University Hospitals and Clinics Salt Lake City, UT CN

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University Hospitals and Clinics
Salt Lake City, UT
CN-UR4008
Date: July, 2008
Page 1 of 14
Clinitek STATUS 
Purpose:
This procedure explains how to read the Bayer Multistix 10 SG urinalysis strips using
the Clinitek Status analyzer. This procedure has been prepared for use by the University
Hospitals (UUHSC) and Clinics.
Principle:
The analyzer is for use in the semi-quantitative detection of bilirubin, blood, glucose,
ketone, leukocytes, nitrite, pH, protein, specific gravity and urobilinogen in urine
samples.
The optical system consists of six light emitting diodes, a light guide, a mirror, a lens and
a detector. Light from the LED travels along the light guide and is reflected off the
calibration bar, or strip, onto the mirror. It is then directed through an aperture on the
lens, from where it is focused onto the detector. The light intensity detected is converted
into electrical impulses, which are processed by the instrument’s microprocessor and
converted into clinical results. When carrying out analysis on a urinalysis strip, the test
table positions strip pads in the “read area”. The light reflected at specific wavelengths
from the test pad is dependent upon the degree of color change in the pad and is directly
related to the concentration of the particular constituent in the urine. The analyzer’s
optical system images the entire strip (all at the same time).
Scope:
This procedure applies to medical personnel performing testing in the University
Hospitals (UUHSC) and Clinics. The Clinitek STATUS analyzer is considered waived
only when used with Bayer reagent strips, manufactured by Bayer HealthCare LLC.
Personal Protective Equipment (PPE):
Dispose of contaminated materials according to your laboratory’s biohazard control
procedures.
This procedure may expose the user to:
[X] Bloodborne pathogens
[X] Hazardous reagents
Rev. 4
University Hospitals and Clinics
Salt Lake City, UT
CN-UR4008
Date: July, 2008
Page 2 of 14
Clinitek STATUS 
To perform this procedure the user must wear:
[X] Gloves
[X] Uniform or fully buttoned laboratory coat over clothing
[X] Wear facial protection when splatter or aerosol formation is possible.
Disinfectant and clean utilizing the following agents:
[X] Diluted Bleach (10% solution of hypochlorite)
(One part household bleach in nine parts of water);
[X] Test table may be removed and placed under running water; dry thoroughly.
Specimen:
Collect:
Freshly voided urine in a clean container; test as soon as possible. The
urine container should be free of all additives.
Collect enough urine to ensure all reagent strips are wet.
Preferred:
First morning specimen, but random collections are acceptable.
Unacceptable: Visibly bloody urine samples or unusually colored urine samples.
Stability:
Ambient: 1 hour (refrigerate after 1 hour), Refrigerated: 24 hours.
Note: If you are unable to test the sample within the recommended time:
o Refrigerate the specimen; but allow the sample to reach room temperature before
testing, mix well before testing.
o Transport the urine specimen to the Clinical Laboratory in the approved urine
transport tube. Light yellow Vacutainer laboratory tube; No additive.
Equipment and Supplies:

