3L81-22

en
Creatinine
Creatinine 3L81-32 3L81
ARCHITECT 3L81-41 306941 / R05
B3L8B0
Read Highlighted Changes: Revised April 2016.

Package insert instructions must be carefully followed. Reliability of Warnings and Precautions
assay results cannot be guaranteed if there are any deviations from •
the instructions in this package insert. • For In Vitro Diagnostic Use
NAME Safety Precautions
Creatinine CAUTION: This product requires the handling of human specimens.
INTENDED USE It is recommended that all human-sourced materials be considered
potentially infectious and handled in accordance with the OSHA
The Creatinine assay is used for the quantitation of creatinine in Standard on Bloodborne Pathogens. Biosafety Level 2 or other
human serum, plasma, or urine. appropriate biosafety practices should be used for materials that
SUMMARY AND EXPLANATION OF THE TEST contain or are suspected of containing infectious agents.6-9
Creatinine is eliminated from blood by glomerular filtration. Reduced The following warnings and precautions apply to:
renal function results in an increased serum creatinine concentration.
Measurement of serum creatinine is used to diagnose and monitor
acute and chronic renal disease, estimate glomerular filtration
rate (GFR), or assess the status of renal dialysis patients. Urine
creatinine analysis is used to calculate creatinine clearance, confirm DANGER Contains sodium hydroxide.
completeness of 24 hour collections, or serve as a reference H314 Causes severe skin burns and eye
quantity for other analytes, such as in calculation of the albumin/ damage.
creatinine ratio.1 H290 May be corrosive to metals.
In 1886 Jaffe developed an assay for creatinine based upon the Prevention
reaction between creatinine and sodium picrate.2 In 1904 Folin3 used P280 Wear protective gloves / protective
this reaction for the quantitative determination of creatinine in urine. clothing / eye protection.
Kinetic procedures based on the observed reaction rates of various P260 Do not breathe mist / vapors / spray.
substances, including creatinine, with alkaline picrate have been P264 Wash hands thoroughly after handling.
proposed by Fabiny4 and Soldin.5 This improved Jaffe chemistry P234 Keep only in original container.
is a kinetic procedure which does not require deproteinization of
Response
the sample and is formulated to reduce the interference of serum
P301+P330+P331 IF SWALLOWED: Rinse mouth. Do NOT
proteins.
induce vomiting.
PRINCIPLES OF THE PROCEDURE P305+P351+P338 IF IN EYES: Rinse cautiously with water
At an alkaline pH, creatinine in the sample reacts with picrate to form for several minutes. Remove contact
a creatinine-picrate complex. The rate of increase in absorbance at lenses, if present and easy to do.
500 nm due to the formation of this complex is directly proportional Continue rinsing.
to the concentration of creatinine in the sample. P303+P361+P353 IF ON SKIN (or hair): Take off immediately
Methodology: Kinetic Alkaline Picrate all contaminated clothing. Rinse skin with
For additional information on system and assay technology, refer to water / shower.
the ARCHITECT System Operations Manual, Section 3. P310 Immediately call a POISON CENTER or
doctor / physician.
REAGENTS P390 Absorb spillage to prevent material
Kit Contents damage.
Creatinine 3L81. Disposal
Supplied as a liquid, ready-to use two-reagent kit. P501 Dispose of contents / container in
accordance with local regulations.
3L81-22 3L81-32 3L81-41
The following warnings and precautions apply to:
1,875* 7,500* 20,570*
Contains picric acid.
5 x 55 mL 10 x 55 mL 10 x 90 mL EUH001 Explosive when dry.
5 x 17 mL 10 x 32 mL 10 x 83 mL Picric acid is a flammable solid when wet as a paste (i.e., not less
than 10% water), and explosive when dry. Prevent from forming
*Calculation is based on the minimum reagent fill volume per kit. crystals. Keep containers tightly sealed. Do not allow to dry out.
Reactive Ingredients Concentration Safety Data Sheets are available at www.abbottdiagnostics.com or
contact your local representative.
Sodium hydroxide 0.8 mol/L For a detailed discussion of safety precautions during system
operation, refer to the ARCHITECT System Operations Manual,
Section 8.
Picric acid 24 mmol/L

