University of Utah Hospital and Clinics
Salt Lake City, UT
CN-UR4004
Rev. 1
Date: November 2006
Page 1 of 7
Urine Macroscopic
Purpose:
To accurately perform a macroscopic examination of urine using:
Reagent Strips for Urinalysis Uristix® - Glucose and Protein. This procedure has been
prepared for the University Hospital (UUHSC) and Clinics.
Principle:
Uristix reagent test strips are used in Point of Care locations to aid in the evaluation of
diseases of the urinary tract and other organ systems. Test pads are read visually and
compared to a Color Chart. Performance is based on clinical and analytical studies and
depends upon several factors: the variability of color perception, the presence or absence
of inhibitory and matrix factors typically found in urine.
Glucose:
This test is based on a double sequential enzyme reaction. One enzyme,
glucose oxidase, catalyzes the formation of gluconic acid and hydrogen
peroxide from the oxidation of glucose. A second enzyme, peroxidase,
catalyzes the reaction of hydrogen peroxide with a potassium iodide
chromogen to oxidize the chromogen to colors ranging from green to
brown.
Protein:
This test is based on the protein-error-of-indicators principle. At a constant
pH, the development of any green color is due to the presence of protein.
Colors range from yellow for “Negative” through yellow-green and green
to green-blue for “Positive” reactions.
Scope:
Personnel may perform urinalysis testing only after completing training by the University
Hospital Point of Care (POC) Department. These Reagent test strips are utilized at the
University of Utah Hospital and Clinics (UUHSC), and the Huntsman Cancer Hospital
(HCH).
Related Documents:
KOVA® Liqua-Trol TM Procedure CN-UR4002; Version 1.
University of Utah Hospital and Clinics
Salt Lake City, UT
CN-UR4004
Rev. 1
Date: November 2006
Page 2 of 7
Urine Macroscopic
Personal Protective Equipment (PPE):
This procedure may expose the user to:
[X] Bloodborne pathogens
[X] Hazardous reagents
To perform this procedure the user must wear:
[X] Gloves
[X] Uniform or fully buttoned laboratory coat over clothing
Disinfectant and clean utilizing the following agents:
[X] Diluted Bleach (10% solution of hypochlorite)
(One part household bleach in nine parts of water).
Equipment and Supplies:


Timing device (e.g. timer or watch)
Plastic transfer pipettes (optional)
Reagents:
NOTE: Be sure to label any reagents/controls with the open date and operator’s
initials.
Uristix Reagent strips:
 Store at Room temperature (15-30° C).
 Store out of direct sunlight.
 Store at all times with the cap tightly closed.
 Good until expiration date on the container.
 Do not remove the desiccant from the bottle.
KOVA Liqua-Trol (assayed) normal and abnormal controls:
 Store at refrigerator temperature (2-8° C).
 Store until expiration date on the box.
Note: Refer to the KOVA Liqua-trol control procedure for instructions on how to perform
testing.
University of Utah Hospital and Clinics
Salt Lake City, UT
CN-UR4004
Rev. 1
Date: November 2006
Page 3 of 7
Urine Macroscopic
Specimen Collection:
Collect:
Freshly voided urine in a sterile container. A first morning specimen is
preferred. Test the urine within two hours after voiding.
Acceptable: Random specimen.
Stability:
Ambient: 2 hours; Refrigerated 24 hours.
Refrigerate the specimen if processing is delayed. Let specimen return to room
temperature before processing (approximately 20-30 minutes).
Quality Control:
Daily:
1. Record how all opened vials of dipsticks have been stored on a daily basis. A
“URINE DIPSTICK QC (Quality Control) and DAILY STORAGE LOG” should be
maintained for each container opened and in use, and on every day that the facility is
open. (See Addendum B).
External: When Opening New vials of dipsticks:
1. Urine controls need to be performed with each new vial of dipsticks.
a) KOVA Liqua-trol controls are used and are performed and read like a patient
sample (see the section titled Procedure, starting at step 3.).
b) Use the reference control sheet located in the KOVA Liqua-trol control box to
determine if all constituents are within the recommended range.
