Page 1 of 9
Title: Clinitek Status ® Urine Dip Strip Test
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3040
Date Issued: July 2008
Clinitek Status®
Purpose
This is a Point of Care Test (POC) and falls under the Ministry of Health and Long-Term Care Testing
Policy for Hospitals and Other Facilities. This policy states, “Under current legislation, only
physicians can authorize point of care testing. In these circumstances, the ordering physician
must take responsibility for the tests performance and the test results produced.” Physicians
can either perform the test themselves or have a properly trained Registered Nurse perform the test in
accordance with the following procedure.
Principle
The Clinitek Status® is a semi-automated Urine Analyzer, configured to read the Multistix 10SG
Reagent strips for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein,
urobilinogen, nitrite, and leukocytes in urine. SG is determined by the apparent pKa change of certain
pretreated polyelectrolytes in relation to ionic concentration as shown by colour indicators. This
instrument may also be used for reading Clinitest ® immunoassay cassettes.
Specimen
Type:
 Random, midstream urine (MSU), catheter, or cystoscopic.
 12ml optimum volume – several drops minimum volume.
 Urines optimally should be run within two hours of collection, or stored at 2-8ºC.
 Bring to room temperature and mix well before assaying
 If sample is highly coloured, bloody or mucoid, do not test. Order a Urine Routine
“URM” and send to BGH for testing
Equipment and Materials
Equipment:
 Clinitek Status®
Materials:
 Bayer Urinalysis Reagent Strips – Multistix 10SG (Bayer #2300A)
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 2 of 9
Title: Clinitek Status ® Urine Dip Strip Test
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3040
Date Issued: July 2008
Preparation:
 Multistix 10SG Strips come ready to use.
 Recap bottles tightly immediately after removing strips to prevent exposure to light, heat, and
moisture.
Storage Requirements:
 Multistix 10SG Strips are to be stored at room temperature sealed.
 Strips are stable to expiry date on bottles.
 Do not refrigerate or freeze.
Performance Parameters:
 Glucose
Bilirubin
Ketones
Specific Gravity
Blood
pH
Protein
Urobilinogen
Nitrites
Leukocytes
4-7 mmol/L
specific for bilirubin
1 mmol/L
1.000 – 1.030
specific for Hemoglobin and Myoglobin
range of 5 – 8.5
sensitive to trace=0.18 – 0.25 g/L albumin
sensitive to 3 umol/L
specific for nitrite positive bacteria
5 –15 cells/uL
Calibration
 The instrument has a white calibration bar, located on the test table, and performs a calibration
automatically each time the instrument is turned on and each time a test is run.
Quality Control
 Positive: Clinitek Status Control (Chek-Stix Positive)
Mneumonic STATUSPOS
Negative: 5% Sodium Chloride (In House)
Mnuemonic STATUSNEG
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 3 of 9
Title: Clinitek Status ® Urine Dip Strip Test
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3040
Date Issued: July 2008
- Positive and Negative controls will be sent to Willett Urgent Care by Integrated
Laboratory staff as required from Brantford General.
- Make fresh positive QC. Label 14-16 urine tubes for each QC and aliquot
approximately 1-2 ml of each QC into tubes. Store frozen if not shipping the same
day.
- Once arrived at Willett, store frozen at or below –18 degrees C
- Thaw, warm to room temperature and mix before testing
 A Positive and Negative quality control specimen must be run at least once a day by a trained
Operator or the analyzer will not allow testing to proceed.
To perform a QC Strip test when due, perform the following steps;
1. At the Select Ready screen, select QC Test Strip due. (The QC Test screen displays)
2. Select QC Strip Test Required. (The Control Lot screen displays)
3. Enter the control lot. Use the alpha keyboard to enter text, to enter numeric text, select 123
4. Select Enter. (The Control Expiration screen displays)
5. Use the arrow keys to indicate the control lot expiration date.
6. Select Enter (The Strip Lot screen displays)
7. Use the alpha keyboard to enter text, to enter numeric text, select 123
8. Select Enter (The Prepare Test screen displays)
9. Select Start
10. Run the test
11. Select Print to print results

QC results are to be entered into the LIS and must fall within the acceptable
ranges before accepting patient results
 QC data will be monitored by a Laboratory Technical Specialist
 On-line retention time for QC is 2 years.
Procedure
1.
Press the instrument "On” (Φ) button. The system will automatically perform a quick
system diagnostic test.
2.
Confirm if QC is due. If QC is due follow the procedure under Quality Control
3.
On the Select screen press Strip Test.
4.
On the Operator ID screen select Use Last Operator or Enter New Operator ID. Key in
the number from the front of the operator’s BCHS badge. Press Enter ⇨.