1
Reagent Handling 24 hour excretion = [(V × c) ÷ (W x100)] mg/kg/day
• Do not use reagents beyond the expiration date. Where:
• Do not pool reagents within a kit or between kits. V = 24 hour urine volume (mL)
• Do not use components from one lot with components from c = analyte concentration (mg/dL)
another lot. W=body weight in kg
• Remove any air bubbles present in the reagents with a new
applicator stick, or allow the reagents to sit at the appropriate To convert results from mmol/L to μmol/kg/day (24 hour urinary
storage temperature to allow the bubbles to dissipate. To excretion)
minimize volume depletion, do not use a transfer pipette to 24 hour excretion = [(V × c) ÷ W] μmol/kg/day
remove bubbles. Where:
CAUTION: Bubbles may interfere with proper detection of V = 24 hour urine volume (mL)
reagent level in the cartridge and cause insufficient reagent c = analyte concentration (mmol/L)
aspiration which could impact results. W=body weight in kg
For a detailed discussion of handling precautions during system
operation, refer to the ARCHITECT System Operations Manual, 24 Hour Urinary Excretion, not adjusted per kg body weight
Section 7. To convert results from mg/dL to mg/day (24 hour urinary excretion)
Reagent Storage 24 hour excretion = [(V × c) ÷ 100] mg/day
Maximum Where:
Storage Storage Additional Storage V = 24 hour urine volume (mL)
Temperature Time Instructions c = analyte concentration (mg/dL)
Unopened 15-30°C Until To convert results from mmol/L to mmol/day (24 hour urinary
expiration excretion)
date
24 hour excretion = [(V × c) ÷ 1000] mmol/day
On board System 5 days After 5 days, the reagent kit
temperature must be discarded. Where:
For information on tracking V = 24 hour urine volume (mL)
onboard time, refer to c = analyte concentration (mmol/L)
the ARCHITECT System
Operations Manual, Section SPECIMEN COLLECTION AND PREPARATION FOR
5. ANALYSIS
For information on unloading reagents, refer to the ARCHITECT Specimen Types
System Operations Manual, Section 5. Verified specimen types to be used with this assay.
Indications of Reagent Deterioration Specimen
Type Collection Vessel Special Conditions
Instability or deterioration should be suspected if there are
precipitates, visible signs of leakage or contamination, turbidity, or if Serum Glass or plastic tubes
calibration or controls do not meet the appropriate package insert with or without gel
and/or ARCHITECT System Operations Manual criteria. barrier
For troubleshooting information, refer to the ARCHITECT System Plasma Glass or plastic tubes
Operations Manual, Section 10. Acceptable
anticoagulants are:
INSTRUMENT PROCEDURE lithium heparin (with
The Creatinine assay file must be installed on the ARCHITECT or without gel barrier)
cSystem prior to performing the assay. EDTA
For detailed information on assay file installation and viewing sodium heparin
and editing assay parameters, refer to the ARCHITECT System Urine (random Collect with no
Operations Manual, Section 2. specimens preservative.
For information on printing assay parameters or for a detailed or timed
description of system procedures, refer to the ARCHITECT System specimens
Operations Manual, Section 5. collected
Alternate Result Units over intervals
The Conventional result unit for the serum Creatinine assay is mg/ shorter than
dL. The corresponding SI result unit is μmol/L. To convert mg/dL to 24 hours)
μmol/L, multiply mg/dL by 88.4.10 To convert μmol/L to mg/dL, divide Urine (24 May be collected with The preferred preservatives
μmol/L by 88.4. hour) preservatives. are boric acid and
The Conventional result unit for the urine Creatinine assay is mg/ hydrochloric acid.11
dL. The corresponding SI result unit is mmol/L. To convert mg/dL Other specimen types and collection tube types/anticoagulants have
to mmol/L, multiply mg/dL by 0.0884. To convert mmol/L to mg/dL, not been verified with this assay.
divide mmol/L by 0.0884. The instrument does not provide the capability to verify specimen
To convert results from mg/kg/day to μmol/kg/day, multiply mg/kg/ type. It is the responsibility of the operator to verify that the correct
day by 8.84. specimen types are used in the assay.
When converting to units other than those listed, refer to the
Specimen Conditions
ARCHITECT System Operations Manual, Section 2.
Liquid anticoagulants may have a dilution effect resulting in lower
24 Hour Urinary Excretion, adjusted per kg body weight
concentrations for individual patient specimens.
To convert results from mg/dL to mg/kg/day (24 hour urinary
excretion)

