional information.
WARNINGS AND PRECAUTIONS Serum and plasma: Specimens with urea nitrogen values exceeding
125 mg/dL (44.6 mmol/L urea) are flagged and may be diluted using
Precautions for Users the Automated Dilution Protocol or the Manual Dilution Procedure.
1. For in vitro diagnostic use. Urine: Urine samples are automatically diluted 1:20 by the system using
2. Do not use components beyond the expiration date. the Standard dilution option, then the system automatically corrects the
3. Do not mix materials from different kit lot numbers. concentration by multiplying the result by the appropriate dilution factor.
4. and contain sodium azide. For a specific listing, refer to This dilution extends urine urea nitrogen linearity to 1,991 mg/dL
the REAGENTS section. Contact with acids liberates very toxic gas. (710.8 mmol/L urea). Samples exceeding this concentration are flagged
This material and its container must be disposed of in a safe way. and may be diluted using the Automated Dilution Protocol or the Manual
NOTE: Refer to Section 8 of the instrument-specific operations Dilution Procedure.
manual for proper handling and disposal of reagents containing Serum/Plasma Automated Dilution Protocol
sodium azide. If using the Automated Dilution Protocol, the system performs
a 1:5 dilution of the specimen and automatically corrects the
concentration by multiplying the result by the appropriate dilution factor.

