en

Crea Enz
08P01
Creatinine (Enzymatic) Reagent Kit G92078R02
B8P0Y0
Revised April 2018.

08P0120
08P0130
Instructions must be carefully followed. Reliability of assay results
08P0120 08P0130
cannot be guaranteed if there are any deviations from these
instructions. Tests per cartridge 360 360
Number of cartridges per kit 4 10
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NAME Tests per kit 1440 3600
Alinity c Creatinine (Enzymatic) Reagent Kit (also referred to as Crea 68.1 mL 68.1 mL
Enz)
26.1 mL 26.1 mL
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INTENDED USE
The Alinity c Creatinine (Enzymatic) assay is used for the quantitative Active ingredients: Good’s buffer (pH 7.5) (25 mmol/L),
determination of creatinine in human serum, plasma, and urine on Creatinase (≥ 12 kU/L), Sarcosine oxidase (≥ 8 kU/L), Catalase
the Alinity c analyzer. (≥ 200 kU/L), ESPMT (0.47 mmol/L). Inactive ingredients: detergent
(< 1%) and preservative.
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SUMMARY AND EXPLANATION OF THE TEST
Active ingredients: Good’s buffer (pH 7.5)
Creatinine is eliminated from blood by glomerular filtration. Reduced
(100 mmol/L), Creatininase (≥ 300 kU/L), Peroxidase (≥ 20 kU/L),
renal function results in an increased serum creatinine concentration.
4-aminoantipyrine (2.95 mmol/L). Inactive ingredient: detergent
Measurement of serum creatinine is used to diagnose and monitor
(< 0.5%). Preservative: sodium azide (< 0.1%).
acute and chronic renal disease, estimate glomerular filtration
rate (GFR), or assess the status of renal dialysis patients. Urine Warnings and Precautions
creatinine analysis is used to calculate creatinine clearance, confirm
•
completeness of 24-hour collections, or serve as a reference
quantity for other analytes, such as in calculation of the albumin/ • For In Vitro Diagnostic Use
creatinine ratio.1 •

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PRINCIPLES OF THE PROCEDURE
Creatinine in the sample is hydrolyzed by creatininase to creatine.
Creatine is in turn hydrolyzed by creatinase to sarcosine and urea.
Sarcosine from this reaction is oxidized by sarcosine oxidase
to glycine and formaldehyde, with the concomitant production
of hydrogen peroxide.2 The hydrogen peroxide reacts with
4-aminoantipyrine and ESPMT* in the presence of peroxidase to
yield a quinoneimine dye. The resulting change in absorbance at
548 nm is proportional to the creatinine concentration in the sample.
This enzymatic method is sensitive and specific for creatinine and
is not affected by endogenous substances, such as ketoacids,
cephalosporins, and bilirubin that interfere with the Jaffe method.3
* ESPMT = N-ethyl-N-sulfopropyl-m-toluidine
Methodology: Enzymatic
For additional information on system and assay technology, refer to
the Alinity ci-series Operations Manual, Section 3.
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REAGENTS
Kit Contents
Alinity c Creatinine (Enzymatic) Reagent Kit 08P01
NOTE: Some kit sizes are not available in all countries. Please
contact your local distributor.
Volumes (mL) listed in the table below indicate the volume per
cartridge.
Safety Precautions
CAUTION: This product requires the handling of human specimens.
It is recommended that all human-sourced materials be considered
potentially infectious and handled in accordance with the OSHA
Standard on Bloodborne Pathogens. Biosafety Level 2 or other
appropriate biosafety practices should be used for materials that
contain or are suspected of containing infectious agents.4-7
The following warnings and precautions apply to:
Contains sodium azide.
EUH032 Contact with acids liberates very toxic gas.
P501 Dispose of contents / container in
accordance with local regulations.
Safety Data Sheets are available at www.abbottdiagnostics.com or
contact your local representative.
For a detailed discussion of safety precautions during system
operation, refer to the Alinity ci-series Operations Manual, Section 8.
Reagent Handling
• Reagents are shipped on wet ice.
• Upon receipt, place reagent cartridges in an upright position for
8 hours before use to allow bubbles that may have formed to
dissipate.
• If a reagent cartridge is dropped, place in an upright position
for 1 hour before use to allow bubbles that may have formed to
dissipate.
• Reagents are susceptible to the formation of foam and bubbles.
Bubbles may interfere with the detection of the reagent level in
the cartridge and cause insufficient reagent aspiration that may
adversely affect results.
For a detailed discussion of reagent handling precautions during
system operation, refer to the Alinity ci-series Operations Manual,
Section 7.