2
For accurate results, serum and plasma specimens should be free of Specimen Dilution Procedures
fibrin, red blood cells, and other particulate matter. Serum specimens The ARCHITECT cSystems have an automatic dilution feature; for
from patients receiving anticoagulant or thrombolytic therapy may additional information, refer to the ARCHITECT System Operations
contain fibrin due to incomplete clot formation and this may cause Manual, Section 2.
erroneous results. Serum and plasma specimens with creatinine values exceeding the
For accurate results, plasma specimens should be free of platelets 37.00 mg/dL (3,270.8 μmol/L) are flagged and may be diluted by
and other particulate matter. Ensure centrifugation is adequate to following the Manual Dilution Procedure, or the Automatic Dilution
remove platelets. Protocol provided in the assay parameters. If an Automatic Dilution
For additional information on specimen conditions, refer to the Protocol is not provided, refer to the ARCHITECT System Operations
Interference section of this package insert. Manual, Section 2 for configuration information, and verify results
Preparation for Analysis according to your laboratory’s standard operating procedures.
Serum: Ensure complete clot formation has taken place prior Urine samples are automatically diluted 1:20 by the system using
to centrifugation. Centrifuge according to tube manufacturer’s the Standard dilution option, then the system automatically corrects
specifications to ensure proper separation of serum from blood cells. the concentration by multiplying the result by the appropriate
Plasma: Centrifuge according to tube manufacturer’s specifications dilution factor. This dilution extends urine Creatinine linearity
to remove platelets and ensure proper separation of plasma from to 740.00 mg/dL (65.42 mmol/L). Samples exceeding this
blood cells. concentration are flagged and may be diluted by following either the
Automated Dilution Protocol or the Manual Dilution Procedure.
NOTE: Stored specimens must be inspected for particulates. If
present, mix and centrifuge the specimen to remove particulates Automated Dilution Protocol
prior to testing. When using the Automated Dilution Protocol, the system performs a
For total sample volume requirements, refer to the ARCHITECT dilution of the specimen and automatically corrects the concentration
System Operations Manual, Section 5. by multiplying the result by the appropriate dilution factor.
Manual Dilution Procedure
Specimen Storage
1. Dilute the specimen with saline (0.85% to 0.90% NaCl).
Analyze fresh specimens if possible.
2. Enter the dilution factor in the Patient or Control order screen.
Avoid repeated freeze/thaw cycles.
The system uses this dilution factor to automatically correct the
Storage Maximum Storage concentration by multiplying the result by the entered factor. If
Specimen Type Temperature Time the operator does not enter the dilution factor, the result must
Serum/Plasma 20-25°C 7 days12 be manually multiplied by the appropriate dilution factor before
2-8°C 7 days12, 13 reporting the result.
-20°C* 3 months12 (Volume of Specimen + Volume of Dilution Reagent)
Urine 20-25°C 2 days12 Manual Dilution Factor =
Volume of Specimen
2-8°C 6 days12, 13
If a diluted specimen result is flagged indicating it is less than
-20°C* 6 months12
the linear low limit, do not report the result. Rerun using an
*A tolerance of ± 10% (± 2°C) is assumed not to change the stability appropriate dilution.
of the specimen. (W. Guder, personal communication, August 6, For detailed information on ordering dilutions, refer to the ARCHITECT
2001). System Operations Manual, Section 5.
Each laboratory may establish a range around -20°C from either the Calibration
freezer manufacturer’s specifications or your laboratory standard
Calibration is stable for 5 days (120 hours), but is required with
operating procedure(s) for specimen storage.
each change in reagent lot number. Verify calibration with at least
Specimen Shipping two levels of controls according to the established quality control
Package and label specimens in compliance with applicable state, requirements for your laboratory. If control results fall outside
federal, and international regulations covering the transport of clinical acceptable ranges, recalibration may be necessary.
specimens and infectious substances. For information on calibrator standardization, refer to the
PROCEDURE Multiconstituent Calibrator package insert.
For detailed information on how to perform an assay calibration, refer
Materials Provided to the ARCHITECT System Operations Manual, Section 6.
3L81 Creatinine Reagent Kit
Quality Control Procedures
Materials Required but not Provided As appropriate, refer to your laboratory standard operating
• 1E65  Multiconstituent Calibrator procedure(s) and/or quality assurance plan for additional quality
• Control material control requirements and potential corrective actions.
• Saline (0.85% to 0.90% NaCl) for specimen dilution • Two levels of controls (normal and abnormal) are to be run every
For information on materials required for operation of the instrument, 24 hours.
refer to the ARCHITECT System Operations Manual, Section 1. • If more frequent control monitoring is required, follow the
For information on materials required for maintenance procedures, established quality control procedures for your laboratory.
refer to the ARCHITECT System Operations Manual, Section 9. • If quality control results do not meet the acceptance criteria
Assay Procedure defined by your laboratory, patient values may be suspect. Follow
the established quality control procedures for your laboratory.
For a detailed description of how to run an assay, refer to the
Recalibration may be necessary.
ARCHITECT System Operations Manual, Section 5.
• Review quality control results and acceptance criteria following a
For sample volume requirements, refer to the ASSAY PARAMETERS
change of reagent or calibrator lot.
section of this package insert. Minimum sample volume is calculated
by the system and printed on the Order List Report. Ensure adequate
sample volume is present prior to running the test.

