Standard Operating Procedure

Subject Urinalysis – Clinitek Status and Visual

Index Number Lab-1583
Section Laboratory
Subsection Regional Clinic / Affiliate Hospital Laboratories
Category Departmental
Contact Darcy Goplin
Last Revised 4/8/2019

References
Required document for Laboratory Accreditation by the College of American Pathologists (CAP), Centers
for Medicare and Medicaid Services (CMS) and/or COLA.

Applicable To
Employees of GLMC clinical laboratories, St. Joseph’s Health Services laboratories, Gundersen Tri-County
Hospital laboratories, Gundersen Boscobel Area Hospital Laboratories and Gundersen Palmer Lutheran
Hospital and Clinic laboratories.

Detail
PRINCIPLE:
Routine urinalysis consists of color, clarity specific gravity and a chemical examination including pH,
albumin, glucose, ketones, bile, leukocyte esterase, nitrite, and blood. Microscopic examination, if
indicated, includes cell identification, casts, crystals, bacteria, and miscellaneous.

Reagent Strip Test Principles

Bayer Multistix 10-SG Reagent Strips contain reagent areas for testing glucose, bilirubin, ketone, specific
gravity, blood, pH, protein, urobilinogen, nitrite and leukocytes. Test results may provide information
regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and
urinary tract infection.

Individual test principles follow:

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.

Bilirubin: This test is based on the coupling of bilirubin with diazotized dichloroaniline in a strongly acid
medium. The color ranges through various shades of tan.

Ketone: This test is based on the development of colors ranging from buff-pink, for a negative reading,
to purple when acetoacetic acid reacts with nitroprusside.

Specific Gravity: This test is based on the apparent pKa (acid) change of certain pretreated
polyelectrolytes in relation to ionic concentration. In the presence of an indicator, colors range from
deep blue-green in the urine of low ionic concentration through green and yellow-green in urine of
increasing ionic concentration.

Page 1 of 17
 Standard Operating Procedure

Blood: This test is based on the peroxidase-like activity of hemoglobin, which catalyzes the reaction to
diisopropylbenzene and 3,3’, 5,5’-tetramethylbenzidine. The resulting color ranges from orange through
green; very high levels of blood may cause the color development to continue to blue.

pH: This test is based on a double indicator principle that gives a broad range of colors covering the
entire urinary pH range. Colors range from orange through yellow and green to blue.

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 to green to green-blue for "positive" reactions.

Urobilinogen: DO NOT REPORT!

Nitrite: This test depends upon the conversion of nitrate (derived from the diet) to nitrite by the action
of gram negative bacteria in the urine. At the acid pH of the reagent area, nitrite in the urine reacts with
p-arsanilic acid to form a diazonium compound. This diazonium compound in turn couples with 1,2,3,4-
tetrahydrobenzo(h)quinolin-3-ol to produce pink color.

Leukocytes: Granulocytic leukocytes contain esterase that catalyze the hydrolysis of the derivatized
pyrrole amino acid ester to liberate 3-hydrozy-5-phenyl pyrrole. This pyrrole then reacts with a
diazonium salt to produce a purple product.

Instrument Principles:
The CLINITEK STATUS Urine Chemistry Analyzer is a semi-automated, bench top instrument designed to
"read" MULTISTIX 10-SG Reagent Strips for urinalysis. This instrument is a reflectance
spectrophotometer that analyzes the intensity and color of the light reflected from the reagent pad area
and prints the results in clinical units. No calculations are required.

CLINICAL SIGNIFICANCE:
The urinalysis is a composite examination that is usually carried out with a single specimen of urine
performed and recorded in a systematic sequence. This examination offers many invaluable clues in the
detection, differential diagnosis and evaluation of urinary tract disorders, especially in the areas of
metabolic and renal disorders.

Glucose: Glycosuria occurs when the blood glucose levels exceed the reabsorption capacity of the renal
tubles. The condition may be a benign condition, renal glycosuria, occurring after ingestion of a
carbohydrate ladened meal or in conjunction with emotional stress; or a pathological condition,
diabetes mellitus, occurring from a marked elevation of the blood glucose and insulin resistance or by
impaired insulin production.

Bilirubin: Bilirubin in the urine is indicative of the presence of hepatocellular disease or intra - or
extrahepatic biliary obstruction.

Ketone: Ketones occurs in the urine when the body metabolizes increasing amounts of fatty acids found
in conditions of impaired or restricted carbohydrate metabolism. These conditions include diabetes

Page 2 of 17
 Standard Operating Procedure

mellitus (ketoacidosis), fever, anorexia, fasting, starvation, vomiting, pernicious vomiting of pregnancy,
and cachexia.