Clinitek Status analyzer:
o
The analyzer must be on a level and stable work surface, with the room
temperature between 22-26° C.
o
Place the analyzer where the temperature and humidity are fairly constant; do not
place the analyzer near windows.
 Test Table:
o
To be placed into the analyzer by holding the table by the end opposite the white
calibration bar and with the white bar facing up. Push the test table into the
analyzer just over halfway.
Note: Do NOT touch the white calibration bar.
 Test table insert: ONLY Multistix 10 SG test strips can be used with this insert.
 Power Supply
 Printer paper: see Cleaning and Maintenance for loading the analyzer printer.
 Paper towel
 2 x 2 gauze; for wiping and drying the test table.
Rev. 4
University Hospitals and Clinics
Salt Lake City, UT
CN-UR4008
Date: July, 2008
Page 3 of 14
Clinitek STATUS 
Reagents:
NOTE: Label all Multistix test strip containers in use with the open date, quality
control date and your initials. Quality control performance should be
assessed and documented before the strips are used on patient samples.
Label the KOVA control products with the open date and your initials when
they are first opened.
 Multistix 10 SG Reagent test strips
o
Must remain in the original bottle.
o
Container must stay tightly capped when not in use.
o
Store at room temperature (15-30° C).
o
Do not use the strips after their expiration date.
o
Do not store the bottle in direct sunlight and do not remove the desiccant from the
urine dipstick container.
 Control Products
o
KOVA Liqua-trol Urinalysis Controls; Normal (Level II) and
Abnormal (Level I).
o
Stable until the expiration date stated on the label when stored between 2-8° C. If
the product is stored in the refrigerator, bring to room temperature before use. DO
NOT FREEZE.
o
If the product is stored at room temperature (15-30° C.), the expiration date is the
earliest of ONLY 30 days from the open date or the manufacturer expiry
date on the bottle.
Calibration:
 A system test is performed each time the instrument is turned on.
 The instrument automatically calibrates each time a test is run. The white calibration
bar (on the test table) provides (National Institute of Standards and Technology)
NIST traceable calibration.
The display screen with display
“Calibrating
Please Wait
Clinitek Status is Calibrating”
Note: Do not move or bump the table while the instrument is calibrating.
Quality Control:
Is required:
1) To be performed daily (each day patient testing is done)
2) Upon opening a new bottle of urine dipsticks; (Multistix 10 SG)
Rev. 4
University Hospitals and Clinics
Salt Lake City, UT
CN-UR4008
Date: July, 2008
Page 4 of 14
Clinitek STATUS 

Two levels of Control Products, (Normal and Abnormal), MUST be performed on the
container of dipsticks each day and the first time they are opened. (see Reagents: for
product information).
 No patient samples can be performed using the new dipsticks until the Normal and
Abnormal KOVA control solutions have been tested.
o
KOVA Liqua-trol controls solutions are tested in the same manner as patient
samples. (See Procedure:).
 After performing each control sample,
o
Compare the printed results from the analyzer, to the KOVA Liqua-trol
manufacturer’s recommended results located on the reference control
sheet. The reference control sheet is located in the KOVA Liqua-trol
control box.
o
Place the KOVA normal and abnormal printouts in the urine dipstick
Quality Control binder located in your area. Daily QC is documented on
the Clintek Status Daily Control log (see Addendum A).
Note: The quality control results MUST be retained and available for 2 years according
to Joint Commission standards.





If any of the test pad results fall outside the manufacturer’s recommended range,
remove another dipstick from the vial and repeat the testing with the same control
solution.
If results are still out of range, check the control solution and dipstick containers to
ensure they are within the established expiration date.
If the KOVA products or dipsticks are expired, open new products and retest.
If the test pad results still do not agree with the manufacturer’s recommended range,
discontinue patient testing and send the patient urine samples to the Clinical
Laboratory for processing.
Contact the Point of Care Department at 585-5247, 585-2849, pager 339-5487 to
report the problem, and to ensure proper corrective action is taken and documented.
Instrumentation:
The Clinitek STATUS analyzer’s display screen will display messages, instructions and
options, to which you respond by touching the appropriate area on the screen. The first
screen you encounter is the “Select” screen.
 The “Select” screen displays the status of the analyzer, and gives you the option to
select the testing that you desire. The only test that you can perform in your area is the
Dipstick “Strip Test”.
o From “Select” screen you are prompted with instructions on how to perform urine
dipstick testing.
Rev. 4
University Hospitals and Clinics
Salt Lake City, UT
CN-UR4008
Date: July, 2008
Page 5 of 14
Clinitek STATUS 