1
Reagent Storage Specimen Conditions
Storage Maximum Additional Storage • For accurate results, serum and plasma specimens should be
Temperature Storage Time Instructions free of fibrin, red blood cells, and other particulate matter. Serum
Unopened 2 to 8°C Until Store in upright position. specimens from patients receiving anticoagulant or thrombolytic
expiration therapy may contain fibrin due to incomplete clot formation.
date • For accurate results, plasma specimens should be free of
Onboard System 30 days platelets and other particulate matter. Ensure centrifugation is
Temperature adequate to remove platelets.
• Urine specimens must be inspected for particulates. If present,
Indications of Reagent Deterioration centrifuge the specimen to remove particulates prior to testing.
Deterioration of the reagents may be indicated when a calibration • To prevent cross contamination, use of disposable pipettes or
error occurs or a control value is out of the specified range. pipette tips is recommended.
Associated test results are invalid, and samples must be retested.
Assay recalibration may be necessary. Preparation for Analysis
For troubleshooting information, refer to the Alinity ci-series • Follow the tube manufacturer’s processing instructions for
Operations Manual, Section 10. collection tubes. Gravity separation is not sufficient for specimen
preparation.
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INSTRUMENT PROCEDURE • Specimens should be free of bubbles. Remove bubbles with an
The Alinity c Creatinine (Enzymatic) assay file must be installed on applicator stick before analysis. Use a new applicator stick for
the Alinity c analyzer prior to performing the assay. each specimen to prevent cross-contamination.
For detailed information on assay file installation and viewing and To ensure consistency in results, recentrifuge specimens prior to
editing assay parameters, refer to the Alinity ci-series Operations testing if
Manual, Section 2. • they contain fibrin, red blood cells, or other particulate matter.
For information on printing assay parameters, refer to the Alinity ci- NOTE: If fibrin, red blood cells, or other particulate matter are
series Operations Manual, Section 5. observed, mix by low speed vortex or by inverting 10 times prior to
For a detailed description of system procedures, refer to the Alinity recentrifugation.
ci-series Operations Manual.
Specimen Storage
Alternate Result Units Maximum Storage
Edit assay parameter "Result Units" to select an alternate unit. Specimen Type Temperature Time
Conversion formula: Serum/Plasma 20 to 25°C 7 days10
(Concentration in Default result unit) x (Conversion factor) = 2 to 8°C 7 days10, 11
(Concentration in Alternate result unit)
-20°C 3 months10
Default Result Unit Conversion Factor Alternate Result Unit
mg/dL (Serum) 88.48 μmol/L Urine 20 to 25°C 2 days10
mg/dL (Urine) 0.0884 mmoL/L 2 to 8°C 6 days10, 11
-20°C 6 months10
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SPECIMEN COLLECTION AND PREPARATION
FOR ANALYSIS Avoid multiple freeze/thaw cycles.
Specimen Types Guder et al. suggest storage of frozen specimens at -20°C for no
longer than the time intervals cited above.10
The specimen types listed below were verified for use with this assay.
Each laboratory may establish a range around -20°C from either the
Other specimen types, collection tube types, and anticoagulants
freezer manufacturer’s specifications or your laboratory standard
have not been verified with this assay.
operating procedure(s) for specimen storage.
Specimen Type Collection Vessel Special Conditions
Stored specimens must be inspected for particulates. If present, mix
Serum Serum tubes (with or Glass tubes were not with a low speed vortex or by inversion and centrifuge the specimen
without gel barrier) tested. to remove particulates prior to testing.
Plasma Collection tubes EDTA is not
recommended. An Specimen Shipping
Acceptable
anticoagulants are: internal study showed Package and label specimens in compliance with applicable state,
decreased results. federal, and international regulations covering the transport of clinical
Lithium heparin (with or
Glass tubes were not specimens and infectious substances.
without gel barrier)
Sodium heparin tested. ll
PROCEDURE
Urine (random Clean plastic or glass Materials Provided
specimens container without 08P01 Alinity c Creatinine (Enzymatic) Reagent Kit
or timed preservatives
specimens Materials Required but not Provided
collected • Alinity c Creatinine (Enzymatic) assay file
over intervals • 08P6501 or 08P6503 Alinity c Clinical Chemistry Calibrator Kit
shorter than 24 NOTE: Some kit sizes may not be available in all countries.
hours) • Commercially available controls containing creatinine
Urine (24 hour) Clean plastic or The preferred • Saline (0.85% to 0.90% NaCl) for specimen dilution
glass container with preservatives are boric For information on materials required for operation of the instrument,
preservatives acid and hydrochloric refer to the Alinity ci-series Operations Manual, Section 1.
acid.9 For information on materials required for maintenance procedures,
• The instrument does not provide the capability to verify specimen refer to the Alinity ci-series Operations Manual, Section 9.
types. It is the responsibility of the operator to verify that the
correct specimen types are used in the assay.