3
RESULTS NKDEP guidelines recommend that eGFR values greater than
60 mL/min/1.73 m2 are reported as eGFR > 60 mL/min/1.73 m2.
(urine creatinine concentration)
1.73 Values less than or equal to 60 mL/min/1.73 m2 are reported as the
Creatinine x (urine volume)
= x eGFR value rounded to the nearest whole number.14
Clearance (serum creatinine concentration)
BSA* If serum creatinine results are determined in μmol/L, divide the
x (urine collection time) creatinine concentration by 88.4 prior to calculation of the eGFR
* BSA = body surface area in square meters value.14
NOTE: Urine and serum creatinine concentrations must be expressed SPECIFIC PERFORMANCE CHARACTERISTICS
in the same units, urine volume must be expressed in mL, and urine
collection time must be expressed in minutes or seconds. Linearity
Estimated GFR (eGFR) can be calculated using the four-parameter Creatinine serum is linear from 0.20 to 37.00 mg/dL (17.7 to
equation from the Modification of Diet in Renal Disease (MDRD) 3,270.8 μmol/L) within ± 10% or ± 0.1 mg/dL (17.7 μmol/L),
study. In the United States, the National Kidney Disease Education whichever is greater with 95% confidence. Creatinine urine is
Program (NKDEP) provides guidelines for calculating and reporting linear from 5.00 to 740.00 mg/dL (0.44 to 65.42 mmol/L) within
eGFR.14 Guidelines may vary in other countries. ± 10% or ± 5 mg/dL (0.442 mmol/L), whichever is greater with 95%
confidence. Linearity was verified using Clinical and Laboratory
Representative performance data are given in the EXPECTED
Standards Institute (CLSI) protocol NCCLS EP6-A.16
VALUES and SPECIFIC PERFORMANCE CHARACTERISTICS sections
of this package insert. Results obtained in individual laboratories may Limit of Detection (LOD)
be different from the data presented. The LOD for Creatinine serum is 0.05 mg/dL (4.5 μmol/L). The
Calculation LOD for Creatinine urine is 4.00 mg/dL (0.35 mmol/L). LOD is the
lowest amount of analyte in a sample that can be detected with 95%
For additional information on results calculations, refer to the
probability.
ARCHITECT System Operations Manual, Appendix C.
Interpretation of Results Limit of Quantitation (LOQ)
The LOQ for Creatinine serum is 0.10 mg/dL (8.8 μmol/L). The LOQ
As with all analyte determinations, the creatinine value should be
for Creatinine urine is 5.00 mg/dL (0.44 mmol/L). The LOQ is the
used in conjunction with information available from clinical evaluation
analyte concentration at which the CV = 20%.
and other diagnostic procedures.
Flags Interference
Interference studies were conducted using an acceptance criteria of
Some results may contain information in the Flags field. For a
≤ 10% of the target value.
description of the flags that may appear in this field, refer to the
ARCHITECT System Operations Manual, Section 5. Interference effects were assessed by Dose Response and Paired
Difference methods, at the medical decision level of the analyte.
LIMITATIONS OF THE PROCEDURE Medical Decision Level 1
Refer to the SPECIMEN COLLECTION AND PREPARATION FOR Interfering Target Observed*
ANALYSIS and SPECIFIC PERFORMANCE CHARACTERISTICS Substance Interferent Concentration N (mg/dL) (μmol/L) (% of Target)
sections of this package insert.
30 mg/dL (513 μmol/L) 4 1.55 137.0 98
Bilirubin
EXPECTED VALUES 60 mg/dL (1,026 μmol/L) 4 1.55 137.0 72
Reference Range 1,000 mg/dL (10 g/L) 4 1.40 123.8 105
Hemoglobin
The serum/plasma reference ranges are from an Abbott Laboratories 2,000 mg/dL (20 g/L) 4 1.40 123.8 109
study of normal healthy adults, age 18 or older (120 males and 120 750 mg/dL (7.5 g/L) 4 1.43 126.4 99
Intralipid
females). The urine reference ranges are based on the data of Junge 1,000 mg/dL (10.0 g/L) 4 1.43 126.4 98
et al.15 1.5 mg/dL (85 μmol/L) 4 1.52 134.4 99
Ascorbate
Serum/Plasma 3.0 mg/dL (170 μmol/L) 4 1.52 134.4 99
Range Range 300 mg/dL (16.5 mmol/L) 4 1.52 134.4 107
Glucose
(mg/dL) (μmol/L) 600 mg/dL (33 mmol/L) 4 1.52 134.4 116
Adult, Male 0.72 to 1.25 63.6 to 110.5 10.6 g/dL (106 g/L) 4 1.54 136.1 108
Protein
Adult, Female 0.57 to 1.11 50.4 to 98.1 14.3 g/dL (143 g/L) 4 1.54 136.1 115
Urine15 *Percentages have been rounded to whole numbers.
Adult Male Adult Female Medical Decision Level 2
Concentration* 63 to 166 mg/dL 47 to 110 mg/dL Interfering Target Observed*
Range (5.6 to 14.7 mmol/L) (4.2 to 9.7 mmol/L) Substance Interferent Concentration N (mg/dL) (μmol/L) (% of Target)
12.1 to 28.9 mg/kg/day 10.7 to 26.0 mg/kg/day 30 mg/dL (513 μmol/L) 4 5.33 471.2 95
Bilirubin
24 Hour (107 to 256 μmol/kg/day) (95 to 230 μmol/kg/day) 60 mg/dL (1,026 μmol/L) 4 5.33 471.2 75
Excretion15 950 to 2,490 mg/day 710 to 1,650 mg/day 1,000 mg/dL (10 g/L) 4 4.70 415.5 102
Hemoglobin
(8.4 to 22.0 mmol/day) (6.3 to 14.6 mmol/day) 2,000 mg/dL (20 g/L) 4 4.70 415.5 103
Adult Male: 66 to 163 mL/min/1.73 m2 BSA 750 mg/dL (7.5 g/L) 4 4.62 408.4 99
Intralipid
Creatinine (1.10 to 2.72 mL/sec/1.73 m2 BSA) 1,000 mg/dL (10.0 g/L) 4 4.62 408.4 99
Clearance15 Adult Female: 66 to 165 mL/min/1.73 m2 BSA 1.5 mg/dL (85 μmol/L) 4 5.23 462.3 100
Ascorbate
(1.10 to 2.75 mL/sec/1.73 m2 BSA) 3.0 mg/dL (170 μmol/L) 4 5.23 462.3 100
300 mg/dL (16.5 mmol/L) 4 5.00 442.0 101
* Concentration is based on a daily urine output of 1.5 L. Glucose
600 mg/dL (33 mmol/L) 4 5.00 442.0 103
It is recommended that each laboratory determine its own reference
10.8 g/dL (108 g/L) 4 5.57 492.4 99
range based upon its particular locale and population characteristics. Protein
14.7 g/dL (147 g/L) 4 5.57 492.4 99
*Percentages have been rounded to whole numbers.

