Automated Urinalysis for Clinitek 50 Effective Date: 06/22/01
Document #11/version #03
®
Purpose Siemens Reagent Strips are for in vitro diagnostic use. Urinalysis can
Principle provide the physician with important information regarding the status of a patient’s health. Test results may provide information regarding the status of carbohydrate metabolism, kidney function and liver function, acid-base balance, and urinary tract infection.
NOTE: As with all laboratory tests, definitive diagnostic or therapeutic decisions should not be based on any single result or method.
Siemens Reagent Strips for urinalysis are read instrumentally by the
Clinitek 50
®
Analyzer. Siemens 10SG Reagent Strips test for:

Glucose

Bilirubin

Ketone

Specific gravity

Blood
 pH

Protein

Urobilinogen

Nitrite

Leukocytes
Sample Obtain a fresh, urine specimen. A first-morning specimen is preferred but random collections are acceptable. Specimen should be at room temperature for no more than two hours before testing. Collect the urine, voided specimens in a clean, dry paper cup. Clean catch urine in a clean, dry, covered sterile container.
The urine specimen should be well mixed and uncentrifuged.
To avoid contamination of a specimen that may warrant a culture, pour off small amount of specimen into alternate container or set culture up prior to performing urinalysis.
Materials Equipment

Clinitek 50
®
Analyzer
Reagents

Siemens 10SG
Reagent Strips

QC materials
Supplies

Specimen collection
containers

Paper towels

PPE
Columbus County Health Department Laboratory, Whiteville NC 28328 1

Automated Urinalysis for Clinitek 50 Effective Date: 06/22/01
Document #11/version #03
Calibration The Clinitek 50
® Analyzer performs a “self-test” and calibration each time it is turned on. In addition the analyzer performs an automatic calibration each time a test is run. The white calibration bar (on the test table) provides NIST traceable calibration.
Quality
Control
Test known abnormal and normal controls daily and when a new bottle of reagent strips is first opened. Kovatrol Level 1 and Level 3 controls are used to monitor performance. The controls are stable until the expiration date on the label when stored unopened at 2-8º C. Do Not Freeze. Once reconstituted, controls are stable for 7 days when stored at 2-8º F.
Controls should be treated as a patient sample, follow procedure. Record reagent strip lot number and expiration date and QC lot numbers of all materials in use along with expiration date on the Urinalysis QC Log.
Record IUD (in-use-date) and initial on reagent strip bottle.
Procedure WARNING: Bring the patient sample to 15-30ºC (68-86ºF) and mix well prior to testing.
WARNING: Do not remove the strip from the bottle until immediately before use. Replace cap immediately and tightly after removing the strip.
Step
1
2
Action
Remove one strip from the bottle and replace the cap.
3
Dip the reagent strip into the urine sample, wetting all pads.
Immediately remove strip from the urine.
Drag the edge of the strip against the side of the sample container as you remove it.
4
5
6
Press the green start key on the analyzer.
Blot by touching the edge of the strip to the paper towel to remove excess urine. Do not lay the pads on the paper towel or cover the pads by the paper towel.
Place the reagent strip in the channel of the test table with the test pads facing up. Slide the strip to the end of the channel.
Do not push or pull test table.
7
8
9
10
The test table and strip will automatically be pulled into the instrument.
The analyzer will perform an automatic calibration and begin analyzing the strip. Do not move or bump the table while the instrument is calibrating.
When the analysis is complete, the Results screen will display the results.
Remove the used urinalysis strip from the test table and dispose of in approved biohazard container. Urine sample containers will be disposed of in biohazard box provided.
Wipe the test strip table with a lint-free tissue. 11
NOTE: There are inherent differences between the colors that are perceived by the human eye and that are detected by any instrument
Columbus County Health Department Laboratory, Whiteville NC 28328 2

Automated Urinalysis for Clinitek 50 Effective Date: 06/22/01
Document #11/version #03 optical system. The human eye is capable of detecting minute differences in shade and very small areas of color; whereas instrument optical systems are less sensitive to such small changes. Conversely, instrument optics are capable of detecting certain colors that are masked by or blended with other colors to the human eye. For this reason, exact agreement between visual results and instrument results might not be found. However, agreement is generally within one visual color block or reported level and is equal to or better than the agreement between two visual readers.
SCHD Laboratory will read samples utilizing the automated method only.
Interpretation
Specific gravity pH
Leukocytes
Nitrite
Protein
Glucose
Ketones normal
1.016 – 1.022
5.0 – 9.0
Negative
Negative
Negative
Negative
Negative abnormal
1.000 – 1.015 / 1.023 – 1.030
NA
Any positive
Positive
Any positive
Any positive
Any positive
Urobilinogen
Bilirubin
Blood
0.2 – 1.0
Negative
Negative
2.0 – 8.0
Any positive
Any positive
Result Reporting Log all results on the lab log and enter into EMR. PANIC VALUES: 4+ positive for glucose and 3+ ketones. All panic values are repeated. All panic values are verbally reported to the clinician immediately. Document results verification on patient requisition and indicate the clinician’s name to whom the results were reported.
Limitations

Substances that cause abnormal urine color may affect the readability of the test pads. For a list of these substances see the package insert.

Contamination of the urines specimen with skin cleansers containing chlorhexidine may affect protein, specific gravity, and bilirubin test results.

It is important to use fresh urine to obtain optimal results.

Discoloration or darkening of reagent areas may indicate deterioration.
References

Multistix package insert, 10/2005.

Siemens HealthCare Clinitek 50
® Analyzer Operator’s Manual,
132387, Rev. C 2005-10.

National Committee for Clinical Laboratory Standards (NCCLS),
Laboratory Documents: Development and Control; Approved
Guideline, Fifth Edition (GP2-A5), 2006.

KovaTrol Product Insert, 2011.

Columbus County Health Department Laboratory, Whiteville NC 28328 3

Automated Urinalysis for Clinitek 50 Effective Date: 06/22/01
Document #11/version #03
Related Documents

Document #1, Urine Collection Procedure.

Policy #2, Specimen Rejection Policy.

Policy #14, EMR Policy.
Karen H. Wall, BSMT (ASCP), Technical Consultant Author
Approval _____________________________
Name
_____________
Date
Signature
Columbus County Health Department Laboratory, Whiteville NC 28328 4