2
Assay Procedure
For a detailed description of how to run an assay, refer to the Alinity
ci-series Operations Manual, Section 5.
• If using primary or aliquot tubes, refer to the Alinity ci-series
Operations Manual, Section 4 to ensure sufficient specimen is
present.
• To minimize the effects of evaporation, verify adequate sample
cup volume is present prior to running the test.
• Minimum sample volume requirements:
–– Sample volume for single test: 3.6 μL (serum/plasma); 20.0
μL (urine).
NOTE: This amount does not include the dead volume
plus the additional over-aspiration volume. For total sample
volume requirements, refer to the Alinity ci-series Operations
Manual, Section 4.
• Refer to the Alinity c Clinical Chemistry Calibrator Kit package
insert and commercially available control package insert for
preparation and usage.
• For general operating procedures, refer to the Alinity ci-series
Operations Manual, Section 5.
• For optimal performance, it is important to perform routine
maintenance as described in the Alinity ci-series Operations
Manual, Section 9. Perform maintenance more frequently when
required by laboratory procedures.
Sample Dilution Procedures
Serum/Plasma
Samples with a creatinine value exceeding
40.00 mg/dL (3536.0 μmol/L) are flagged with the code
"> 40.00 mg/dL" (>3536.0 μmol/L) and may be diluted with either the
Automated Dilution Protocol or the Manual Dilution Procedure.
Urine
Urine samples are automatically diluted 1:10 by the system using
the Standard dilution option, then the system automatically corrects
the concentration by multiplying the result by the appropriate
dilution factor. This dilution extends urine linearity to 400.00 mg/dL
(35.36 mmol/L). Samples exceeding 400.00 mg/dL (35.36 mmol/L)
are flagged with the code "> 400.00 mg/dL" (> 35.36 mmol/L) and
may be diluted with either the Automated Dilution Protocol or the
Manual Dilution Procedure.
Automated Dilution Protocol
If using an automated dilution protocol, the system performs a dilution
of the sample and automatically calculates the concentration by
multiplying the result by the dilution factor. For details on configuring
automated dilutions, refer to the Alinity ci-series Operations Manual,
Section 2.
Manual Dilution Procedure
Dilute the sample with saline (0.85% to 0.90% NaCl).
The operator must enter the dilution factor in the Specimen or
Control tab of the Create Order screen. The system will use this
dilution factor to automatically calculate the concentration of the
sample and report the result.
If the operator does not enter the dilution factor, the result must be
manually multiplied by the appropriate dilution factor before reporting
the result. If a diluted sample result is less than the lower value of
the measuring interval of 0.10 mg/dL (8.8 μmol/L) for the serum/
plasma application, and 2.50 mg/dL (0.22 mmol/L) for the urine
application, do not report the result. Rerun using an appropriate
dilution.
For detailed information on ordering dilutions, refer to the Alinity ci-
series Operations Manual, Section 5.
3
Calibration
For instructions on performing a calibration, refer to the Alinity ci-
series Operations Manual, Section 5.
Calibration is stable for approximately 7 days (168 hours), but is
required with each change in reagent lot. Verify calibration with
at least 2 levels of controls according to the established quality
control requirements for your laboratory. If control results fall outside
acceptable ranges, recalibration may be necessary.
This assay may require recalibration after maintenance to critical
parts or subsystems or after service procedures have been
performed.
Quality Control Procedures
As appropriate, refer to your laboratory standard operating