Specific Gravity: Specific gravity measures the concentrating and diluting abilities of the kidney. Low
specific gravity can occur in patients with diabetes insipidus, glomerular nephritis, pyelonephritis and
various renal abnormalities where the kidney has lost the ability to concentrate the urine. High specific
gravity can occur in patients with adrenal insufficiency, hepatic disease, congestive heart failure, fever,
vomiting and diarrhea.

Blood: Occult blood occurs in the urine as intact RBCs and hemoglobin which can occur during
urological, nephrological and bleeding disorders. Blood is often found in the urine of menstruating
females.

pH: Urine pH is a general indicator of the acid-base balance of the body controlled in part by the kidney.
Certain dietary conditions can produce acid or alkaline urines, which can be useful in the treatment of
some calculi.

Protein: Protein in the urine can be the result of urological and nephrological disorders, glomerular or
tubular abnormalities and temporarily elevated in the absence of renal abnormality by strenuous
exercise, orthostatic proteinuria, dehydration, urinary tract infections and acute illness with fever.

Urobilinogen: Do Not Report!

Nitrite: Many enteric gram-negative microorganisms possess the characteristic of conversion of dietary
nitrates to nitrite and yield a positive nitrite when given adequate bladder incubation. Significant
bacteriuria is probable with a positive nitrite result, but not ruled out with a negative nitrate result.

Leukocytes: An increase in leukocytes is an indication of pyuria found in nearly all diseases / infections of
the kidney and urinary tract.

SPECIMEN:
Patient Identification occurs by verbal verification of the patient's name and birthdate (outpatient
setting), or the verification of the patient’s name and MRN/clinic number found on the patient’s ID
armband (inpatient setting). Refer to Lab-1330 Patient Identification Including Blood Bank ID
Requirements for procedural guidelines.

Patient Preparation: N/A

Type/Amount:
1 - 15 cc of clean voided, catheterized, or random urine (first voided morning specimen is the most
concentrated) in a labeled container. The minimum specimen volume is 1.0 cc. Turbid specimens
containing amorphous urates should be heated under hot tap water to dissolve crystals. Specimen
should be refrigerated at 2-8oC, if it is not run immediately. Urines should ideally be tested within 30
minutes, but up to two hours at room temp is acceptable. Urines stored in the refrigerator may be
tested up to 24 hours after collection or within 72 hours in a Vacuette preservative tube. Any
refrigerated or cold specimen must be allowed to return to room temperature and be mixed well before

Page 3 of 17
 Standard Operating Procedure

testing. An aliquot should be saved for 48 hours for additional testing as needed in other areas in the
lab.

Unacceptable specimens:
1. Unlabeled specimens
2. Specimens kept at room temperature for more than 2 hours
3. Fecal contamination

Refrigerated specimens greater than 24 hours old, or greater than 72 hours old in a preservative tube.

Urine collection Vacuette Tube and Transfer Device

1. Collect urine specimen according to specimen collection procedure.
2. Place the "straw" end of the transfer device into the urine in the collection cup.
3. Insert vacuette tube into large yellow end of transfer device.
4. Push Vacuette tube to the end of transfer device.
5. The correct amount of urine will transfer to the tube automatically.
6. Label tube with collection information.
7. Refrigerate filled Vacuette.
8. Save and refrigerate an aliquot for 48 hours.
9. Discard transfer device in sharps container.

REAGENTS / MATERIALS:
Multistix 10-SG, Bayer
Greiner tube vacuette #455003
Centrifuge tubes, (Tubes have a 0.4 ml retention volume after decanting.)
Plain glass slides
Plastic pipettes
Coverslips, 22x22
Store all reagents at room temperature.

EQUIPMENT/INSTRUMENTATION:
Clinitek Status
Fixed head centrifuge
Microscope - Phase contrast or bright field.

The Clinitek Status is a bench top semi-automated urine chemistry analyzers. Designed to read Multistix
10-SG reagent strips for urinalysis. The Clinitek Status is a reflectance spectrophotometer that analyzes
the color and the intensity of the light that is reflected from the reagent area. The results are then
printed in clinical units and reported. No calculations are required.

Calibration:
Clinitek Status - Calibration is performed automatically each time a reagent strip is analyzed.

Maintenance:
The instrument must be kept clean to provide accurate test results and to operate properly. Operators
must initial the daily log sheet to document maintenance. For daily cleaning and maintenance see

Page 4 of 17
 Standard Operating Procedure

Clinitek Status manual section 9. See the manual for any questions concerning the operation of the
instrument. Fixed head centrifuge - Clean weekly, remove tube holders, wipe the holders and the
centrifuge shell with appropriate disinfectant. Refer to Lab-0105 Safety: Biological if breakage occurs.
Microscope-Phase contrast, phase alignment should be performed and documented weekly.

General cleaning
Keep the exterior free of dust by periodically wiping the exterior using a damp cloth and mild detergent.
The display screen may be cleaned using a soft, non-abrasive cloth. (Do not use Kimwipes.) Do not spray
with glass cleaner.