4
Bilirubin solutions at the above concentrations were prepared by Accuracy
addition of a bilirubin stock to human serum pools. Hemoglobin The bias for Creatinine serum or plasma is ≤ 10% or ± 0.1 mg/dL
solutions at the above concentrations were prepared by addition of (8.8 μmol/L), whichever is greater, and the Total Error is ≤ 22%.
hemolysate to human serum pools. Intralipid solutions at the above Representative data from studies using IDMS traceable NIST SRM
concentrations were prepared by addition of Intralipid to human 967 are summarized below.
serum pools. Ascorbate solutions at the above concentrations
Serum SRM 967 SRM 967
were prepared by addition of ascorbic acid to human serum pools.
Level 1 Level 2
Glucose solutions at the above concentrations were prepared by
addition of glucose to human serum pools. Protein solutions at the (Target 0.753 mg/dL) (Target 3.916 mg/dL)
above concentrations were prepared by addition of gamma globulin (Target 66.6 μmol/L) (Target 346.2 μmol/L)
to human serum pools. N 11 11
For the urine application, acetic acid (8.5 N) up to 6.25 mL/dL Concentration (mg/dL) 0.747 3.810
(531 mmol/L), ascorbate up to 200 mg/dL (11.4 mmol/L), boric Concentration (μmol/L) 66.0 336.8
acid up to 250 mg/dL (40.4 mmol/L), glucose up to Bias (mg/dL) -0.006 -0.106
1,000 mg/dL (55.5 mmol/L), hydrochloric acid (6 N) up to 2.5 mL/dL Bias (μmol/L) -0.5 -9.4
(150 mmol/L), nitric acid (6 N) up to 5.0 mL/dL (300 mmol/L), % Bias -0.84 -2.70
protein up to 50 mg/dL (0.50 g/L), sodium carbonate up to 1.25 g/dL Total Error (%)* 10.74 9.06
(117.9 mmol/L), sodium fluoride up to 400 mg/dL (95.3 mmol/L), and
sodium oxalate up to 60 mg/dL (4.5 mmol/L) demonstrated less than *Total Error = %Bias + 2 x %CV
10% interference. Total error was calculated using the absolute % Bias from the
Interferences from medications or endogenous substances may target SRM 967 values and total imprecision (%CV) determined at
affect results.17 creatinine concentrations within 1 mg/dL (88.4 μmol/L) of the SRM
967 target values.
Precision
Total Error Level 1 = 0.84% + 2 x 4.95% = 10.74%.
Serum
Total Error Level 2 = 2.70% + 2 x 3.18% = 9.06%.
The imprecision of the Creatinine serum assay is ≤ 6% Total CV.
Representative data from studies using CLSI protocol NCCLS Method Comparison
EP5-A218 are summarized below. Correlation studies were performed using CLSI protocol NCCLS
Control Level 1 Level 2 EP9-A220 with Passing-Bablok regression. Serum and urine results
from the Creatinine assay on an ARCHITECT cSystem and the
N 80 80
AEROSET System were compared with those from a commercially
Mean (mg/dL) 1.20 4.66
available alkaline picrate methodology.
Mean (μmol/L) 106.1 411.9
Serum and urine results from the Creatinine assay on an ARCHITECT
SD (mg/dL) 0.01 0.03 cSystem were compared with those from the Creatinine assay on the
Within Run SD (μmol/L) 0.9 2.7 AEROSET System.
%CV 0.76 0.57
Serum AEROSET vs. ARCHITECT vs.
SD (mg/dL) 0.01 0.04 Comparative Comparative ARCHITECT vs.
Between Run SD (μmol/L) 0.9 3.5 Method Method AEROSET
%CV 0.81 0.80 N 130 129 129
SD (mg/dL) 0.06 0.14 Y-Intercept (mg/dL) -0.07 -0.07 0.01
Between Day SD (μmol/L) 5.3 12.4 Y-Intercept (μmol/L) -6.2 -6.2 0.9
%CV 4.83 3.02 Correlation 0.9978 0.9979 1.0000
SD (mg/dL) 0.06 0.15 Coefficient
Total SD (μmol/L) 5.3 13.3 Slope 0.98 1.00 1.02
%CV 4.95 3.18 Range (mg/dL) 0.30 to 34.04 0.30 to 32.46 0.45 to 35.00
Urine Range (μmol/L) 26.5 to 3009.1 26.5 to 2869.5 39.8 to 3094.0
The imprecision of the Creatinine urine assay is ≤ 6% Total CV. Urine AEROSET vs. ARCHITECT vs.
Representative data from studies using CLSI protocol NCCLS Comparative Comparative ARCHITECT vs.
EP10-A219 are summarized below. Method Method AEROSET
Control Level 1 Level 2 N 58 58 58
N 50 50 Y-Intercept (mg/dL) -0.43 0.36 1.23
Mean (mg/dL) 61.95 145.48 Y-Intercept (mmol/L) -0.038 0.032 0.109
Mean (mmol/L) 5.476 12.860 Correlation 0.9992 0.9990 0.9992
SD (mg/dL) 0.57 1.79 Coefficient
Within Run SD (mmol/L) 0.050 0.158 Slope 1.01 0.97 0.96
%CV 0.92 1.23 Range (mg/dL) 7.32 to 591.08 7.32 to 591.08 5.81 to 594.82
SD (mg/dL) 0.61 0.45 Range (mmol/L) 0.647 to 52.251 0.647 to 52.251 0.514 to 52.582
Between Run SD (mmol/L) 0.054 0.040
%CV 0.98 0.31
SD (mg/dL) 0.00 0.00
Between Day SD (mmol/L) 0.000 0.000
%CV 0.00 0.00
SD (mg/dL) 0.83 1.85
Total SD (mmol/L) 0.073 0.164
%CV 1.34 1.27