2
PROCEDURE (Continued) EXPECTED VALUES (Continued)
Urine Automated Dilution Protocol Mass Conversion of Urea Nitrogen to Urea
If using the Automated Dilution Protocol, the system performs a dilution mg/dL urea nitrogen × 2.14 = mg/dL urea
of the specimen and automatically corrects the concentration by mg/dL urea ÷ 100 = g/L urea
multiplying the result by the appropriate dilution factor. To set up the SI Unit Conversion of Urea
automatic dilution feature, refer to Section 2 of the instrument-specific
operations manual for additional information. g/L urea ÷ 60.0 g/mol = mol/L urea
mol/L urea ×1000 = mmol/L urea
Manual Dilution Procedure
Manual dilutions should be performed as follows: To convert results from mg/dL urea nitrogen to mmol/L urea, multiply
mg/dL by 0.357.
• Use saline (0.85% to 0.90% NaCl) to dilute the sample.
• The operator must enter the dilution factor in the patient or control Urine10
order screen. The system uses this dilution factor to automatically Urea Nitrogen Urea Range
correct the concentration by multiplying the result by the entered Range (g/day) (mmol/day)
factor. All 12 to 20 428 to 714
• If the operator does not enter the dilution factor, the result must
be multiplied by the appropriate dilution factor before reporting the To convert results from g/day urea nitrogen to mmol/day urea, multiply
result. g/day by 35.7.
NOTE: If a diluted sample result is flagged indicating it is less than the It is recommended that each laboratory determine its own reference
linear low limit, do not report the result. Rerun using an appropriate range based upon its particular locale and population characteristics.
dilution.
For detailed information on ordering dilutions, refer to Section 5 of the 24 Hour Urinary Excretion
instrument-specific operations manual. To convert results from mg/dL to g/day urea nitrogen (24 hour urinary
excretion)
CALIBRATION Where:
Calibration is stable for approximately 7 days (168 hours) and is V = 24 hour urine volume (mL)
required with each change in reagent lot number. Verify calibration c = analyte concentration (mg/dL)
with at least two levels of controls according to the established quality 24 hour excretion = [(V × c) ÷ 100,000] g/day urea nitrogen
control requirements for your laboratory. If control results fall outside
acceptable ranges, recalibration may be necessary. To convert results from mmol/L to mmol/day urea (24 hour urinary
excretion)
For a detailed description of how to calibrate an assay, refer to
Section 6 of the instrument-specific operations manual. Where:
For information on calibrator standardization, refer to the V = 24 hour urine volume (mL)
c = analyte concentration (mmol/L)
Multiconstituent Calibrator package insert. 24 hour excretion = [(V × c) ÷ 1000] mmol/day urea
QUALITY CONTROL
The following is the recommendation of Abbott Laboratories for quality
SPECIFIC PERFORMANCE CHARACTERISTICS
control. As appropriate, refer to your laboratory standard operating Linearity
procedure(s) and/or quality assurance plan for additional quality control Urea nitrogen serum is linear up to 125 mg/dL (44.6 mmol/L urea).
requirements and potential corrective actions. Urea nitrogen urine is linear up to 1,991 mg/dL (710.8 mmol/L urea).
• Two levels of controls (normal and abnormal) are to be run every Linearity was verified using Clinical and Laboratory Standards Institute
24 hours. (CLSI) protocol NCCLS EP6-P.11
• If more frequent control monitoring is required, follow the Limit of Detection (LOD)
established quality control procedures for your laboratory.
• If quality control results do not meet the acceptance criteria The LOD for urea nitrogen serum is 0.7 mg/dL (0.25 mmol/L urea). The
defined by your laboratory, patient values may be suspect. Follow LOD for urea nitrogen urine is 15.0 mg/dL (5.4 mmol/L urea). The LOD
the established quality control procedures for your laboratory. is the mean concentration of an analyte-free sample + 2 SD, where
Recalibration may be necessary. SD = the pooled, within-run standard deviation of the analyte-free
• Review quality control results and acceptance criteria following a sample. A study performed on an ARCHITECT c System and an
change of reagent or calibrator lot. AEROSET System produced an LOD for the Urea Nitrogen assay
(serum) of 0.6 mg/dL (0.22 mmol/L) and 11.3 mg/dL (4.04 mmol/L)
RESULTS for the Urea Nitrogen assay (urine).
Refer to the instrument-specific operations manual for information on
results calculations. Limit of Quantitation (LOQ)
• ARCHITECT System Operations Manual—Appendix C The LOQ for urea nitrogen serum is 1.4 mg/dL (0.50 mmol/L urea). The
LOQ for urea nitrogen urine is 40.0 mg/dL (14.28 mmol/L urea). The
• AEROSET System Operations Manual—Appendix A LOQ is the analyte concentration at which the CV = 20%.
Representative performance data are given in the EXPECTED VALUES
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this Interfering Substances12
package insert. Results obtained in individual laboratories may vary. Interference studies were conducted using CLSI protocol
NCCLS EP7-P.13 Interference effects were assessed by Dose Response
LIMITATIONS OF THE PROCEDURE and Paired Difference methods, at the medical decision level of the
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC analyte.
PERFORMANCE CHARACTERISTICS sections of this package insert.
Interfering Target Observed
Interferent Concentration N (mg/dL)
EXPECTED VALUES Substance (% of Target)
30 mg/dL (513 μmol/L) 4 20.8 99.5
Reference Range Bilirubin 60 mg/dL (1,026 μmol/L) 4 20.8 98.2
Serum/Plasma9
Hemoglobin 2,000 mg/dL
1,000 (10.0 g/L)
mg/dL (20.0 g/L)
4
4
19.8
19.8
96.5
97.4
Urea Nitrogen Urea Range
Age 750 mg/dL (7.5 g/L) 4 20.8 99.8
Range (mg/dL) (mmol/L) Intralipid
Children 1,000 mg/dL (10.0 g/L) 4 20.8 99.0
1 to 3 years 5.1 to 16.8 1.8 to 6.0 Bilirubin solutions at the above concentrations were prepared by
4 to 13 years 7.0 to 16.8 2.5 to 6.0 addition of a bilirubin stock to human serum pools. Hemoglobin
14 to 19 years 8.4 to 21.0 3.0 to 7.5 solutions at the above concentrations were prepared by addition of
Adult, Male hemolysate to human serum pools. Intralipid solutions at the above
< 50 years 8.9 to 20.6 3.2 to 7.4 concentrations were prepared by addition of Intralipid to human serum
> 50 years 8.4 to 25.7 3.0 to 9.2 pools.
Adult, Female
< 50 years 7.0 to 18.7 2.5 to 6.7 For the urine application, protein up to 50 mg/dL, glucose up to
> 50 years 9.8 to 20.1 3.5 to 7.2 1,000 mg/dL, sodium oxalate up to 60 mg/dL, ascorbate up to
200 mg/dL, acetic acid (8.5 N) up to 6.25 mL/dL, boric acid up to
Values in the cited reference were converted from urea (mg/dL) to 250 mg/dL, hydrochloric acid (6 N) up to 2.5 mL/dL, nitric acid (6 N) up
urea nitrogen (mg/dL), and subsequently converted to SI units for to 5.0 mL/dL, sodium fluoride up to 400 mg/dL, and sodium carbonate
urea (mmol/L). up to 1.25 g/dL demonstrated less than 10% interference.