Clinitek Status Daily Cleaning

1. Remove the test table strip pulling table straight out of instrument.
2. Clean the feed table and insert with a cotton- tipped swab that has been dampened with
distilled water. Caution: Do not touch or scratch the white calibration bar/chip.
3. Inspect the white calibration bar for scratches, foreign material or dust. If visibly dirty, clean
with a new swab that has been dampened in distilled water. Dry the table thoroughly (except
for the calibration bar) with a soft cloth, allowing the calibration bar to air dry.
4. Gently reinsert the feed table about halfway.

Clinitek Status Disinfection

1. Perform daily cleaning procedure.
2. Prepare 0.05% hypochlorite solution using Clorox bleach. Place 1 ml bleach into 99 mls water.
3. Fill an empty Multistix container to a depth of 4" with cleaning solution.
4. Immerse the test table insert or the test table into the solution making sure that the white
calibration bar/chip remains above the liquid if inserting the test table.
5. Soak for a minimum of two minutes or a maximum of 10 minutes.
6. Rinse thoroughly with distilled water.
7. Dry the table thoroughly (except for the calibration bar) with a soft cloth, allowing the
calibration bar to air dry.
8. Re-insert half way into analyzer.

Weekly Clinitek Date and Time Check

Weekly check the date and time on the Clinitek Status to ensure that it's one minute behind the date
and time on the Gundersen Health network computer in the lower right hand corner of the computer
screen.
1. Press the Instrument Setup Pad
2. Arrow to Date and Time
3. Press Select
4. Adjust the date and time as needed by using the arrow keys
5. Press Set
6. Press Done

QUALITY CONTROL:
BioRad quantify Levels 1 and 2 urinalysis controls for qualitative and semi-quantitative procedures. It is a
stable control material made from human urine. Analyte levels are adjusted with various pure chemicals
and preparations of erythrocytes, human leukocytes and hCG (Levels 1 and 2 only) from human source

Page 5 of 17
 Standard Operating Procedure

material and simulated leukocytes. Available from Microgenics Corporation, Fremont, California or from
Bio Rad Laboratories Hercules, California.

Storage and stability

Store vials at 2-8oC. Unopened bottles are stable until the expiration date of the label.

Preparation/Procedure
Regional and affiliate laboratories performing urine microscopics:
120 ml bottles are mixed by gentle inversion and 12, 5 ml aliquots are poured off without allowing the
primary bottle to warm to room temp. Once opened, an aliquot is stable for 30 days at 2-8oC.

Regional and affiliate laboratories performing urine macroscopics only:

12 ml bottles must be mixed prior to use and opened bottles may be stored at 2-8oC. Unopened bottles
are good until the expiration date on the bottle when stored in the refrigerator. Once opened, this
product will be stable for 31 days when stored tightly capped at 2-8oC.

Procedure for both Non-waived and Waived testing labs

1. Allow aliquot or bottle to warm to room temp (approximately 1/2 hour). Thoroughly mix the
contents of the aliquot or bottle before testing.
2. Print the QC label from the LIS. QC aliquot is tested the same as a patient and results are
documented in lab LIS system.
3. Perform macroscopic and microscopic on both levels (micros in non-waived labs only).
4. QC is run and documented every 24 hrs in the LIS.
5. QC should be reviewed monthly by supervisor or technical leader.
6. Every new lot or shipment of Multistix must have QC performed and documented before
patients are tested. Record lot, opened date and expiration date in LIS. Write the opened date
on the bottle.
7. If new lot fails QC, in LIS the failed component is marked as rejected and repeat is requested and
QC is retested. If still unacceptable, open a new bottle and test. If QC fails on the new bottle,
then new lot is rejected.

QC limits are established with each new lot of controls. Controls are run in parallel for a minimum of 20
data points from which new limits are established.

QC is performed every day on which patient testing occurs, upon opening a new bottle of strips or
whenever patient results are questioned.

QC is recorded in LIS. QC is reviewed monthly by a lab supervisor or technical leader.

Implementation
Clinitek Status Start-Up
1. The main menu will display date, time, and four options including Instrument set up, Recall
Results, Cassette Test and Strip Test.
2. Press Test Strip and note that the screen indicates use of Multistix 10 SG.
3. Select new Patient and scan QC barcode.
4. The prepare test screen appears indicating that the analyzer is ready to accept the strip.

Page 6 of 17
 Standard Operating Procedure

5. Run QC.

Clinitek Status Routine Operation

Testing should be performed on fresh urine or urine in a preservative tube. If urine has been
refrigerated, allow to warm to room temperature 18 - 28oC. All urines should be tested as soon as they
arrive and should not be routinely placed in the refrigerator.