5
Serum and urine results from Creatinine 3L81 assay were BIBLIOGRAPHY
compared with those from Creatinine (Enzymatic) 8L24 assay on an
1. Thomas L, editor. Clinical Laboratory Diagnostics: Use and
ARCHITECT cSystem. Assessment of Clinical Laboratory Results. Frankfurt, Germany: TH-
Serum Creatinine 3L81 vs. Creatinine Books Verlagsgesellschaft mbH; 1998:366–374.
(Enzymatic) 8L24 2. Jaffe M. Ueber den Niederschlag, welchen Pikrinsaure in normalem
N 129 Harn erzeugt und uber eine neue Reaction des Kreatinins. Hoppe
Y-Intercept (mg/dL) 0.05 Seylers Z Physiol Chem 1886;10:391–400.
Y-Intercept (μmol/L) 4.4 3. Folin O. Beitrag zur Chemie des Kreatinins und Kreatins Im Harne.
Hoppe Seylers Z Physiol Chem 1904;41:223–242.
Correlation Coefficient 0.9997 4. Fabiny DL, Ertingshausen G. Automated reaction-rate method for
Slope 1.00 determination of serum creatinine with the CentrifiChem. Clin Chem
Range (mg/dL) 0.43 to 36.79 1971;17:696–700.
Range (μmol/L) 38.0 to 3252.2 5. Soldin S, Henderson L, Hill G. The effect of bilirubin and ketones
on reaction rate methods for the measurement of creatinine. Clin
Urine Creatinine 3L81 vs. Creatinine
Biochem 1978:82–86.
(Enzymatic) 8L24 6. US Department of Labor, Occupational Safety and Health
N 58 Administration, 29 CFR Part 1910.1030, Bloodborne pathogens.
Y-Intercept (mg/dL) 2.20 7. US Department of Health and Human Services. Biosafety in
Y-Intercept (mmol/L) 0.194 Microbiological and Biomedical Laboratories. 5th ed. Washington, DC:
Correlation Coefficient 0.9998 US Government Printing Office; December 2009.
Slope 0.94 8. World Health Organization. Laboratory Biosafety Manual. 3rd ed.
Geneva: World Health Organization; 2004.
Range (mg/dL) 6.62 to 618.71
9. Clinical and Laboratory Standards Institute (CLSI). Protection
Range (mmol/L) 0.585 to 54.694 of Laboratory Workers From Occupationally Acquired Infections;
Approved Guideline—Fourth Edition. CLSI Document M29-A4. Wayne,
PA: CLSI; 2014.
10. Burtis CA, Ashwood ER, editors. Tietz Fundamentals of Clinical
Chemistry, 5th ed. Philadelphia, PA: WB Saunders; 2001:975.
11. Rabinovitch A, Sarewitz SJ, Woodcock SM, et al. Urinalysis and
Collection Transportation, and Preservation of Urine Specimens;
Approved Guideline—Second Edition (GP16-A2). Wayne, PA: The
National Committee for Clinical Laboratory Standards, 2001.
12. Guder WG, da Fonseca-Wollheim F, Heil W, et al. The Quality of
Diagnostic Samples. Darmstadt, Germany: GIT Verlag; 2001:24–25,
50–51.
13. US Pharmacopeial Convention, Inc. General notices. In: US
Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18).
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
14. NKDEP Resources Web Site. Suggestions for laboratories. Revised
February 2007. Available at: http://nkdep.nih.gov/resources/
laboratory_reporting.htm. Accessed November 5, 2007.
15. Junge W, Wilke B, Halabi A, et al. Determination of reference
intervals for serum creatinine, creatinine excretion and creatinine
clearance with an enzymatic and a modified Jaffé method. Clin Chim
Acta 2004;344:137–148.
16. National Committee for Clinical Laboratory Standards (NCCLS).
Evaluation of the Linearity of Quantitative Measurement Procedures:
A Statistical Approach; Approved Guideline. NCCLS Document
EP6-A. Wayne, PA: NCCLS; 2003.
17. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
Washington, DC: AACC Press; 1995:3-190–3-208.
18. National Committee for Clinical Laboratory Standards (NCCLS).
Evaluation of Precision Performance of Quantitative Measurement
Methods; Approved Guideline—Second Edition. NCCLS Document
EP5-A2. Wayne, PA: NCCLS; 2004.
19. Krouwer JS, Tholen DW, Garber CC, et al. Preliminary Evaluation
of Quantitative Clinical Laboratory Methods; Approved Guideline—
Second Edition (EP10-A2). Wayne, PA: The National Committee for
Clinical Laboratory Standards, 2002.
20. National Committee for Clinical Laboratory Standards (NCCLS).
Method Comparison and Bias Estimation Using Patient Samples;
Approved Guideline—Second Edition. NCCLS Document EP9-A2.
Wayne, PA: NCCLS; 2002.