procedure(s) and/or quality assurance plan for additional quality
control requirements and potential corrective actions.
• Two levels of controls (normal and abnormal) are to be run every
24 hours.
• If more frequent control monitoring is required, follow the
established quality control procedures for your laboratory.
• If quality control results do not meet the acceptance criteria
defined by your laboratory, sample results may be suspect.
Follow the established quality control procedures for your
laboratory. Recalibration may be necessary. For troubleshooting
information, refer to the Alinity ci-series Operations Manual,
Section 10.
• Review quality control results and acceptance criteria following a
change of reagent or calibrator lot.
Commercial controls should be used according to the guidelines
and recommendations of the control manufacturer. Concentration
ranges provided in the control package insert should be used only for
guidance.
For any control material in use, the laboratory should ensure that the
matrix of the control material is suitable for use in the assay per the
assay package insert.
Quality Control Guidance
Refer to “Basic QC Practices” by James O Westgard, Ph.D. for
guidance on laboratory quality control practices.12
Verification of Assay Claims
For protocols to verify package insert claims, refer to Verification of
Assay Claims in the Alinity ci-series Operations Manual.
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RESULTS
Calculation
The Alinity c Creatinine (Enzymatic) assay utilizes the Linear data
reduction method to generate a calibration and results.
For information on alternate result units, refer to the INSTRUMENT
PROCEDURE, Alternate Result Units section of this package insert.
Measuring Interval
Serum/Plasma
Measuring interval is defined as the range of values in mg/dL
(μmol/L) which meets the limits of acceptable performance for
linearity, imprecision, and bias.
The measuring interval of the Alinity c Creatinine (Enzymatic) assay
is 0.10 to 40.00 mg/dL (8.8 to 3536.0 μmol/L).
Urine
Measuring interval is defined as the range of values in mg/dL
(mmol/L) which meets the limits of acceptable performance for
linearity, imprecision, and bias.
The measuring interval of the Alinity c Creatinine (Enzymatic) assay
is 2.50 to 400.00 mg/dL (0.22 to 35.36 mmol/L).
Flags
Some results may contain information in the Flags field. For a
description of the flags that may appear in this field, refer to the
Alinity ci-series Operations Manual, Section 5.
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LIMITATIONS OF THE PROCEDURE Precision
• Very rarely unreliable results (i.e. pseudohypercreatininemia) Within-Laboratory Precision
secondary to occurrence of monoclonal protein have Serum/Plasma
been described in patients affected by Waldenstrom’s A study was performed based on guidance from CLSI EP05-A2.
macroglobulinemia13 (only IgM type) or by monoclonal Testing was conducted using 1 lot of the Alinity c Creatinine
gammopathy of unknown significance13 (IgG or IgM). (Enzymatic) Reagent Kit, 1 lot of the Alinity c Clinical Chemistry
• N-acetyl-L-cysteine at therapeutically achieved concentrations Calibrator Kit, and 1 lot of commercially available controls and 1
may lead to falsely low results in serum/plasma samples. instrument. Three serum controls were assayed in a minimum of 2
• Alpha-methyldopa may cause falsely low results in serum/plasma replicates at 2 separate times per day on 20 different days.18
samples. Within-Run Within-Laboratory
Refer to the SPECIMEN COLLECTION AND PREPARATION FOR Mean (Repeatability) (Total)a
ANALYSIS and SPECIFIC PERFORMANCE CHARACTERISTICS Sample n (mg/dL) SD %CV SD %CV
sections of this package insert. Control Level 1 120 0.79 0.008 1.0 0.010 1.3