Note: Only Multistix 10 SG should be used for strip testing. Use of any other strip will cause erroneous
results.
1. Press strip Test.
2. Scan patient’s UA label.
3. Press the Start button (make sure that you have your strip out, urine uncovered and paper towel
ready) you will now have 8 seconds to prepare and load your sample.
4. While avoiding the ID band, completely immerse all reagent areas of the Multistix 10 SG reagent
strip in fresh well mixed urine. While removing, run the edge of the strip against the side of the
urine container to remove the excess urine. Edge blot the strip by touching the edge of the strip
to the paper towel to remove excess urine. Note: do not drag the strip across the paper towel
or lay the pads on the paper towel.
5. Place strip on test table with the reagent areas up. Urine strip will automatically be pulled into
instrument. Once the strip has been pulled into the analyzer the Clinitek will automatically
calibrate followed by analysis.
6. Select urine color (press next) and clarity (press next).
7. Results will appear on screen for two minutes. Results will not print or be displayed until after
the color and clarity have been entered.
8. Touch "Done" to complete the test and return to the main select screen.
9. Discard Multistix strip after each test is completed. Wipe feed table with a water dampened kim
wipe.

Note: If you need to re-dip your specimen to check a parameter, reject the parameter in LIS, request
repeat, and re-dip before verifying the results.

Visual Method
Testing should be performed on fresh urine or urine from a preservative tube. If urine has been
refrigerated, allow to warm to room temperature 18 - 28oC. All urines should be tested as soon as they
arrive and should not be routinely placed in the refrigerator.
1. Mix urine well before testing.
2. Remove strip from the bottle and replace the cap. Do not touch test areas. Completely immerse
Multistix 10 SG reagent strip in the urine. Remove immediately running the edge of the strip
along the rim of the urine container. Edge blot the strip by touching the edge of the strip to the
paper towel to remove excess urine. Note: do not drag the strip across the paper towel or lay
the pads on the paper towel. Hold strip in a horizontal position to reduce running of reagents.
3. Test timing begins when the testing areas on the strip become wet with urine.
4. Hold the strip close to the chart and carefully match the color on the strip to that on the chart at
the appropriate time.

Page 7 of 17
 Standard Operating Procedure

5. Proper read time is crucial for optimal results. Protein and pH may be read at any time up to two
minutes after immersion into urine. Read glucose at 30 sec, bilirubin at 30 sec, ketones at 40
sec, specific gravity at 45 sec, blood and nitrite tests at 60 sec and leukocytes at 2 minutes.
DO NOT REPORT THE UROBILINOGEN TEST RESULT.
6. Color changes that occur after two minutes are not to be reported.
7. Report all results following uniform reporting guidelines established under the interpretation
guidelines.

PROCEDURE NOTES:
Troubleshooting
Common reasons for strip rejection by the instrument include:
1. Reagent strip improperly positioned on table.
2. Reagent strip is missing a test pad.
3. Wrong LIS barcode label scanned.
For instrument error codes please see troubleshooting for Clinitek Status section 7-1 - 7-9.

Computer Downtime
During a computer downtime, continue to dip urine samples on the Clinitek Status. When the computer
comes back up, go to the Main Menu on the Status, select "Recall Results" and then select "Send All
Data".

CALCULATIONS: N/A

INTERPRETATION:
Color:
The color of urine is affected by many components (concentration, food pigments, dyes, blood or
various pathological conditions). The intensity of the color of normal urine is dependent on the
concentration of the urine. Yellow or amber color is due to the presence of a pigment called urochrome.

Substances that cause abnormal urine color affect the readability of the test strip. These substances
include visible levels of blood or bilirubin and drugs containing dyes [e.g., Pyridium, Azo Gantrisin, Azo
Gantanol, nitrofuranatin (Macrodantin or Furadantin)], and riboflavin. Defer these specimens to the
laboratory for complete urinalysis.

Reporting choices:
Colorless
Yellow (defined as all shades - straw to dark yellow urines)
Amber (Yellow-Brown color). Choose "other" on the Clinitek Status.
Green ( Methylene Blue)
Orange (Uristat), order a urine microscopic. If tested on the Clinitest Status, the individual tests will be
resulted as CANCEL with the comment "Not reported due to interfering substances."
Red (Blood)
Brown (Aged blood)

Limitations:

Page 8 of 17
 Standard Operating Procedure

Variations from the normal shades of yellow may be due to drugs containing azo dyes, abnormal
metabolic functions, excessive physical activity, ingested materials or foods (B vitamins), or pathologic
conditions. Abnormally colored or very dark urine may interfere or obscure reagent strip results. If such
a specimen is submitted, results should not be reported and an explanation given on the report form.
If urine is orange, the tech should cancel the macroscopic and order a microscopic. An orange urine will
discolor the reagent strip, while an amber urine will not.
Grossly bloody urines - spin the urine and dip the supernatant.
If the supernatant is pink tinged or yellow, the occult blood should be resulted as 3+.
If the supernatant is still red, use the comment .beakuagrosslybloody- unable to result, for glucose,
ketones, albumin, nitrate, bilirubin, pH and leukocytes. The blood is resulted as 3+ and a refractometer
specific gravity is resulted.
Specimens requiring refractometer specific gravity must be sent to LaCrosse campus for the
refractometer specific gravity.
Verification of other results should occur. You can leave the SG blank. These will be resulted and
verified in LAX. Enter a note in the lab comments (yellow box) saying, "SG sent to LAX" This will at least
provide a method type for the test (CAP reg). You cannot put this on a packing list so you must send to
LAX and call to let folks know it's coming.
If you are unable to perform a microscopic please refer to La Crosse.