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 4 of 9
Title: Clinitek Status ® Urine Dip Strip Test
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3040
Date Issued: July 2008
5.
Note: If a number gets keyed incorrectly use the  button to erase the number or letter
and retype. The ⇦ Back key can also be pressed to return to the previous screen.
6.
Press Enter Patient ID. Verify the patient’s name to be tested and the urine is correctly
labeled.
7.
Scan the Patient Barcode using the barcode scanner and press Enter ⇨ when done. If
running a second test on the same patient, the Recall Patient button can be pressed.
Use the up ⇧and down ⇩arrow buttons to scroll through the list of patients; the most
recent testing will be at the top. Once the patient is highlighted, touch the Select button.
8.
At the Enter Strip Lot# Screen Select Use Last Lot or enter new strip data, select Enter
new lot and expiration.
9.
Use the alpha keyboard to enter text, to enter numeric text, select 123
10. On the Prepare Test screen, make sure the test table insert has the reagent strip holder
facing upward, set up to receive the sample strip. When the test strip and urine sample
are ready touch Start to begin. There are 8 seconds allowed to dip and process the
reagent strip, instructions following.
9. Remove one strip from the reagent bottle and immediately re-cap the bottle.
10 Briefly immerse the whole reagent strip into the well-mixed urine specimen, wetting all the
pads. Run the edge of the strip along the rim of the container to remove excess urine.
If running Quality Control, pipette QC sample onto the urine strip, wetting all the pads
11. Place the reagent strip in the channel of the table with the test pads facing up. Slide the
strip to end of the channel. Note: Do not push or pull the test table. The timer will count
down the time remaining in analyzing the strip.
12. While the strip is being analyzed, a Select Appearance screen will be displayed. The
urine sample must be visually observed and then the appropriate colour and clarity must
be selected. If the urine sample is yellow and clear, touch the Yellow and Clear button.
If the urine sample is not yellow and clear, touch the Other button for more choices.
Select the appropriate colour by touching the circle button that corresponds to the correct
description. Select the clarity by touching the circle that corresponds to the correct
description. Touch Next.
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 5 of 9
Title: Clinitek Status ® Urine Dip Strip Test
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3040
Date Issued: July 2008
13. When testing is complete, the results will print out. If the results are positive, an asterisk*
will appear next to the results.
14. If test results are positive for WBC, blood, nitrites or protein, order a Urine Routine
“URM” and send urine to BGH for testing
Reporting Results
Reference Interval:
GLU
BIL
KET
SG
BLD
Ph
PRO
UBG
NIT
LEU
Negative
Negative
Negative
1.003 – 1.030
Negative for blood.
Normal 5.0-7.0
Negative - Trace for protein.
3.2 µmol/L
Negative
<15 cells/µL
Procedure for Abnormal Results:
 If test results are positive for WBC, blood, nitrites or protein, sent to Brantford General
Lab for testing
Reporting Format:
 GLU To one decimal place in mmol/L.
BIL
Negative, small, moderate or large.
KET To one decimal place in mmol/L.
SG
To three decimal places.
BLD Negative, trace, small, moderate, and large.
Ph
To one decimal place.
PRO To one decimal place in g/L.
UBG 3.2 –17 µmol/L
NIT
Negative or Positive.
LEU Negative, 15 cells/µL, 70 cells/µL, 125 cells/µL and 500 cells/µL.
Interpretation:

Urinalysis is performed as a routine health screen, in the evaluation of patients with suspected
renal dysfunction, urinary tract disease, diabetes, prenatal evaluation, etc.
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 6 of 9
Title: Clinitek Status ® Urine Dip Strip Test
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3040
Date Issued: July 2008
Procedure Notes
 A microscopic examination of a urine specimen should be performed on routine urinalysis if one
or more of the NITRITE, PROTEIN, BLOOD, or LEUKOCYTES tests are abnormal and the
sample is < 4 hours old.
 If a culture/sensitivity is required, aseptically pour off urine into another labeled urine container
for urine dip
Limitations of the Procedure
 There must be sufficient urine specimen to adequately moisten each reagent pad on the
Multistix 10SG strip.
 Highly coloured urines may interfere with testing. Do not test on the STATUS. Send to BGH
for testing
 Crystaluria will not be detected by routine urine testing; a microscopic examination is necessary.