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EXPECTED VALUES Control Level 2
Control Level 3
120
120
1.94
6.07
0.016
0.049
0.8
0.8
0.019
0.056
1.0
0.9
It is recommended that each laboratory determine its own reference
a Includes within-run, between-run, and between-day variability.
range based upon its particular locale and population characteristics.
Serum/Plasma14 Within-Run Within-Laboratory
Mean (Repeatability) (Total)a
Range (mg/dL) Range (μmol/L)
Sample n (µmol/L) SD %CV SD %CV
Male 0.73 to 1.18 64 to 104
Control Level 1 120 69.4 0.67 1.0 0.85 1.2
Female 0.55 to 1.02 49 to 90
Control Level 2 120 171.5 1.41 0.8 1.67 1.0
Urine Control Level 3 120 536.2 4.35 0.8 5.00 0.9
Adult Male Adult Female a Includes within-run, between-run, and between-day variability.
Concentration* 58 to 161 mg/dL 45 to 106 mg/dL Urine
Range (5.1 to 14.2 mmol/L) (3.9 to 9.4 mmol/L) A study was performed based on guidance from CLSI EP05-A2.
24-Hour 11.1 to 27.9 mg/kg/day 9.8 to 24.7 mg/kg/day Testing was conducted using 1 lot of the Alinity c Creatinine
Excretion13 (98 to 247 μmol/kg/day) (87 to 218 μmol/kg/day) (Enzymatic) Reagent Kit, 1 lot of the Alinity c Clinical Chemistry
870 to 2410 mg/day 670 to 1590 mg/day Calibrator Kit, and 1 lot of commercially available controls and 1
(7.7 to 21.3 mmol/day) (5.9 to 14.1 mmol/day) instrument. Two urine controls were assayed in a minimum of 2
Creatinine 61 to 147 mL/min/1.73 m2 BSA 59 to 151 mL/min/1.73 m2 BSA replicates at 2 separate times per day on 20 different days.18
Clearance13 (1.02 to 2.45 mL/sec/1.73 m2 BSA) (0.98 to 2.52 mL/sec/1.73 m2 BSA)
Within-Run Within-Laboratory
* Concentration is based on a daily urine output of 1.5 L. Mean (Repeatability) (Total)a
Ceriotti et al.15 have published pediatric reference ranges, based on Sample n (mg/dL) SD %CV SD %CV
the data of Schlebusch et al.16 Control Level 1 126 65.65 0.318 0.5 0.468 0.7
National Kidney Disease Education Program (NKDEP) guidelines Control Level 2 120 119.98 0.658 0.5 0.825 0.7
recommend that, for patients 18 and older, estimated GFR (eGFR) a Includes within-run, between-run, and between-day variability.
values greater than or equal to 60 mL/min/1.73 m2 are reported as Within-Run Within-Laboratory
eGFR ≥ 60 mL/min/1.73 m2.17 Mean (Repeatability) (Total)a
To convert results from mg/kg/day to μmol/kg/day, multiply mg/kg/ Sample n (mmol/L) SD %CV SD %CV
day by 8.84. Control Level 1 126 5.80 0.028 0.5 0.042 0.7
(urine creatinine concentration) x (urine volume) 1.73 Control Level 2 120 10.61 0.059 0.6 0.074 0.7
Creatinine Clearance = x
(serum creatinine concentration) x (collection time) BSA* a Includes within-run, between-run, and between-day variability.
* BSA = body surface area in square meters Lower Limits of Measurement
NOTE: Urine and serum creatinine concentrations must be expressed A study was performed based on guidance from CLSI EP17-A2.
in the same units, urine volume must be expressed in mL, and Testing was conducted using 3 lots of the Alinity c Creatinine
collection time must be expressed in minutes or seconds. (Enzymatic) Reagent Kit on each of 2 instruments over a minimum
eGFR can be calculated using the four-parameter equation from the of 3 days. The Limit of Blank (LoB), Limit of Detection (LoD),
Modification of Diet in Renal Disease (MDRD) study. In the United and Limit of Quantitation (LoQ) values are summarized below.
States, the NKDEP provides guidelines for calculating and reporting These representative data support the lower limit of the measuring
eGFR.17 Guidelines may vary in other countries. interval.19
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SPECIFIC PERFORMANCE CHARACTERISTICS Serum/Plasma
mg/dL μmol/L
Representative performance data are provided in this section. Results
LoBa 0.02 1.8
obtained in individual laboratories may vary.
LoDb 0.04 3.5
The Alinity c analyzer, and the ARCHITECT c System and AEROSET
System utilize the same reagents and sample/reagent ratios. LoQc, d 0.10 8.8
Unless otherwise specified, all studies were performed on the Alinity a The LoB represents the 95th percentile from n ≥ 60 replicates of
c analyzer. zero-analyte samples.
b The LoD represents the lowest concentration at which the analyte