6
Key to Symbols
Consult instructions for use

Manufacturer

Sufficient for

Temperature limitation

Use by/Expiration date

Contains Picric Acid: Prevent

from forming crystals. Do not
allow to dry out.
Authorized Representative in the
European Community
Identifies products to be used
together
Information needed for United
States of America only
In Vitro Diagnostic Medical
Device
Lot Number
Manufactured for
Product of United Kingdom
Reagent 1
Reagent 2
List Number
Serial number

The ARCHITECT cSystem family of instruments consists of c4000,

c8000, and c16000 instruments.
AEROSET, ARCHITECT, c4000, c8000, c16000, cSystem, and
SmartWash are trademarks of Abbott Laboratories in various
jurisdictions.
All other trademarks are property of their respective owners.

Abbott Laboratories ABBOTT

Diagnostics Division Max-Planck-Ring 2
Abbott Park, IL 60064 65205 Wiesbaden
USA Germany
+49-6122-580

Abbott Laboratories
Customer Service: Contact your local representative
or find country-specific contact information on
www.abbottdiagnostics.com
Revised April 2016.
©2009, 2016 Abbott Laboratories

7
ASSAY PARAMETERS

Creatinine 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: CreaC Type: Photometric Version: † Assay: CreaC
Number: 1068
COMPONENT REAGENT / ASSAY WASH Volume Replicates
Run controls for onboard reagents by: Lot
● Reaction definition о Reagent / Sample о Validity checks
Reaction mode: Rate up
Primary Secondary Read times
Wavelength: 500 / 572 Main: 21 – 26 Creatinine Serum/Plasma—Conventional Units
Last required read: 26 Flex: ___ – ___
Absorbance range: ___ – ___ Color correction: ___ – ___ Configure assay parameters — Results
Sample blank type: Self Blank: 11 – 16 о General о Calibration о SmartWash ● Results о Interpretation
Assay: CreaC Assay number: 1068
о Reaction definition ● Reagent / Sample о Validity checks Dilution default range: Result units: mg/dL
R1 R2 Low-Linearity: 0.20
Reagent: CREAC Reagent volume: 38 30 High-Linearity: 37.00
Diluent: Saline Water volume: 114 0 Gender and age specific ranges:
Diluent dispense mode: Type 0 Dispense mode: Type 0 Type 0 GENDER AGE (UNITS) NORMAL EXTREME
Male 18 – 130 (Y) 0.72 – 1.25
Diluted Default Female 18 – 130 (Y) 0.57 – 1.11
Dilution name Sample sample Diluent Water Dilution factor dilution
STANDARD : 8.0 ___ ___ ___ = 1:1.00 ●
_________ : ___ ___ ___ ___ = о Configure result units
_________ : ___ ___ ___ ___ = о
Assay: CreaC
Version: †
о Reaction definition о Reagent / Sample ● Validity checks Result units: mg/dL
Reaction check: None Decimal places: 2 [Range 0 – 4]
Correlation factor: 1.0000
Intercept: 0.0000
Rate linearity %: ___
Creatinine Serum/Plasma—SI Units
Configure assay parameters — Calibration
о General ● Calibration о SmartWash о Results о Interpretation Configure assay parameters — Results
Assay: CreaC Calibration method: Linear о General о Calibration о SmartWash ● Results о Interpretation
● Calibrators о Volumes о Intervals о Validity checks Assay: CreaC Assay number: 1068
Calibrator set: Calibrator level: Concentration: Dilution default range: Result units: µmol/L
MCC Blank: Water 0‡ Low-Linearity: 17.7
Cal 1: MCC1 ‡‡ High-Linearity: 3270.8
Replicates: 3 [Range 1 – 3] Cal 2: MCC2 ‡‡ Gender and age specific ranges:
GENDER AGE (UNITS) NORMAL EXTREME
Male 18 – 130 (Y) 63.6 – 110.5
о Calibrators ● Volumes о Intervals о Validity checks Female 18 – 130 (Y) 50.4 – 98.1
Calibrator: MCC Diluted
Calibrator level Sample sample Diluent Water
Blank: Water 8.0 ___ ___ ___
Cal 1: MCC1 8.0 ___ ___ ___ Configure result units
Cal 2: MCC2 8.0 ___ ___ ___ Assay: CreaC
Version: †
Result units: µmol/L
о Calibrators о Volumes ● Intervals о Validity checks Decimal places: 1 [Range 0 – 4]
Calibration intervals:
Correlation factor: 1.0000
Full interval: 120 (hours)
Intercept: 0.0000
Calibration type:
Adjust type: None