3
SPECIFIC PERFORMANCE CHARACTERISTICS BIBLIOGRAPHY
(Continued) 1. Talke H, Schubert GE. Klinische Wochenschrift 1965;43:174.
Precision 2. Tietz NW, editor. Clinical Guide to Laboratory Tests, 3rd ed.
Philadelphia, PA: WB Saunders; 1995:622–4.
The imprecision of the Urea Nitrogen serum assay is ≤ 4.5% Total CV.
Representative data from studies using CLSI protocol NCCLS EP5-T214 3. US Department of Labor, Occupational Safety and Health
are summarized below. Administration. 29 CFR Part 1910.1030, Occupational Exposure to
Bloodborne Pathogens.
Serum 4. US Department of Health and Human Services. Biosafety in
Control Level 1 Level 2 Microbiological and Biomedical Laboratories. HHS Publication
N 80 80 (CDC), 4th ed. Washington, DC: US Government Printing Office,
Mean (mg/dL) 15.5 48.0 May 1999.
SD 0.20 0.45 5. World Health Organization. Laboratory Biosafety Manual. Geneva:
Within Run World Health Organization, 2004.
%CV 1.3 0.9
SD 0.07 0.24 6. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
Between Run Workers from Occupationally Acquired Infections; Approved
%CV 0.5 0.5
Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and
SD 0.17 0.83 Laboratory Standards Institute, 2005.
Between Day
%CV 1.1 1.7 7. Guder WG, Narayanan S, Wisser H, et al. List of analytes—
SD 0.27 0.97 preanalytical variables. Annex In: Samples: From the Patient to
Total
%CV 1.8 2.0 the Laboratory. Darmstadt, Germany: GIT Verlag; 1996:Annex
The imprecision of the Urea Nitrogen urine assay is ≤ 4.5% 22–3, 42–3.
Total CV. Representative data from studies using CLSI protocol 8. US Pharmacopeial Convention, Inc. General notices. In: US
NCCLS EP10-T215 are summarized below. Pharmacopeia National Formulary, 1995 ed. (USP 23/NF 18).
Urine Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
9. Thomas L. Clinical Laboratory Diagnostics: Use and Assessment of
Control Level 1 Level 2 Clinical Laboratory Results. Frankfurt/Main, Germany: TH-Books
N 50 50 Verlagsgesellschaft mbH; 1998:374–7.
Mean (mg/dL) 504.8 896.4 10. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical
SD 13.69 22.87 Chemistry, 2nd ed. Philadelphia, PA: WB Saunders; 1994:2209.
Within Run 11. Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity
%CV 2.7 2.6
SD 8.92 15.77 of Quantitative Analytical Methods; Proposed Guideline (EP6-P).
Between Run Villanova, PA: The National Committee for Clinical Laboratory
%CV 1.8 1.8
SD 9.73 0.00 Standards, 1986.
Between Day 12. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
%CV 1.9 0.0
Washington, DC: AACC Press; 1995:3-599–3-609.
SD 19.02 27.78
Total 13. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in
%CV 3.8 3.1 Clinical Chemistry; Proposed Guideline (EP7-P). Villanova, PA:
Method Comparison The National Committee for Clinical Laboratory Standards, 1986.
Correlation studies were performed using CLSI protocol 14. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
NCCLS EP9-A.16 Performance of Clinical Chemistry Devices—Second Edition;
Serum and urine results from the Urea Nitrogen assay on the AEROSET Tentative Guideline (EP5-T2). Villanova, PA: The National
System were compared with those from a commercially available Committee for Clinical Laboratory Standards, 1992.
urease methodology. 15. Garber CC, Clark LW, Garrett PE, et al. Preliminary Evaluation of
Serum and urine results from the Urea Nitrogen assay on an Quantitative Clinical Laboratory Methods—Second Edition; Tentative
ARCHITECT c System were compared with the Urea Nitrogen assay on Guideline (EP10-T2). Villanova, PA: The National Committee for
an AEROSET System. Clinical Laboratory Standards, 1993.
Serum AEROSET 16. Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison and
ARCHITECT Bias Estimation Using Patient Samples; Approved Guideline (EP9-A).
vs. Comparative Wayne, PA: The National Committee for Clinical Laboratory
vs. AEROSET
Method Standards, 1995.
N 80 102
TRADEMARKS
Y - Intercept 0.904 0.236
AEROSET and ARCHITECT are registered trademarks of Abbott
Correlation Coefficient 0.997 0.999 Laboratories.
Slope 1.038 1.019 c System is a trademark of Abbott Laboratories.
Range (mg/dL)* 10.52 to 173.58 2.64 to 120.55 All other trademarks, brands, product names, and trade names are the
*AEROSET Range property of their respective companies.

Urine AEROSET
ARCHITECT
vs. Comparative
vs. AEROSET
Method
N 80 89
Y - Intercept 9.993 -0.613
Correlation Coefficient 0.992 0.997
Slope 0.983 0.898
Range (mg/dL)* 53.5 to 1,242.6 54.5 to 1,989.17
*AEROSET Range

4
ARCHITECT c SYSTEMS ASSAY PARAMETERS

Urea Nitrogen 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: Urea Type: Photometric Version: 1 Assay: Urea
Number: 1005 COMPONENT REAGENT / ASSAY WASH Volume Replicates
● Reaction definition о Reagent / Sample о Validity checks Cuvette Trig 10% Detergent B*** 345
Reaction mode: Rate down
Primary Secondary Read times
Wavelength: 340 / 380 Main: 24 – 28
Last required read: 28 Flex: ___ – ___ *** Select “Detergent B” for software versions prior to 2.2.
Absorbance range: ___ – ___ Color correction: ___ – ___
Sample blank type: None Urea Nitrogen Serum/Plasma—Conventional Units
Configure assay parameters — Results — Conventional units
о Reaction definition ● Reagent / Sample о Validity checks о General о Calibration о SmartWash ● Results о Interpretation
R1 R2 Assay: Urea Result units: mg/dL
Reagent: UREA0 Reagent volume: 28 28 Assay defaults:
Diluent: Saline Water volume: 252 ___ Low-Linearity: 2 †
Diluent dispense mode: Type 0 Dispense mode: Type 0 Type 0 High-Linearity: 125
Diluted Default Gender and age specific ranges:
Dilution name Sample sample Diluent Water Dilution factor dilution GENDER AGE (UNITS) NORMAL EXTREME
STANDARD : 2.4 ___ ___ ___ = 1:1.00 ● Male 0 – 130 (Y) 8 – 26
1:5 : 20.0 2.4 80 ___ = 1:5.00 о Female 0 – 130 (Y) 7 – 20
________ : ___ ___ ___ ___ = о Either 0 – 130 (Y) 7 – 26

о Reaction definition о Reagent / Sample ● Validity checks

Reaction check: Rate Subtraction Configure result units — Conventional units
A B
Assay: Urea
Read time: 21 – 23 26 – 28
Version: 1
Calculation limits: -0.2000 – 0.2000
Result units: mg/dL
Rate linearity %: ___ Decimal places: 0 [Range 0 – 4]
Correlation factor: 1.0000
Configure assay parameters — Calibration Intercept: 0.0000
о General ● Calibration о SmartWash о Results о Interpretation
Assay: Urea Calibration method: Linear Urea Nitrogen Serum/Plasma—SI Units

● Calibrators о Volumes о Intervals о Validity checks Configure assay parameters — Results — SI units
Calibrator set: Calibrator level: Concentration: о General о Calibration о SmartWash ● Results о Interpretation
MCC Blank: Water 0†† Assay: Urea Result units: mmol/L
Cal 1: MCC1 ‡ Assay defaults:
Replicates: 3 [Range 1 – 3] Cal 2: MCC2 ‡ Low-Linearity: 0.5†
High-Linearity: 44.6
Gender and age specific ranges:
о Calibrators ● Volumes о Intervals о Validity checks GENDER AGE (UNITS) NORMAL EXTREME
Calibrator: MCC Diluted
Calibrator level Sample sample Diluent Water Male 0 – 130 (Y) 3.0 – 9.2
Blank: Water 2.4 ___ ___ ___ Female 0 – 130 (Y) 2.5 – 7.2
Cal 1: MCC1 2.4 ___ ___ ___ Either 0 – 130 (Y) 2.5 – 9.2
Cal 2: MCC2 2.4 ___ ___ ___
Configure result units — SI units
о Calibrators о Volumes ● Intervals о Validity checks Assay: Urea
Calibration intervals: Version: 1
Full interval: 168 (hours) Result units: mmol/L
Calibration type: Decimal places: 1 [Range 0 – 4]
Adjust type: None Correlation factor: 1.0000
Intercept: 0.0000
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

† The linear low value (Low-LInearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.
‡ Refer to concentration specified on calibrator labeling or value sheet.
†† Displays the number of decimal places defined in the decimal places parameter field.