can be detected with 95% probability based on n ≥ 60 replicates of

low-analyte level samples.
c The LoQ is defined as the lowest concentration at which a total

allowable error of 15% was met.

d This value represents the observed LoQ on the ARCHITECT

System. The LoQ observed on the Alinity c analyzer supports this

LoQ.

4
Urine Interferent Level Creatinine
Potentially
mg/dL mmoL/L Interfering Target Level Recovery
LoBa 0.16 0.01 Substance Default Units (mg/dL) (% of Target)
LoDb 0.26 0.02 Gliclazide 200 μmol/L 1.073 101.6
LoQc, d 2.20 0.19 Ibuprofen 5000 μmol/L 1.20 98.3
a Alpha-methyldopa 71 μmol/L 1.20 79.2
The LoB represents the 95th percentile from n ≥ 60 replicates of
N-acetyl-L-cysteine 4908.0 µmol/L 1.24 90.8
zero-analyte samples.
b The LoD represents the lowest concentration at which the analyte 4908.0 µmol/L 5.10 90.0
can be detected with 95% probability based on n ≥ 60 replicates of Nitrofurantoin 30 μmol/L 1.20 99.2
low-analyte level samples. Phenindione 150 μmol/L 1.073 101.6
c The LoQ is defined as the lowest concentration at which a total Ranitidine 30 μmol/L 1.20 99.2
allowable error of 15% was met. Spironolactone 3 μmol/L 1.20 99.2
d This value represents the observed LoQ on the ARCHITECT Triamterene 50 μmol/L 1.20 99.2
System. The LoQ observed on the Alinity c analyzer supports this Urine
LoQ. Urine interference studies were conducted using an acceptance
Linearity criteria of ± 8% or 8 mg/dL deviation, whichever is greater, from the
A study was performed based on guidance from CLSI EP06-A.20 target value. The Creatinine (Enzymatic) assay is not affected by
Serum/Plasma the presence of the following interferents up to the concentrations
This assay is linear across the measuring interval of 0.10 to indicated below.
40.00 mg/dL (8.8 to 3536.0 μmol/L). Interferent Level Creatinine
Urine Potentially Absolute Recovery
Interfering Default Units Target Level Bias (% of
This assay is linear across the measuring interval of 2.50 to Substance (mg/dL) Alternate Units (mg/dL) (mg/dL) Target)
400.00 mg/dL (0.22 to 35.36 mmoL/L).
Ascorbic acid 250 14.2 mmol/L 78.86 0.4 100.5
Interference Bilirubin 400 6840 μmol/L 81.42 -5.3 93.4
This study was performed on the ARCHITECT c System and (conjugated)
AEROSET System. Glucose 3000 166 mmol/L 81.71 -2.7 96.7
Potentially Interfering Substances and Potentially Interfering Drugs Hemoglobin 1000 10 g/L 80.90 3.0 103.6
Serum Protein 300 3 g/L 78.41 2.5 103.1
Serum interference studies were conducted using an acceptance Preferred Preservatives
criteria of ± 8% or 0.09 mg/dL deviation, whichever is greater, from Boric acid 1000 161.7 mmol/L 80.89 0.4 100.5
the target value. Hydrochloric * 300 mmol/L 77.56 0.1 100.2
The Creatinine (Enzymatic) assay is not affected by the presence of acid
the following interferents up to the concentrations indicated below. * 5 mL/dL of Hydrochloric Acid 6N solution (300 mmol/L)
Interferent Level Creatinine The following drugs were tested for interference at the concentration
Potentially Absolute Recovery indicated using an acceptance criteria of ≤ 10% deviation for urine.
Interfering Default Units Target Level Bias (% of
Potentially Interferent Level Creatinine
Substance (mg/dL) Alternate Units (mg/dL) (mg/dL) Target)
Interfering Target Level Recovery
Bilirubin, 26 445 μmol/L 0.56 -0.09 83.9
conjugated Substance Default Units (mg/dL) (% of Target)
Acetaminophen 132.4 μmol/L 116.46 96.8
Bilirubin, 66 1129 μmol/L 0.54 -0.04 92.6
unconjugated Acetazolamide 400 μmol/L 116.46 97.9
Hemoglobin 1000 10 g/L 1.04 -0.07 92.9 Acetylsalicylic acid 5 mmol/L 78.18 100.5
Intralipid 600 6 g/L 0.50 -0.07 86.0 Ascorbic acid 500 μmol/L 78.18 102.9
Creatine 100 7.6 mmol/L 1.16 0.05 104.3 Cefazolin 4000 μmol/L 78.18 101.0
Ascorbic acid 120 6.8 mmol/L 1.16 -0.07 94.0 Chlorothiazide 100 μmol/L 78.18 102.7
Glucose 6000 333 mmol/L 1.15 -0.05 95.7 Cimetidine 500 μmol/L 78.18 101.7
Dexamethasone 3 μmol/L 78.18 100.9
The following drugs were tested for interference at the concentration Digoxin 10 nmol/L 78.18 101.7
indicated using an acceptance criteria of ≤ 8% deviation from the Furosemide 250 μmol/L 78.18 101.2
target value for serum. With the exception of alpha-methyldopa and
Gliclazide 200 μmol/L 116.46 100.9
N-acetyl-L-cysteine, none showed interference.
Ibuprofen 5000 μmol/L 78.18 102.9
Potentially Interferent Level Creatinine
Alpha-methyldopa 100 μmol/L 78.18 101.2
Interfering Target Level Recovery
Nitrofurantoin 30 μmol/L 78.18 98.2
Substance Default Units (mg/dL) (% of Target)
Phenindione 150 μmol/L 116.46 97.0
Acetaminophen 1324.5 µmol/L 0.83 98.9
Ranitidine 30 μmol/L 78.18 101.2
Acetazolamide 400 μmol/L 1.073 100.6
Spironolactone 3 μmol/L 78.18 98.5
Acetylsalicylic acid 5 mmol/L 1.20 99.2
Triamterene 50 μmol/L 78.18 100.9
Ascorbic acid 500 μmol/L 1.20 100.8
Cefazolin 4000 μmol/L 1.20 97.5
Chlorothiazide 100 μmol/L 1.20 102.5
Cimetidine 500 μmol/L 1.20 100.0
Dexamethasone 3 μmol/L 1.20 99.2
Digoxin 10 nmol/L 1.20 99.2
Dipyrone 300.3 µmol/L 0.84 98.6
Furosemide 250 μmol/L 1.20 99.2