о Calibrators о Volumes о Intervals ● Validity checks

Blank absorbance range: _____ – _____
Span: Blank – Blank
Span absorbance range: _____ – _____
Expected cal factor: 0.00
Expected cal factor tolerance %: 0

† Due to differences in instrument systems and unit configurations, version numbers may vary.
‡ Displays the number of decimal places defined in the decimal places parameter field.
‡‡ Refer to the concentration specified on calibrator labeling or value sheet. These values are defined on the Configure calibrator set screen.

8
 ASSAY PARAMETERS

Creatinine 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: CreaCU Type: Photometric Version: † Assay: CreaCU
Number: 1096 COMPONENT REAGENT / ASSAY WASH Volume Replicates
Run controls for onboard reagents by: Lot
● Reaction definition о Reagent / Sample о Validity checks
Reaction mode: Rate up
Primary Secondary Read times
Wavelength: 500 / 572 Main: 21 – 26 Creatinine Urine—Conventional Units
Last required read: 26 Flex: ___ – ___
Absorbance range: ___ – ___ Color correction: ___ – ___ Configure assay parameters — Results
Sample blank type: Self Blank: 11 – 16
о General о Calibration о SmartWash ● Results о Interpretation
Assay: CreaCU Assay number: 1096
о Reaction definition ● Reagent / Sample о Validity checks Dilution default range: Result units: mg/dL
R1 R2 Low-Linearity: 0.25††
Reagent: CREAC Reagent volume: 38 30 High-Linearity: 37.00
Diluent: Saline Water volume: 114 ___ Gender and age specific ranges:
Diluent dispense mode: Type 0 Dispense mode: Type 0 Type 0 GENDER AGE (UNITS) NORMAL EXTREME
Diluted Default
Dilution name Sample sample Diluent Water Dilution factor dilution
1:20 : 8.0 8.0 152 ___ = 1:20.00 ●
_________ : ___ ___ ___ ___ = о
_________ : ___ ___ ___ ___ = о Configure result units
Assay: CreaCU
о Reaction definition о Reagent / Sample ● Validity checks Version: †
Reaction check: None Result units: mg/dL
Decimal places: 2 [Range 0 – 4]
Correlation factor: 1.0000
Rate linearity %: ___ Intercept: 0.0000

Configure assay parameters — Calibration

Creatinine Urine—SI Units
о General ● Calibration о SmartWash о Results о Interpretation
Assay: CreaCU Calibration method: Linear
Configure assay parameters — Results
● Calibrators о Volumes о Intervals о Validity checks о General о Calibration о SmartWash ● Results о Interpretation
Calibrator set: Calibrator level: Concentration:
Assay: CreaCU Assay number: 1096
MCC Blank: Water 0‡
Cal 1: MCC1 ‡‡ Dilution default range: Result units: mmol/L
Replicates: 3 [Range 1 – 3] Cal 2: MCC2 ‡‡ Low-Linearity: 0.022††
High-Linearity: 3.271
Gender and age specific ranges:
GENDER AGE (UNITS) NORMAL EXTREME
о Calibrators ● Volumes о Intervals о Validity checks
Calibrator: MCC Diluted
Calibrator level Sample sample Diluent Water
Blank: Water 8.0 ___ ___ ___
Cal 1: MCC1 8.0 ___ ___ ___ Configure result units
Cal 2: MCC2 8.0 ___ ___ ___
Assay: CreaCU
Version: †
Result units: mmol/L
о Calibrators о Volumes ● Intervals о Validity checks Decimal places: 3††† [Range 0 – 4]
Calibration intervals: Correlation factor: 1.0000
Full interval: 120 (hours) Intercept: 0.0000
Calibration type:
Adjust type: None

о Calibrators о Volumes о Intervals ● Validity checks

Blank absorbance range: _____ – _____
Span: Blank – Blank
Span absorbance range: _____ – _____
Expected cal factor: 0.00
Expected cal factor tolerance %: 0

† Due to differences in instrument systems and unit configurations, version numbers may vary.
‡ Displays the number of decimal places defined in the decimal places parameter field.
‡‡ Refer to the concentration specified on calibrator labeling or value sheet. These values are defined on the Configure calibrator set screen.
†† Low-Linearity is the linear low value divided by the Standard dilution factor, then rounded up to the number of decimal places defined in the
decimal places field. The linear high value (High-Linearity) is linearity divided by the Standard dilution factor.
††† Three decimal places are required for an accurate calibration curve using calibrator values in mmol/L units. Do not alter decimal places.

9
10