o Touch the “Strip Test” button to begin a urine test, which will move you to the
next screen; “Prepare Test”
The “Select” screen also allows you to observe the date and time and “Recall
Results”.
In some cases, the screen will also display instructions, messages or error messages.
(See section entitled Troubleshooting:)
Procedure:
The analyzer should remain “ON” and the screen will indicate that you are on the
“Select” menu page.
 If the analyzer has been turned off, turn the Clinitek analyzer “ON” using the
ON / OFF button, located on the front of the analyzer directly above the test table slot.
 The system will briefly perform a diagnostic check and proceed to the “Select” menu
page. (Ensure that the test table is clean, see Cleaning and Maintenance: )
 Wear gloves when handling urine and Kova control solutions.
Testing a Quality Control sample; KOVA Normal and Abnormal.
1. From the “Select” page, touch the “Strip Test” button; you are directed to the
“Operator ID” page.
2. Touch “Enter New Operator ID“.
 In the upper left hand corner, press the button labeled 123, and manually enter
your University ID Number. (exclude the proceeding “u”), touch “Enter”.
 If a mistake is made when entering your ID number, use the back arrow button,
(located in the upper right corner of the screen), to input your ID number
correctly.
3. Touch “Enter New patient”; type the name “KOVA”, and the level of control being
tested; Normal or Abnormal, touch “Enter”.
4. Touch “Enter Patient ID”, type the lot number of the control level you are testing;
touch “Enter”
5. Test each control sample as you would a patient sample. (refer to Testing a Patient
Sample)
Note: If at anytime you take too long to move to the next screen, the analyzer will
automatically default back to the “Select” menu page.
Testing a Patient Sample:
1. From the “Select” page, touch the “Strip Test” button, and you are directed to the
“Operator ID” screen.
2. Touch the “Enter New Operator ID“.
Rev. 4
University Hospitals and Clinics
Salt Lake City, UT
CN-UR4008
Date: July, 2008
Page 6 of 14
Clinitek STATUS 

In the upper left hand corner, press the button labeled 123, and manually enter
your University ID Number. (exclude the proceeding “u”), touch “Enter”.
 If a mistake is made when entering your ID number, use the back arrow button,
(located in the upper right corner of the screen), to input your ID number
correctly.
 The “Patient Information” screen will appear.
3. Touch “Enter New patient”.
 Type the patient’s last name and first name or last name and first initial, touch
“Enter”. You are directed to the “Enter Patient ID” screen.
 In the upper left hand corner, press the button labeled 123, and manually enter
the patient MRN, touch “Enter”.
4. The next screen displayed will be “Prepare Test”. At this point you MUST prepare
your supplies and urine sample prior to testing.
o Remove a dipstick from the urine container and immediately replace the lid on
the dipstick container.
o Have the freshly voided patient urine sample; properly labeled, and gently
mixed ready for testing. Remove the lid from the urine container.
o Lay out a paper towel for blotting excess urine from the dipstick.
5. Touch the large “START” button on the analyzer display screen and
IMMEDIATELY (within 8 seconds) complete the following 3 steps.
a) Dip the dipstick test strip into the urine sample, wetting all pads and quickly remove the
strip from the urine sample by dragging the edge of the strip against the side of the
sample container.
b) Blot the edge of the dipstick by touching the test strip on to the paper towel. (This will
remove the excess urine).
c) Place the dipstick in to the test table channel located on the analyzer; with the test pads
facing up. Slide the test strip to the end of the test table channel.
At the end of the 8 second timer, the test table and strip will automatically be pulled into
the analyzer.
NOTE:



Do not allow the test pads to lay flat on the paper towel after wetting with urine.
Do not push or pull the test table after the urine dipped test pad has been applied to
the test table.
Do not move or bump the table while the analyzer is calibrating.
Rev. 4
University Hospitals and Clinics
Salt Lake City, UT
CN-UR4008
Date: July, 2008
Page 7 of 14
Clinitek STATUS 
6. The timer will begin another count down indicating the time remaining to analyze the
dipstick results.
 While the strip is being analyzed, a “Select Appearance” screen will be
displayed.
 Observe the urine sample and choose the appropriate color and clarity.
o If the urine sample is yellow and clear, touch the “Yellow and Clear” button.
o If the urine is another color and clarity, touch the button labeled “Other”.
 The Other button will prompt you to select from a list of alternate colors.
 Press the “Next” button to select the appropriate clarity of the specimen.
7. After the color and clarity have been entered, the next screen displayed will either be
“Analyzing”, (if the strip is still being analyzed), “Print” results or “Results”; with the
results displayed on the analyzer screen. The results will automatically print to the
paper from the Clinitek analyzer.
8. Remove the used test strip from the test table and quickly examine the test pads for
any inconsistencies, such as pink spots on the nitrite pad instead of a solid pink color.
If any pad appears to be inconsistent with the results obtained from the printout, send
the urine sample to the Clinical Laboratory for confirmation.
9. Dispose of the strip according to your unit’s bio-hazard policy. Replace the lid on the
patient urine sample.
10. Wipe the test table with gauze dampened with warm water and dried after removing
the used dipstick. NEVER use Kleenex or Saniwipes.
11. Touch “Done” after the test has printed, and you will be returned to the main
“Select” menu page.
Note: the results will be displayed on the screen for 2 minutes. After this time, the display
will return to the“Select” menu page even if “Done” was not pressed.
Records and Retention:
1. Remove the printed results from the analyzer and remove the backing, leaving a
sticky label to be applied to the patient’s chart.
2. Attach the sticky label to a staff notes sheet, stamped with the patient’s information
and place the staff note sheet in the patient’s chart.
The printed label will include:
 Patient’s name and MRN.
 The type of test strip used,
 The date and time of testing,
 The operator ID; the employee that performed the test,
 The analyzer’s test sequence number,
 The color and clarity selected by the operator and
Rev. 4
University Hospitals and Clinics
Salt Lake City, UT
CN-UR4008
Date: July, 2008
Page 8 of 14
Clinitek STATUS 

The urine dipstick test results.
Reporting and Interpreting Results:



All patient and quality control information (results) MUST be maintained for a period
of 2 years according to Joint Commission Standards.
Patient test results from the analyzer MUST be placed in the patient’s chart.
Quality control (QC) results will be kept in a binder located in the area where testing
is being performed.
Reference (Normal) Ranges:
Glucose:
<15 mg/dL
Bilirubin:
Negative
Ketone:
< 2 mg/dL
Specific Gravity:
1.001 – 1.035
Blood:
3 RBC µL
pH:
4.6-8.0
Protein:
Less than 150 mg of total protein is excreted / day.
Urobilinogen:
1.0 mg/dL
Nitrite:
No nitrite detected
Leukocytes:
Negative

It is recommended that a positive bilirubin or protein result from the Clinitek
STATUS analyzer, (on a patient sample), be sent to the Clinical Laboratory for
confirmation testing if clinically indicated.
Transport the urine specimen to the Clinical Laboratory in the approved urine transport
tube. Light yellow Vacutainer laboratory tube; No additive
Procedural Notes:
 Do NOT test visibly bloody or unusually colored urine specimens on the Clinitek
STATUS in either the Emergency Department or Emergency Department Observation
Unit. Send the urine sample to the Clinical Laboratory for testing.
Transport the urine specimen to the Clinical Laboratory in the approved urine transport
tube. Light yellow Vacutainer laboratory tube; No additive


Work areas and specimen containers should always be free of detergents and other
contaminating substances (i.e. Bleach, Saniwipes..).
Before turning the analyzer off, always ensure that there is no strip on the test table,
and that the table and insert are clean. If a strip is left on the test table, the table will
not retract as required.
Rev. 4
University Hospitals and Clinics
Salt Lake City, UT
CN-UR4008
Date: July, 2008
Page 9 of 14
Clinitek STATUS 