5
ARCHITECT c SYSTEMS ASSAY PARAMETERS

Urea Nitrogen 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: Urea-U Type: Photometric Version: 1 Assay: Urea-U
Number: 1036 COMPONENT REAGENT / ASSAY WASH Volume Replicates
● Reaction definition о Reagent / Sample о Validity checks Cuvette Trig 10% Detergent B*** 345
Reaction mode: Rate down
Primary Secondary Read times
Wavelength: 340 / 380 Main: 24 – 28
Last required read: 28 Flex: ___ – ___ *** Select “Detergent B” for software versions prior to 2.2.
Absorbance range: ___ – ___ Color correction: ___ – ___
Sample blank type: None
Urea Nitrogen Urine—Conventional Units
о Reaction definition ● Reagent / Sample о Validity checks Configure assay parameters — Results — Conventional units
R1 R2 о General о Calibration о SmartWash ● Results о Interpretation
Reagent: UREA0 Reagent volume: 28 28 Assay: Urea-U Result units: mg/dL
Diluent: Saline Water volume: 252 ___ Assay defaults:
Diluent dispense mode: Type 0 Dispense mode: Type 0 Type 0 Low-Linearity: 2†
Diluted Default High-Linearity: 99†
Dilution name Sample sample Diluent Water Dilution factor dilution Gender and age specific ranges:
STD(1:20) : 10.0 2.4 190 ___ = 1:20.00 ● GENDER AGE (UNITS) NORMAL EXTREME
_________ : ___ ___ ___ ___ = о
_________ : ___ ___ ___ ___ = о
Configure result units — Conventional units
о Reaction definition о Reagent / Sample ● Validity checks Assay: Urea-U
Reaction check: None Version: 1
Rate linearity %: ___ Result units: mg/dL
Decimal places: 0 [Range 0 – 4]
Correlation factor: 1.0000
Configure assay parameters — Calibration Intercept: 0.0000
о General ● Calibration о SmartWash о Results о Interpretation
Assay: Urea-U Calibration method: Linear

● Calibrators о Volumes о Intervals о Validity checks Urea Nitrogen Urine—SI Units

Calibrator set: Calibrator level: Concentration:
MCC Blank: Water 0†† Configure assay parameters — Results — SI units
Cal 1: MCC1 ‡ о General о Calibration о SmartWash ● Results о Interpretation
Replicates: 3 [Range 1 – 3] Cal 2: MCC2 ‡ Assay: Urea-U Result units: mmol/L
Assay defaults:
о Calibrators ● Volumes о Intervals о Validity checks Low-Linearity: 0.8†
Calibrator: MCC High-Linearity: 35.5†
Diluted Gender and age specific ranges:
Calibrator level Sample sample Diluent Water
Blank: Water 2.4 ___ ___ ___ GENDER AGE (UNITS) NORMAL EXTREME
Cal 1: MCC1 2.4 ___ ___ ___
Cal 2: MCC2 2.4 ___ ___ ___
Configure result units — SI units
о Calibrators о Volumes ● Intervals о Validity checks Assay: Urea-U
Calibration intervals: Version: 1
Full interval: 168 (hours) Result units: mmol/L
Calibration type: Decimal places: 1 [Range 0 – 4]
Adjust type: None Correlation factor: 1.0000
Intercept: 0.0000
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

† The linear low value (Low-Linearity) is LOQ divided by the standard dilution factor, then rounded up to the number of decimal places defined in
the decimal places parameter field. The linear high value (High-Linearity) is linearity divided by the standard dilution factor.
‡ Refer to concentration specified on calibrator labeling or value sheet.
†† Displays the number of decimal places defined in the decimal places parameter field.

6
AEROSET SYSTEM ASSAY PARAMETERS

Urea Nitrogen Serum/Plasma—Conventional Units Urea Nitrogen Serum/Plasma—SI Units

Assay Configuration: Outline Page Assay Configuration: Outline Page
Assay Name Assay # Line Assay Name Assay # Line
Urea 5 A-Line Urea 5 A-Line
Quantitative Ranges Quantitative Ranges
Max Max
Min Text Min Panic-L L-Reference-H Panic-H Max Min Text Min Panic-L L-Reference-H Panic-H Max
Text Text
* 0.0* 0.0 7.0 25.7 0.0 0.0* * * 0.0* 0.0 2.5 9.2 0.0 0.0* *
2** L-Linear Range-H 125 0.5** L-Linear Range-H 44.6
Reference Ranges* Reference Ranges*
Age Male Female Age Male Female
0 Year 8.4 – 25.7 7.0 – 20.1 0 Year 3.0 – 9.2 2.5 – 7.2
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 Linearity % Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex Linearity %
RATE DOWN 340 / 380 24 – 28 / 0 – 0 0.0 RATE DOWN 340 / 380 24 – 28 / 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 20.0 2.4 80 0 Diluent: DILUENT C–10* Dil 1 20.0 2.4 80 0 Diluent: DILUENT C–10*
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 UREA061‡‡ – ___* 28 252 0 Reagent 1 UREA061‡‡ – ___* 28 252 0
Reagent 2 UREA062‡‡ – ___* 28 0 0 Reagent 2 UREA062‡‡ – ___* 28 0 0
Reaction Check Read Time – A/B Range Minimum Reaction Check Read Time – A/B Range Minimum
RATE SUB 21 – 23 / 26 – 28 -0.2 – 0.2 0.0 RATE SUB 21 – 23 / 26 – 28 -0.2 – 0.2 0.0
Factor/Intercept Decimal Places Units Factor/Intercept Decimal Places Units
1.0 / 0.0 0 mg/dL 1.0 / 0.0 1 mmol/L

Assay Configuration: Calibration Page Assay Configuration: Calibration Page

Calib Mode Interval (H) Calib Mode Interval (H)
Linear 168 Linear 168
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 MCC 1 2.4 0.0 0 0 Cal Deviation C1 MCC 1 2.4 0.0 0 0 Cal Deviation
C2 MCC 2 2.4 0.0 0 0 0.0 C2 MCC 2 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
— — — — — —
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.
‡‡ Rgt Name listed is for 7D75-20. For 7D75-30, change Reagent 1 name to UREA051; change Reagent 2 name to UREA052.

7
 AEROSET SYSTEM ASSAY PARAMETERS

Urea Nitrogen Urine—Conventional Units Urea Nitrogen Urine—SI Units

Assay Configuration: Outline Page Assay Configuration: Outline Page
Assay Name Assay # Line Assay Name Assay # Line
Urea-U 36 A-Line Urea-U 36 A-Line
Quantitative Ranges Quantitative Ranges
Max Max
Min Text Min Panic-L L-Reference-H Panic-H Max Min Text Min Panic-L L-Reference-H Panic-H Max
Text Text
* 0.0* 0.0 0.0 0.0 0.0 0.0* * * 0.0* 0.0 0.0 0.0 0.0 0.0* *
2** L-Linear Range-H 99** 0.8** L-Linear Range-H 35.5**
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 Linearity % Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex Linearity %
RATE DOWN 340 / 380 24 – 28 / 0 – 0 0.0 RATE DOWN 340 / 380 24 – 28 / 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 10.0 2.4 190 0 Rgt Name/Pos Standard 10.0 2.4 190 0 Rgt Name/Pos
Dil 1 10.0 2.4 190 0 Diluent: DILUENT C–10* Dil 1 10.0 2.4 190 0 Diluent: DILUENT C–10*
Dil 2 10.0 2.4 190 0 Type# 0 Dil 2 10.0 2.4 190 0 Type# 0
Rgt Name/Pos R.Vol W.Vol Type# Rgt Name/Pos R.Vol W.Vol Type#
Reagent 1 UREA061‡‡ – ___* 28 252 0 Reagent 1 UREA061‡‡ – ___* 28 252 0
Reagent 2 UREA062‡‡ – ___* 28 0 0 Reagent 2 UREA062‡‡ – ___* 28 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 0 mg/dL 1.0 / 0.0 1 mmol/L

Assay Configuration: Calibration Page Assay Configuration: Calibration Page

Calib Mode Interval (H) Calib Mode Interval (H)
Linear 168 Linear 168
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 MCC 1 2.4 0.0 0 0 Cal Deviation C1 MCC 1 2.4 0.0 0 0 Cal Deviation
C2 MCC 2 2.4 0.0 0 0 0.0 C2 MCC 2 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
— — — — — —
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 divided by the standard dilution factor, then rounded up to the number of decimal places defined in
the decimal places parameter field. The linear high value (Linear Range-H) is linearity divided by the standard dilution factor.
‡‡ Rgt Name listed is for 7D75-20. For 7D75-30, change Reagent 1 name to UREA051; change Reagent 2 name to UREA052.