Clarity
Normal freshly voided urine is usually clear or transparent, but may also have a cloudy or turbid
appearance due to the formation of amorphous crystals. Abnormal turbidity may also occur with urinary
tract infections or upon refrigeration.

Reporting Choices:
Clear (No turbidity seen, no particles seen).
Slightly Cloudy (Light turbidity, few solid particles seen, hazy appearance)
Cloudy (Obviously turbid, unable to see through urine)
Turbid (Unable to see through urine, clumps or precipitate present, cannot see print through urine)

Glucose
Normal Range - Negative
Report results from all reading methods as Negative, Trace, 1+, 2+ or 3+.
Sensitivity: 75 - 125 mg/dl
Limitations:
**If screening for galactosemia is desired, a urine specimen should be submitted for a urine galactose. If
a request for urine reducing substances is made by a clinician, contact ordering provider to confirm that
urine galactose testing is appropriate.
***Old urine increases in alkalinity.

Ascorbic acid levels and moderately high ketone levels reduce the sensitivity of the glucose test. Glucose
test reactivity is decreased when the urine is colder than room temperature.

Bilirubin
Normal Range - Negative
Report results from all reading methods as negative, 1+, 2+ or 3+.

Page 9 of 17
 Standard Operating Procedure

Sensitivity: 0.4 - 0.8 mg/dl

Limitations:
Indoxyl sulfate can produce a yellow-orange to red color that may interfere with the interpretation of a
positive or negative bilirubin. Metabolites of Lodine (etodolac) may cause false positive or atypical
results. All positive results will include the following attached comment in LIS: "False positive bilirubin
reactions can occur due to Etodolac". Ascorbic acid concentrations of 25 mg/dl or greater may cause
false negatives.

Ketones
Normal Range - Negative
Report all results from all reading methods as negative, trace, 1+, 2+ or 3+ (Report any 4+ Ketone as a
3+, not to exceed our standard reporting criteria). Note: The RALS interface will automatically convert
the 4+ to 3+.
Sensitivity: 5 - 10 mg/dl aceto acetic acid
Limitations:
False positive results may occur with highly colored urine or urines containing drugs including levodopa
metabolites or mensa compounds.

Specific Gravity
Normal Range - 1.005 - 1.025
Reportable visual reading range 1.005 - 1.030
Reportable instrument reading range 1.005 - 1.030
Sensitivity 1.000 - 1.030
Limitations:
Visual method: If the pH reading is 6.5 or higher, the specific gravity must be corrected by adding .005 to
the reading.
Instrument methods: Strips read by an instrument automatically adjusted for the pH.
All results are not affected by glucose or the presence of radio opaque dyes.
Elevated specific gravity may be obtained in the presence of moderate amounts of protein (2+ or 3+).

Blood
Normal Range - Negative
Report results from all reading methods as negative, trace, 1+, 2+, or 3+.
Sensitivity: Hemoglobin concentrations of 0.015 - 0.062 mg/dl (approximately 5 - 20 intact cells per ml).
Limitations:
Elevated Specific gravity may reduce reactivity.
False positives may be caused by bleach contaminants, Catopril (an ace inhibitor), or microbial
peroxidase activity associated with urinary tract infections.
Grossly bloody urines - spin the urine and dip the supernatant. If the supernatant is pink tinged or
yellow, the occult blood should be resulted as 3+. If the supernatant is still red, use the comment
@2306, (Grossly bloody) to result glucose, ketones, albumin, nitrite, bilirubin, pH and leukocytes. The
blood is resulted as 3+ and a refractometer specific gravity is resulted. Specimens requiring
refractometer specific gravity must be sent to LaCrosse campus for the refractometer specific gravity.
Note: Any urine with 3+ occult blood with color OTHER THAN yellow, light yellow, and dark yellow will
not auto verify. The results will be held for manual intervention and verification.

Page 10 of 17
 Standard Operating Procedure

pH
Normal Range - 5.0 - 8.0
Reportable visual range 5.0 - 8.5
Reportable instrument Range 5.0 - 9.0
Sensitivity 5.0 - 9.0
Limitations: Urine pH of 8.5 - > 9.0 will be resulted in LIS with the following comment:"

Albumin assay may not be accurate due to high pH".