Do not push on the touch screen with any hard or pointed objects; this could damage
the screen.
 Do not manually push or pull the test table fully into the analyzer as the test table may
become jammed and prevent the use of the analyzer.
 Do not move or bump the table while the instrument is calibrating.
 A total of 200 tests can be stored in the analyzer. The tests are listed in chronological
order. When the limit of 200 has been reached, the oldest test will be deleted from the
analyzer.
Note: deleted information cannot be retrieved from the analyzer.
 The strips should be read in good light; do not read in direct sunlight.
 Do not remove the strip from the bottle until immediately prior to use.
 Discoloration or darkening of the test pads may indicate deterioration. If this is
evident, or if test results are questionable or inconsistent with expected findings, the
following steps are recommended.
o Confirm that the dipsticks are within the expiration date shown on the label.
o Check the performance of the dipsticks against the KOVA; Normal and Abnormal
control product.
o Retest new dipsticks with the KOVA control product.
o If proper results are not obtained, discontinue patient testing and contact the Point
of Care Department at 585-5247, 585-2849, pager 339-5487.
Cleaning and Maintenance:
Daily: (see Addendum B for recording)
After testing ANY patient or quality control sample:
Wipe the test table with a gauze dampened with warm water; dry.
Clean the outside of the Clinitek STATUS analyzer:
 Turn off the analyzer by pressing the ON / OFF button for 2 seconds. Wipe the
outside (including the display) with a damp (not wet) cloth and a 10% solution of
bleach.
DO NOT:
 Spray glass cleaner directly onto the display screen.
 Use laboratory wipes, (such as Kimwipes or Kleenex) as they may scratch the
display screen
 Allow liquid to enter the printer compartment.
Rev. 4
University Hospitals and Clinics
Salt Lake City, UT
CN-UR4008
Date: July, 2008
Page 10 of 14
Clinitek STATUS 
MONTHLY: (see Addendum B for recording)
Cleaning of Test Table:
1. Remove the test table by pulling it slowly out of the analyzer. Lift the insert from the
test table; drain the drip tray if necessary.
2. Wet a cotton-tipped stick with water and carefully clean the test table; EXCEPT for
the white calibration bar.
3. Dry the test table thoroughly with gauze or lint-free tissue. DO NOT use Kleenex (Do
Not touch the white calibration bar),
4. Reinsert the test table into the analyzer by holding the table at the end opposite the
white calibration bar, with the white calibration bar facing upwards. Push the test
table firmly but slowly, just over halfway into the analyzer.
5. Replace the insert.
Checking the White Calibration Bar:
1. Remove the insert from the test table.
2. Remove the test table by pulling it slowly out of the analyzer.
3. Check the white calibration bar on the test table for dirt or discoloration.
o
If the white calibration bar is clean and unmarked, replace the table into the
analyzer by holding the table at the end opposite the white calibration bar, with
the calibration bar facing upwards. Push the test table firmly but slowly, just over
half way into the analyzer. Replace the test table insert.
o
If the white calibration bar is dirty or discolored, gently wipe and clean it with a
new cotton-tipped stick or lint-free cloth moistened with warm water.
Note: Do not use any solvents to the clean the bar.
4. Allow the calibration bar to air dry and then inspect the surface for dust, foreign
material, scratches or scuffs. If the calibration bar cannot be cleaned or is still marked,
obtain a new test table. This can be done by contacting the Point of Care Department
to order a new bar.
5. Discontinue testing and return the analyzer to the Point of Care Department until a
new bar is ordered, installed and tested.
Loading the analyzer printer paper:
1.
Open the printer cover by pulling up on the tab.
2.
Open the paper roll compartment cover by pressing down on the tab and pulling
out.
3.
Lift the paper holding arm into the open, upright position
Rev. 4
University Hospitals and Clinics
Salt Lake City, UT
CN-UR4008
Date: July, 2008
Page 11 of 14
Clinitek STATUS 
4.
5.
6.
7.
Place the new paper roll into the printer paper compartment with the paper
unrolling from underneath and toward the compartment wall.
Feed the paper up along wall and through the printer. Once you have
approximately 4 inches or paper through the printer then feed the edge of the
paper through the printer cover
Push the paper holding arm down in to the closed position.
Close the printer and paper roll covers by clicking them into position.
Troubleshooting:
Error messages: will be displayed on the analyzer screen to inform you when the
Clinitek Status needs your attention.
 Some of these errors messages will prevent the analyzer from being used at all, and
all selection areas on the screen will be disabled.
o
Discontinue patient testing and contact the Point of Care Department at 585-5247
to perform the proper corrective action and to re-enable the analyzer.
o
The Point of Care Department will rerun the KOVA control products to ensure
accurate results.
Advisory messages: errors of less importance will be presented on the Select screen
when that screen is next displayed.
 When you have taken the proper corrective action, the message will be removed
from the display.
 If more than one of this type of message occurs, clearing one message will enable the
next to be displayed in order of importance to a user.
Result Alert: If an error occurs during testing and the test cannot continue, you will be
presented with this message.
 Details of these errors will be shown on the Results Alert screen. You will be
provided with details of the error and show that the test has been cancelled.
 The test table will be extended so that the urinalysis strip can be removed.
 Discontinue patient testing and contact the Point of Care Department at 585-5247 to
perform the proper corrective action and to re-enable the analyzer.
Paper-out Icon: this will appear in the top of the title bar when the printer paper/label
roll needs replacing.
 An advisory message will be displayed on the main Select screen.
 Replace with a new paper or label roll as instructed. Print will be disabled and you
will be able to select Help to view instructions on replacing the printer paper.
Error Codes and Advisory Messages: A series of “E” codes may appear on the screen,
and will require corrective action before continuing with patient testing.
Contact the Point of Care Department; 585-5247 for a description of the error and the
appropriate action that needs to be taken.
Rev. 4
University Hospitals and Clinics
Salt Lake City, UT
CN-UR4008
Date: July, 2008
Page 12 of 14
Clinitek STATUS 
Instrument Validation:
All validation material can be located in the Point of Care Department.
Backup Procedure:
If for any reason you are not able to utilize the Clinitek STATUS analyzer, you MUST
send the patient urine sample to the Clinical Laboratory for testing.
Note: send the sample in the appropriate transport tubes.
Method Limitations:






The sensitivities listed for each reagent are the generally detectable levels of the
analytes in contrived urines; however, because of the inherent variability of clinical
urines, lesser concentrations may be detected under certain conditions. The percentage
of clinical specimens correctly detected as positive increases with analyte
concentration.
If a positive nitrite is obtained on a patient sample from the Clinitek analyzer, visually
look at the completed urine dipstick that was interpreted by the Clinitek analyzer and
determine if the nitrite test pad is solid pink or only has pink edges. If the pad only
has pink spots or pink edges, the test pad should not be interpreted as a positive result.
With a black pen, cross out the positive result with one single line, write “negative”
adjacent to the original result and initial.
Each instrumental result represents a range of values. Because of specimen and
reading variability, specimens with analyte concentrations that fall between nominal
levels may give results at either level. Results will usually be within one level of the
true concentration. Exact agreement between visual results and instrumental results
might not be found because of the inherent difference between the perception of the
human eye and the optical systems of the instruments.
Definitive diagnostic or therapeutic decisions should not be based on any single result
or method.
Substances that cause abnormal urine color may affect the readability of test pads on
urinalysis reagent strips. These substances include visible levels of blood or bilirubin
and drugs containing dyes (e.g. Pyridium, Azo Gantrisin, Azo Gantanol),
nitrofurantoin (Macrodantin, Furadantin), or riboflavin.
Use fresh urine to obtain optimal results especially with the tests for bilirubin and
urobilinogen, as these compounds are very unstable when exposed to room
temperature and light.
Rev. 4
University Hospitals and Clinics
Salt Lake City, UT
CN-UR4008
Date: July, 2008
Page 13 of 14
Clinitek STATUS 

