Microgenics Corporation

Part of Thermo Fisher Scientific

DRI CREATININE-DETECT ASSAY APPLICATION

BECKMAN COULTER AU5800®
Catalog No. 1797
Intended for the quantitative determination of creatinine in human urine for the
detection of adulteration by dilution or substitution with a non-urine solution.

For In Vitro Diagnostic and Rx Use

Intended Use The information provided in this application sheet is intended as a supplement to the
package insert. Refer to the package insert for information on intended use, reagent
storage, reagent preparation, specimen collection, specimen preparation, specimen
storage, quality control, and additional performance data.

Ordering Item Size Catalog Number

Information ®
DRI Creatinine-Detect Assay 500 mL 1797
DRI® Creatinine-Detect Calibrator Kit 2 x 25 mL 100272
DRI® Creatinine-Detect 1.3 mg/dL Control 25 mL 100273
DRI® Creatinine-Detect 7.5 mg/dL Control 25 mL 100274
DRI® Creatinine-Detect 23.0 mg/dL Control 25 mL 100275

To place an order or for technical service, contact:

USA In Europe

Tel: (800) 232-3342 Tel: +49 (0)851-88 6890

Fax: (510) 829-8115 Fax: +49 (0)851-88 68910

Microgenics Corporation, part of Thermo Fisher Scientific

46500 Kato Road, Fremont, CA 94538 USA
U.S. Toll free: (800) 232-3342 / Tel: (510) 979-5000
U.S. Toll free fax: (888) 829-8115 / Fax: (510) 979-5420

EC REP B• R• A• H• M• S GmbH, Neuendorfstrasse 25, 16761, Hennigsdorf, Germany

Tel: +49 (0)851-88 6890/ Fax: +49 (0)851-88 68910

Continued on next page

Clinical Diagnostics 46500 Kato Road Fremont, CA USA 510-979-5000 www.thermoscientific.com/diagnostics

Microgenics Corporation 94538 510-979-5420 fax Toll Free: 800-232-3342
 Microgenics Corporation
Part of Thermo Fisher Scientific

Reagent Refer to the package insert for information on reagent storage.

Storage

Procedure for 1. Refer to the operator’s manuals for information on analyzer operation.
Analyzer
2. See package insert for specimen preparation.

3. Dispense adequate amounts of Reagent 1 and Reagent 2 into appropriate

containers.

4. Place the filled reagent containers on the reagent trays in positions defined by
the user. Ensure that reagents have equilibrated to temperature of analyzer
reagent compartment before starting analysis.

5. Perform a reagent volume check as instructed in the operator’s manual.

6. Select “All” to calibrate the test. It is not necessary to test the blank rack during
calibration.

7. Define a worklist as instructed in the operator’s manual. Press START to begin

analysis.

8. Results for calibrators will be printed in Optical Density (OD). Results for
samples will be printed in mg/dL.

Results and Results for samples will be printed in mg/dL.

Data
Interpretation

Page 2 of 4 10021168APS, Rev. 2

08-2017
Clinical Diagnostics 46500 Kato Road Fremont, CA USA 510-979-5001 www.thermoscientific.com/diagnostics
Microgenics Corporation 94538 510-979-5420 fax Toll Free: 800-232-3342
 Microgenics Corporation
Part of Thermo Fisher Scientific

Beckman Coulter AU5800 Parameters

DRI Creatinine-Detect Assay

Parameters Specific Test Parameters

General LIH ISE HbA1c Calculated Test Range
Test Name: # ∇ < > Type: Urine ∇ Operation Yes ∇

Sample Volume 2.5 µL Dilution 0 µL OD Limit

Pre-Dilution Rate 1 ∇ Diluent Bottle # ∇ Min.OD -2.00 Max.OD 3.00
Rgt. Volume R1(R1-1) 80 µL Dilution 0 µL Reagent OD Limit
st
R1-2 µL Dilution µL 1 . Low -2.00 High 3.00
Last Low -2.00 High 3.00
R2(R2-1) 80 µL Dilution 0 µL
Dynamic Range Low 0.1 High 184
Common Rgt. Type None Name None Correlation Factor A 1 B 0
Wavelength Pri 520 ∇nm Sec. 600 ∇nm Factor for Maker A 1 B 0
Method FIXED1* ∇
Reaction Slope + ∇ Onboard Stability Period # Day # Hour
st
Measuring Point1 1 13 Last 17 LIH Influence Check # ∇
st
Measuring Point2 1 Last Lipemia ∇
Linearity Limit % Icterus ∇
Lag Time Check No ∇ Hemolysis ∇

Parameters Specific Test Parameters

General LIH ISE HbA1c Calculated Tests Range

Test Name # ∇ < > Type Urine ∇

Value/Flag # ∇
Level Low High Panic Value
-9999999 9999999
Low High
Specific Ranges: From To # #
Sex Year Month Year Month Low High
 1 # ∇ # # # # # #
 2 # ∇ # # # # # #
 3 # ∇ # # # # # #
 4 # ∇ # # # # # #
 5 # ∇ # # # # # #
 6 # ∇ # # # # # #
7 Standard Demographics # #
8 Not within expected values # #

Panic Value Low # High # Unit mg/dL Decimal Places #

# User defined

Page 3 of 4 10021168APS, Rev. 2

08-2017
Clinical Diagnostics 46500 Kato Road Fremont, CA USA 510-979-5001 www.thermoscientific.com/diagnostics
Microgenics Corporation 94538 510-979-5420 fax Toll Free: 800-232-3342
 Microgenics Corporation
Part of Thermo Fisher Scientific

Beckman Coulter AU5800 Parameters

DRI Creatinine-Detect Assay (continued)
Parameters Calibration Parameters
Calibrators Calibration Specific STAT Table Calibration

Test Name # ∇ < > Type Urine ∇ □ Use Serum Cal.

Calibration Type AA ∇ Formula Y=AX+B ∇ Counts 2 ∇

< Calibrator Parameters> Factor Range Slope Check + ∇

Calibrator OD Conc Low High
Point-1 # ∇ 2.0 -99999 99999 Allowable Range Check
Point-2 # ∇ 20.0 -99999 99999 □ Reagent Blank
Point-3 ∇ □ Calibration
Point-4 ∇
Point-5 ∇ Advanced Calibration
Point-6 ∇ Operation No ∇
Point-7 ∇ Interval (RB/ACAL) ∇
Point-8 ∇
Point-9 ∇ □ Lot Calibration
Point-10 ∇
< Point Cal. For Master Curve > No. of Correction Points ∇ Use Master Curve ∇
OD Range
Calibrator OD Conc Low High Stability
Point-1 ∇ Reagent Blank # Day # Hour
Point-2 ∇ Calibration # Day # Hour
MB Type Factor 1-Point Calibration Point None ∇ □ with Conc-0

# User defined

© 2017 Thermo Fisher Scientific Inc. All rights reserved.

All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.
CEDIA is a trademark of Roche Diagnostics.
AU Series Systems are trademarks of Beckman Coulter.

End

Page 4 of 4 10021168APS, Rev. 2

08-2017
Clinical Diagnostics 46500 Kato Road Fremont, CA USA 510-979-5001 www.thermoscientific.com/diagnostics
Microgenics Corporation 94538 510-979-5420 fax Toll Free: 800-232-3342