Visual reading only - If the visual pH reading is 6.5 or higher, correct the specific gravity result by adding
.005 to the result.

It is important to drag the edge of the strip against the rim of the container removing excess urine.
Excess urine may cause a "run over" effect in which the buffer from the protein test pad runs onto the
pH pad causing the pH pad to become two-toned. In this situation visually compare the darkest shade
with the color chart and report this pH reading.

Protein
Normal Range - Negative
Report results from all reading methods as: negative, trace, 1+, 2+, or 3+.
Sensitivity: 10 - 30 mg/dl albumin
Limitations:
Highly buffered or alkaline urines (pH 9.0) may cause a false positive protein result.
Urine pH of 8.5 - > 9.0 will be resulted in LIS with the following comment:" Albumin assay may not be
accurate due to high pH".
Contamination of the urine specimen with skin cleanser, antiseptics or detergents may cause a false
positive result.

Urobilinogen
Results are not recorded.

Nitrite
Normal Range - Negative
Results are reported from all methods as negative or positive.
Sensitivity: 0.1 mg/dl nitrite ion.
Limitations:
Sensitivity of the nitrite test is reduced for urine with a high specific gravity.
Ascorbic acid (>25 mg/dl) may cause a false negative result.
A negative result does not rule out the presence of bacteria in urine. Negative results may occur in the
presence of bacteria when the urine has not completed the 4 hour bladder incubation required for the
conversion of nitrates to nitrites or if the bacteria is a non-nitrate producing bacteria.

Leukocytes
Normal Range - Negative
Report results from all reading methods as negative, trace,1+, 2+, or 3+.
Sensitivity: 5 - 15 WBC/hpf
Limitations :

Page 11 of 17
 Standard Operating Procedure

Elevated glucose concentrations (>3+) or high specific gravity's can decrease test results.
Certain drugs (cephalexin, cephalothin, and oxalic acid) can decrease test results.
Tetracycline may decrease test reactivity and cause a false negative reaction.

Standardized Reporting for Urine Dipsticks

pH 5.0 - - >9.0

** urine pH >9.0, albumin may be inaccurate – add comment to report

** visually read urine pH >6.5, add 0.005 to specific gravity

Protein Neg, trace, 1+, 2+, 3+
Glucose Neg, trace, 1+, 2+, 3+
Ketones Neg, Tr, 1+, 2+, 3+
Bilirubin Neg, 1+, 2+, 3+
Urobilinogen Do not report
Occult blood Neg, Tr, 1+, 2+, 3+
Sp. Gr. <1.005 - - >1.030
Leukocyte Esterase Neg, Tr, 1+, 2+, 3+
Nitrites Neg or Pos
Color Yellow, green, orange, red, brown, amber (other)
Orange Urines Cancel dipstick and reflex microscopic
Clarity Clear, slightly cloudy, cloudy, turbid

REFLEX TESTING:
The lab will not be performing microscopic on specimens with normal dips, unless requested by a
provider. If the dip is abnormal, the lab will reflex a microscopic.

Providers will be able to order these three tests:

1. Dip only: Dip urine only, no microscopic.
2. Routine UA: Dip urine, if normal urine does not exceed criteria for color, clarity, leukocyte
esterase, nitrite, protein or blood (no microscopic). If abnormal, a microscopic will be ordered
by the laboratory as listed below.
Note: Children under the age of 6 years will automatically receive both the macroscopic and
microscopic urinalysis results.

If a dip is ordered lab will charge and perform only a dip. If a Routine urinalysis is ordered lab will charge
and perform only the dip if dip is normal, if dip is abnormal (according to protocol) lab will charge and
perform microscopic (routine urinalysis). If the provider orders a routine urinalysis with microscopic lab
will automatically perform both the dip and the microscopic and charge a routine urinalysis.

Accredited regional clinic and affiliate hospital laboratories will perform a microscopic on any routine
urinalysis that is positive for any of the following tests.

Reflex Criteria
Color Abnormal (red, amber, green, brown and orange)

Page 12 of 17
 Standard Operating Procedure

Clarity Turbid
Leukocytes Trace, 1+, 2+, 3+
Nitrite Positive
Protein 1+, 2+, 3+
Blood Trace, 1+, 2+, or 3+

MICROSCOPIC (Non-waived locations)

1. Pour 10 cc of fresh, well mixed urine into a urine centrifuge tube. Tubes have a 0.4 ml retention
volume after decanting. For unspun microscopic and QNS comment.
2. Centrifuge specimen for 5 minutes at 1,800 RPM - 2,000 RPM.
3. If no additional tests are to be done, decant supernatant by tipping tube. Do not shake.
Approximately 0.4 cc of sediment should remain in the tube.
4. Mix sediment well using pipette.
5. Hold pipette upright, placing one free falling drop on a clean slide. Apply one 22x22 cover slip.
Place only one patient per slide to avoid reporting incorrect results.
6. Examination of sediment
a. Examine sediment under low power screening around the edges of the cover slip
looking for casts and large elements.
b. Examine under high power to identify cells and smaller elements.
c. Report RBC's and WBC's as average number/hpf. Over 100 will be reported as >100
cells/hpf.
d. All other structures, cells and casts are reported under high power.
e. Each result should be reported following the uniform guidelines in this procedure.
7. Microscopic elements
a. Microscopic elements in an extremely cellular sediment can be identified by using a
large coverslip (22x40) to spread the sample thinner; multiply the results by 2 to
compensate for the larger coverslip. A 1:2 dilution can be made using saline and the
results multiplied by two.
b. Correlate microscopic findings of casts, bacteria, WBC's and RBC's with strip results of
positive protein (look for casts), nitrite (look for bacteria), leukocytes (look for WBC's)
and occult blood (look for red cells).
c. If occult blood is negative and RBC's are found microscopically, ascorbic acid
interference should be suspected. Be sure the formed elements are RBC's, not yeast or
unusual Ca oxalate crystals.
d. If the occult blood is positive but no RBC's are seen microscopically, check for low
specific gravity indicating a hypotonic solution which may lyse RBC's.
e. Leukocyte esterase - generally when the leukocyte esterase is positive, = or > 5 WBC/hpf
will be seen microscopically. Primary exception: If leukocyte esterase is positive an = or
>5 WBC/hpf are not detected microscopically; check for low specific gravity (1.000 -
1.010) indicating a hypotonic solution which may cause WBC's to lyse. Large numbers of
eosinophils or significant infestation with the vaginal parasite Trichomonas Vaginalis
may provide sufficient esterase to give a positive result.
f. Generally when the leukocyte esterase is negative, <5 WBC/hpf will be seen
microscopically. Primary exception: If the leukocyte esterase is negative and = or >5
WBC/hpf are detected microscopically, check for high specific gravity (1.025 - 1.030)

Page 13 of 17
 Standard Operating Procedure

indicating a hypertonic solution which may crenate the WBC's thereby preventing the
WBC granules from reacting with the test pad.
g. If fat globules are suspected, perform both the Sudan Fat Stain (see Lab-8160) and
examine with polarized microscope. Specimens requiring the Sudan Fat Stain must be
sent to La Crosse for testing.
h. Increased number of or abnormal casts must be accompanied by proteinuria, also the
degree of proteinuria can vary. In contrast, proteinuria may occur without cast
formation.
i. Hyaline Casts: Hyaline casts are the result of solidification of Tamm-Horsfall
mucoprotein which is secreted by the renal tubular cells and they may be present
without significant proteinuria. A few may be seen in the urine of a healthy person.
They may be seen in increased numbers after strenuous exercise and in some renal
diseases.
ii. Mixed Cellular Casts: A cellular cast may be composed of any of the cells found in
the urine sediment such as RBC, WBC, epithelial cells. Bacterial cell casts have also
been described.
iii. RBC Casts: RBC's may be found in a cast either as the result of leakage of RBC's
through the glomerular membrane or by bleeding into the tubules at any point
along the nephron. Other forms of RBC cast include hemoglobin cast, which are the
result of degeneration of RBC's with the cast matrix. The cells are no longer visible,
yet the remaining hemoglobin pigment imparts a characteristic orange-yellow or
red-brown color, which distinguishes them from waxy cast. Dipstick should have
positive blood and protein.
iv. WBC Casts: usually composed of neutrophils. Dipstick findings are positive protein,
leukocyte esterase and nitrite if nitrite reducing bacteria are present.
v. Epithelial Casts: Composed of renal epithelial cells. A serious pathologic finding,
associated with acute tubular necrosis, viral disease such as infection with
cytomegalovirus, and exposure to nephrotoxic substances such as mercury,
ethylene glycol and various drugs. They may be difficult to distinguish from WBC
cast, especially as they begin to degenerate into granular cast. Because of this,
report with caution.
vi. Granular Casts: Are the result of degeneration of cells in cellular casts. Their
significance lies with the cast from which they were formed. Granular cast may also
be seen following periods of stress and strenuous exercise. No distinction will be
made between coarse and fine granular.
vii. Waxy Cast: Represent the final stage in the degeneration of cells within a cast - -
from cellular to granular to waxy. Associated with severe chronic renal disease and
renal amyloidosis, waxy casts are only rarely seen in acute renal disease. Waxy casts
are homogeneous, like hyaline casts, but they are more refractile, with sharper
outlines and they tend to have broken or blunt ends and fissure or cracks along the
sides. It is important that waxy cast not be confused with fibers from disposable
diapers or other contaminants. The presence of protein on the reagent strip and
lack of polarization of the waxy cast with polarized light help with this distinction.
viii. Fatty Casts: Contain globules of fat, either as triglyceride or normal fat, which can be
stained with Sudan Stain, or as cholesterol which will polarize as a Maltese cross.

Page 14 of 17
 Standard Operating Procedure

Standardized Criteria for Reporting Urine Micros

WBC & RBC Average # of cells. No ranges will be used.
Highest reportable value >100/hpf
WBC CLUMPS OCC 0 – 2/HPF
FEW 2 – 5 /HPF
MOD 5 – 10/HPF
MANY >10/HPF
EPITHELIAL CELLS NONE SEEN
NOTE: Quantitate renal epis the same as squamous OCC 0 – 2/HPF
epis and report as non-squamous epithelial cells. Do FEW 2 – 5/HPF
not report as renal cells. MOD 5 – 10/HPF
Do not report clue cells in urines MANY >10/HPF
PRESENT: use with comment re: field obscured
by WBC’s
BACTERIA NEG <10/hpf
BORDERLINE (+/-) 10 – 100/hpf
POSITIVE (+) >100/HPF
MUCOUS THREADS DO NOT REPORT
CASTS 1 – 10/hpf
Reported by type per HPF. < 1/hpf >10/hpf
NOTE: Please note if broad forms of casts are present
as these are clinically significant. Broad forms are 2-3
x Normal size.
CRYSTALS OCC 0 – 2/hpf
Leucine, cysteine and tyrosine will be reported as rare, FEW 2 – 5 /hpf
occ, few, moderate or many. All other crystals will be MOD 5 – 10 / hpf
reported as few, moderate or many. *Unidentified MANY >10 hpf
crystals must be sent to the La Crosse lab for
identification.
SPERM PRESENT OR NOT PRESENT
Report in all specimens.
OVAL FAT BODIES & FAT DROPLETS PRESENT
YEAST PRESENT
CLUE CELLS ** Do not report clue cells in urines.
VOLUME The volume of urine will be reported on all
urines that reflex a microscopic an are less than
10cc.

Microscopic Normal Range:

WBC (0-5 / HPF)
RBC (0-2 / HPF)
Bacteria (<10 / HPF)

Urine specimen comments available for use:

Dysmorphic RBC No specimen collected

Page 15 of 17
 Standard Operating Procedure

Fecal contamination Catheterized sample

Menses
Grossly Bloody
Field Obscured by WBC or RBC
pH >9.0: Albumin may not be
accurate due to high pH
QNS unspun micro
ORANGE URINES: (perform micro) and report
comment: Unable to report due to interfering
substances

Recording Results
Patient test results are transferred into the patient's electronic/permanent medical record via LIS
interface or manual LIS entry. Report format options include dictation or manual documentation of the
urine dip result into the OB flow sheet. Critical Call values are not required for these test parameters, in
accordance with Lab-0130 Critical Call Values, Lab Reporting Protocol.

Proficiency Testing
All proficiency testing samples are run as patient samples. To properly identify these samples, use the
Status keypad and enter the bottle number being tested. Example: testing bottle XU 11. Touch the ABC
pad and enter XU, touch the space pad, touch the ABC pad again and enter 11.

Special Notes
See manufacturer’s product insert for a complete explanation of all test limitations.

Multistix 10 SG test results are transferred electronically as a test profile. If a result within the defined
profile is missing, the complete profile will fail to transfer to the electronic chart.

If the ID test pad on the Multistix 10 SG becomes wet during the dipping process, the potential is for the
Clinitek Status to read the test pads as if a Multistix Pro exists. In this case, the strip is identified a
multistix PRO and the specific gravity and pH are missing on the printout. If this happens, test results
must be discarded and the urine dip must be repeated.

Any Multistix 10 SG test demonstrating an error code message on the Clinitek Status is permanently
blocked from data transfer into the electronic chart.

REVIEW AND CHANGES:

This document and all attached forms should be reviewed optimally on an annual basis, with 2 years as
the maximum review date. Review will be done by the Technical Leader, Supervisor, Manager, Medical
Director or designated person. Changes require retyping document or form and review by the Medical
Director.

REFERENCES:
1. Multistix 10 SG Reagent Strips package insert, revised 02/92, Bayer Corporation, Elkhart, IN
46515
2. Operating Manual Clinitek Status revised 05/08 Bayer Corporation Elkhart, IN 46515
3. Clinical Laboratory Technical Procedure Manuals, NCCLS, wnd Ed, Approved Guidelines, July
1992, Vol. 12, No. 10
4. Urinalysis and collection, Transportation, and Preservation of Urine Specimens; Approved
Guidelines, NCCLS, GP16A, Vol. 15, No. 15

Page 16 of 17
 Standard Operating Procedure

5. Urinalysis and Body Fluids, Ringsrud and Linne

6. Fundamentals of Urine and Body Fluid Analysis, Brunzel, Nancy, WB Saunders & Co, 1994.

Page 17 of 17