Contamination of the urine specimen with skin cleansers containing chlorhexidine
may affect protein (and to a lesser extent specific gravity and bilirubin) test results.
Protein Test Pad:
 Urinary protein excretions can be temporarily elevated in the absence of renal
abnormality by strenuous exercise, orthostatic proteinuria, dehydration, urinary tract
infections, and acute illness with fever. Clinical judgment is needed to evaluate the
significance of “trace” results.
 Visibly bloody urine sample may cause elevated protein results.
Blood Test Pad:
 Certain oxidizing contaminants, such as hypochlorite, (bleach) may produce false
positive blood results.
 Microbial peroxidase associated with urinary tract infections may cause a false
positive blood reaction.
 The test is equally sensitive to myoglobin as to hemoglobin.
Leukocyte Test Pad:
 Elevated glucose concentrations (> 3g/dL) may cause a decreased leukocyte test
result.
 The presence of cephalexin (Keflex), Cephalotin (Keflin), or high concentrations of
oxalic acid may also cause a decreased leukocyte test result.
 Tetracycline may cause decreased reactivity, and high levels of the drug may cause a
false negative leukocyte reaction.
 Positive leukocyte test results may occasionally be due to contamination of the
specimen by vaginal discharge.
Nitrite Test Pad:
 Pink spots or pink edges on the nitrite test pad should not be interpreted as a positive
result.
 Nitrite concentration during infection increases with the length of time the urine
specimen is retained in the bladder prior to collection. A minimum of four hours of
bladder incubation significantly increases the likelihood of obtaining a positive result.
 A false negative nitrite result may occur with shortened bladder incubation of the
urine, absence of dietary nitrate, or the present of nonreductive pathological microbes.
Ketone Test Pad:
 False trace results may occur with highly pigmented urine specimens.
Rev. 4
University Hospitals and Clinics
Salt Lake City, UT
CN-UR4008
Date: July, 2008
Page 14 of 14
Clinitek STATUS 

Clinical judgment is needed to determine the significance of “trace” results, which
may occur during physiological stress conditions such as fasting, pregnancy and
frequent strenuous exercise.
pH Test Pad:
 Bacterial growth in a urine specimen by certain organisms may cause a marked
alkaline shift in the pH (ph > 8.0) because of urea conversion to ammonia.
Specific Gravity Test Pad:
 Test strips read instrumentally are automatically adjusted for pH by the instrument.
 Highly buffered alkaline urines may cause low readings, while the presence of
moderate quantities of protein may cause elevated readings for the specific gravity.
Bilirubin Test Pad:
 Normal adult urine contains about 0.02 mg/dL of bilirubin, which is not detectable by
even the most sensitive methods. Even trace amounts of bilirubin are sufficiently
abnormal to require further investigation. When very small amounts of bilirubin in
urine are sought, confirmation testing is recommended.
 Atypical colors (colors that are unlike the negative or positive color blocks shown on
the color chart) may indicate that bilirubin-derived bile pigments are present in the
urine sample and may be masking the bilirubin reaction. These colors may indicate
bile pigment abnormalities and the urine specimen should have confirmation testing
performed.
References:
Clinitek STATUS Analyzer Operator’s Manual, Rev. D, 06/2006.
Multistix Reagent Strip Manufacturer’s insert, Rev. 11/05, Bayer Health Care.
KOVA Liqua-Trol Urinalysis Control Manufacturer’s insert, 10/2006, HYCOR.
ARUP Laboratories Procedure “Urinalysis CL-UR4006, Rev. 7, May 2007
Rev. 4
CN-UR4008
Date: July, 2008
University Hospitals and Clinics
Salt Lake City, UT
Clinitek STATUS 
APPROVED BY:
DATE APPROVED:
TECHNICAL SUPERVISOR APPROVAL:
GROUP MANAGER APPROVAL:
DATE ADOPTED:
RETIRED:
REPLACES: Rev 3
Copy #
Location
1
2
Master SOP Manual
Detailed list of Units utilizing this procedure may be obtained through the Point of Care
Department; ARUP / University of Utah Hospitals 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
Rev. 4
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