2. The results of the KOVA Liqua-trol normal and abnormal controls should be recorded
either on the MediTape report form if available, or on the “URINE DIPSTICK QC
(Quality Control) and DAILY STORAGE LOG” sheet (see ADDENDUM B). Store
QC documentation with the patient result carbons for a period of 2 years.
3. If any results are out of range, remove another dipstick from the vial and repeat with
the same control solution.
Note: If results are still out of range, open a new bottle of reagent strips and retest with
the same control solutions.
o
If results are still not within the recommended range, open a new set of controls, and
retest with the new reagent strips.
o
If results still fall outside of range, DO NOT report out patient results. Send urine to
the University of Utah Hospital Clinical Laboratory for testing.
o
Notify the POC (Point of Care) Department at: 585-5247.
(Document any corrective action that was taken for controls that fall outside the
recommended ranges).
University of Utah Hospital and Clinics
Salt Lake City, UT
CN-UR4004
Rev. 1
Date: November 2006
Page 4 of 7
Urine Macroscopic
Procedure:
Note: See Addendum A for urine collection instructions. Instruct the patient on an
acceptable way to collect a clean-catch urine specimen.
1. Obtain a urine sample from the patient and label the container with the patient’s name
and unique identification number.
2. Record the name from the urine container on the MediTape report form (along with
other required fields that are on the MediTape), or compare the name on the container
with the patient’s medical chart to properly identify that the urine has been collected
on the correct patient.
Note: Allow urine to come to room temperature if previously refrigerated.
(Approximately 20-30 minutes).
3. Mix the sample well. Observe the color and clarity of the urine and record the results
on the MediTape report form.
Colors vary from:
Colorless, straw, pale yellow, medium yellow, dark yellow
Brown, orange, red, green/blue or black.
Clarity:
Clear, hazy, turbid or cloudy.
Note: If Protein and Glucose results are going to be recorded in the patient’s chart, color
and clarity do not need to be recorded.
4. Remove a dipstick from the container and replace the cap. Completely immerse and
remove the reagent pads quickly into the sample of urine, (or if the sample is
insufficient, place a small drop of urine on each test patch with a disposable pipette).
Drag the urine dipstick across the edge of the container; quickly blot the strip on an
absorbent towel to remove any excess urine and to prevent “run-over”.
5. Using the timing device, read and record the results of the various chemical tests at
the appropriate times, using the color chart located on the side of the dipstick
container.
Glucose:
30 seconds
Protein:
Time not critical. May be read immediately.
Note: Hold the strip close enough to color blocks and match carefully. Avoid laying the
strip directly on the color chart located on the container, as this will result in the urine
soiling the chart.
University of Utah Hospital and Clinics
Salt Lake City, UT
CN-UR4004
Rev. 1
Date: November 2006
Page 5 of 7
Urine Macroscopic
Result Reporting:
Note: Contact your unit educator or manager for more information on which
Form to record your patient results on, and what is specific for your unit.
If the MediTape Report Form is used:
 Record the patient’s name, medical record number (MRN) or DOB, testing
location, date, time, patient results and performing individual’s initials.
If the Patient’s chart is used:
 Record the dipstick results in the appropriate sections of the “Patient Care
Record”, along with the performing individual’s initials.
 Ensure that the Patient Care Record is labeled with the appropriate patient
information, (i.e. Embossed stamper plate or label).
Record Retention:
All Point of Care (POC) testing results and quality control data MUST be available for
review for 2 years.
Normal or Reference Range:
Protein:
Glucose:
< 15 mg/dL
< 15 mg/dL
Procedure Notes:





Substances that cause abnormal urine color may affect the readability of the test pads
on the reagent strips. These substances include visible blood or bilirubin and drugs
containing dyes (i.e. Pyridium, or nitrofurantoin).
Visibly bloody urine may cause falsely elevated protein results.
Ketone bodies reduce the sensitivity of the glucose test.
Performance of testing is based on the variability of color perception; and the
environment in which the testing is performed (i.e. good lighting, and temperature).
Exact agreement between visual results and Laboratory instrument results might not
be found due to inherent differences between the perception of the human eye and the
optical systems of the instruments.
University of Utah Hospital and Clinics
Salt Lake City, UT
CN-UR4004
Rev. 1
Date: November 2006
Page 6 of 7
Urine Macroscopic
Limitations:







Do not remove the strip from the bottle until immediately before it is to be used for
testing.
Do not touch the test areas of the strip.
Discoloration or darkening of the test pads may indicate deterioration. Steps that can
be taken are:
 Check the expiration date of the dipsticks
 Do not use product after expiration date shown on the label.
 Check the performance of the dipsticks with the quality control product used in
your clinic.
 Retest with a new container of dipsticks.
Strips must remain in the original bottle and stored at room temperature.
Do not store the bottle of dipsticks in direct sunlight.
Do not remove the desiccant from the bottle.
Ketone bodies reduce the sensitivity of the glucose test; moderately high ketone levels
(40 mg/dL) may cause false negatives for specimens containing small amounts of
glucose (75-125 mg/dL) but the combination of such ketone levels and low glucose
levels is metabolically improbable in screening.
References:
 Clinical Diagnosis and Management by Laboratory Methods, John B. Henry, MD, 19th
Edition, WB Saunders Co., 1996
 Urinalysis and Body Fluids, Susan King Strasinger, ed. 2; 1989
 Uristix Reagent strips product insert; Bayer Health Care; 1991, 2005.
 KOVA Liqua-trol product insert; HYCOR 3/04
 Procedure-KOVA Liqua-trol CN-UR2004 version 1
 Procedure-PSS-PROC-6053; Rev.8
Back-Up Procedure:
If the urine dipstick test strips are unavailable, or the results you obtain are questioned,
send the urine specimen in a standard yellow top vacutainer tube (and a gray top, Boric
Acid tube if a culture is also required), to the Clinical Laboratory for testing.
Method Validation:
A copy of the validation performed for the Uristix Reagent strips is kept in the UUHSC
Clinical Laboratory Instrument files.
University of Utah Hospital and Clinics
Salt Lake City, UT
CN-UR4004
Rev. 1
Date: November 2006
Page 7 of 7
Urine Macroscopic
ADDENDUM A
Urine Collection “Clean-Catch”
Important: For accurate results, please read all directions first and follow carefully.
Females:
1. Wash your hands thoroughly.
2. Separate the skin folds around the urinary opening.
3. Open the towelette provided and wash the urinary opening and the surrounding areas
from front to back. Discard the towelette into the waste basket.
4. Begin urinating into the toilet – IMPORTANT – and wait until the urine stream is
well established before moving the empty container into the path of the stream. Catch
the middle portion of your urine flow.
5. Screw the cap onto the container securely without touching the inside of the rim.
6. Label the container with your name and Date of Birth.
7. Deliver the container to the laboratory or your nurse.
Males:
1. Wash your hands thoroughly.
2. Draw the foreskin back away from the urinary opening.
3. Open the towelette and wash the urinary opening and surrounding area. Discard the
towelette into the waste basket.
4. Begin urinating into the toilet – IMPORTANT – and wait until the urine stream is
well established before moving the empty container into the path of the stream. Catch
the middle portion of your urine flow.
5. Screw the cap onto the container securely without touching the inside of the rim.
6. Label the container with your name and Date of Birth.
7. Deliver the container to the laboratory or your nurse.
CN-UR4002
Rev. 1
Date: November, 2006
University of Utah Hospital and Clinics
Salt Lake City, UT
Urine Macroscopic
APPROVED BY:
DATE APPROVED:
MEDICAL DIRECTOR:
TECHNICAL SUPERVISOR APPROVAL:
GROUP MANAGER APPROVAL:
DATE ADOPTED:
RETIRED:
REPLACES: Original
Copy #
Location
1
2
Master SOP Manual
Detailed list of clinics and Hospital Units may be obtained through the Point of Care Department;
ARUP / University of Utah Hospital and Clinics
REVIEWED:
Date ____________ By ____________________________ Comments ________________________________________
Date ____________ By ____________________________ Comments ________________________________________
Date ____________ By ____________________________ Comments ________________________________________
Date ____________ By ____________________________ Comments ________________________________________
AUTHORIZED TO APPROVE:
Medical Director
Assistant Medical Director
AUTHORIZED TO REVIEW:
Medical Director
Assistant Medical Director
Group Manager
Technical Supervisor