5
Method Comparison 20. Clinical and Laboratory Standards Institute (CLSI). Evaluation of
A study was performed based on guidance from CLSI EP09-A3 using the Linearity of Quantitative Measurement Procedures: A Statistical
Approach; Approved Guideline. CLSI Document EP06-A. Wayne, PA:
the Passing-Bablok regression method.21
CLSI; 2003.
Correlation Concentration 21. Clinical and Laboratory Standards Institute (CLSI). Measurement
Units n Coefficient Intercept Slope Range Procedure Comparison and Bias Estimation Using Patient Samples;
Alinity c Serum mg/dL 141 1.00 0.04 0.97 0.60 - 39.89 Approved Guideline—Third Edition. CLSI Document EP09-A3. Wayne,
Creatinine µmol/L 141 1.00 3.38 0.97 52.6 - 3526.3 PA: CLSI; 2013.
(Enzymatic) Note for number formatting:
vs ARCHITECT Urine mg/dL 48 1.00 0.57 0.98 11.57 - 373.34
Creatinine mmol/L 48 1.00 0.05 0.98 1.02 - 33.00 • A space is used as thousands separator (example: 10 000
(Enzymatic) specimens).
• A period is used to separate the integer part from the fractional
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BIBLIOGRAPHY part of a number written in decimal form (example: 3.12%).
1. Thomas L, editor. Clinical Laboratory Diagnostics: Use and
Assessment of Clinical Laboratory Results. Frankfurt, Germany: TH- ll
Key to Symbols
Books Verlagsgesellschaft mbH; 1998:366–374. ISO 15223 Symbols
2. Lamb E, Newman DJ, Price CP. Kidney Function Tests. In: Burtis CA, Consult instructions for use
Ashwood ER, Bruns DE, editors. Tietz Textbook of Clinical Chemistry
and Molecular Diagnostics, 4th ed. St Louis, MO: Elsevier Saunders;
Manufacturer
2006:799.
3. Peake M, Whiting M. Measurement of serum creatinine – current
status and future goals. Clin Biochem Rev 2006;27(4):173-184. Sufficient for
4. US Department of Labor, Occupational Safety and Health
Administration, 29 CFR Part 1910.1030, Bloodborne pathogens.
5. US Department of Health and Human Services. Biosafety in Temperature limitation
Microbiological and Biomedical Laboratories. 5th ed. Washington, DC:
US Government Printing Office; December 2009.
Use by/Expiration date
6. World Health Organization. Laboratory Biosafety Manual. 3rd ed.
Geneva: World Health Organization; 2004.
7. Clinical and Laboratory Standards Institute (CLSI). Protection In Vitro Diagnostic Medical
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