Maintenance
 Daily: Remove the test table insert and thoroughly clean. Rinse both sides of the table insert
under running water. Dry and replace insert on the test table. Run QC
 Weekly: Remove the test table by pulling it slowly out of the analyzer. Lift the test table insert
from the test table, drain the drip tray if necessary. Wipe down the test table with
a GLUCO-CHLOR pads being careful NOT to touch the white calibration bar. Repeat
cleaning procedure with a cotton swab moistened with water and dry thoroughly with a
soft cloth or lint free tissue, again not touching the white calibration strip. 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. Replace the test table insert. Run QC
 White Calibration Bar: Remove the test table by pulling it slowly out of the analyzer. Check the
white calibration bar on the test table for dirt or discolouration. If the white calibration bar
is clean and unmarked, replace 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. If the white
calibration bar is dirty or discoloured, gently wipe and clean it with a new cotton swab or
lint-free cloth dampened with distilled water. Allow the calibration bar to air dry and
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 7 of 9
Title: Clinitek Status ® Urine Dip Strip Test
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3040
Date Issued: July 2008
inspect again for dust, scratches or foreign material. If the bar cannot be cleaned or is
still marked, obtain a new test table. Reinsert the test table as described above. Run QC
 Analyzer: Turn the analyzer off by pressing the on/off button for 2 seconds. Wipe the outside,
including the display, with a damp (NOT wet) cloth.
 Replacing the Paper Roll:
- A paper-out icon appears 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.
- Instructions are found on the inside of the printer paper compartment cover, or to view
instructions on the display touch the Error Report selection area, or follow the
instructions listed below.
To replace:
Open the printer cover by pulling up on the tab.
Open the paper roll compartment cover by pressing down on its tab and pulling out.
Lift the paper holding arm into the open, upright position.
Place the new paper roll into the printer paper compartment with the paper unrolling from
underneath and toward the compartment wall.
5) Feed the paper up along wall and through the printer. Once there are approximately 4”
of paper through the printer then feed the edge of the paper through the printer cover.
6) Push the paper holding arm down in to the closed position.
7) Close the printer and paper roll covers by clicking them into position.
1)
2)
3)
4)
Troubleshooting

There are four type of Error messages:
I.
Disable Errors: Errors may occur which disable the instrument until corrected. All
selection areas on the screen will be disabled.
II.
Other errors: Sample testing may be affected but other instrument functions are
available.
III.
Advisory Messages: Errors of less importance will be displayed on the Select screen.
When corrective action has been taken, the message will be removed from the
display. If more than one message is present, clearing the first message will enable
the second message to be displayed.
IV.
Results Alert: If an error occurs during testing and the test cannot continue because
of the error, the message will appear on the Results Alert screen. The test will be
cancelled and the test table will be extended so that the urinalysis strip can be
removed.
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 8 of 9
Title: Clinitek Status ® Urine Dip Strip Test
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3040
Date Issued: July 2008
Common Errors:


Paper Out: refer to Maintenance Section, Replacing the Paper.
Common Error Codes: refer to following table
Error Code
E10 or e48
Description
Loss of test results
E11
Failure of test table.
E24
No printer paper.
E25, E64 or
E65`
Failure of automatic
calibration.
E27
Set up failure.
E28
Printer error.
E57
E59
E60
E63
Missing strip
Inverted strip
Tilted strip
Failure to find end of
strip
- positioned on the
test table.
Dry strip.
positioned on the test
E61
Action
1. Switch the instrument off by pressing the on/off
button for 2 seconds.
2. 2. Switch the instrument on again by pressing the
on/off button.
3. 3. Repeat the test.
1. Make sure that the test table is in place. Move the
test table in or out of the instrument slightly to
reposition the test table.
2. If the error remains, with the instrument powered
on, unplug the power cord from rear of the
instrument and plug back in. Turn instrument on
by pressing the gray power button.
3. If the error remains with the test table in place, call
the Core Lab Technical Specialist.
Replace the printer paper. Refer to instructions
above.
Clean the calibration strip, refer to method above. If
the error remains after cleaning, contact the Core Lab
Technical Specialist.
1.Switch the instrument off by pressing the on/off
button for 2 seconds.
2. Switch the instrument on again by pressing the
on/off button.
Lift the printer cover and push the paper holding arm
back into position. Refer also to replacing printer
paper method above.
Repeat the test ensuring that the strip is positioned on
the test table.
Repeat the test ensuring that the strip is in contact
with the sample.
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 9 of 9
Title: Clinitek Status ® Urine Dip Strip Test
Manual: Point of Care Testing Section: Laboratory
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3040
Date Issued: July 2008
table.
E02, E12,
E20, E62 or
any codes
for
computer
software
failure
Contact the Core Lab Technical Specialist.
References
 Clinitek Status® Operator’s Manual
 Siemens Multistix 10SG Package Insert
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled